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Substantial very late MACE risk after PCI for SIHD
Patients with stable ischemic heart disease remain at substantial risk for major adverse cardiovascular events 1-5 years after percutaneous coronary intervention, even with contemporary second-generation drug-eluting stents, according to a pooled analysis of long-term follow-up data on 10,987 patients in 19 prospective, randomized, head-to-head metallic stent trials.
The analysis showed that, although most major adverse cardiovascular events (MACE) occurred during the first year after stenting, no plateau in MACE was reached between years 1 and 5, Mahesh V. Madhavan, MD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.
“Further studies are required to understand the mechanisms of late events and whether improvements in stent technology, revascularization technique, and adjunctive therapies may improve outcomes in patients with SIHD [stable ischemic heart disease],” said Dr. Madhavan, a cardiology fellow at Columbia University Irving Medical Center and New York–Presbyterian Hospital.
This post hoc analysis of pooled individual patient-level data from 19 randomized trials included 10,987 metallic stent recipients with SIHD. Sixty-one percent got second-generation drug-eluting stents (DES), 25% received first-generation DES, and 15% got bare metal stents (BMS). The largest prospective head-to-head RCT was SPIRIT IV, with 2,130 patients. All five TAXUS trials were also included.
The 5-year rate of the primary composite MACE endpoint composed of cardiac death, MI, or ischemia-driven target lesion revascularization was 24.1% in patients with BMS stents, 17.9% with first-gen DES, and 13.4% with second-gen DES, reflecting the advances in stent technology over time. Most of these MACE events occurred during the first year after PCI, with rates of 18%, 8.6%, and 5.3%, respectively, in the three groups. However, the MACE rate beyond the first year out through year 5 remained substantial: 10.2% with first-gen DES, 8.5% with second-gen DES, and 7.4% in the BMS group.
The cardiac death rate from PCI through year 5 was 3.8% with second-gen DES, 3.6% with first-gen DES, and 3.3% with BMS. The MI rate was 7.7% with first-gen DES, 6.1% with BMS, and 5% with second-gen DES.
Stent thrombosis occurred during the first year in 0.9% of first-gen DES and BMS recipients and in 0.7% of patients with second-gen DES. During years 1-5, the rates were 1.6% with first-gen DES, 0.9% with second-gen devices, and 0.2% with BMS.
Second-gen DES provided a big advantage in terms of lessened need for ischemia-driven target lesion revascularization through the first 5 years, with a rate of 7.3%, compared to 18.7% in patients with first-gen DES and 10.5% with BMS.
In a multivariate regression analysis, independent predictors of MACE in the first 5 years post PCI included indicators of greater lesion and/or procedural complexity, such as left main or left anterior descending disease, greater lesion length, and more than one treated lesion, as well as standard cardiovascular risk factors, including recent smoking, hypertension, and diabetes.
In contrast, hyperlipidemia was associated with a significant 15% reduction in MACE risk, which in an interview Dr. Madhavan said may have been due to aggressive lipid-lowering therapy, although he added that this is conjecture because he and his coinvestigators didn’t have access to data on the use of guideline-directed medical therapy or antiplatelet regimens.
Asked about future prospects for reducing the substantial very late risk of MACE highlighted in his study, Dr. Madhavan cited the use of adjunctive imaging during PCI as promising.
“The currently enrolling ILUMEN IV trial, among other studies, will help determine whether imaging-guided intervention can help improve intermediate and long-term rates of MACE,” he observed.
Promising medical therapies that could potentially confer benefit in terms of reducing long-term MACE in patients who’ve undergone PCI for SIHD include novel lipid-lowering drugs, tailored antithrombotic strategies, new anti-inflammatory agents, and the SGLT2 inhibitors, Dr. Madhavan continued.
In terms of advances in stent design, he cited recent evidence that ultrathin-strut stents featuring bioresorbable polymer, such as the Orsiro stent, may reduce late stent-related MACE through 3 years.
“We’ll have to see if these benefits extend to longer-term follow-up up to 5 years,” he said.
He deemed his study results “fairly consistent” with those of the ISCHEMIA trial, where ischemic events in the patients with SIHD assigned to an initial invasive strategy continued to occur in the latter years of follow-up without any clear plateau effect (N Engl J Med. 2020 Apr 9;382[15]:1395-407).
Dr. Madhavan reported no financial conflicts regarding his study, funded by an institutional research grant from the National Heart, Lung, and Blood Institute.
Shortly following Dr. Madhavan’s presentation at ACC 2020, the study results were published online (Circ Cardiovasc Interv. 2020 Apr;13[4[:e008565. doi: 10.1161/CIRCINTERVENTIONS.119.008565).
SOURCE: Madhavan MV. ACC 2020, Abstract 909-10.
Patients with stable ischemic heart disease remain at substantial risk for major adverse cardiovascular events 1-5 years after percutaneous coronary intervention, even with contemporary second-generation drug-eluting stents, according to a pooled analysis of long-term follow-up data on 10,987 patients in 19 prospective, randomized, head-to-head metallic stent trials.
The analysis showed that, although most major adverse cardiovascular events (MACE) occurred during the first year after stenting, no plateau in MACE was reached between years 1 and 5, Mahesh V. Madhavan, MD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.
“Further studies are required to understand the mechanisms of late events and whether improvements in stent technology, revascularization technique, and adjunctive therapies may improve outcomes in patients with SIHD [stable ischemic heart disease],” said Dr. Madhavan, a cardiology fellow at Columbia University Irving Medical Center and New York–Presbyterian Hospital.
This post hoc analysis of pooled individual patient-level data from 19 randomized trials included 10,987 metallic stent recipients with SIHD. Sixty-one percent got second-generation drug-eluting stents (DES), 25% received first-generation DES, and 15% got bare metal stents (BMS). The largest prospective head-to-head RCT was SPIRIT IV, with 2,130 patients. All five TAXUS trials were also included.
The 5-year rate of the primary composite MACE endpoint composed of cardiac death, MI, or ischemia-driven target lesion revascularization was 24.1% in patients with BMS stents, 17.9% with first-gen DES, and 13.4% with second-gen DES, reflecting the advances in stent technology over time. Most of these MACE events occurred during the first year after PCI, with rates of 18%, 8.6%, and 5.3%, respectively, in the three groups. However, the MACE rate beyond the first year out through year 5 remained substantial: 10.2% with first-gen DES, 8.5% with second-gen DES, and 7.4% in the BMS group.
The cardiac death rate from PCI through year 5 was 3.8% with second-gen DES, 3.6% with first-gen DES, and 3.3% with BMS. The MI rate was 7.7% with first-gen DES, 6.1% with BMS, and 5% with second-gen DES.
Stent thrombosis occurred during the first year in 0.9% of first-gen DES and BMS recipients and in 0.7% of patients with second-gen DES. During years 1-5, the rates were 1.6% with first-gen DES, 0.9% with second-gen devices, and 0.2% with BMS.
Second-gen DES provided a big advantage in terms of lessened need for ischemia-driven target lesion revascularization through the first 5 years, with a rate of 7.3%, compared to 18.7% in patients with first-gen DES and 10.5% with BMS.
In a multivariate regression analysis, independent predictors of MACE in the first 5 years post PCI included indicators of greater lesion and/or procedural complexity, such as left main or left anterior descending disease, greater lesion length, and more than one treated lesion, as well as standard cardiovascular risk factors, including recent smoking, hypertension, and diabetes.
In contrast, hyperlipidemia was associated with a significant 15% reduction in MACE risk, which in an interview Dr. Madhavan said may have been due to aggressive lipid-lowering therapy, although he added that this is conjecture because he and his coinvestigators didn’t have access to data on the use of guideline-directed medical therapy or antiplatelet regimens.
Asked about future prospects for reducing the substantial very late risk of MACE highlighted in his study, Dr. Madhavan cited the use of adjunctive imaging during PCI as promising.
“The currently enrolling ILUMEN IV trial, among other studies, will help determine whether imaging-guided intervention can help improve intermediate and long-term rates of MACE,” he observed.
Promising medical therapies that could potentially confer benefit in terms of reducing long-term MACE in patients who’ve undergone PCI for SIHD include novel lipid-lowering drugs, tailored antithrombotic strategies, new anti-inflammatory agents, and the SGLT2 inhibitors, Dr. Madhavan continued.
In terms of advances in stent design, he cited recent evidence that ultrathin-strut stents featuring bioresorbable polymer, such as the Orsiro stent, may reduce late stent-related MACE through 3 years.
“We’ll have to see if these benefits extend to longer-term follow-up up to 5 years,” he said.
He deemed his study results “fairly consistent” with those of the ISCHEMIA trial, where ischemic events in the patients with SIHD assigned to an initial invasive strategy continued to occur in the latter years of follow-up without any clear plateau effect (N Engl J Med. 2020 Apr 9;382[15]:1395-407).
Dr. Madhavan reported no financial conflicts regarding his study, funded by an institutional research grant from the National Heart, Lung, and Blood Institute.
Shortly following Dr. Madhavan’s presentation at ACC 2020, the study results were published online (Circ Cardiovasc Interv. 2020 Apr;13[4[:e008565. doi: 10.1161/CIRCINTERVENTIONS.119.008565).
SOURCE: Madhavan MV. ACC 2020, Abstract 909-10.
Patients with stable ischemic heart disease remain at substantial risk for major adverse cardiovascular events 1-5 years after percutaneous coronary intervention, even with contemporary second-generation drug-eluting stents, according to a pooled analysis of long-term follow-up data on 10,987 patients in 19 prospective, randomized, head-to-head metallic stent trials.
The analysis showed that, although most major adverse cardiovascular events (MACE) occurred during the first year after stenting, no plateau in MACE was reached between years 1 and 5, Mahesh V. Madhavan, MD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. The meeting was conducted online after its cancellation because of the COVID-19 pandemic.
“Further studies are required to understand the mechanisms of late events and whether improvements in stent technology, revascularization technique, and adjunctive therapies may improve outcomes in patients with SIHD [stable ischemic heart disease],” said Dr. Madhavan, a cardiology fellow at Columbia University Irving Medical Center and New York–Presbyterian Hospital.
This post hoc analysis of pooled individual patient-level data from 19 randomized trials included 10,987 metallic stent recipients with SIHD. Sixty-one percent got second-generation drug-eluting stents (DES), 25% received first-generation DES, and 15% got bare metal stents (BMS). The largest prospective head-to-head RCT was SPIRIT IV, with 2,130 patients. All five TAXUS trials were also included.
The 5-year rate of the primary composite MACE endpoint composed of cardiac death, MI, or ischemia-driven target lesion revascularization was 24.1% in patients with BMS stents, 17.9% with first-gen DES, and 13.4% with second-gen DES, reflecting the advances in stent technology over time. Most of these MACE events occurred during the first year after PCI, with rates of 18%, 8.6%, and 5.3%, respectively, in the three groups. However, the MACE rate beyond the first year out through year 5 remained substantial: 10.2% with first-gen DES, 8.5% with second-gen DES, and 7.4% in the BMS group.
The cardiac death rate from PCI through year 5 was 3.8% with second-gen DES, 3.6% with first-gen DES, and 3.3% with BMS. The MI rate was 7.7% with first-gen DES, 6.1% with BMS, and 5% with second-gen DES.
Stent thrombosis occurred during the first year in 0.9% of first-gen DES and BMS recipients and in 0.7% of patients with second-gen DES. During years 1-5, the rates were 1.6% with first-gen DES, 0.9% with second-gen devices, and 0.2% with BMS.
Second-gen DES provided a big advantage in terms of lessened need for ischemia-driven target lesion revascularization through the first 5 years, with a rate of 7.3%, compared to 18.7% in patients with first-gen DES and 10.5% with BMS.
In a multivariate regression analysis, independent predictors of MACE in the first 5 years post PCI included indicators of greater lesion and/or procedural complexity, such as left main or left anterior descending disease, greater lesion length, and more than one treated lesion, as well as standard cardiovascular risk factors, including recent smoking, hypertension, and diabetes.
In contrast, hyperlipidemia was associated with a significant 15% reduction in MACE risk, which in an interview Dr. Madhavan said may have been due to aggressive lipid-lowering therapy, although he added that this is conjecture because he and his coinvestigators didn’t have access to data on the use of guideline-directed medical therapy or antiplatelet regimens.
Asked about future prospects for reducing the substantial very late risk of MACE highlighted in his study, Dr. Madhavan cited the use of adjunctive imaging during PCI as promising.
“The currently enrolling ILUMEN IV trial, among other studies, will help determine whether imaging-guided intervention can help improve intermediate and long-term rates of MACE,” he observed.
Promising medical therapies that could potentially confer benefit in terms of reducing long-term MACE in patients who’ve undergone PCI for SIHD include novel lipid-lowering drugs, tailored antithrombotic strategies, new anti-inflammatory agents, and the SGLT2 inhibitors, Dr. Madhavan continued.
In terms of advances in stent design, he cited recent evidence that ultrathin-strut stents featuring bioresorbable polymer, such as the Orsiro stent, may reduce late stent-related MACE through 3 years.
“We’ll have to see if these benefits extend to longer-term follow-up up to 5 years,” he said.
He deemed his study results “fairly consistent” with those of the ISCHEMIA trial, where ischemic events in the patients with SIHD assigned to an initial invasive strategy continued to occur in the latter years of follow-up without any clear plateau effect (N Engl J Med. 2020 Apr 9;382[15]:1395-407).
Dr. Madhavan reported no financial conflicts regarding his study, funded by an institutional research grant from the National Heart, Lung, and Blood Institute.
Shortly following Dr. Madhavan’s presentation at ACC 2020, the study results were published online (Circ Cardiovasc Interv. 2020 Apr;13[4[:e008565. doi: 10.1161/CIRCINTERVENTIONS.119.008565).
SOURCE: Madhavan MV. ACC 2020, Abstract 909-10.
FROM ACC 20
COVID-19: An opportunity, challenge for addiction treatment, NIDA boss says
The COVID-19 pandemic is posing significant challenges while also providing unique opportunities for patients with substance use disorders (SUD), a leading expert says.
Nora Volkow, MD, director of the National Institute on Drug Abuse, said that the pandemic has accelerated the use of telemedicine, making it easier for patients with SUD to access treatment. It has also led to the proliferation of more mental health hotlines, which is critical since the vast majority of these patients have comorbid mental illness.
In addition, COVID-19 has resulted in increased availability of “alternative” peer support mechanisms via cellphones or computers to aid individuals’ sobriety.
Dr. Volkow spoke at the virtual American Psychiatric Association Spring Highlights Meeting 2020, which is replacing the organization’s canceled annual meeting.
While methadone clinics have had to close during the pandemic, making it challenging for those on medically assisted treatment to receive methadone or buprenorphine, some of the rules and regulations have been relaxed in order to make these medications accessible without the need for in-person attendance at a clinic. In addition, the Substance Abuse and Mental Health Services Administration has relaxed some of its own regulations regarding telehealth and opioid treatment programs.
Social isolation, stigma intensified
A pandemic increases anxiety in the general population, but for patients with SUD who may be also be struggling with homelessness and comorbid mental illness, the situation can further exacerbate social stigma and isolation – leading to relapse, more overdoses, and overdose deaths, Dr. Volkow said. Social interaction is “extraordinarily important” for patients and “one of the most powerful tools we have” to build resilience.
Right now, said Dr. Volkow, “we are in the dark as to how COVID infections have affected the number of overdose deaths.”
However, she noted that
“So even through this devastation, we can actually extract something that may help others in future,” she said.
Dr. Volkow noted that during the pandemic it is critical to reinforce the importance of engaging in – and remaining in – treatment to SUD patients. It’s also crucial to make patients aware of social support systems and behavioral interventions to help them cope with stress and to mitigate relapse risk.
COVID-19 and relapse
Elie G. Aoun, MD, assistant professor of psychiatry at New York University and vice chair of the APA’s Council on Addiction Psychiatry, said in an interview that Dr. Volkow’s presentation provided “exactly the kind of accessible information” clinicians need.
Dr. Aoun said he sees the impact of the COVID-19 crisis in his practice every day. Patients with SUD “are getting the short end of the stick.”
Social distancing measures prompted by the pandemic can be “very triggering” for SUD patients, he said. One of his patients told him the current isolation, loneliness, movement restrictions, and boredom remind her of the way she felt when she used drugs.
Dr. Aoun said four of his patients have relapsed since the pandemic began. Two of them had just started treatment after years of using drugs, so this was a “major setback” for them.
He and his colleagues were “not really prepared” to provide care via video link, which he believes is not as effective as in-person sessions.
In addition to disrupting patient care, said Dr. Aoun, the pandemic is forcing the medical community to face social determinants of health, such as poverty and homelessness, as they relate to addiction disorders and whether or not someone receives care.
This article originally appeared on Medscape.com.
The COVID-19 pandemic is posing significant challenges while also providing unique opportunities for patients with substance use disorders (SUD), a leading expert says.
Nora Volkow, MD, director of the National Institute on Drug Abuse, said that the pandemic has accelerated the use of telemedicine, making it easier for patients with SUD to access treatment. It has also led to the proliferation of more mental health hotlines, which is critical since the vast majority of these patients have comorbid mental illness.
In addition, COVID-19 has resulted in increased availability of “alternative” peer support mechanisms via cellphones or computers to aid individuals’ sobriety.
Dr. Volkow spoke at the virtual American Psychiatric Association Spring Highlights Meeting 2020, which is replacing the organization’s canceled annual meeting.
While methadone clinics have had to close during the pandemic, making it challenging for those on medically assisted treatment to receive methadone or buprenorphine, some of the rules and regulations have been relaxed in order to make these medications accessible without the need for in-person attendance at a clinic. In addition, the Substance Abuse and Mental Health Services Administration has relaxed some of its own regulations regarding telehealth and opioid treatment programs.
Social isolation, stigma intensified
A pandemic increases anxiety in the general population, but for patients with SUD who may be also be struggling with homelessness and comorbid mental illness, the situation can further exacerbate social stigma and isolation – leading to relapse, more overdoses, and overdose deaths, Dr. Volkow said. Social interaction is “extraordinarily important” for patients and “one of the most powerful tools we have” to build resilience.
Right now, said Dr. Volkow, “we are in the dark as to how COVID infections have affected the number of overdose deaths.”
However, she noted that
“So even through this devastation, we can actually extract something that may help others in future,” she said.
Dr. Volkow noted that during the pandemic it is critical to reinforce the importance of engaging in – and remaining in – treatment to SUD patients. It’s also crucial to make patients aware of social support systems and behavioral interventions to help them cope with stress and to mitigate relapse risk.
COVID-19 and relapse
Elie G. Aoun, MD, assistant professor of psychiatry at New York University and vice chair of the APA’s Council on Addiction Psychiatry, said in an interview that Dr. Volkow’s presentation provided “exactly the kind of accessible information” clinicians need.
Dr. Aoun said he sees the impact of the COVID-19 crisis in his practice every day. Patients with SUD “are getting the short end of the stick.”
Social distancing measures prompted by the pandemic can be “very triggering” for SUD patients, he said. One of his patients told him the current isolation, loneliness, movement restrictions, and boredom remind her of the way she felt when she used drugs.
Dr. Aoun said four of his patients have relapsed since the pandemic began. Two of them had just started treatment after years of using drugs, so this was a “major setback” for them.
He and his colleagues were “not really prepared” to provide care via video link, which he believes is not as effective as in-person sessions.
In addition to disrupting patient care, said Dr. Aoun, the pandemic is forcing the medical community to face social determinants of health, such as poverty and homelessness, as they relate to addiction disorders and whether or not someone receives care.
This article originally appeared on Medscape.com.
The COVID-19 pandemic is posing significant challenges while also providing unique opportunities for patients with substance use disorders (SUD), a leading expert says.
Nora Volkow, MD, director of the National Institute on Drug Abuse, said that the pandemic has accelerated the use of telemedicine, making it easier for patients with SUD to access treatment. It has also led to the proliferation of more mental health hotlines, which is critical since the vast majority of these patients have comorbid mental illness.
In addition, COVID-19 has resulted in increased availability of “alternative” peer support mechanisms via cellphones or computers to aid individuals’ sobriety.
Dr. Volkow spoke at the virtual American Psychiatric Association Spring Highlights Meeting 2020, which is replacing the organization’s canceled annual meeting.
While methadone clinics have had to close during the pandemic, making it challenging for those on medically assisted treatment to receive methadone or buprenorphine, some of the rules and regulations have been relaxed in order to make these medications accessible without the need for in-person attendance at a clinic. In addition, the Substance Abuse and Mental Health Services Administration has relaxed some of its own regulations regarding telehealth and opioid treatment programs.
Social isolation, stigma intensified
A pandemic increases anxiety in the general population, but for patients with SUD who may be also be struggling with homelessness and comorbid mental illness, the situation can further exacerbate social stigma and isolation – leading to relapse, more overdoses, and overdose deaths, Dr. Volkow said. Social interaction is “extraordinarily important” for patients and “one of the most powerful tools we have” to build resilience.
Right now, said Dr. Volkow, “we are in the dark as to how COVID infections have affected the number of overdose deaths.”
However, she noted that
“So even through this devastation, we can actually extract something that may help others in future,” she said.
Dr. Volkow noted that during the pandemic it is critical to reinforce the importance of engaging in – and remaining in – treatment to SUD patients. It’s also crucial to make patients aware of social support systems and behavioral interventions to help them cope with stress and to mitigate relapse risk.
COVID-19 and relapse
Elie G. Aoun, MD, assistant professor of psychiatry at New York University and vice chair of the APA’s Council on Addiction Psychiatry, said in an interview that Dr. Volkow’s presentation provided “exactly the kind of accessible information” clinicians need.
Dr. Aoun said he sees the impact of the COVID-19 crisis in his practice every day. Patients with SUD “are getting the short end of the stick.”
Social distancing measures prompted by the pandemic can be “very triggering” for SUD patients, he said. One of his patients told him the current isolation, loneliness, movement restrictions, and boredom remind her of the way she felt when she used drugs.
Dr. Aoun said four of his patients have relapsed since the pandemic began. Two of them had just started treatment after years of using drugs, so this was a “major setback” for them.
He and his colleagues were “not really prepared” to provide care via video link, which he believes is not as effective as in-person sessions.
In addition to disrupting patient care, said Dr. Aoun, the pandemic is forcing the medical community to face social determinants of health, such as poverty and homelessness, as they relate to addiction disorders and whether or not someone receives care.
This article originally appeared on Medscape.com.
Trials and tribulations: Neurology research during COVID-19
However, researchers remain determined to forge ahead – with many redesigning their studies, at least in part to optimize the safety of their participants and research staff.
Keeping people engaged while protocols are on hold; expanding normal safety considerations; and re-enlisting statisticians to keep their findings as significant as possible are just some of study survival strategies underway.
Alzheimer’s disease research on hold
The pandemic is having a significant impact on Alzheimer’s disease research, and medical research in general, says Heather Snyder, PhD, vice president, Medical & Scientific Relations at the Alzheimer’s Association.
“Many clinical trials worldwide are pausing, changing, or halting the testing of the drug or the intervention,” she told Medscape Medical News. “How the teams have adapted depends on the study,” she added. “As you can imagine, things are changing on a daily basis.”
The US Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) trial, for example, is on hold until at least May 31. The Alzheimer’s Association is helping to implement and fund the study along with Wake Forest University Medical Center.
“We’re not randomizing participants at this point in time and the intervention — which is based on a team meeting, and there is a social aspect to that — has been paused,” Dr. Snyder said.
Another pivotal study underway is the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study (the A4 Study). Investigators are evaluating if an anti-amyloid antibody, solanezumab (Eli Lilly), can slow memory loss among people with amyloid on imaging but no symptoms of cognitive decline at baseline.
“The A4 Study is definitely continuing. However, in an effort to minimize risk to participants, site staff and study integrity, we have implemented an optional study hiatus for both the double-blind and open-label extension phases,” lead investigator Reisa Anne Sperling, MD, told Medscape Medical News.
“We wanted to prioritize the safety of our participants as well as the ability of participants to remain in the study … despite disruptions from the COVID-19 pandemic,” said Dr. Sperling, who is professor of neurology at Harvard Medical School and director of the Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital and Massachusetts General Hospital in Boston.
The ultimate goal is for A4 participants to receive the full number of planned infusions and assessments, even if it takes longer, she added.
Many Alzheimer’s disease researchers outside the United States face similar challenges. “As you probably are well aware, Spain is now in a complete lockdown. This has affected research centers like ours, the Barcelona Brain Research Center, and the way we work,” José Luís Molinuevo Guix, MD, PhD, told Medscape Medical News.
All participants in observational studies like the ALFA+ study and initiatives, as well as those in trials including PENSA and AB1601, “are not allowed, by law, to come in, hence from a safety perspective we are on good grounds,” added Dr. Molinuevo Guix, who directs the Alzheimer’s disease and other cognitive disorders unit at the Hospital Clinic de Barcelona.
The investigators are creating protocols for communicating with participants during the pandemic and for restarting visits safely after the lockdown has ended.
Stroke studies amended or suspended
A similar situation is occurring in stroke trials. Stroke is “obviously an acute disease, as well as a disease that requires secondary prevention,” Mitchell Elkind, MD, president-elect of the American Heart Association, told Medscape Medical News.
“One could argue that patients with stroke are going to be in the hospital anyway – why not enroll them in a study? They’re not incurring any additional risk,” he said. “But the staff have to come in to see them, and we’re really trying to avoid exposure.”
One ongoing trial, the Atrial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke (ARCADIA), stopped randomly assigning new participants to secondary prevention with apixaban or aspirin because of COVID-19. However, Dr. Elkind and colleagues plan to provide medication to the 440 people already in the trial.
“Wherever possible, the study coordinators are shipping the drug to people and doing follow-up visits by phone or video,” said Dr. Elkind, chief of the Division of Neurology Clinical Outcomes Research and Population Sciences at Columbia University in New York City.
Protecting patients, staff, and ultimately society is a “major driving force in stopping the randomizations,” he stressed.
ARCADIA is part of the StrokeNet prevention trials network, run by the NIH’s National Institute of Neurologic Disorders and Stroke (NINDS). Additional pivotal trials include the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) and the Multi-arm Optimization of Stroke Thrombolysis (MOST) studies, he said.
Joseph Broderick, MD, director of the national NIH StrokeNet, agreed that safety comes first. “It was the decision of the StrokeNet leadership and the principal investigators of the trials that we needed to hold recruitment of new patients while we worked on adapting processes of enrollment to ensure the safety of both patients and researchers interacting with study patients,” he told Medscape Medical News.
Potential risks vary based on the study intervention and the need for in-person interactions. Trials that include stimulation devices or physical therapy, for example, might be most affected, added Dr. Broderick, professor and director of the UC Gardner Neuroscience Institute at the University of Cincinnati in Ohio.
Nevertheless, “there are potential ways … to move as much as possible toward telemedicine and digital interactions during this time.”
Multiple challenges in multiple sclerosis
At the national level, the COVID-19 pandemic has had an “unprecedented impact on almost all the clinical trials funded by NINDS,” said Clinton Wright, MD, director of the Division of Clinical Research at NINDS. “Investigators have had to adapt quickly.”
Supplementing existing grants with money to conduct research on COVID-19 and pursuing research opportunities from different institutes are “some of the creative approaches [that] have come from the NIH [National Institutes of Health] itself,” Dr. Wright said. “Other creative approaches have come from investigators trying to keep their studies and trials going during the pandemic.”
In clinical trials, “everything from electronic consent to in-home research drug delivery is being brought to bear.”
“A few ongoing trials have been able to modify their protocols to obtain consent and carry out evaluations remotely by telephone or videoconferencing,” Dr. Wright said. “This is especially critical for trials that involve medical management of specific risk factors or conditions, where suspension of the trial could itself have adverse consequences due to reduced engagement with research participants.”
For participants already in MS studies, “each upcoming visit is assessed for whether it’s critical or could be done virtually or just skipped. If a person needs a treatment that cannot be postponed or skipped, they come in,” Jeffrey Cohen, MD, director of the Experimental Therapeutics Program at the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, Ohio, told Medscape Medical News.
New study enrollment is largely on hold and study visits for existing participants are limited, said Dr. Cohen, who is also president of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).
Some of the major ongoing trials in MS are “looking at very fundamental questions in the field,” Dr. Cohen said. The Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (DELIVER-MS) and Traditional Versus Early Aggressive Therapy for Multiple Sclerosis (TREAT-MS) trials, for example, evaluate whether treatment should be initiated with one of the less efficacious agents with escalation as needed, or whether treatment should begin with a high-efficacy agent.
Both trials are currently on hold because of the pandemic, as is the Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS) study.
“There has been a lot of interest in hematopoietic stem cell transplants and where they fit into our overall treatment strategy, and this is intended to provide a more definitive answer,” Dr. Cohen said.
Making the most of down time
“The pandemic has been challenging” in terms of ongoing MS research, said Benjamin M. Segal, MD, chair of the Department of Neurology and director of the Neuroscience Research Institute at the Ohio State University Wexner Medical Center, Columbus.
“With regard to the lab, our animal model experiments have been placed on hold. We have stopped collecting samples from clinical subjects for biomarker studies.
“However, my research team has been taking advantage of the time that has been freed up from bench work by analyzing data sets that had been placed aside, delving more deeply into the literature, and writing new grant proposals and articles,” he added.
Two of Dr. Segal’s trainees are writing review articles on the immunopathogenesis of MS and its treatment. Another postdoctoral candidate is writing a grant proposal to investigate how coinfection with a coronavirus modulates CNS pathology and the clinical course of an animal model of MS.
“I am asking my trainees to plan out experiments further in advance than they ever have before, so they are as prepared as possible to resume their research agendas once we are up and running again,” Dr. Segal said.
Confronting current challenges while planning for a future less disrupted by the pandemic is a common theme that emerges.
“The duration of this [pandemic] will dictate how we analyze the data at the end [for the US POINTER study]. There is a large group of statisticians working on this,” Dr. Snyder said.
Dr. Sperling of Harvard Medical School also remains undeterred. “This is definitely a challenging time, as we must not allow the COVID-19 to interfere with our essential mission to find a successful treatment to prevent cognitive decline in AD. We do need, however, to be as flexible as possible to protect our participants and minimize the impact to our overall study integrity,” she said.
NIH guidance
Dr. Molinuevo Guix, of the Barcelona Brain Research Center, is also determined to continue his Alzheimer’s disease research. “I am aware that after the crisis, there will be less [risk] but still a COVID-19 infection risk, so apart from trying to generate part of our visits virtually, we want to make sure we have all necessary safety measures in place. We remain very active to preserve the work we have done to keep up the fight against Alzheimer’s and dementia,” he said.
Such forward thinking also applies to major stroke trials, said Dr. Broderick of the University of Cincinnati. “As soon as we shut down enrollment in stroke trials, we immediately began to make plans about how and when we can restart our stroke trials,” he explained. “One of our trials can do every step of the trial process remotely without direct in-person interactions and will be able to restart soon.”
An individualized approach is needed, Dr. Broderick added. “For trials involving necessary in-person and hands-on assessments, we will need to consider how best to use protective equipment and expanded testing that will likely match the ongoing clinical care and requirements at a given institution.
“Even if a trial officially reopens enrollment, the decision to enroll locally will need to follow local institutional environment and guidelines. Thus, restart of trial enrollment will not likely be uniform, similar to how trials often start in the first place,” Dr. Broderick said.
The NIH published uniform standards for researchers across its institutes to help guide them during the pandemic. Future contingency plans also are underway at the NINDS.
“As the pandemic wanes and in-person research activities restart, it will be important to have in place safety measures that prevent a resurgence of the virus, such as proper personal protective equipment for staff and research participants, said Dr. Wright, the clinical research director at NINDS.
For clinical trials, NINDS is prepared to provide supplemental funds to trial investigators to help support additional activities undertaken as a result of the pandemic.
“This has been an instructive experience. The pandemic will end, and we will resume much of our old patterns of behavior,” said Ohio State’s Dr. Segal. “But some of the strategies that we have employed to get through this time will continue to influence the way we communicate information, plan experiments, and prioritize research activities in the future, to good effect.”
Drs. Snyder, Sperling, Molinuevo Guix, Elkind, Broderick, Wright, Cohen, and Segal have disclosed no relevant disclosures.
This story first appeared on Medscape.com.
However, researchers remain determined to forge ahead – with many redesigning their studies, at least in part to optimize the safety of their participants and research staff.
Keeping people engaged while protocols are on hold; expanding normal safety considerations; and re-enlisting statisticians to keep their findings as significant as possible are just some of study survival strategies underway.
Alzheimer’s disease research on hold
The pandemic is having a significant impact on Alzheimer’s disease research, and medical research in general, says Heather Snyder, PhD, vice president, Medical & Scientific Relations at the Alzheimer’s Association.
“Many clinical trials worldwide are pausing, changing, or halting the testing of the drug or the intervention,” she told Medscape Medical News. “How the teams have adapted depends on the study,” she added. “As you can imagine, things are changing on a daily basis.”
The US Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) trial, for example, is on hold until at least May 31. The Alzheimer’s Association is helping to implement and fund the study along with Wake Forest University Medical Center.
“We’re not randomizing participants at this point in time and the intervention — which is based on a team meeting, and there is a social aspect to that — has been paused,” Dr. Snyder said.
Another pivotal study underway is the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study (the A4 Study). Investigators are evaluating if an anti-amyloid antibody, solanezumab (Eli Lilly), can slow memory loss among people with amyloid on imaging but no symptoms of cognitive decline at baseline.
“The A4 Study is definitely continuing. However, in an effort to minimize risk to participants, site staff and study integrity, we have implemented an optional study hiatus for both the double-blind and open-label extension phases,” lead investigator Reisa Anne Sperling, MD, told Medscape Medical News.
“We wanted to prioritize the safety of our participants as well as the ability of participants to remain in the study … despite disruptions from the COVID-19 pandemic,” said Dr. Sperling, who is professor of neurology at Harvard Medical School and director of the Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital and Massachusetts General Hospital in Boston.
The ultimate goal is for A4 participants to receive the full number of planned infusions and assessments, even if it takes longer, she added.
Many Alzheimer’s disease researchers outside the United States face similar challenges. “As you probably are well aware, Spain is now in a complete lockdown. This has affected research centers like ours, the Barcelona Brain Research Center, and the way we work,” José Luís Molinuevo Guix, MD, PhD, told Medscape Medical News.
All participants in observational studies like the ALFA+ study and initiatives, as well as those in trials including PENSA and AB1601, “are not allowed, by law, to come in, hence from a safety perspective we are on good grounds,” added Dr. Molinuevo Guix, who directs the Alzheimer’s disease and other cognitive disorders unit at the Hospital Clinic de Barcelona.
The investigators are creating protocols for communicating with participants during the pandemic and for restarting visits safely after the lockdown has ended.
Stroke studies amended or suspended
A similar situation is occurring in stroke trials. Stroke is “obviously an acute disease, as well as a disease that requires secondary prevention,” Mitchell Elkind, MD, president-elect of the American Heart Association, told Medscape Medical News.
“One could argue that patients with stroke are going to be in the hospital anyway – why not enroll them in a study? They’re not incurring any additional risk,” he said. “But the staff have to come in to see them, and we’re really trying to avoid exposure.”
One ongoing trial, the Atrial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke (ARCADIA), stopped randomly assigning new participants to secondary prevention with apixaban or aspirin because of COVID-19. However, Dr. Elkind and colleagues plan to provide medication to the 440 people already in the trial.
“Wherever possible, the study coordinators are shipping the drug to people and doing follow-up visits by phone or video,” said Dr. Elkind, chief of the Division of Neurology Clinical Outcomes Research and Population Sciences at Columbia University in New York City.
Protecting patients, staff, and ultimately society is a “major driving force in stopping the randomizations,” he stressed.
ARCADIA is part of the StrokeNet prevention trials network, run by the NIH’s National Institute of Neurologic Disorders and Stroke (NINDS). Additional pivotal trials include the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) and the Multi-arm Optimization of Stroke Thrombolysis (MOST) studies, he said.
Joseph Broderick, MD, director of the national NIH StrokeNet, agreed that safety comes first. “It was the decision of the StrokeNet leadership and the principal investigators of the trials that we needed to hold recruitment of new patients while we worked on adapting processes of enrollment to ensure the safety of both patients and researchers interacting with study patients,” he told Medscape Medical News.
Potential risks vary based on the study intervention and the need for in-person interactions. Trials that include stimulation devices or physical therapy, for example, might be most affected, added Dr. Broderick, professor and director of the UC Gardner Neuroscience Institute at the University of Cincinnati in Ohio.
Nevertheless, “there are potential ways … to move as much as possible toward telemedicine and digital interactions during this time.”
Multiple challenges in multiple sclerosis
At the national level, the COVID-19 pandemic has had an “unprecedented impact on almost all the clinical trials funded by NINDS,” said Clinton Wright, MD, director of the Division of Clinical Research at NINDS. “Investigators have had to adapt quickly.”
Supplementing existing grants with money to conduct research on COVID-19 and pursuing research opportunities from different institutes are “some of the creative approaches [that] have come from the NIH [National Institutes of Health] itself,” Dr. Wright said. “Other creative approaches have come from investigators trying to keep their studies and trials going during the pandemic.”
In clinical trials, “everything from electronic consent to in-home research drug delivery is being brought to bear.”
“A few ongoing trials have been able to modify their protocols to obtain consent and carry out evaluations remotely by telephone or videoconferencing,” Dr. Wright said. “This is especially critical for trials that involve medical management of specific risk factors or conditions, where suspension of the trial could itself have adverse consequences due to reduced engagement with research participants.”
For participants already in MS studies, “each upcoming visit is assessed for whether it’s critical or could be done virtually or just skipped. If a person needs a treatment that cannot be postponed or skipped, they come in,” Jeffrey Cohen, MD, director of the Experimental Therapeutics Program at the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, Ohio, told Medscape Medical News.
New study enrollment is largely on hold and study visits for existing participants are limited, said Dr. Cohen, who is also president of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).
Some of the major ongoing trials in MS are “looking at very fundamental questions in the field,” Dr. Cohen said. The Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (DELIVER-MS) and Traditional Versus Early Aggressive Therapy for Multiple Sclerosis (TREAT-MS) trials, for example, evaluate whether treatment should be initiated with one of the less efficacious agents with escalation as needed, or whether treatment should begin with a high-efficacy agent.
Both trials are currently on hold because of the pandemic, as is the Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS) study.
“There has been a lot of interest in hematopoietic stem cell transplants and where they fit into our overall treatment strategy, and this is intended to provide a more definitive answer,” Dr. Cohen said.
Making the most of down time
“The pandemic has been challenging” in terms of ongoing MS research, said Benjamin M. Segal, MD, chair of the Department of Neurology and director of the Neuroscience Research Institute at the Ohio State University Wexner Medical Center, Columbus.
“With regard to the lab, our animal model experiments have been placed on hold. We have stopped collecting samples from clinical subjects for biomarker studies.
“However, my research team has been taking advantage of the time that has been freed up from bench work by analyzing data sets that had been placed aside, delving more deeply into the literature, and writing new grant proposals and articles,” he added.
Two of Dr. Segal’s trainees are writing review articles on the immunopathogenesis of MS and its treatment. Another postdoctoral candidate is writing a grant proposal to investigate how coinfection with a coronavirus modulates CNS pathology and the clinical course of an animal model of MS.
“I am asking my trainees to plan out experiments further in advance than they ever have before, so they are as prepared as possible to resume their research agendas once we are up and running again,” Dr. Segal said.
Confronting current challenges while planning for a future less disrupted by the pandemic is a common theme that emerges.
“The duration of this [pandemic] will dictate how we analyze the data at the end [for the US POINTER study]. There is a large group of statisticians working on this,” Dr. Snyder said.
Dr. Sperling of Harvard Medical School also remains undeterred. “This is definitely a challenging time, as we must not allow the COVID-19 to interfere with our essential mission to find a successful treatment to prevent cognitive decline in AD. We do need, however, to be as flexible as possible to protect our participants and minimize the impact to our overall study integrity,” she said.
NIH guidance
Dr. Molinuevo Guix, of the Barcelona Brain Research Center, is also determined to continue his Alzheimer’s disease research. “I am aware that after the crisis, there will be less [risk] but still a COVID-19 infection risk, so apart from trying to generate part of our visits virtually, we want to make sure we have all necessary safety measures in place. We remain very active to preserve the work we have done to keep up the fight against Alzheimer’s and dementia,” he said.
Such forward thinking also applies to major stroke trials, said Dr. Broderick of the University of Cincinnati. “As soon as we shut down enrollment in stroke trials, we immediately began to make plans about how and when we can restart our stroke trials,” he explained. “One of our trials can do every step of the trial process remotely without direct in-person interactions and will be able to restart soon.”
An individualized approach is needed, Dr. Broderick added. “For trials involving necessary in-person and hands-on assessments, we will need to consider how best to use protective equipment and expanded testing that will likely match the ongoing clinical care and requirements at a given institution.
“Even if a trial officially reopens enrollment, the decision to enroll locally will need to follow local institutional environment and guidelines. Thus, restart of trial enrollment will not likely be uniform, similar to how trials often start in the first place,” Dr. Broderick said.
The NIH published uniform standards for researchers across its institutes to help guide them during the pandemic. Future contingency plans also are underway at the NINDS.
“As the pandemic wanes and in-person research activities restart, it will be important to have in place safety measures that prevent a resurgence of the virus, such as proper personal protective equipment for staff and research participants, said Dr. Wright, the clinical research director at NINDS.
For clinical trials, NINDS is prepared to provide supplemental funds to trial investigators to help support additional activities undertaken as a result of the pandemic.
“This has been an instructive experience. The pandemic will end, and we will resume much of our old patterns of behavior,” said Ohio State’s Dr. Segal. “But some of the strategies that we have employed to get through this time will continue to influence the way we communicate information, plan experiments, and prioritize research activities in the future, to good effect.”
Drs. Snyder, Sperling, Molinuevo Guix, Elkind, Broderick, Wright, Cohen, and Segal have disclosed no relevant disclosures.
This story first appeared on Medscape.com.
However, researchers remain determined to forge ahead – with many redesigning their studies, at least in part to optimize the safety of their participants and research staff.
Keeping people engaged while protocols are on hold; expanding normal safety considerations; and re-enlisting statisticians to keep their findings as significant as possible are just some of study survival strategies underway.
Alzheimer’s disease research on hold
The pandemic is having a significant impact on Alzheimer’s disease research, and medical research in general, says Heather Snyder, PhD, vice president, Medical & Scientific Relations at the Alzheimer’s Association.
“Many clinical trials worldwide are pausing, changing, or halting the testing of the drug or the intervention,” she told Medscape Medical News. “How the teams have adapted depends on the study,” she added. “As you can imagine, things are changing on a daily basis.”
The US Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk (U.S. POINTER) trial, for example, is on hold until at least May 31. The Alzheimer’s Association is helping to implement and fund the study along with Wake Forest University Medical Center.
“We’re not randomizing participants at this point in time and the intervention — which is based on a team meeting, and there is a social aspect to that — has been paused,” Dr. Snyder said.
Another pivotal study underway is the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study (the A4 Study). Investigators are evaluating if an anti-amyloid antibody, solanezumab (Eli Lilly), can slow memory loss among people with amyloid on imaging but no symptoms of cognitive decline at baseline.
“The A4 Study is definitely continuing. However, in an effort to minimize risk to participants, site staff and study integrity, we have implemented an optional study hiatus for both the double-blind and open-label extension phases,” lead investigator Reisa Anne Sperling, MD, told Medscape Medical News.
“We wanted to prioritize the safety of our participants as well as the ability of participants to remain in the study … despite disruptions from the COVID-19 pandemic,” said Dr. Sperling, who is professor of neurology at Harvard Medical School and director of the Center for Alzheimer Research and Treatment at Brigham and Women’s Hospital and Massachusetts General Hospital in Boston.
The ultimate goal is for A4 participants to receive the full number of planned infusions and assessments, even if it takes longer, she added.
Many Alzheimer’s disease researchers outside the United States face similar challenges. “As you probably are well aware, Spain is now in a complete lockdown. This has affected research centers like ours, the Barcelona Brain Research Center, and the way we work,” José Luís Molinuevo Guix, MD, PhD, told Medscape Medical News.
All participants in observational studies like the ALFA+ study and initiatives, as well as those in trials including PENSA and AB1601, “are not allowed, by law, to come in, hence from a safety perspective we are on good grounds,” added Dr. Molinuevo Guix, who directs the Alzheimer’s disease and other cognitive disorders unit at the Hospital Clinic de Barcelona.
The investigators are creating protocols for communicating with participants during the pandemic and for restarting visits safely after the lockdown has ended.
Stroke studies amended or suspended
A similar situation is occurring in stroke trials. Stroke is “obviously an acute disease, as well as a disease that requires secondary prevention,” Mitchell Elkind, MD, president-elect of the American Heart Association, told Medscape Medical News.
“One could argue that patients with stroke are going to be in the hospital anyway – why not enroll them in a study? They’re not incurring any additional risk,” he said. “But the staff have to come in to see them, and we’re really trying to avoid exposure.”
One ongoing trial, the Atrial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke (ARCADIA), stopped randomly assigning new participants to secondary prevention with apixaban or aspirin because of COVID-19. However, Dr. Elkind and colleagues plan to provide medication to the 440 people already in the trial.
“Wherever possible, the study coordinators are shipping the drug to people and doing follow-up visits by phone or video,” said Dr. Elkind, chief of the Division of Neurology Clinical Outcomes Research and Population Sciences at Columbia University in New York City.
Protecting patients, staff, and ultimately society is a “major driving force in stopping the randomizations,” he stressed.
ARCADIA is part of the StrokeNet prevention trials network, run by the NIH’s National Institute of Neurologic Disorders and Stroke (NINDS). Additional pivotal trials include the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) and the Multi-arm Optimization of Stroke Thrombolysis (MOST) studies, he said.
Joseph Broderick, MD, director of the national NIH StrokeNet, agreed that safety comes first. “It was the decision of the StrokeNet leadership and the principal investigators of the trials that we needed to hold recruitment of new patients while we worked on adapting processes of enrollment to ensure the safety of both patients and researchers interacting with study patients,” he told Medscape Medical News.
Potential risks vary based on the study intervention and the need for in-person interactions. Trials that include stimulation devices or physical therapy, for example, might be most affected, added Dr. Broderick, professor and director of the UC Gardner Neuroscience Institute at the University of Cincinnati in Ohio.
Nevertheless, “there are potential ways … to move as much as possible toward telemedicine and digital interactions during this time.”
Multiple challenges in multiple sclerosis
At the national level, the COVID-19 pandemic has had an “unprecedented impact on almost all the clinical trials funded by NINDS,” said Clinton Wright, MD, director of the Division of Clinical Research at NINDS. “Investigators have had to adapt quickly.”
Supplementing existing grants with money to conduct research on COVID-19 and pursuing research opportunities from different institutes are “some of the creative approaches [that] have come from the NIH [National Institutes of Health] itself,” Dr. Wright said. “Other creative approaches have come from investigators trying to keep their studies and trials going during the pandemic.”
In clinical trials, “everything from electronic consent to in-home research drug delivery is being brought to bear.”
“A few ongoing trials have been able to modify their protocols to obtain consent and carry out evaluations remotely by telephone or videoconferencing,” Dr. Wright said. “This is especially critical for trials that involve medical management of specific risk factors or conditions, where suspension of the trial could itself have adverse consequences due to reduced engagement with research participants.”
For participants already in MS studies, “each upcoming visit is assessed for whether it’s critical or could be done virtually or just skipped. If a person needs a treatment that cannot be postponed or skipped, they come in,” Jeffrey Cohen, MD, director of the Experimental Therapeutics Program at the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, Ohio, told Medscape Medical News.
New study enrollment is largely on hold and study visits for existing participants are limited, said Dr. Cohen, who is also president of the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).
Some of the major ongoing trials in MS are “looking at very fundamental questions in the field,” Dr. Cohen said. The Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (DELIVER-MS) and Traditional Versus Early Aggressive Therapy for Multiple Sclerosis (TREAT-MS) trials, for example, evaluate whether treatment should be initiated with one of the less efficacious agents with escalation as needed, or whether treatment should begin with a high-efficacy agent.
Both trials are currently on hold because of the pandemic, as is the Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS) study.
“There has been a lot of interest in hematopoietic stem cell transplants and where they fit into our overall treatment strategy, and this is intended to provide a more definitive answer,” Dr. Cohen said.
Making the most of down time
“The pandemic has been challenging” in terms of ongoing MS research, said Benjamin M. Segal, MD, chair of the Department of Neurology and director of the Neuroscience Research Institute at the Ohio State University Wexner Medical Center, Columbus.
“With regard to the lab, our animal model experiments have been placed on hold. We have stopped collecting samples from clinical subjects for biomarker studies.
“However, my research team has been taking advantage of the time that has been freed up from bench work by analyzing data sets that had been placed aside, delving more deeply into the literature, and writing new grant proposals and articles,” he added.
Two of Dr. Segal’s trainees are writing review articles on the immunopathogenesis of MS and its treatment. Another postdoctoral candidate is writing a grant proposal to investigate how coinfection with a coronavirus modulates CNS pathology and the clinical course of an animal model of MS.
“I am asking my trainees to plan out experiments further in advance than they ever have before, so they are as prepared as possible to resume their research agendas once we are up and running again,” Dr. Segal said.
Confronting current challenges while planning for a future less disrupted by the pandemic is a common theme that emerges.
“The duration of this [pandemic] will dictate how we analyze the data at the end [for the US POINTER study]. There is a large group of statisticians working on this,” Dr. Snyder said.
Dr. Sperling of Harvard Medical School also remains undeterred. “This is definitely a challenging time, as we must not allow the COVID-19 to interfere with our essential mission to find a successful treatment to prevent cognitive decline in AD. We do need, however, to be as flexible as possible to protect our participants and minimize the impact to our overall study integrity,” she said.
NIH guidance
Dr. Molinuevo Guix, of the Barcelona Brain Research Center, is also determined to continue his Alzheimer’s disease research. “I am aware that after the crisis, there will be less [risk] but still a COVID-19 infection risk, so apart from trying to generate part of our visits virtually, we want to make sure we have all necessary safety measures in place. We remain very active to preserve the work we have done to keep up the fight against Alzheimer’s and dementia,” he said.
Such forward thinking also applies to major stroke trials, said Dr. Broderick of the University of Cincinnati. “As soon as we shut down enrollment in stroke trials, we immediately began to make plans about how and when we can restart our stroke trials,” he explained. “One of our trials can do every step of the trial process remotely without direct in-person interactions and will be able to restart soon.”
An individualized approach is needed, Dr. Broderick added. “For trials involving necessary in-person and hands-on assessments, we will need to consider how best to use protective equipment and expanded testing that will likely match the ongoing clinical care and requirements at a given institution.
“Even if a trial officially reopens enrollment, the decision to enroll locally will need to follow local institutional environment and guidelines. Thus, restart of trial enrollment will not likely be uniform, similar to how trials often start in the first place,” Dr. Broderick said.
The NIH published uniform standards for researchers across its institutes to help guide them during the pandemic. Future contingency plans also are underway at the NINDS.
“As the pandemic wanes and in-person research activities restart, it will be important to have in place safety measures that prevent a resurgence of the virus, such as proper personal protective equipment for staff and research participants, said Dr. Wright, the clinical research director at NINDS.
For clinical trials, NINDS is prepared to provide supplemental funds to trial investigators to help support additional activities undertaken as a result of the pandemic.
“This has been an instructive experience. The pandemic will end, and we will resume much of our old patterns of behavior,” said Ohio State’s Dr. Segal. “But some of the strategies that we have employed to get through this time will continue to influence the way we communicate information, plan experiments, and prioritize research activities in the future, to good effect.”
Drs. Snyder, Sperling, Molinuevo Guix, Elkind, Broderick, Wright, Cohen, and Segal have disclosed no relevant disclosures.
This story first appeared on Medscape.com.
Remdesivir now ‘standard of care’ for COVID-19, Fauci says
, according to a preliminary data analysis from a U.S.-led randomized, controlled trial.
On the basis of as yet unpublished data, remdesivir “will be the standard of care” for patients with COVID-19, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), said during a press conference at the White House April 29.
The randomized, placebo-controlled international trial was sponsored by NIAID, which is part of the National Institutes of Health, and enrolled 1,063 patients. It began on Feb. 21.
The interim results, discussed in the press conference and in a NIAID press release, show that time to recovery (i.e., being well enough for hospital discharge or to return to normal activity level) was 31% faster for patients who received remdesivir than for those who received placebo (P < .001).
The median time to recovery was 11 days for patients treated with remdesivir, compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir and 11.6% for the patients who received placebo (P = .059).
The study, known as the Adaptive COVID-19 Treatment Trial (ACTT), is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19. It is being conducted at 68 sites – 47 in the United States and 21 in countries in Europe and Asia.
The data are being released after an interim review by the independent data safety monitoring board found significant benefit with the drug, Dr. Fauci said.
“The reason we are making the announcement now is something that people don’t fully appreciate: Whenever you have clear-cut evidence that a drug works, you have an ethical obligation to let the people in the placebo group know so they could have access,” he explained.
“When I was looking at the data with our team the other night, it was reminiscent of 34 years ago in 1986 when we were struggling for drugs for HIV,” said Dr. Fauci, who was a key figure in HIV/AIDS research. “We did the first randomized, placebo-controlled trial with AZT. It turned out to have an effect that was modest but that was not the endgame because, building on that, every year after, we did better and better.”
Similarly, new trials of drugs for COVID-19 will build on remdesivir, with other agents being added to block other pathways or viral enzymes, Dr. Fauci said.
The study will be submitted to a journal for peer review, he noted, but the New York Times is reporting that the Food and Drug Administration will approve remdesivir for emergency use soon.
In contrast to the positive results Dr. Fauci described from the NIAID-sponsored trial, a randomized, placebo-controlled clinical trial of remdesivir among hospitalized patients with severe COVID-19 in China was inconclusive.
The study, published online in The Lancet, showed some nonsignificant trends toward benefit but did not meet its primary endpoint.
The study was stopped early after 237 of the intended 453 patients were enrolled, owing to a lack of additional patients who met the eligibility criteria. The trial was thus underpowered.
Results showed that treatment with remdesivir did not significantly speed recovery or reduce deaths from COVID-19, but with regard to prespecified secondary outcomes, time to clinical improvement and duration of invasive mechanical ventilation were shorter among a subgroup of patients who began undergoing treatment with remdesivir within 10 days of showing symptoms, in comparison with patients who received standard care.
“To me, the studies reported here in The Lancet appear to be less promising than some statements released today from the NIH, so the situation is a bit puzzling to me,” said Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, who was not involved in the study. “I would need to look more closely at the data which NIH is looking at to understand the differences.”
Trial details
The published trial was conducted at 10 hospitals in Hubei, China. Enrollment criteria included being admitted to hospital with laboratory-confirmed SARS-CoV-2 infection within 12 days of symptom onset, having oxygen saturation of 94% or less, and having radiologically confirmed pneumonia.
Patients were randomly assigned in a 2:1 ratio to receive intravenous remdesivir (200 mg on day 1 followed by 100 mg on days 2–10 in single daily infusions) or placebo infusions for 10 days. Patients were permitted concomitant use of lopinavir-ritonavir, interferons, and corticosteroids.
The primary endpoint was time to clinical improvement to day 28, defined as the time (in days) from randomization to the point of a decline of two levels on a six-point ordinal scale of clinical status (on that scale, 1 indicated that the patient was discharged, and 6 indicated death) or to the patient’s being discharged alive from hospital, whichever came first.
The trial was stopped early because stringent public health measures used in Wuhan led to marked reductions in new patient presentations and because lack of available hospital beds resulted in most patients being enrolled later in the course of disease.
Between Feb. 6, 2020, and March 12, 2020, 237 patients were enrolled and were randomly assigned to receive either remdesivir (n = 158) or placebo (n = 79).
Results showed that use of remdesivir was not associated with a difference in time to clinical improvement (hazard ratio [HR], 1.23; 95% confidence interval [CI], 0.87-1.75).
Although not statistically significant, time to clinical improvement was numerically faster for patients who received remdesivir than for those who received placebo among patients with symptom duration of 10 days or less (median, 18 days vs. 23 days; HR, 1.52; 95% CI, 0.95-2.43).
The mortality rates were similar for the two groups (14% of patients who received remdesivir died vs. 13% of those who received placebo). There was no signal that viral load decreased differentially over time between the two groups.
Adverse events were reported in 66% of remdesivir recipients, vs. 64% of those who received placebo. Remdesivir was stopped early because of adverse events in 12% of patients; it was stopped early for 5% of those who received placebo.
The authors, led by Yeming Wang, MD, China-Japan Friendship Hospital, Beijing, noted that compared with a previous study of compassionate use of remdesivir, the population in the current study was less ill and was treated somewhat earlier in the disease course (median, 10 days vs. 12 days).
Because the study was terminated early, the researchers said they could not adequately assess whether earlier treatment with remdesivir might have provided clinical benefit.
“However, among patients who were treated within 10 days of symptom onset, remdesivir was not a significant factor but was associated with a numerical reduction of 5 days in median time to clinical improvement,” they stated.
They added that remdesivir was adequately tolerated and that no new safety concerns were identified.
In an accompanying comment in The Lancet, John David Norrie, MD, Edinburgh Clinical Trials Unit, United Kingdom, pointed out that this study “has not shown a statistically significant finding that confirms a remdesivir treatment benefit of at least the minimally clinically important difference, nor has it ruled such a benefit out.”
Dr. Norrie was cautious about the fact that the subgroup analysis suggested possible benefit for those treated within 10 days.
Although he said it seems biologically plausible that treating patients earlier could be more effective, he added that “as well as being vigilant against overinterpretation, we need to ensure that hypotheses generated in efficacy-based trials, even in subgroups, are confirmed or refuted in subsequent adequately powered trials or meta-analyses.”
Noting that several other trials of remdesivir are underway, he concluded: “With each individual study at heightened risk of being incomplete, pooling data across possibly several underpowered but high-quality studies looks like our best way to obtain robust insights into what works, safely, and on whom.”
A version of this article originally appeared on Medscape.com.
, according to a preliminary data analysis from a U.S.-led randomized, controlled trial.
On the basis of as yet unpublished data, remdesivir “will be the standard of care” for patients with COVID-19, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), said during a press conference at the White House April 29.
The randomized, placebo-controlled international trial was sponsored by NIAID, which is part of the National Institutes of Health, and enrolled 1,063 patients. It began on Feb. 21.
The interim results, discussed in the press conference and in a NIAID press release, show that time to recovery (i.e., being well enough for hospital discharge or to return to normal activity level) was 31% faster for patients who received remdesivir than for those who received placebo (P < .001).
The median time to recovery was 11 days for patients treated with remdesivir, compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir and 11.6% for the patients who received placebo (P = .059).
The study, known as the Adaptive COVID-19 Treatment Trial (ACTT), is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19. It is being conducted at 68 sites – 47 in the United States and 21 in countries in Europe and Asia.
The data are being released after an interim review by the independent data safety monitoring board found significant benefit with the drug, Dr. Fauci said.
“The reason we are making the announcement now is something that people don’t fully appreciate: Whenever you have clear-cut evidence that a drug works, you have an ethical obligation to let the people in the placebo group know so they could have access,” he explained.
“When I was looking at the data with our team the other night, it was reminiscent of 34 years ago in 1986 when we were struggling for drugs for HIV,” said Dr. Fauci, who was a key figure in HIV/AIDS research. “We did the first randomized, placebo-controlled trial with AZT. It turned out to have an effect that was modest but that was not the endgame because, building on that, every year after, we did better and better.”
Similarly, new trials of drugs for COVID-19 will build on remdesivir, with other agents being added to block other pathways or viral enzymes, Dr. Fauci said.
The study will be submitted to a journal for peer review, he noted, but the New York Times is reporting that the Food and Drug Administration will approve remdesivir for emergency use soon.
In contrast to the positive results Dr. Fauci described from the NIAID-sponsored trial, a randomized, placebo-controlled clinical trial of remdesivir among hospitalized patients with severe COVID-19 in China was inconclusive.
The study, published online in The Lancet, showed some nonsignificant trends toward benefit but did not meet its primary endpoint.
The study was stopped early after 237 of the intended 453 patients were enrolled, owing to a lack of additional patients who met the eligibility criteria. The trial was thus underpowered.
Results showed that treatment with remdesivir did not significantly speed recovery or reduce deaths from COVID-19, but with regard to prespecified secondary outcomes, time to clinical improvement and duration of invasive mechanical ventilation were shorter among a subgroup of patients who began undergoing treatment with remdesivir within 10 days of showing symptoms, in comparison with patients who received standard care.
“To me, the studies reported here in The Lancet appear to be less promising than some statements released today from the NIH, so the situation is a bit puzzling to me,” said Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, who was not involved in the study. “I would need to look more closely at the data which NIH is looking at to understand the differences.”
Trial details
The published trial was conducted at 10 hospitals in Hubei, China. Enrollment criteria included being admitted to hospital with laboratory-confirmed SARS-CoV-2 infection within 12 days of symptom onset, having oxygen saturation of 94% or less, and having radiologically confirmed pneumonia.
Patients were randomly assigned in a 2:1 ratio to receive intravenous remdesivir (200 mg on day 1 followed by 100 mg on days 2–10 in single daily infusions) or placebo infusions for 10 days. Patients were permitted concomitant use of lopinavir-ritonavir, interferons, and corticosteroids.
The primary endpoint was time to clinical improvement to day 28, defined as the time (in days) from randomization to the point of a decline of two levels on a six-point ordinal scale of clinical status (on that scale, 1 indicated that the patient was discharged, and 6 indicated death) or to the patient’s being discharged alive from hospital, whichever came first.
The trial was stopped early because stringent public health measures used in Wuhan led to marked reductions in new patient presentations and because lack of available hospital beds resulted in most patients being enrolled later in the course of disease.
Between Feb. 6, 2020, and March 12, 2020, 237 patients were enrolled and were randomly assigned to receive either remdesivir (n = 158) or placebo (n = 79).
Results showed that use of remdesivir was not associated with a difference in time to clinical improvement (hazard ratio [HR], 1.23; 95% confidence interval [CI], 0.87-1.75).
Although not statistically significant, time to clinical improvement was numerically faster for patients who received remdesivir than for those who received placebo among patients with symptom duration of 10 days or less (median, 18 days vs. 23 days; HR, 1.52; 95% CI, 0.95-2.43).
The mortality rates were similar for the two groups (14% of patients who received remdesivir died vs. 13% of those who received placebo). There was no signal that viral load decreased differentially over time between the two groups.
Adverse events were reported in 66% of remdesivir recipients, vs. 64% of those who received placebo. Remdesivir was stopped early because of adverse events in 12% of patients; it was stopped early for 5% of those who received placebo.
The authors, led by Yeming Wang, MD, China-Japan Friendship Hospital, Beijing, noted that compared with a previous study of compassionate use of remdesivir, the population in the current study was less ill and was treated somewhat earlier in the disease course (median, 10 days vs. 12 days).
Because the study was terminated early, the researchers said they could not adequately assess whether earlier treatment with remdesivir might have provided clinical benefit.
“However, among patients who were treated within 10 days of symptom onset, remdesivir was not a significant factor but was associated with a numerical reduction of 5 days in median time to clinical improvement,” they stated.
They added that remdesivir was adequately tolerated and that no new safety concerns were identified.
In an accompanying comment in The Lancet, John David Norrie, MD, Edinburgh Clinical Trials Unit, United Kingdom, pointed out that this study “has not shown a statistically significant finding that confirms a remdesivir treatment benefit of at least the minimally clinically important difference, nor has it ruled such a benefit out.”
Dr. Norrie was cautious about the fact that the subgroup analysis suggested possible benefit for those treated within 10 days.
Although he said it seems biologically plausible that treating patients earlier could be more effective, he added that “as well as being vigilant against overinterpretation, we need to ensure that hypotheses generated in efficacy-based trials, even in subgroups, are confirmed or refuted in subsequent adequately powered trials or meta-analyses.”
Noting that several other trials of remdesivir are underway, he concluded: “With each individual study at heightened risk of being incomplete, pooling data across possibly several underpowered but high-quality studies looks like our best way to obtain robust insights into what works, safely, and on whom.”
A version of this article originally appeared on Medscape.com.
, according to a preliminary data analysis from a U.S.-led randomized, controlled trial.
On the basis of as yet unpublished data, remdesivir “will be the standard of care” for patients with COVID-19, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID), said during a press conference at the White House April 29.
The randomized, placebo-controlled international trial was sponsored by NIAID, which is part of the National Institutes of Health, and enrolled 1,063 patients. It began on Feb. 21.
The interim results, discussed in the press conference and in a NIAID press release, show that time to recovery (i.e., being well enough for hospital discharge or to return to normal activity level) was 31% faster for patients who received remdesivir than for those who received placebo (P < .001).
The median time to recovery was 11 days for patients treated with remdesivir, compared with 15 days for those who received placebo. Results also suggested a survival benefit, with a mortality rate of 8.0% for the group receiving remdesivir and 11.6% for the patients who received placebo (P = .059).
The study, known as the Adaptive COVID-19 Treatment Trial (ACTT), is the first clinical trial launched in the United States to evaluate an experimental treatment for COVID-19. It is being conducted at 68 sites – 47 in the United States and 21 in countries in Europe and Asia.
The data are being released after an interim review by the independent data safety monitoring board found significant benefit with the drug, Dr. Fauci said.
“The reason we are making the announcement now is something that people don’t fully appreciate: Whenever you have clear-cut evidence that a drug works, you have an ethical obligation to let the people in the placebo group know so they could have access,” he explained.
“When I was looking at the data with our team the other night, it was reminiscent of 34 years ago in 1986 when we were struggling for drugs for HIV,” said Dr. Fauci, who was a key figure in HIV/AIDS research. “We did the first randomized, placebo-controlled trial with AZT. It turned out to have an effect that was modest but that was not the endgame because, building on that, every year after, we did better and better.”
Similarly, new trials of drugs for COVID-19 will build on remdesivir, with other agents being added to block other pathways or viral enzymes, Dr. Fauci said.
The study will be submitted to a journal for peer review, he noted, but the New York Times is reporting that the Food and Drug Administration will approve remdesivir for emergency use soon.
In contrast to the positive results Dr. Fauci described from the NIAID-sponsored trial, a randomized, placebo-controlled clinical trial of remdesivir among hospitalized patients with severe COVID-19 in China was inconclusive.
The study, published online in The Lancet, showed some nonsignificant trends toward benefit but did not meet its primary endpoint.
The study was stopped early after 237 of the intended 453 patients were enrolled, owing to a lack of additional patients who met the eligibility criteria. The trial was thus underpowered.
Results showed that treatment with remdesivir did not significantly speed recovery or reduce deaths from COVID-19, but with regard to prespecified secondary outcomes, time to clinical improvement and duration of invasive mechanical ventilation were shorter among a subgroup of patients who began undergoing treatment with remdesivir within 10 days of showing symptoms, in comparison with patients who received standard care.
“To me, the studies reported here in The Lancet appear to be less promising than some statements released today from the NIH, so the situation is a bit puzzling to me,” said Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, who was not involved in the study. “I would need to look more closely at the data which NIH is looking at to understand the differences.”
Trial details
The published trial was conducted at 10 hospitals in Hubei, China. Enrollment criteria included being admitted to hospital with laboratory-confirmed SARS-CoV-2 infection within 12 days of symptom onset, having oxygen saturation of 94% or less, and having radiologically confirmed pneumonia.
Patients were randomly assigned in a 2:1 ratio to receive intravenous remdesivir (200 mg on day 1 followed by 100 mg on days 2–10 in single daily infusions) or placebo infusions for 10 days. Patients were permitted concomitant use of lopinavir-ritonavir, interferons, and corticosteroids.
The primary endpoint was time to clinical improvement to day 28, defined as the time (in days) from randomization to the point of a decline of two levels on a six-point ordinal scale of clinical status (on that scale, 1 indicated that the patient was discharged, and 6 indicated death) or to the patient’s being discharged alive from hospital, whichever came first.
The trial was stopped early because stringent public health measures used in Wuhan led to marked reductions in new patient presentations and because lack of available hospital beds resulted in most patients being enrolled later in the course of disease.
Between Feb. 6, 2020, and March 12, 2020, 237 patients were enrolled and were randomly assigned to receive either remdesivir (n = 158) or placebo (n = 79).
Results showed that use of remdesivir was not associated with a difference in time to clinical improvement (hazard ratio [HR], 1.23; 95% confidence interval [CI], 0.87-1.75).
Although not statistically significant, time to clinical improvement was numerically faster for patients who received remdesivir than for those who received placebo among patients with symptom duration of 10 days or less (median, 18 days vs. 23 days; HR, 1.52; 95% CI, 0.95-2.43).
The mortality rates were similar for the two groups (14% of patients who received remdesivir died vs. 13% of those who received placebo). There was no signal that viral load decreased differentially over time between the two groups.
Adverse events were reported in 66% of remdesivir recipients, vs. 64% of those who received placebo. Remdesivir was stopped early because of adverse events in 12% of patients; it was stopped early for 5% of those who received placebo.
The authors, led by Yeming Wang, MD, China-Japan Friendship Hospital, Beijing, noted that compared with a previous study of compassionate use of remdesivir, the population in the current study was less ill and was treated somewhat earlier in the disease course (median, 10 days vs. 12 days).
Because the study was terminated early, the researchers said they could not adequately assess whether earlier treatment with remdesivir might have provided clinical benefit.
“However, among patients who were treated within 10 days of symptom onset, remdesivir was not a significant factor but was associated with a numerical reduction of 5 days in median time to clinical improvement,” they stated.
They added that remdesivir was adequately tolerated and that no new safety concerns were identified.
In an accompanying comment in The Lancet, John David Norrie, MD, Edinburgh Clinical Trials Unit, United Kingdom, pointed out that this study “has not shown a statistically significant finding that confirms a remdesivir treatment benefit of at least the minimally clinically important difference, nor has it ruled such a benefit out.”
Dr. Norrie was cautious about the fact that the subgroup analysis suggested possible benefit for those treated within 10 days.
Although he said it seems biologically plausible that treating patients earlier could be more effective, he added that “as well as being vigilant against overinterpretation, we need to ensure that hypotheses generated in efficacy-based trials, even in subgroups, are confirmed or refuted in subsequent adequately powered trials or meta-analyses.”
Noting that several other trials of remdesivir are underway, he concluded: “With each individual study at heightened risk of being incomplete, pooling data across possibly several underpowered but high-quality studies looks like our best way to obtain robust insights into what works, safely, and on whom.”
A version of this article originally appeared on Medscape.com.
Standing orders for vaccines may improve pediatric vaccination rates
The biggest barrier to using standing orders for childhood immunizations is concern that patients will receive the wrong vaccine, according to a survey of pediatricians published in Pediatrics.
The other top reasons pediatricians give for not using standing orders for vaccines are concerns that parents may want to talk to the doctor about the vaccine before their child gets it, and a belief that the doctor should be the one who personally recommends a vaccine for their patient.
But with severe drops in vaccination rates resulting from the COVID-19 pandemic, standing orders may be a valuable tool for ensuring children get their vaccines on time, suggested lead author, Jessica Cataldi, MD, of the University of Colorado and Children’s Hospital Colorado in Aurora.
“As we work to bring more families back to their pediatrician’s office for well-child checks, standing orders are one process that can streamline the visit by saving providers time and increasing vaccine delivery,” she said in an interview. “We will also need use standing orders to support different ways to get children their immunizations during times of social distancing. This could take the form of drive-through immunization clinics or telehealth well-child checks that are paired with a quick immunization-only visit.”
The American Academy of Pediatrics issued guidance April 14 that emphasizes the need to prioritize immunization of children through 2-years-old.
Paul A. Offit, MD, director of the Vaccine Education Center and an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, agreed that it’s essential children do not fall behind on the recommended schedule during the pandemic.
“It’s important not to have greater collateral damage from this COVID-19 pandemic by putting children at increased risk from other infections that are circulating, like measles and pertussis,” he said, noting that nearly 1,300 measles cases and more than 15,000 pertussis cases occurred in the United States in 2019.
It’s important “not to delay those primary vaccines because it’s hard to catch up,” he said in an interview
Although “standing orders” may go by other names in non–inpatient settings, the researchers defined them in their survey as “a written or verbal policy that persons other than a medical provider, such as a nurse or medical assistant, may consent and vaccinate a person without speaking with the physician or advanced care provider first.” Further, the “vaccine may be given before or after a physician encounter or in the absence of a physician encounter altogether.”
Research strongly suggests that standing orders for childhood vaccines are cost-effective and increase immunization rates, the authors noted. The Centers for Disease Control and Prevention, its Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the federal National Vaccine Advisory Committee all recommend using standing orders to improve vaccination access and rates.
The authors sought to understand how many pediatricians use standing orders and what reasons stop them from doing so. During June-September 2017, they sent out 471 online and mail surveys to a nationally representative sample of AAP members who spent at least half their time in primary care.
The 372 pediatricians who completed the survey made up a response rate of 79%, with no differences in response based on age, sex, years in practice, practice setting, region or rural/urban location.
More than half the respondents (59%) used standing orders for childhood immunizations. Just over a third of respondents (36%) said they use standing orders for all routinely recommended vaccines, and 23% use them for some vaccines.
Among those who did not use standing orders, 68% cited the concern that patients would get the incorrect vaccine by mistake as a barrier to using them. That came as a surprise to Dr Offit, who would expect standing orders to reduce the likelihood of error.
“The standing order should make things a little more foolproof so that you’re less likely to make a mistake,” Dr Offit said.
No studies have shown that vaccine errors occur more often in clinics that use standing orders for immunizations, but the question merits continued monitoring, Dr Cataldi said.
“It is important for any clinic that is new to the use of standing orders to provide adequate education to providers and other staff about when and how to use standing orders, and to always leave room for staff to bring vaccination questions to the provider,” Dr Cataldi told this newspaper
Nearly as many physicians (62%) believed that families would want to speak to the doctor about a vaccine before getting it, and 57% of respondents who didn’t use standing orders believed they should be the one who recommends a vaccine to their patient’s parents.
All three of these reasons also ranked highest as barriers in responses from all respondents, including those who use standing orders. But those who didn’t use them were significantly more likely to cite these reasons (P less than .0001).
Since the survey occurred in 2017, however, it’s possible the pandemic and the rapid increase in telehealth as a result may influence perceptions moving forward.
“With provider concerns that standing orders remove physicians from the vaccination conversation, it may be that those conversations become less crucial as some families may start to value and accept immunizations more as a result of this pandemic,” Dr Cataldi said. “Or for families with vaccine questions, telehealth might support those conversations with a provider well.”
After adjusting for potential confounders, the only practice or physician factor significantly associated with not using standing orders for vaccines was physicians’ having a higher “physician responsibility score.” Doctors with these higher scores also were marginally more likely to make independent decisions about vaccines than counterparts working at practices where system-level decisions occur.
“Perhaps physicians who feel more personal responsibility about their role in vaccination are more likely to choose practice settings where they have more independent decision-making ability,” the authors wrote. “Alternatively, knowing the level of decision-making about vaccines in the practice may influence the amount of personal responsibility that pediatricians feel about their role in vaccine delivery.”
Again, attitudes may have shifted since the coronavirus pandemic began. The biggest risk to children in terms of immunizations is not getting them, Dr Offit said.
“The parents are scared, and the doctors are scared,” he said. “They feel that going to a doctor’s office is going to a concentrated area where they’re more likely to pick up this virus.”
He’s expressed uncertainty about whether standing orders could play a role in alleviating that anxiety. But Dr Cataldi suggests it’s possible.
“I think standing orders will be important to increasing vaccination rates during a pandemic as they can be used to support delivery of vaccines through public health departments and through vaccine-only nurse visits,” she said.
The research was funded by the Centers for Disease Control and Prevention. The authors had no relevant financial disclosures.
SOURCE: Cataldi J et al. Pediatrics. 2020 Apr;e20191855.
The biggest barrier to using standing orders for childhood immunizations is concern that patients will receive the wrong vaccine, according to a survey of pediatricians published in Pediatrics.
The other top reasons pediatricians give for not using standing orders for vaccines are concerns that parents may want to talk to the doctor about the vaccine before their child gets it, and a belief that the doctor should be the one who personally recommends a vaccine for their patient.
But with severe drops in vaccination rates resulting from the COVID-19 pandemic, standing orders may be a valuable tool for ensuring children get their vaccines on time, suggested lead author, Jessica Cataldi, MD, of the University of Colorado and Children’s Hospital Colorado in Aurora.
“As we work to bring more families back to their pediatrician’s office for well-child checks, standing orders are one process that can streamline the visit by saving providers time and increasing vaccine delivery,” she said in an interview. “We will also need use standing orders to support different ways to get children their immunizations during times of social distancing. This could take the form of drive-through immunization clinics or telehealth well-child checks that are paired with a quick immunization-only visit.”
The American Academy of Pediatrics issued guidance April 14 that emphasizes the need to prioritize immunization of children through 2-years-old.
Paul A. Offit, MD, director of the Vaccine Education Center and an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, agreed that it’s essential children do not fall behind on the recommended schedule during the pandemic.
“It’s important not to have greater collateral damage from this COVID-19 pandemic by putting children at increased risk from other infections that are circulating, like measles and pertussis,” he said, noting that nearly 1,300 measles cases and more than 15,000 pertussis cases occurred in the United States in 2019.
It’s important “not to delay those primary vaccines because it’s hard to catch up,” he said in an interview
Although “standing orders” may go by other names in non–inpatient settings, the researchers defined them in their survey as “a written or verbal policy that persons other than a medical provider, such as a nurse or medical assistant, may consent and vaccinate a person without speaking with the physician or advanced care provider first.” Further, the “vaccine may be given before or after a physician encounter or in the absence of a physician encounter altogether.”
Research strongly suggests that standing orders for childhood vaccines are cost-effective and increase immunization rates, the authors noted. The Centers for Disease Control and Prevention, its Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the federal National Vaccine Advisory Committee all recommend using standing orders to improve vaccination access and rates.
The authors sought to understand how many pediatricians use standing orders and what reasons stop them from doing so. During June-September 2017, they sent out 471 online and mail surveys to a nationally representative sample of AAP members who spent at least half their time in primary care.
The 372 pediatricians who completed the survey made up a response rate of 79%, with no differences in response based on age, sex, years in practice, practice setting, region or rural/urban location.
More than half the respondents (59%) used standing orders for childhood immunizations. Just over a third of respondents (36%) said they use standing orders for all routinely recommended vaccines, and 23% use them for some vaccines.
Among those who did not use standing orders, 68% cited the concern that patients would get the incorrect vaccine by mistake as a barrier to using them. That came as a surprise to Dr Offit, who would expect standing orders to reduce the likelihood of error.
“The standing order should make things a little more foolproof so that you’re less likely to make a mistake,” Dr Offit said.
No studies have shown that vaccine errors occur more often in clinics that use standing orders for immunizations, but the question merits continued monitoring, Dr Cataldi said.
“It is important for any clinic that is new to the use of standing orders to provide adequate education to providers and other staff about when and how to use standing orders, and to always leave room for staff to bring vaccination questions to the provider,” Dr Cataldi told this newspaper
Nearly as many physicians (62%) believed that families would want to speak to the doctor about a vaccine before getting it, and 57% of respondents who didn’t use standing orders believed they should be the one who recommends a vaccine to their patient’s parents.
All three of these reasons also ranked highest as barriers in responses from all respondents, including those who use standing orders. But those who didn’t use them were significantly more likely to cite these reasons (P less than .0001).
Since the survey occurred in 2017, however, it’s possible the pandemic and the rapid increase in telehealth as a result may influence perceptions moving forward.
“With provider concerns that standing orders remove physicians from the vaccination conversation, it may be that those conversations become less crucial as some families may start to value and accept immunizations more as a result of this pandemic,” Dr Cataldi said. “Or for families with vaccine questions, telehealth might support those conversations with a provider well.”
After adjusting for potential confounders, the only practice or physician factor significantly associated with not using standing orders for vaccines was physicians’ having a higher “physician responsibility score.” Doctors with these higher scores also were marginally more likely to make independent decisions about vaccines than counterparts working at practices where system-level decisions occur.
“Perhaps physicians who feel more personal responsibility about their role in vaccination are more likely to choose practice settings where they have more independent decision-making ability,” the authors wrote. “Alternatively, knowing the level of decision-making about vaccines in the practice may influence the amount of personal responsibility that pediatricians feel about their role in vaccine delivery.”
Again, attitudes may have shifted since the coronavirus pandemic began. The biggest risk to children in terms of immunizations is not getting them, Dr Offit said.
“The parents are scared, and the doctors are scared,” he said. “They feel that going to a doctor’s office is going to a concentrated area where they’re more likely to pick up this virus.”
He’s expressed uncertainty about whether standing orders could play a role in alleviating that anxiety. But Dr Cataldi suggests it’s possible.
“I think standing orders will be important to increasing vaccination rates during a pandemic as they can be used to support delivery of vaccines through public health departments and through vaccine-only nurse visits,” she said.
The research was funded by the Centers for Disease Control and Prevention. The authors had no relevant financial disclosures.
SOURCE: Cataldi J et al. Pediatrics. 2020 Apr;e20191855.
The biggest barrier to using standing orders for childhood immunizations is concern that patients will receive the wrong vaccine, according to a survey of pediatricians published in Pediatrics.
The other top reasons pediatricians give for not using standing orders for vaccines are concerns that parents may want to talk to the doctor about the vaccine before their child gets it, and a belief that the doctor should be the one who personally recommends a vaccine for their patient.
But with severe drops in vaccination rates resulting from the COVID-19 pandemic, standing orders may be a valuable tool for ensuring children get their vaccines on time, suggested lead author, Jessica Cataldi, MD, of the University of Colorado and Children’s Hospital Colorado in Aurora.
“As we work to bring more families back to their pediatrician’s office for well-child checks, standing orders are one process that can streamline the visit by saving providers time and increasing vaccine delivery,” she said in an interview. “We will also need use standing orders to support different ways to get children their immunizations during times of social distancing. This could take the form of drive-through immunization clinics or telehealth well-child checks that are paired with a quick immunization-only visit.”
The American Academy of Pediatrics issued guidance April 14 that emphasizes the need to prioritize immunization of children through 2-years-old.
Paul A. Offit, MD, director of the Vaccine Education Center and an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, agreed that it’s essential children do not fall behind on the recommended schedule during the pandemic.
“It’s important not to have greater collateral damage from this COVID-19 pandemic by putting children at increased risk from other infections that are circulating, like measles and pertussis,” he said, noting that nearly 1,300 measles cases and more than 15,000 pertussis cases occurred in the United States in 2019.
It’s important “not to delay those primary vaccines because it’s hard to catch up,” he said in an interview
Although “standing orders” may go by other names in non–inpatient settings, the researchers defined them in their survey as “a written or verbal policy that persons other than a medical provider, such as a nurse or medical assistant, may consent and vaccinate a person without speaking with the physician or advanced care provider first.” Further, the “vaccine may be given before or after a physician encounter or in the absence of a physician encounter altogether.”
Research strongly suggests that standing orders for childhood vaccines are cost-effective and increase immunization rates, the authors noted. The Centers for Disease Control and Prevention, its Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the federal National Vaccine Advisory Committee all recommend using standing orders to improve vaccination access and rates.
The authors sought to understand how many pediatricians use standing orders and what reasons stop them from doing so. During June-September 2017, they sent out 471 online and mail surveys to a nationally representative sample of AAP members who spent at least half their time in primary care.
The 372 pediatricians who completed the survey made up a response rate of 79%, with no differences in response based on age, sex, years in practice, practice setting, region or rural/urban location.
More than half the respondents (59%) used standing orders for childhood immunizations. Just over a third of respondents (36%) said they use standing orders for all routinely recommended vaccines, and 23% use them for some vaccines.
Among those who did not use standing orders, 68% cited the concern that patients would get the incorrect vaccine by mistake as a barrier to using them. That came as a surprise to Dr Offit, who would expect standing orders to reduce the likelihood of error.
“The standing order should make things a little more foolproof so that you’re less likely to make a mistake,” Dr Offit said.
No studies have shown that vaccine errors occur more often in clinics that use standing orders for immunizations, but the question merits continued monitoring, Dr Cataldi said.
“It is important for any clinic that is new to the use of standing orders to provide adequate education to providers and other staff about when and how to use standing orders, and to always leave room for staff to bring vaccination questions to the provider,” Dr Cataldi told this newspaper
Nearly as many physicians (62%) believed that families would want to speak to the doctor about a vaccine before getting it, and 57% of respondents who didn’t use standing orders believed they should be the one who recommends a vaccine to their patient’s parents.
All three of these reasons also ranked highest as barriers in responses from all respondents, including those who use standing orders. But those who didn’t use them were significantly more likely to cite these reasons (P less than .0001).
Since the survey occurred in 2017, however, it’s possible the pandemic and the rapid increase in telehealth as a result may influence perceptions moving forward.
“With provider concerns that standing orders remove physicians from the vaccination conversation, it may be that those conversations become less crucial as some families may start to value and accept immunizations more as a result of this pandemic,” Dr Cataldi said. “Or for families with vaccine questions, telehealth might support those conversations with a provider well.”
After adjusting for potential confounders, the only practice or physician factor significantly associated with not using standing orders for vaccines was physicians’ having a higher “physician responsibility score.” Doctors with these higher scores also were marginally more likely to make independent decisions about vaccines than counterparts working at practices where system-level decisions occur.
“Perhaps physicians who feel more personal responsibility about their role in vaccination are more likely to choose practice settings where they have more independent decision-making ability,” the authors wrote. “Alternatively, knowing the level of decision-making about vaccines in the practice may influence the amount of personal responsibility that pediatricians feel about their role in vaccine delivery.”
Again, attitudes may have shifted since the coronavirus pandemic began. The biggest risk to children in terms of immunizations is not getting them, Dr Offit said.
“The parents are scared, and the doctors are scared,” he said. “They feel that going to a doctor’s office is going to a concentrated area where they’re more likely to pick up this virus.”
He’s expressed uncertainty about whether standing orders could play a role in alleviating that anxiety. But Dr Cataldi suggests it’s possible.
“I think standing orders will be important to increasing vaccination rates during a pandemic as they can be used to support delivery of vaccines through public health departments and through vaccine-only nurse visits,” she said.
The research was funded by the Centers for Disease Control and Prevention. The authors had no relevant financial disclosures.
SOURCE: Cataldi J et al. Pediatrics. 2020 Apr;e20191855.
FROM PEDIATRICS
Two rare neurologic conditions linked to COVID-19
A 50-year-old man developed Miller Fisher syndrome and a 39-year-old man developed polyneuritis cranialis. Both are variants of Guillain-Barré syndrome (GBS), which physicians in China and Italy also linked to COVID-19 infection, as previously reported by Medscape Medical News.
In both cases, physicians made the diagnoses based on abnormal eye examinations. The two patients responded to treatment and improved over 2 weeks, with only the 50-year-old featuring residual symptoms of anosmia and ageusia.
The report was published online April 17 in Neurology.
The 50-year-old man was admitted to an emergency room with a temperature of 99.9°F (37.7°C). He reported 2 days of vertical diplopia, perioral paresthesias, and gait instability. His neurologic examination showed intact cognitive function and language.
Five days earlier he developed a cough, malaise, headache, low back pain, fever, anosmia, and ageusia.
His neuro-ophthalmologic examination showed right hypertropia in all fields of gaze, severe limitations to the adduction and downgaze movements of his right eye, and left eye nystagmus on left gaze. These findings were consistent with right internuclear ophthalmoparesis and right fascicular oculomotor palsy.
He responded to intravenous (IV) immunoglobulin therapy and was discharged home 2 weeks after admission.
The 39-year-old man was admitted to the emergency room with acute onset diplopia and ageusia. Three days earlier he had presented with diarrhea, a low-grade fever and in generally poor condition, without any headache, respiratory symptoms, or dyspnea.
He showed esotropia of 10 prism diopters at distance and 4 prism diopters at near, severe abduction deficits in both eyes, and fixation nystagmus, with the upper gaze more impaired, all consistent with bilateral abducens palsy.
The patient was discharged home and treated symptomatically with acetaminophen and telemedicine monitoring “due to a complete hospital saturation with COVID-19 patients,” wrote the researchers, led by Consuelo Gutiérrez-Ortiz, MD, PhD, Hospital Universitario Príncipe de Asturias, Madrid, Spain.
Two weeks later, he had made a complete neurologic recovery with no ageusia, complete eye movements, and normal deep tendon reflexes.
“Fisher syndrome and polyneuritis cranialis in these two patients with the SARS-CoV-2 infection could be simply coincidental. However, taking into account the temporal relationship, we feel that COVID-19 might have been responsible for the development of these two neurological pictures,” the authors noted.
European Regional Development Funds (FEDER) supported this research.
This article first appeared on Medscape.com.
A 50-year-old man developed Miller Fisher syndrome and a 39-year-old man developed polyneuritis cranialis. Both are variants of Guillain-Barré syndrome (GBS), which physicians in China and Italy also linked to COVID-19 infection, as previously reported by Medscape Medical News.
In both cases, physicians made the diagnoses based on abnormal eye examinations. The two patients responded to treatment and improved over 2 weeks, with only the 50-year-old featuring residual symptoms of anosmia and ageusia.
The report was published online April 17 in Neurology.
The 50-year-old man was admitted to an emergency room with a temperature of 99.9°F (37.7°C). He reported 2 days of vertical diplopia, perioral paresthesias, and gait instability. His neurologic examination showed intact cognitive function and language.
Five days earlier he developed a cough, malaise, headache, low back pain, fever, anosmia, and ageusia.
His neuro-ophthalmologic examination showed right hypertropia in all fields of gaze, severe limitations to the adduction and downgaze movements of his right eye, and left eye nystagmus on left gaze. These findings were consistent with right internuclear ophthalmoparesis and right fascicular oculomotor palsy.
He responded to intravenous (IV) immunoglobulin therapy and was discharged home 2 weeks after admission.
The 39-year-old man was admitted to the emergency room with acute onset diplopia and ageusia. Three days earlier he had presented with diarrhea, a low-grade fever and in generally poor condition, without any headache, respiratory symptoms, or dyspnea.
He showed esotropia of 10 prism diopters at distance and 4 prism diopters at near, severe abduction deficits in both eyes, and fixation nystagmus, with the upper gaze more impaired, all consistent with bilateral abducens palsy.
The patient was discharged home and treated symptomatically with acetaminophen and telemedicine monitoring “due to a complete hospital saturation with COVID-19 patients,” wrote the researchers, led by Consuelo Gutiérrez-Ortiz, MD, PhD, Hospital Universitario Príncipe de Asturias, Madrid, Spain.
Two weeks later, he had made a complete neurologic recovery with no ageusia, complete eye movements, and normal deep tendon reflexes.
“Fisher syndrome and polyneuritis cranialis in these two patients with the SARS-CoV-2 infection could be simply coincidental. However, taking into account the temporal relationship, we feel that COVID-19 might have been responsible for the development of these two neurological pictures,” the authors noted.
European Regional Development Funds (FEDER) supported this research.
This article first appeared on Medscape.com.
A 50-year-old man developed Miller Fisher syndrome and a 39-year-old man developed polyneuritis cranialis. Both are variants of Guillain-Barré syndrome (GBS), which physicians in China and Italy also linked to COVID-19 infection, as previously reported by Medscape Medical News.
In both cases, physicians made the diagnoses based on abnormal eye examinations. The two patients responded to treatment and improved over 2 weeks, with only the 50-year-old featuring residual symptoms of anosmia and ageusia.
The report was published online April 17 in Neurology.
The 50-year-old man was admitted to an emergency room with a temperature of 99.9°F (37.7°C). He reported 2 days of vertical diplopia, perioral paresthesias, and gait instability. His neurologic examination showed intact cognitive function and language.
Five days earlier he developed a cough, malaise, headache, low back pain, fever, anosmia, and ageusia.
His neuro-ophthalmologic examination showed right hypertropia in all fields of gaze, severe limitations to the adduction and downgaze movements of his right eye, and left eye nystagmus on left gaze. These findings were consistent with right internuclear ophthalmoparesis and right fascicular oculomotor palsy.
He responded to intravenous (IV) immunoglobulin therapy and was discharged home 2 weeks after admission.
The 39-year-old man was admitted to the emergency room with acute onset diplopia and ageusia. Three days earlier he had presented with diarrhea, a low-grade fever and in generally poor condition, without any headache, respiratory symptoms, or dyspnea.
He showed esotropia of 10 prism diopters at distance and 4 prism diopters at near, severe abduction deficits in both eyes, and fixation nystagmus, with the upper gaze more impaired, all consistent with bilateral abducens palsy.
The patient was discharged home and treated symptomatically with acetaminophen and telemedicine monitoring “due to a complete hospital saturation with COVID-19 patients,” wrote the researchers, led by Consuelo Gutiérrez-Ortiz, MD, PhD, Hospital Universitario Príncipe de Asturias, Madrid, Spain.
Two weeks later, he had made a complete neurologic recovery with no ageusia, complete eye movements, and normal deep tendon reflexes.
“Fisher syndrome and polyneuritis cranialis in these two patients with the SARS-CoV-2 infection could be simply coincidental. However, taking into account the temporal relationship, we feel that COVID-19 might have been responsible for the development of these two neurological pictures,” the authors noted.
European Regional Development Funds (FEDER) supported this research.
This article first appeared on Medscape.com.
Survey: Hydroxychloroquine use fairly common in COVID-19
One of five physicians in front-line treatment roles has prescribed hydroxychloroquine for COVID-19, according to a new survey from health care market research company InCrowd.
The most common treatments were acetaminophen, prescribed to 82% of patients, antibiotics (41%), and bronchodilators (40%), InCrowd said after surveying 203 primary care physicians, pediatricians, and emergency medicine or critical care physicians who are treating at least 20 patients with flulike symptoms.
On April 24, the Food and Drug Administration warned against the use of hydroxychloroquine or chloroquine outside of hospitals and clinical trials.
The InCrowd survey, which took place April 14-15 and is the fourth in a series investigating COVID-19’s impact on physicians, showed that access to testing was up to 82% in mid-April, compared with 67% in March and 20% in late February. The April respondents also were twice as likely (59% vs. 24% in March) to say that their facilities were prepared to treat patients, InCrowd reported.
“U.S. physicians report sluggish optimism around preparedness, safety, and institutional efforts, while many worry about the future, including a second outbreak and job security,” the company said in a separate written statement.
The average estimate for a return to normal was just over 6 months among respondents, and only 28% believed that their facility was prepared for a second outbreak later in the year, InCrowd noted.
On a personal level, 45% of the respondents were concerned about the safety of their job. An emergency/critical care physician from Tennessee said, “We’ve been cutting back on staff due to overall revenue reductions, but have increased acuity and complexity which requires more staffing. This puts even more of a burden on those of us still here.”
Support for institutional responses to slow the pandemic was strongest for state governments, which gained approval from 54% of front-line physicians, up from 33% in March. Actions taken by the federal government were supported by 21% of respondents, compared with 38% for the World Health Organization and 46% for governments outside the United States, InCrowd reported.
Suggestions for further actions by state and local authorities included this comment from an emergency/critical care physician in Florida: “Continued, broad and properly enforced stay at home and social distancing measures MUST remain in place to keep citizens and healthcare workers safe, and the latter alive and in adequate supply.”
One of five physicians in front-line treatment roles has prescribed hydroxychloroquine for COVID-19, according to a new survey from health care market research company InCrowd.
The most common treatments were acetaminophen, prescribed to 82% of patients, antibiotics (41%), and bronchodilators (40%), InCrowd said after surveying 203 primary care physicians, pediatricians, and emergency medicine or critical care physicians who are treating at least 20 patients with flulike symptoms.
On April 24, the Food and Drug Administration warned against the use of hydroxychloroquine or chloroquine outside of hospitals and clinical trials.
The InCrowd survey, which took place April 14-15 and is the fourth in a series investigating COVID-19’s impact on physicians, showed that access to testing was up to 82% in mid-April, compared with 67% in March and 20% in late February. The April respondents also were twice as likely (59% vs. 24% in March) to say that their facilities were prepared to treat patients, InCrowd reported.
“U.S. physicians report sluggish optimism around preparedness, safety, and institutional efforts, while many worry about the future, including a second outbreak and job security,” the company said in a separate written statement.
The average estimate for a return to normal was just over 6 months among respondents, and only 28% believed that their facility was prepared for a second outbreak later in the year, InCrowd noted.
On a personal level, 45% of the respondents were concerned about the safety of their job. An emergency/critical care physician from Tennessee said, “We’ve been cutting back on staff due to overall revenue reductions, but have increased acuity and complexity which requires more staffing. This puts even more of a burden on those of us still here.”
Support for institutional responses to slow the pandemic was strongest for state governments, which gained approval from 54% of front-line physicians, up from 33% in March. Actions taken by the federal government were supported by 21% of respondents, compared with 38% for the World Health Organization and 46% for governments outside the United States, InCrowd reported.
Suggestions for further actions by state and local authorities included this comment from an emergency/critical care physician in Florida: “Continued, broad and properly enforced stay at home and social distancing measures MUST remain in place to keep citizens and healthcare workers safe, and the latter alive and in adequate supply.”
One of five physicians in front-line treatment roles has prescribed hydroxychloroquine for COVID-19, according to a new survey from health care market research company InCrowd.
The most common treatments were acetaminophen, prescribed to 82% of patients, antibiotics (41%), and bronchodilators (40%), InCrowd said after surveying 203 primary care physicians, pediatricians, and emergency medicine or critical care physicians who are treating at least 20 patients with flulike symptoms.
On April 24, the Food and Drug Administration warned against the use of hydroxychloroquine or chloroquine outside of hospitals and clinical trials.
The InCrowd survey, which took place April 14-15 and is the fourth in a series investigating COVID-19’s impact on physicians, showed that access to testing was up to 82% in mid-April, compared with 67% in March and 20% in late February. The April respondents also were twice as likely (59% vs. 24% in March) to say that their facilities were prepared to treat patients, InCrowd reported.
“U.S. physicians report sluggish optimism around preparedness, safety, and institutional efforts, while many worry about the future, including a second outbreak and job security,” the company said in a separate written statement.
The average estimate for a return to normal was just over 6 months among respondents, and only 28% believed that their facility was prepared for a second outbreak later in the year, InCrowd noted.
On a personal level, 45% of the respondents were concerned about the safety of their job. An emergency/critical care physician from Tennessee said, “We’ve been cutting back on staff due to overall revenue reductions, but have increased acuity and complexity which requires more staffing. This puts even more of a burden on those of us still here.”
Support for institutional responses to slow the pandemic was strongest for state governments, which gained approval from 54% of front-line physicians, up from 33% in March. Actions taken by the federal government were supported by 21% of respondents, compared with 38% for the World Health Organization and 46% for governments outside the United States, InCrowd reported.
Suggestions for further actions by state and local authorities included this comment from an emergency/critical care physician in Florida: “Continued, broad and properly enforced stay at home and social distancing measures MUST remain in place to keep citizens and healthcare workers safe, and the latter alive and in adequate supply.”
COVID-19: No U.S. spike expected in pandemic-related suicidal ideation
Americans are not feeling more suicidal even in the depths of the COVID-19 pandemic of spring 2020, according to analysis of real-time national data accrued through the Crisis Text Line.
But that’s not to say Americans are feeling less distressed. Quite the contrary, Nancy Lublin, CEO and cofounder of Crisis Text Line, noted at the virtual annual meeting of the American Association of Suicidology.
“We’ve seen a 40% increase in volume since early March. Seventy-eight percent of our conversations are now including words like ‘freaked out,’ ‘panicked,’ ‘scared.’ People are worried about COVID-19. They’re nervous about symptoms; they’re concerned for family on the front lines,” she said.
And yet, from mid-March through mid-April, only 22% of texters to the crisis line expressed suicidal ideation, down from a usual background rate of 28%. Moreover, just 13% of texters who mentioned ‘COVID,’ ‘quarantine,’ or ‘virus’ expressed suicidal ideation, compared with 25% of other texters.
Ms. Lublin and her data crunchers are tracking not only the impact of the disease, but they’re also monitoring the mental health effects of the quarantine and social distancing.
“People are away from their routines, and perhaps [are] quarantined with abusive people. We’ve seen a 48% increase in texts involving sexual abuse and a 74% increase in domestic violence,” she said.
Texts focused on eating disorders or body image issues have jumped by 45%. And roughly two-thirds of texters now describe feelings of depression.
One of the biggest mental health impacts she and colleagues have seen stem from the economic recession triggered by the pandemic.
“We’ve seen more people reach out with fears of bankruptcy, fears of homelessness, fears of financial ruin. Thirty-two percent of our texters now report household incomes under $20,000 per year. That’s up from 19% before,” according to Ms. Lublin.
The Crisis Text Line (text HOME to 741741) uses machine-learning algorithms that sift through incoming text messages from people in crisis for key words, then ranks the messages by severity. Since its launch in 2013, this service, available 24/7, has processed roughly 150 million text messages. The high-risk texters – for example, someone who’s swallowed a bottle of pills or is texting from the San Francisco’s Golden Gate Bridge, as has occurred some 500 times – are connected in an average of 24 seconds with a thoroughly trained volunteer crisis counselor. And there is a third party in these texting conversations: a paid staff supervisor with a master’s degree in a relevant discipline who follows the encounter in real time and can step in if needed.
“Active rescues are involved in less than 1% of our conversations, but still we do them on average 26 times per day. Over the years, we’ve completed more than 32,000 active rescues,” she said.
The Crisis Text Line is not exclusively a suicide prevention hotline. The top five issues people text about involve relationship concerns, depression, anxiety, self-harm, and suicidal ideation. Over time, Ms. Lublin and staff have used Big Data to tweak the screening algorithm as they’ve identified even higher red flag texting words than “suicide.”
“The word ‘military’ makes it twice as likely that we’ll have to call 9-1-1 than the word ‘suicide.’ ‘Gun,’ ‘rope’ – four times as likely. In the [United KIngdom], where we’re also operating, we see the word ‘cliff’ is a more lethal word than the word ‘suicide.’ But the most dangerous words that we see are any named pill,” she said.
The Crisis Text Line was recently awarded a 2020 TED Audacious Project grant to expand their services from English to also be offered in Spanish, French, Portuguese, and Arabic worldwide within the next two and a half years. This will provide coverage to one-third of the world’s population, including people with cell phones living in countries with very limited mental health services.
Will COVID-19 trigger a spike in deaths by suicide?
Whether the COVID-19 pandemic will result in a bump in suicide rates is unclear and will remain so for quite a while, according to David Gunnell, MD, PhD, a suicidologist and professor of epidemiology at the University of Bristol (England).
In the United Kingdom, investigation of a suspicious death typically takes more than 6 months before an official declaration of suicide is recorded by the medical examiner. The lag time is even longer in the United States: The latest national suicide rate data are for 2018 because state-by-state reporting practices vary widely, he noted at a National Press Foundation briefing on COVID-19 and mental health.
Although suicide is consistently the 10th-leading cause of death in the United States, it’s important to put it in perspective, he added. In 2018, there were an average of 4,000 deaths by suicide per month nationally, whereas in March and April of 2020, there were 28,400 deaths per month attributable to COVID-19.
A classic study of the Spanish influenza pandemic in the United States during 1918-1919 concluded that there was “a slight upturn” in the rate of suicide in the months following the pandemic’s peak. More recently, a study of the 2003 SARS (severe acute respiratory syndrome) epidemic in Hong Kong found roughly a 30% increase in the rate of suicide among the elderly during that time frame, Dr. Gunnell noted.
“What limited evidence there is provides an indication of a small rise in suicides, but the number of deaths is far outweighed by the number of deaths associated with these big pandemics,” according to the epidemiologist.
Pandemics aside, there is far more compelling evidence that periods of economic recession are associated with an increase in the suicide rate, he added.
Another speaker, Holly C. Wilcox, PhD, a psychiatric epidemiologist at Johns Hopkins University, Baltimore, commented: “It’s not surprising that, during times of disaster the suicide rates decrease a bit. It could be because of people coming toghether. It could be one silver lining of COVID-19. But if there’s prolonged stress economically and socially and we can’t work towards reducing stress for people, we could see an increase. I don’t know if we will.”
In a recent article, Dr. Gunnell and coauthors offered a series of recommendations aimed at blunting the mental health consequences of COVID-19 and the related economic fallout (Lancet Psychiatry. 2020 Apr 21. doi: 10.1016/S2215-0366[20]30171-1).
The authors highlighted the need for interventions aimed at defusing the adverse impact of self-isolation, social distancing, fear, an anticipated rise in alcohol misuse, joblessness, interrupted education, bereavement, and complicated grief. Governments can blunt the well-established effect of financial distress as a risk factor for suicide by providing safety nets in the form of supports for housing, food, and unemployment benefits. And it will be important that those mental health services that develop expertise in performing psychiatric assessments and interventions remotely via telemedicine share their insights, Dr. Gunnell said.
Americans are not feeling more suicidal even in the depths of the COVID-19 pandemic of spring 2020, according to analysis of real-time national data accrued through the Crisis Text Line.
But that’s not to say Americans are feeling less distressed. Quite the contrary, Nancy Lublin, CEO and cofounder of Crisis Text Line, noted at the virtual annual meeting of the American Association of Suicidology.
“We’ve seen a 40% increase in volume since early March. Seventy-eight percent of our conversations are now including words like ‘freaked out,’ ‘panicked,’ ‘scared.’ People are worried about COVID-19. They’re nervous about symptoms; they’re concerned for family on the front lines,” she said.
And yet, from mid-March through mid-April, only 22% of texters to the crisis line expressed suicidal ideation, down from a usual background rate of 28%. Moreover, just 13% of texters who mentioned ‘COVID,’ ‘quarantine,’ or ‘virus’ expressed suicidal ideation, compared with 25% of other texters.
Ms. Lublin and her data crunchers are tracking not only the impact of the disease, but they’re also monitoring the mental health effects of the quarantine and social distancing.
“People are away from their routines, and perhaps [are] quarantined with abusive people. We’ve seen a 48% increase in texts involving sexual abuse and a 74% increase in domestic violence,” she said.
Texts focused on eating disorders or body image issues have jumped by 45%. And roughly two-thirds of texters now describe feelings of depression.
One of the biggest mental health impacts she and colleagues have seen stem from the economic recession triggered by the pandemic.
“We’ve seen more people reach out with fears of bankruptcy, fears of homelessness, fears of financial ruin. Thirty-two percent of our texters now report household incomes under $20,000 per year. That’s up from 19% before,” according to Ms. Lublin.
The Crisis Text Line (text HOME to 741741) uses machine-learning algorithms that sift through incoming text messages from people in crisis for key words, then ranks the messages by severity. Since its launch in 2013, this service, available 24/7, has processed roughly 150 million text messages. The high-risk texters – for example, someone who’s swallowed a bottle of pills or is texting from the San Francisco’s Golden Gate Bridge, as has occurred some 500 times – are connected in an average of 24 seconds with a thoroughly trained volunteer crisis counselor. And there is a third party in these texting conversations: a paid staff supervisor with a master’s degree in a relevant discipline who follows the encounter in real time and can step in if needed.
“Active rescues are involved in less than 1% of our conversations, but still we do them on average 26 times per day. Over the years, we’ve completed more than 32,000 active rescues,” she said.
The Crisis Text Line is not exclusively a suicide prevention hotline. The top five issues people text about involve relationship concerns, depression, anxiety, self-harm, and suicidal ideation. Over time, Ms. Lublin and staff have used Big Data to tweak the screening algorithm as they’ve identified even higher red flag texting words than “suicide.”
“The word ‘military’ makes it twice as likely that we’ll have to call 9-1-1 than the word ‘suicide.’ ‘Gun,’ ‘rope’ – four times as likely. In the [United KIngdom], where we’re also operating, we see the word ‘cliff’ is a more lethal word than the word ‘suicide.’ But the most dangerous words that we see are any named pill,” she said.
The Crisis Text Line was recently awarded a 2020 TED Audacious Project grant to expand their services from English to also be offered in Spanish, French, Portuguese, and Arabic worldwide within the next two and a half years. This will provide coverage to one-third of the world’s population, including people with cell phones living in countries with very limited mental health services.
Will COVID-19 trigger a spike in deaths by suicide?
Whether the COVID-19 pandemic will result in a bump in suicide rates is unclear and will remain so for quite a while, according to David Gunnell, MD, PhD, a suicidologist and professor of epidemiology at the University of Bristol (England).
In the United Kingdom, investigation of a suspicious death typically takes more than 6 months before an official declaration of suicide is recorded by the medical examiner. The lag time is even longer in the United States: The latest national suicide rate data are for 2018 because state-by-state reporting practices vary widely, he noted at a National Press Foundation briefing on COVID-19 and mental health.
Although suicide is consistently the 10th-leading cause of death in the United States, it’s important to put it in perspective, he added. In 2018, there were an average of 4,000 deaths by suicide per month nationally, whereas in March and April of 2020, there were 28,400 deaths per month attributable to COVID-19.
A classic study of the Spanish influenza pandemic in the United States during 1918-1919 concluded that there was “a slight upturn” in the rate of suicide in the months following the pandemic’s peak. More recently, a study of the 2003 SARS (severe acute respiratory syndrome) epidemic in Hong Kong found roughly a 30% increase in the rate of suicide among the elderly during that time frame, Dr. Gunnell noted.
“What limited evidence there is provides an indication of a small rise in suicides, but the number of deaths is far outweighed by the number of deaths associated with these big pandemics,” according to the epidemiologist.
Pandemics aside, there is far more compelling evidence that periods of economic recession are associated with an increase in the suicide rate, he added.
Another speaker, Holly C. Wilcox, PhD, a psychiatric epidemiologist at Johns Hopkins University, Baltimore, commented: “It’s not surprising that, during times of disaster the suicide rates decrease a bit. It could be because of people coming toghether. It could be one silver lining of COVID-19. But if there’s prolonged stress economically and socially and we can’t work towards reducing stress for people, we could see an increase. I don’t know if we will.”
In a recent article, Dr. Gunnell and coauthors offered a series of recommendations aimed at blunting the mental health consequences of COVID-19 and the related economic fallout (Lancet Psychiatry. 2020 Apr 21. doi: 10.1016/S2215-0366[20]30171-1).
The authors highlighted the need for interventions aimed at defusing the adverse impact of self-isolation, social distancing, fear, an anticipated rise in alcohol misuse, joblessness, interrupted education, bereavement, and complicated grief. Governments can blunt the well-established effect of financial distress as a risk factor for suicide by providing safety nets in the form of supports for housing, food, and unemployment benefits. And it will be important that those mental health services that develop expertise in performing psychiatric assessments and interventions remotely via telemedicine share their insights, Dr. Gunnell said.
Americans are not feeling more suicidal even in the depths of the COVID-19 pandemic of spring 2020, according to analysis of real-time national data accrued through the Crisis Text Line.
But that’s not to say Americans are feeling less distressed. Quite the contrary, Nancy Lublin, CEO and cofounder of Crisis Text Line, noted at the virtual annual meeting of the American Association of Suicidology.
“We’ve seen a 40% increase in volume since early March. Seventy-eight percent of our conversations are now including words like ‘freaked out,’ ‘panicked,’ ‘scared.’ People are worried about COVID-19. They’re nervous about symptoms; they’re concerned for family on the front lines,” she said.
And yet, from mid-March through mid-April, only 22% of texters to the crisis line expressed suicidal ideation, down from a usual background rate of 28%. Moreover, just 13% of texters who mentioned ‘COVID,’ ‘quarantine,’ or ‘virus’ expressed suicidal ideation, compared with 25% of other texters.
Ms. Lublin and her data crunchers are tracking not only the impact of the disease, but they’re also monitoring the mental health effects of the quarantine and social distancing.
“People are away from their routines, and perhaps [are] quarantined with abusive people. We’ve seen a 48% increase in texts involving sexual abuse and a 74% increase in domestic violence,” she said.
Texts focused on eating disorders or body image issues have jumped by 45%. And roughly two-thirds of texters now describe feelings of depression.
One of the biggest mental health impacts she and colleagues have seen stem from the economic recession triggered by the pandemic.
“We’ve seen more people reach out with fears of bankruptcy, fears of homelessness, fears of financial ruin. Thirty-two percent of our texters now report household incomes under $20,000 per year. That’s up from 19% before,” according to Ms. Lublin.
The Crisis Text Line (text HOME to 741741) uses machine-learning algorithms that sift through incoming text messages from people in crisis for key words, then ranks the messages by severity. Since its launch in 2013, this service, available 24/7, has processed roughly 150 million text messages. The high-risk texters – for example, someone who’s swallowed a bottle of pills or is texting from the San Francisco’s Golden Gate Bridge, as has occurred some 500 times – are connected in an average of 24 seconds with a thoroughly trained volunteer crisis counselor. And there is a third party in these texting conversations: a paid staff supervisor with a master’s degree in a relevant discipline who follows the encounter in real time and can step in if needed.
“Active rescues are involved in less than 1% of our conversations, but still we do them on average 26 times per day. Over the years, we’ve completed more than 32,000 active rescues,” she said.
The Crisis Text Line is not exclusively a suicide prevention hotline. The top five issues people text about involve relationship concerns, depression, anxiety, self-harm, and suicidal ideation. Over time, Ms. Lublin and staff have used Big Data to tweak the screening algorithm as they’ve identified even higher red flag texting words than “suicide.”
“The word ‘military’ makes it twice as likely that we’ll have to call 9-1-1 than the word ‘suicide.’ ‘Gun,’ ‘rope’ – four times as likely. In the [United KIngdom], where we’re also operating, we see the word ‘cliff’ is a more lethal word than the word ‘suicide.’ But the most dangerous words that we see are any named pill,” she said.
The Crisis Text Line was recently awarded a 2020 TED Audacious Project grant to expand their services from English to also be offered in Spanish, French, Portuguese, and Arabic worldwide within the next two and a half years. This will provide coverage to one-third of the world’s population, including people with cell phones living in countries with very limited mental health services.
Will COVID-19 trigger a spike in deaths by suicide?
Whether the COVID-19 pandemic will result in a bump in suicide rates is unclear and will remain so for quite a while, according to David Gunnell, MD, PhD, a suicidologist and professor of epidemiology at the University of Bristol (England).
In the United Kingdom, investigation of a suspicious death typically takes more than 6 months before an official declaration of suicide is recorded by the medical examiner. The lag time is even longer in the United States: The latest national suicide rate data are for 2018 because state-by-state reporting practices vary widely, he noted at a National Press Foundation briefing on COVID-19 and mental health.
Although suicide is consistently the 10th-leading cause of death in the United States, it’s important to put it in perspective, he added. In 2018, there were an average of 4,000 deaths by suicide per month nationally, whereas in March and April of 2020, there were 28,400 deaths per month attributable to COVID-19.
A classic study of the Spanish influenza pandemic in the United States during 1918-1919 concluded that there was “a slight upturn” in the rate of suicide in the months following the pandemic’s peak. More recently, a study of the 2003 SARS (severe acute respiratory syndrome) epidemic in Hong Kong found roughly a 30% increase in the rate of suicide among the elderly during that time frame, Dr. Gunnell noted.
“What limited evidence there is provides an indication of a small rise in suicides, but the number of deaths is far outweighed by the number of deaths associated with these big pandemics,” according to the epidemiologist.
Pandemics aside, there is far more compelling evidence that periods of economic recession are associated with an increase in the suicide rate, he added.
Another speaker, Holly C. Wilcox, PhD, a psychiatric epidemiologist at Johns Hopkins University, Baltimore, commented: “It’s not surprising that, during times of disaster the suicide rates decrease a bit. It could be because of people coming toghether. It could be one silver lining of COVID-19. But if there’s prolonged stress economically and socially and we can’t work towards reducing stress for people, we could see an increase. I don’t know if we will.”
In a recent article, Dr. Gunnell and coauthors offered a series of recommendations aimed at blunting the mental health consequences of COVID-19 and the related economic fallout (Lancet Psychiatry. 2020 Apr 21. doi: 10.1016/S2215-0366[20]30171-1).
The authors highlighted the need for interventions aimed at defusing the adverse impact of self-isolation, social distancing, fear, an anticipated rise in alcohol misuse, joblessness, interrupted education, bereavement, and complicated grief. Governments can blunt the well-established effect of financial distress as a risk factor for suicide by providing safety nets in the form of supports for housing, food, and unemployment benefits. And it will be important that those mental health services that develop expertise in performing psychiatric assessments and interventions remotely via telemedicine share their insights, Dr. Gunnell said.
FROM AAS 2020
COVID-19: Calls to NYC crisis hotline soar
Calls to a mental health crisis hotline in New York City have soared during the COVID-19 pandemic, which has closed schools and businesses, put millions out of work, and ushered in stay-at-home orders.
ensuring that care is available when and where needed during a crisis, whether that be an individual crisis, a local community crisis, or a national mental health crisis like we are facing right now,” said Kimberly Williams, president and CEO of Vibrant Emotional Health.
Vibrant Emotional Health, formerly the Mental Health Association of New York City, provides crisis line services across the United States in partnership with local and federal governments and corporations. NYC Well is one of them.
Ms. Williams and two of her colleagues spoke about crisis hotlines April 25 during the American Psychiatric Association’s Virtual Spring Highlights Meeting.
Rapid crisis intervention
Crisis hotlines provide “rapid crisis intervention, delivering help immediately from trained crisis counselors who respond to unique needs, actively engage in collaborative problem solving, and assess risk for suicide,” Ms. Williams said.
They have a proven track record, she noted. Research shows that they are able to decrease emotional distress and reduce suicidality in crisis situations.
Kelly Clarke, program director of NYC Well, noted that inbound call volume has increased roughly 50% since the COVID-19 pandemic hit.
Callers to NYC Well most commonly report mood/anxiety concerns, stressful life events, and interpersonal problems. “Many people are reaching out to seek support in how to manage their own emotional well-being in light of the pandemic and the restrictions put in place,” said Ms. Clarke.
Multilingual peer support specialists and counselors with NYC Well provide free, confidential support by talk, text, or chat 24 hours per day, 7 days per week, 365 days a year. The service also provides mobile crisis teams and follow-up services. NYC Well has set up a landing page of resources specifically geared toward COVID-19.
How to cope with the rapid growth and at the same time ensure high quality of services are two key challenges for NYC Well, Ms. Clarke said.
“Absolutely essential” service
For John Draper, PhD, the experience early in his career of working on a mobile mental health crisis team in Brooklyn “changed his life.”
First, it showed him that, for people who are severely psychiatrically ill, “care has to come to them,” said Dr. Draper, executive vice president of national networks for Vibrant Emotional Health.
“So many of the people we were seeing were too depressed to get out of bed, much less get to a clinic, and I realized our system was not set up to serve its customers. It was like putting a spinal cord injury clinic at the top of a stairs,” he said.
Crisis hotlines are “absolutely essential.” Their value for communities and individuals “can’t be overestimated,” said Dr. Draper.
This was revealed after the terrorist attacks of 9/11 and now with COVID-19, said Dr. Draper. He noted, that following the attacks of 9/11, a federal report referred to crisis hotlines as “the single most important asset in the response.”
A version of this article originally appeared on Medscape.com.
Calls to a mental health crisis hotline in New York City have soared during the COVID-19 pandemic, which has closed schools and businesses, put millions out of work, and ushered in stay-at-home orders.
ensuring that care is available when and where needed during a crisis, whether that be an individual crisis, a local community crisis, or a national mental health crisis like we are facing right now,” said Kimberly Williams, president and CEO of Vibrant Emotional Health.
Vibrant Emotional Health, formerly the Mental Health Association of New York City, provides crisis line services across the United States in partnership with local and federal governments and corporations. NYC Well is one of them.
Ms. Williams and two of her colleagues spoke about crisis hotlines April 25 during the American Psychiatric Association’s Virtual Spring Highlights Meeting.
Rapid crisis intervention
Crisis hotlines provide “rapid crisis intervention, delivering help immediately from trained crisis counselors who respond to unique needs, actively engage in collaborative problem solving, and assess risk for suicide,” Ms. Williams said.
They have a proven track record, she noted. Research shows that they are able to decrease emotional distress and reduce suicidality in crisis situations.
Kelly Clarke, program director of NYC Well, noted that inbound call volume has increased roughly 50% since the COVID-19 pandemic hit.
Callers to NYC Well most commonly report mood/anxiety concerns, stressful life events, and interpersonal problems. “Many people are reaching out to seek support in how to manage their own emotional well-being in light of the pandemic and the restrictions put in place,” said Ms. Clarke.
Multilingual peer support specialists and counselors with NYC Well provide free, confidential support by talk, text, or chat 24 hours per day, 7 days per week, 365 days a year. The service also provides mobile crisis teams and follow-up services. NYC Well has set up a landing page of resources specifically geared toward COVID-19.
How to cope with the rapid growth and at the same time ensure high quality of services are two key challenges for NYC Well, Ms. Clarke said.
“Absolutely essential” service
For John Draper, PhD, the experience early in his career of working on a mobile mental health crisis team in Brooklyn “changed his life.”
First, it showed him that, for people who are severely psychiatrically ill, “care has to come to them,” said Dr. Draper, executive vice president of national networks for Vibrant Emotional Health.
“So many of the people we were seeing were too depressed to get out of bed, much less get to a clinic, and I realized our system was not set up to serve its customers. It was like putting a spinal cord injury clinic at the top of a stairs,” he said.
Crisis hotlines are “absolutely essential.” Their value for communities and individuals “can’t be overestimated,” said Dr. Draper.
This was revealed after the terrorist attacks of 9/11 and now with COVID-19, said Dr. Draper. He noted, that following the attacks of 9/11, a federal report referred to crisis hotlines as “the single most important asset in the response.”
A version of this article originally appeared on Medscape.com.
Calls to a mental health crisis hotline in New York City have soared during the COVID-19 pandemic, which has closed schools and businesses, put millions out of work, and ushered in stay-at-home orders.
ensuring that care is available when and where needed during a crisis, whether that be an individual crisis, a local community crisis, or a national mental health crisis like we are facing right now,” said Kimberly Williams, president and CEO of Vibrant Emotional Health.
Vibrant Emotional Health, formerly the Mental Health Association of New York City, provides crisis line services across the United States in partnership with local and federal governments and corporations. NYC Well is one of them.
Ms. Williams and two of her colleagues spoke about crisis hotlines April 25 during the American Psychiatric Association’s Virtual Spring Highlights Meeting.
Rapid crisis intervention
Crisis hotlines provide “rapid crisis intervention, delivering help immediately from trained crisis counselors who respond to unique needs, actively engage in collaborative problem solving, and assess risk for suicide,” Ms. Williams said.
They have a proven track record, she noted. Research shows that they are able to decrease emotional distress and reduce suicidality in crisis situations.
Kelly Clarke, program director of NYC Well, noted that inbound call volume has increased roughly 50% since the COVID-19 pandemic hit.
Callers to NYC Well most commonly report mood/anxiety concerns, stressful life events, and interpersonal problems. “Many people are reaching out to seek support in how to manage their own emotional well-being in light of the pandemic and the restrictions put in place,” said Ms. Clarke.
Multilingual peer support specialists and counselors with NYC Well provide free, confidential support by talk, text, or chat 24 hours per day, 7 days per week, 365 days a year. The service also provides mobile crisis teams and follow-up services. NYC Well has set up a landing page of resources specifically geared toward COVID-19.
How to cope with the rapid growth and at the same time ensure high quality of services are two key challenges for NYC Well, Ms. Clarke said.
“Absolutely essential” service
For John Draper, PhD, the experience early in his career of working on a mobile mental health crisis team in Brooklyn “changed his life.”
First, it showed him that, for people who are severely psychiatrically ill, “care has to come to them,” said Dr. Draper, executive vice president of national networks for Vibrant Emotional Health.
“So many of the people we were seeing were too depressed to get out of bed, much less get to a clinic, and I realized our system was not set up to serve its customers. It was like putting a spinal cord injury clinic at the top of a stairs,” he said.
Crisis hotlines are “absolutely essential.” Their value for communities and individuals “can’t be overestimated,” said Dr. Draper.
This was revealed after the terrorist attacks of 9/11 and now with COVID-19, said Dr. Draper. He noted, that following the attacks of 9/11, a federal report referred to crisis hotlines as “the single most important asset in the response.”
A version of this article originally appeared on Medscape.com.
Volunteer surgeon describes working at a New York hospital
In an April 18 Twitter post, Dr. Salles wrote that her unit had experienced three code blues and two deaths in a single night.
“I don’t know how many times I’ve called to tell someone their loved one has died,” she wrote in the post. “I had to do it again last night. ... Of the five patients I’ve personally been responsible for in the past two nights, two have come so close to dying that we called a code blue. That means 40% of my patients have coded. Never in my life has anything close to that happened,” she continued in the thread.
Dr. Salles, a minimally invasive and bariatric surgeon and scholar in residence at Stanford (Calif.) University, headed to New York in mid-April to assist with COVID-19 treatment efforts. Before the trip, she collected as many supplies and as much personal protective equipment as she could acquire, some of which were donated by Good Samaritans. On her first day as a volunteer, Dr. Salles recounted the stark differences between what she is used to seeing and her new environment and the novel challenges she has encountered in New York.
“Things that were not normal now seem normal,” she wrote in an April 15 Twitter post. “ICU patients in [a postanesthesia care unit] and Preop is the new normal. Patients satting in the 70s and 80s seems normal. ICU docs managing [continuous veno-venous hemodialysis] seems normal. Working with strangers seems normal. ... Obviously everyone walking around with barely any skin exposed is also the new normal.”
Similar to a “normal” ICU, new patients are admitted daily, Dr. Salles noted. However, the majority of those who leave the ICU do not go home, she wrote.
“Almost all of the ones who leave are doing so because they’ve died rather than getting better,” she wrote in the same April 19 Twitter thread. “There is a pervasive feeling of helplessness. ... The tools we are working with seem insufficient. For the sickest patients, there are no ventilator settings that seem to work, there are no medications that seem to help. I am not used to this.”
When patients are close to dying, health care workers do their best to connect the patient to loved ones through video calls, watching as family members say their last goodbyes through a screen, Dr. Salles detailed in a later post.
“Their voices cracked, and though they weren’t speaking English, I could hear their pain,” she wrote in an April 20 Twitter post. “For a moment, I imagined having to say goodbye to my mother this way. To not be able to be there, to not be able to hold her hand, to not be able to hug her. And I watched my colleague, who amazingly kept her composure until they had said everything they wanted to say. It was only after they hung up that I saw the tears well up in her eyes.”
But amid the dark days and bleak outcomes, Dr. Salles has found silver linings, humor, and gifts for which to be thankful.
“People are really generous,” she wrote in an April 15 post. “So many have offered to pay for transportation. Other docs in NY have offered to help me with supplies (and I am paying it forward). Grateful to you all!”
In another post, Dr. Salles joked that her “small head” makes it difficult to wear PPE.
“Wearing an N95 for hours really sucks,” she wrote. “It rides up, I pull it down. It digs into my cheeks, I pull it up. Repeat.”
The volunteer experience thus far has also made Dr. Salles question the future and worry about the mental health of her fellow health care professionals.
“The people who have been in NYC since the beginning of this, and those who work in Lombardy, Italy, and in Wuhan, China have faced loss for weeks to months,” she wrote in an April 18 Twitter post. “Not only do we not know when this will end, but it is likely that after it fades, it will come back in a second wave. I am lucky. I’m just a visitor here. I have the privilege to observe and learn and hopefully help, knowing I will be able to walk away. But what about those who can’t walk away? Social distancing is starting to work. But for healthcare workers, the ongoing devastation is very real. What is our long term plan?”
Dr. Salles expressed concern for health care workers who are witnessing “horrible things” with little time to process the experiences.
“It may be especially hard for those who are now working in specialties they are not used to, having to provide care they are not familiar with. They are all doing their best, but inevitably mistakes will be made, and they will likely blame themselves,” she wrote. “How do we best support them?”
Stay tuned for upcoming commentaries from Dr. Salles on her COVID-19 volunteer experience in New York City.
In an April 18 Twitter post, Dr. Salles wrote that her unit had experienced three code blues and two deaths in a single night.
“I don’t know how many times I’ve called to tell someone their loved one has died,” she wrote in the post. “I had to do it again last night. ... Of the five patients I’ve personally been responsible for in the past two nights, two have come so close to dying that we called a code blue. That means 40% of my patients have coded. Never in my life has anything close to that happened,” she continued in the thread.
Dr. Salles, a minimally invasive and bariatric surgeon and scholar in residence at Stanford (Calif.) University, headed to New York in mid-April to assist with COVID-19 treatment efforts. Before the trip, she collected as many supplies and as much personal protective equipment as she could acquire, some of which were donated by Good Samaritans. On her first day as a volunteer, Dr. Salles recounted the stark differences between what she is used to seeing and her new environment and the novel challenges she has encountered in New York.
“Things that were not normal now seem normal,” she wrote in an April 15 Twitter post. “ICU patients in [a postanesthesia care unit] and Preop is the new normal. Patients satting in the 70s and 80s seems normal. ICU docs managing [continuous veno-venous hemodialysis] seems normal. Working with strangers seems normal. ... Obviously everyone walking around with barely any skin exposed is also the new normal.”
Similar to a “normal” ICU, new patients are admitted daily, Dr. Salles noted. However, the majority of those who leave the ICU do not go home, she wrote.
“Almost all of the ones who leave are doing so because they’ve died rather than getting better,” she wrote in the same April 19 Twitter thread. “There is a pervasive feeling of helplessness. ... The tools we are working with seem insufficient. For the sickest patients, there are no ventilator settings that seem to work, there are no medications that seem to help. I am not used to this.”
When patients are close to dying, health care workers do their best to connect the patient to loved ones through video calls, watching as family members say their last goodbyes through a screen, Dr. Salles detailed in a later post.
“Their voices cracked, and though they weren’t speaking English, I could hear their pain,” she wrote in an April 20 Twitter post. “For a moment, I imagined having to say goodbye to my mother this way. To not be able to be there, to not be able to hold her hand, to not be able to hug her. And I watched my colleague, who amazingly kept her composure until they had said everything they wanted to say. It was only after they hung up that I saw the tears well up in her eyes.”
But amid the dark days and bleak outcomes, Dr. Salles has found silver linings, humor, and gifts for which to be thankful.
“People are really generous,” she wrote in an April 15 post. “So many have offered to pay for transportation. Other docs in NY have offered to help me with supplies (and I am paying it forward). Grateful to you all!”
In another post, Dr. Salles joked that her “small head” makes it difficult to wear PPE.
“Wearing an N95 for hours really sucks,” she wrote. “It rides up, I pull it down. It digs into my cheeks, I pull it up. Repeat.”
The volunteer experience thus far has also made Dr. Salles question the future and worry about the mental health of her fellow health care professionals.
“The people who have been in NYC since the beginning of this, and those who work in Lombardy, Italy, and in Wuhan, China have faced loss for weeks to months,” she wrote in an April 18 Twitter post. “Not only do we not know when this will end, but it is likely that after it fades, it will come back in a second wave. I am lucky. I’m just a visitor here. I have the privilege to observe and learn and hopefully help, knowing I will be able to walk away. But what about those who can’t walk away? Social distancing is starting to work. But for healthcare workers, the ongoing devastation is very real. What is our long term plan?”
Dr. Salles expressed concern for health care workers who are witnessing “horrible things” with little time to process the experiences.
“It may be especially hard for those who are now working in specialties they are not used to, having to provide care they are not familiar with. They are all doing their best, but inevitably mistakes will be made, and they will likely blame themselves,” she wrote. “How do we best support them?”
Stay tuned for upcoming commentaries from Dr. Salles on her COVID-19 volunteer experience in New York City.
In an April 18 Twitter post, Dr. Salles wrote that her unit had experienced three code blues and two deaths in a single night.
“I don’t know how many times I’ve called to tell someone their loved one has died,” she wrote in the post. “I had to do it again last night. ... Of the five patients I’ve personally been responsible for in the past two nights, two have come so close to dying that we called a code blue. That means 40% of my patients have coded. Never in my life has anything close to that happened,” she continued in the thread.
Dr. Salles, a minimally invasive and bariatric surgeon and scholar in residence at Stanford (Calif.) University, headed to New York in mid-April to assist with COVID-19 treatment efforts. Before the trip, she collected as many supplies and as much personal protective equipment as she could acquire, some of which were donated by Good Samaritans. On her first day as a volunteer, Dr. Salles recounted the stark differences between what she is used to seeing and her new environment and the novel challenges she has encountered in New York.
“Things that were not normal now seem normal,” she wrote in an April 15 Twitter post. “ICU patients in [a postanesthesia care unit] and Preop is the new normal. Patients satting in the 70s and 80s seems normal. ICU docs managing [continuous veno-venous hemodialysis] seems normal. Working with strangers seems normal. ... Obviously everyone walking around with barely any skin exposed is also the new normal.”
Similar to a “normal” ICU, new patients are admitted daily, Dr. Salles noted. However, the majority of those who leave the ICU do not go home, she wrote.
“Almost all of the ones who leave are doing so because they’ve died rather than getting better,” she wrote in the same April 19 Twitter thread. “There is a pervasive feeling of helplessness. ... The tools we are working with seem insufficient. For the sickest patients, there are no ventilator settings that seem to work, there are no medications that seem to help. I am not used to this.”
When patients are close to dying, health care workers do their best to connect the patient to loved ones through video calls, watching as family members say their last goodbyes through a screen, Dr. Salles detailed in a later post.
“Their voices cracked, and though they weren’t speaking English, I could hear their pain,” she wrote in an April 20 Twitter post. “For a moment, I imagined having to say goodbye to my mother this way. To not be able to be there, to not be able to hold her hand, to not be able to hug her. And I watched my colleague, who amazingly kept her composure until they had said everything they wanted to say. It was only after they hung up that I saw the tears well up in her eyes.”
But amid the dark days and bleak outcomes, Dr. Salles has found silver linings, humor, and gifts for which to be thankful.
“People are really generous,” she wrote in an April 15 post. “So many have offered to pay for transportation. Other docs in NY have offered to help me with supplies (and I am paying it forward). Grateful to you all!”
In another post, Dr. Salles joked that her “small head” makes it difficult to wear PPE.
“Wearing an N95 for hours really sucks,” she wrote. “It rides up, I pull it down. It digs into my cheeks, I pull it up. Repeat.”
The volunteer experience thus far has also made Dr. Salles question the future and worry about the mental health of her fellow health care professionals.
“The people who have been in NYC since the beginning of this, and those who work in Lombardy, Italy, and in Wuhan, China have faced loss for weeks to months,” she wrote in an April 18 Twitter post. “Not only do we not know when this will end, but it is likely that after it fades, it will come back in a second wave. I am lucky. I’m just a visitor here. I have the privilege to observe and learn and hopefully help, knowing I will be able to walk away. But what about those who can’t walk away? Social distancing is starting to work. But for healthcare workers, the ongoing devastation is very real. What is our long term plan?”
Dr. Salles expressed concern for health care workers who are witnessing “horrible things” with little time to process the experiences.
“It may be especially hard for those who are now working in specialties they are not used to, having to provide care they are not familiar with. They are all doing their best, but inevitably mistakes will be made, and they will likely blame themselves,” she wrote. “How do we best support them?”
Stay tuned for upcoming commentaries from Dr. Salles on her COVID-19 volunteer experience in New York City.