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What do early remdesivir data suggest?
New data on the investigational antiviral drug remdesivir (Gilead) suggest clinical improvement in 36 of 53 patients (68%) hospitalized for severe COVID-19, according to a new study published online April 10 in the New England Journal of Medicine.
But experts are warning that these data come from compassionate use in a wide variety of patients, with no randomization and no control group.
“It is impossible to know the outcome for this relatively small group of patients had they not received remdesivir,” commented Stephen Griffin, PhD, associate professor at the University of Leeds School of Medicine, United Kingdom, who was not involved with the study.
“As the authors point out, a randomized clinical trial is necessary to determine the true effectiveness of this drug,” Griffin added in comments he provided to the Science Media Centre in London. Such trials are underway.
“The data from this paper are almost uninterpretable,” said Stephen Evans, MSc, FRCP, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, who provided comments to the Science Media Centre.
Evans notes that the authors describe multiple caveats that limit interpretation of the results, including the small sample size, the relatively short follow-up, missing data, no follow-up on eight patients, and lack of a randomized control group.
Meanwhile, Josh Farkas, MD, who writes the PulmCrit blog, details his criticisms in a piece entitled, “Eleven reasons the NEJM paper on remdesivir reveals nothing.” Beyond the issues the authors list, he points out several more, including cherry picking of patients. “Remdesivir was aggressively sought-after by thousands of patients with COVID-19,” he writes. “Of these patients, 61 ended up receiving the drug. Why did these patients receive medication, out of scores of patients applying to receive it?”
Also, there are no follow-up data for 8 of the 61 patients who received an initial dose of the drug, leaving 53 for the published analysis, continues Farkas, who is an assistant professor of pulmonary and critical care medicine at the University of Vermont in Burlington.
“What happened to these patients? Did they die from anaphylaxis? Did they get well, sign out against medical advice, and go party? This is unknown — but I’m worried that these patients actually didn’t fare so well,” Farkas writes.
Farkas, like Evans and Griffin, concludes that the data are largely unusable. “Until [a randomized controlled trial] is performed, further compassionate use of remdesivir probably isn’t justified,” he writes.
Data from Compassionate Use Program
The data in the NEJM article come from a compassionate use program set up by Gilead. The company says it has provided emergency access to remdesivir for several hundred patients in the United States, Europe, and Japan.
The authors, led by Jonathan Grein, MD, from Cedars–Sinai Medical Center, Los Angeles, California, report on 61 patients who received remdesivir as part of this program.
The authors, several of whom are employees of Gilead, note that data on 8 patients could not be analyzed (including 7 patients with no posttreatment data and 1 with a dosing error).
Of the 53 patients whose data were included, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan.
These were patients hospitalized with COVID-19 who had confirmed SARS-CoV-2 infection and had an oxygen saturation of 94% or less while they were breathing ambient air, or who were receiving oxygen support.
Patients received a 10-day course of remdesivir, consisting of 200 mg administered intravenously on day 1, followed by 100 mg daily for the remaining 9 days of treatment.
At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation.
During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 (57%) of 30 patients receiving mechanical ventilation who were extubated.
A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation.
While the authors acknowledge limitations of the data they collected, they nevertheless comment that “comparisons with contemporaneous cohorts from the literature, in whom general care is expected to be consistent with that of our cohort, suggest that remdesivir may have clinical benefit in patients with severe COVID-19.”
“Currently there is no proven treatment for COVID-19. We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful,” said Grein in a Cedars–Sinai press release. “We look forward to the results of controlled clinical trials to potentially validate these findings.”
Experts are not convinced, however.
“The drug was being used in patients who were severely ill, but reporting on 61 out of several hundred makes it clear that generalizations about the efficacy and safety must be treated with great caution,” said Evans. “There is some evidence suggesting efficacy, but we simply do not know what would have happened to these patients had they not been given the drug.”
“I would say it’s impossible to discern whether there is a treatment effect or not,” said Duncan Richards, MA, DM, FRCP, clinical pharmacologist and professor of clinical therapeutics, University of Oxford, UK. “This is in part due to the mixed patient population, ranging from those needing low dose oxygen, who are more likely to survive anyway, to much more severe cases ... [who] show a much more mixed picture.”
“There are ongoing large international randomized controlled trials with remdesivir — we really need to see those data, “ he said in comments to Science Media Centre. “Safe and effective treatments for COVID-19 are critically needed and should be expedited wherever possible, but it’s important not to compromise on the quality of the research.”
Multiple coauthors are employees of Gilead, the company developing remdesivir. Griffin, Evans, and Farkas have disclosed no relevant financial relationships. Richards consults for GlaxoSmithKline in the field of drug safety. GSK does not manufacture any of the products mentioned.
N Engl J Med. 2020 Apr 10. Full text.
This article first appeared on Medscape.com.
New data on the investigational antiviral drug remdesivir (Gilead) suggest clinical improvement in 36 of 53 patients (68%) hospitalized for severe COVID-19, according to a new study published online April 10 in the New England Journal of Medicine.
But experts are warning that these data come from compassionate use in a wide variety of patients, with no randomization and no control group.
“It is impossible to know the outcome for this relatively small group of patients had they not received remdesivir,” commented Stephen Griffin, PhD, associate professor at the University of Leeds School of Medicine, United Kingdom, who was not involved with the study.
“As the authors point out, a randomized clinical trial is necessary to determine the true effectiveness of this drug,” Griffin added in comments he provided to the Science Media Centre in London. Such trials are underway.
“The data from this paper are almost uninterpretable,” said Stephen Evans, MSc, FRCP, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, who provided comments to the Science Media Centre.
Evans notes that the authors describe multiple caveats that limit interpretation of the results, including the small sample size, the relatively short follow-up, missing data, no follow-up on eight patients, and lack of a randomized control group.
Meanwhile, Josh Farkas, MD, who writes the PulmCrit blog, details his criticisms in a piece entitled, “Eleven reasons the NEJM paper on remdesivir reveals nothing.” Beyond the issues the authors list, he points out several more, including cherry picking of patients. “Remdesivir was aggressively sought-after by thousands of patients with COVID-19,” he writes. “Of these patients, 61 ended up receiving the drug. Why did these patients receive medication, out of scores of patients applying to receive it?”
Also, there are no follow-up data for 8 of the 61 patients who received an initial dose of the drug, leaving 53 for the published analysis, continues Farkas, who is an assistant professor of pulmonary and critical care medicine at the University of Vermont in Burlington.
“What happened to these patients? Did they die from anaphylaxis? Did they get well, sign out against medical advice, and go party? This is unknown — but I’m worried that these patients actually didn’t fare so well,” Farkas writes.
Farkas, like Evans and Griffin, concludes that the data are largely unusable. “Until [a randomized controlled trial] is performed, further compassionate use of remdesivir probably isn’t justified,” he writes.
Data from Compassionate Use Program
The data in the NEJM article come from a compassionate use program set up by Gilead. The company says it has provided emergency access to remdesivir for several hundred patients in the United States, Europe, and Japan.
The authors, led by Jonathan Grein, MD, from Cedars–Sinai Medical Center, Los Angeles, California, report on 61 patients who received remdesivir as part of this program.
The authors, several of whom are employees of Gilead, note that data on 8 patients could not be analyzed (including 7 patients with no posttreatment data and 1 with a dosing error).
Of the 53 patients whose data were included, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan.
These were patients hospitalized with COVID-19 who had confirmed SARS-CoV-2 infection and had an oxygen saturation of 94% or less while they were breathing ambient air, or who were receiving oxygen support.
Patients received a 10-day course of remdesivir, consisting of 200 mg administered intravenously on day 1, followed by 100 mg daily for the remaining 9 days of treatment.
At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation.
During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 (57%) of 30 patients receiving mechanical ventilation who were extubated.
A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation.
While the authors acknowledge limitations of the data they collected, they nevertheless comment that “comparisons with contemporaneous cohorts from the literature, in whom general care is expected to be consistent with that of our cohort, suggest that remdesivir may have clinical benefit in patients with severe COVID-19.”
“Currently there is no proven treatment for COVID-19. We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful,” said Grein in a Cedars–Sinai press release. “We look forward to the results of controlled clinical trials to potentially validate these findings.”
Experts are not convinced, however.
“The drug was being used in patients who were severely ill, but reporting on 61 out of several hundred makes it clear that generalizations about the efficacy and safety must be treated with great caution,” said Evans. “There is some evidence suggesting efficacy, but we simply do not know what would have happened to these patients had they not been given the drug.”
“I would say it’s impossible to discern whether there is a treatment effect or not,” said Duncan Richards, MA, DM, FRCP, clinical pharmacologist and professor of clinical therapeutics, University of Oxford, UK. “This is in part due to the mixed patient population, ranging from those needing low dose oxygen, who are more likely to survive anyway, to much more severe cases ... [who] show a much more mixed picture.”
“There are ongoing large international randomized controlled trials with remdesivir — we really need to see those data, “ he said in comments to Science Media Centre. “Safe and effective treatments for COVID-19 are critically needed and should be expedited wherever possible, but it’s important not to compromise on the quality of the research.”
Multiple coauthors are employees of Gilead, the company developing remdesivir. Griffin, Evans, and Farkas have disclosed no relevant financial relationships. Richards consults for GlaxoSmithKline in the field of drug safety. GSK does not manufacture any of the products mentioned.
N Engl J Med. 2020 Apr 10. Full text.
This article first appeared on Medscape.com.
New data on the investigational antiviral drug remdesivir (Gilead) suggest clinical improvement in 36 of 53 patients (68%) hospitalized for severe COVID-19, according to a new study published online April 10 in the New England Journal of Medicine.
But experts are warning that these data come from compassionate use in a wide variety of patients, with no randomization and no control group.
“It is impossible to know the outcome for this relatively small group of patients had they not received remdesivir,” commented Stephen Griffin, PhD, associate professor at the University of Leeds School of Medicine, United Kingdom, who was not involved with the study.
“As the authors point out, a randomized clinical trial is necessary to determine the true effectiveness of this drug,” Griffin added in comments he provided to the Science Media Centre in London. Such trials are underway.
“The data from this paper are almost uninterpretable,” said Stephen Evans, MSc, FRCP, professor of pharmacoepidemiology, London School of Hygiene & Tropical Medicine, who provided comments to the Science Media Centre.
Evans notes that the authors describe multiple caveats that limit interpretation of the results, including the small sample size, the relatively short follow-up, missing data, no follow-up on eight patients, and lack of a randomized control group.
Meanwhile, Josh Farkas, MD, who writes the PulmCrit blog, details his criticisms in a piece entitled, “Eleven reasons the NEJM paper on remdesivir reveals nothing.” Beyond the issues the authors list, he points out several more, including cherry picking of patients. “Remdesivir was aggressively sought-after by thousands of patients with COVID-19,” he writes. “Of these patients, 61 ended up receiving the drug. Why did these patients receive medication, out of scores of patients applying to receive it?”
Also, there are no follow-up data for 8 of the 61 patients who received an initial dose of the drug, leaving 53 for the published analysis, continues Farkas, who is an assistant professor of pulmonary and critical care medicine at the University of Vermont in Burlington.
“What happened to these patients? Did they die from anaphylaxis? Did they get well, sign out against medical advice, and go party? This is unknown — but I’m worried that these patients actually didn’t fare so well,” Farkas writes.
Farkas, like Evans and Griffin, concludes that the data are largely unusable. “Until [a randomized controlled trial] is performed, further compassionate use of remdesivir probably isn’t justified,” he writes.
Data from Compassionate Use Program
The data in the NEJM article come from a compassionate use program set up by Gilead. The company says it has provided emergency access to remdesivir for several hundred patients in the United States, Europe, and Japan.
The authors, led by Jonathan Grein, MD, from Cedars–Sinai Medical Center, Los Angeles, California, report on 61 patients who received remdesivir as part of this program.
The authors, several of whom are employees of Gilead, note that data on 8 patients could not be analyzed (including 7 patients with no posttreatment data and 1 with a dosing error).
Of the 53 patients whose data were included, 22 were in the United States, 22 in Europe or Canada, and 9 in Japan.
These were patients hospitalized with COVID-19 who had confirmed SARS-CoV-2 infection and had an oxygen saturation of 94% or less while they were breathing ambient air, or who were receiving oxygen support.
Patients received a 10-day course of remdesivir, consisting of 200 mg administered intravenously on day 1, followed by 100 mg daily for the remaining 9 days of treatment.
At baseline, 30 patients (57%) were receiving mechanical ventilation and 4 (8%) were receiving extracorporeal membrane oxygenation.
During a median follow-up of 18 days, 36 patients (68%) had an improvement in oxygen-support class, including 17 (57%) of 30 patients receiving mechanical ventilation who were extubated.
A total of 25 patients (47%) were discharged, and 7 patients (13%) died; mortality was 18% (6 of 34) among patients receiving invasive ventilation and 5% (1 of 19) among those not receiving invasive ventilation.
While the authors acknowledge limitations of the data they collected, they nevertheless comment that “comparisons with contemporaneous cohorts from the literature, in whom general care is expected to be consistent with that of our cohort, suggest that remdesivir may have clinical benefit in patients with severe COVID-19.”
“Currently there is no proven treatment for COVID-19. We cannot draw definitive conclusions from these data, but the observations from this group of hospitalized patients who received remdesivir are hopeful,” said Grein in a Cedars–Sinai press release. “We look forward to the results of controlled clinical trials to potentially validate these findings.”
Experts are not convinced, however.
“The drug was being used in patients who were severely ill, but reporting on 61 out of several hundred makes it clear that generalizations about the efficacy and safety must be treated with great caution,” said Evans. “There is some evidence suggesting efficacy, but we simply do not know what would have happened to these patients had they not been given the drug.”
“I would say it’s impossible to discern whether there is a treatment effect or not,” said Duncan Richards, MA, DM, FRCP, clinical pharmacologist and professor of clinical therapeutics, University of Oxford, UK. “This is in part due to the mixed patient population, ranging from those needing low dose oxygen, who are more likely to survive anyway, to much more severe cases ... [who] show a much more mixed picture.”
“There are ongoing large international randomized controlled trials with remdesivir — we really need to see those data, “ he said in comments to Science Media Centre. “Safe and effective treatments for COVID-19 are critically needed and should be expedited wherever possible, but it’s important not to compromise on the quality of the research.”
Multiple coauthors are employees of Gilead, the company developing remdesivir. Griffin, Evans, and Farkas have disclosed no relevant financial relationships. Richards consults for GlaxoSmithKline in the field of drug safety. GSK does not manufacture any of the products mentioned.
N Engl J Med. 2020 Apr 10. Full text.
This article first appeared on Medscape.com.
Remdesivir tops list of promising COVID-19 treatments in review of nearly 300 trials
, according to authors of a recent review covering nearly 300 active clinical treatment trials underway for the disease.
Remdesivir, which has potent in vitro activity against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is not approved by the Food and Drug Administration and is currently being tested in randomized trials, according to the review authors, led by James M. Sanders, PhD, of the department of pharmacy at University of Texas Southwestern Medical Center in Dallas.
By contrast, oseltamivir has not demonstrated efficacy against the virus, corticosteroids are not recommended, and promising data from a small French hydroxychloroquine study are balanced by “several major limitations” including small sample size and exclusion of early dropouts from the analysis, among others, Dr. Sanders and coauthors said in their report.
“These limitations coupled with concerns of additive cardiotoxicity with combination therapy [i.e., hydroxychloroquine with azithromycin] do not support adoption of this regimen without additional studies,” the researchers wrote. Their report is in JAMA.
Dr. Sanders and colleagues identified 291 COVID-19–specific studies listed in ClinicalTrials.gov through April 2, including 29 placebo-controlled trials.
This might represent just a sliver of the treatments that could combat COVID-19, according to the researchers, who said more than 3,000 small-molecule drug candidates with potential activity against human coronaviruses have been identified.
“This large amount of potential agents will hopefully yield more candidate therapeutics in the race to find effective treatments or preventive strategies against COVID-19,” said Dr. Sanders and coauthors.
Remdesivir for COVID-19
Remdesivir, an investigational nucleotide analog, is one promising agent because of its broad-spectrum and potent activity against SARS-CoV-2 and other novel coronaviruses, they said, adding that phase 1 trials demonstrated the drug was well tolerated without observed liver or kidney toxicity.
There have been “successful” case reports of remdesivir use in COVID-19, and at least five ongoing clinical trials are evaluating the drug’s safety and antiviral activity in this disease. Among those studies is a National Institutes of Health–sponsored adaptive, randomized, placebo-controlled trial that will provide data on the use of remdesivir versus supportive care.
“As the results from randomized controlled trials are anticipated, inclusion of this agent for treatment of COVID-19 may be considered,” Dr. Sanders and colleagues wrote in their report. To date, remdesivir remains investigational and needs to be obtained via compassionate use, through expanded access, or by participating in a clinical trial, they added.
Hydroxychloroquine and chloroquine
Among the published hydroxychloroquine studies is a “promising” 36-patient open-label nonrandomized French study, in which the antimalarial agent given every 8 hours improved virologic clearance by day 6 versus controls (70% vs. 12.5%, respectively), the review authors said. Moreover, viral clearance was 100% for 6 patients who received hydroxychloroquine plus azithromycin, compared to 57% (8 of 14) for patients treated with hydroxychloroquine alone. However, that study had several important limitations, including the small sample size, variable viral loads at baseline between groups, and a lack of safety and clinical outcomes reporting, according to the investigators. Moreover, six patients in the hydroxychloroquine group were taken out of the analysis because of early treatment stoppage due to medical intolerance or critical illness, the authors noted.
One prospective study including 30 patients in China demonstrated no difference in virologic outcomes for patients randomized to hydroxychloroquine plus standard of care versus standard of care alone, they added. There is also a case series of more than 100 patients with COVID-19 that reportedly improved viral clearance and reduced disease progression, though they said results haven’t been published or presented beyond a news briefing in China.
Randomized, controlled trials of chloroquine and hydroxychloroquine for COVID-19 treatment are underway, and studies are planned or enrolling to look at chloroquine prophylaxis in health care personnel and hydroxychloroquine for postexposure prophylaxis, authors said.
In results from one of those randomized trials, just reported, a higher dose of chloroquine was associated with a cardiac adverse event and an increased mortality risk, leading to the closure of that study arm. In the parallel, double-blinded, phase IIb clinical trial, patients in Brazil with SARS-CoV-2 infection received low or high doses of chloroquine plus ceftriaxone and azithromycin. According to the preprint publication, a higher rate of heart rate–corrected QT interval (QTc) prolongation and a “trend toward higher lethality” was observed in the high-dose group, leading investigators to “strongly recommend” the higher dose be abandoned.
“No apparent benefit of chloroquine was seen regarding lethality in our patients so far, but we will still enroll patients in the low chloroquine dose group to complete the originally planned sample size,” said investigators of the study, which at the time of the report had enrolled 81 out of an anticipated 440 patients.
Other COVID-19 pharmacologic therapies under study
Treatments of note in the review included the following:
- Tocilizumab. This monoclonal antibody IL-6 receptor antagonist, approved by the FDA for treatment of rheumatoid arthritis and for cytokine release syndrome related to chimeric antigen receptor (CAR) T-cell therapy, has yielded success in small series of patients with severe cases of COVID-19, according to authors. In one 21-patient report, 91% had clinical improvement, usually after a single dose. In China, tocilizumab is included in COVID-19 treatment guidelines, and several randomized clinical trials are underway in China including patients with COVID-19 with severe pneumonia.
- Immunoglobulin therapy. Antibodies from recovered COVID-19 patients could help with free virus and infected cell immune clearance, the authors said, adding that further studies are warranted beyond a few small published case series that suggest promise. Furthermore, on March 24 the FDA released guidance for screening donors for COVID-19 convalescent plasma and on emergency investigational new drug applications based on this modality.
- Lopinavir/ritonavir. Despite demonstrated in vitro activity against other novel coronaviruses, there is no published in vitro data for lopinavir/ritonavir in SARS-CoV-2, and likely a “limited role” for this combination anticipated in treating COVID-19, according to the review authors. In an open-label randomized clinical trial published in the New England Journal of Medicine (2020 Mar 18. doi: 10.1056/NEJMoa2001282), there were no differences in clinical improvement, viral clearance, or mortality for antiviral treatment versus standard care. Delayed treatment initiation may explain the ineffectiveness, though a subgroup analysis didn’t show a shorter time to clinical improvement for those who got the treatment earlier.
- Ribavirin. Likewise, this antiviral medication has efficacy and safety data suggesting “limited value” for treatment of COVID-19. Treatment of SARS yielded “inconclusive results” for ribavirin, which was also associated with substantial toxicity that included hemolytic anemia in 60% of SARS patients.
- Oseltamivir. While it may treat influenza, it has no documented activity against SARS-CoV-2 in vitro: “This agent has no role in the management of COVID-19 once influenza has been excluded,” said Dr. Sanders and coauthors.
- Corticosteroids. They could decrease inflammatory responses in the lung, but they could also lead to delays in viral clearance and increases in secondary infection risk. Guidelines for COVID-19 say to avoid corticosteroids, and the authors of the review concur, saying that potential harms and lack of proven benefit mean they usually should not be used outside of a randomized clinical trial setting.
- Vaccines. Clearly, vaccines represent the “most effective long-term strategy” to prevent future COVID-19 outbreaks, though at least 12-18 months would be required until vaccines can be widely deployed, authors said.
Dr. Sanders reported no potential conflicts. Senior author James B. Cutrell, MD, also of the University of Texas Southwestern Medical Center, reported nonfinancial support from Gilead and Regeneron outside of the study. No other authors reported disclosures.
, according to authors of a recent review covering nearly 300 active clinical treatment trials underway for the disease.
Remdesivir, which has potent in vitro activity against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is not approved by the Food and Drug Administration and is currently being tested in randomized trials, according to the review authors, led by James M. Sanders, PhD, of the department of pharmacy at University of Texas Southwestern Medical Center in Dallas.
By contrast, oseltamivir has not demonstrated efficacy against the virus, corticosteroids are not recommended, and promising data from a small French hydroxychloroquine study are balanced by “several major limitations” including small sample size and exclusion of early dropouts from the analysis, among others, Dr. Sanders and coauthors said in their report.
“These limitations coupled with concerns of additive cardiotoxicity with combination therapy [i.e., hydroxychloroquine with azithromycin] do not support adoption of this regimen without additional studies,” the researchers wrote. Their report is in JAMA.
Dr. Sanders and colleagues identified 291 COVID-19–specific studies listed in ClinicalTrials.gov through April 2, including 29 placebo-controlled trials.
This might represent just a sliver of the treatments that could combat COVID-19, according to the researchers, who said more than 3,000 small-molecule drug candidates with potential activity against human coronaviruses have been identified.
“This large amount of potential agents will hopefully yield more candidate therapeutics in the race to find effective treatments or preventive strategies against COVID-19,” said Dr. Sanders and coauthors.
Remdesivir for COVID-19
Remdesivir, an investigational nucleotide analog, is one promising agent because of its broad-spectrum and potent activity against SARS-CoV-2 and other novel coronaviruses, they said, adding that phase 1 trials demonstrated the drug was well tolerated without observed liver or kidney toxicity.
There have been “successful” case reports of remdesivir use in COVID-19, and at least five ongoing clinical trials are evaluating the drug’s safety and antiviral activity in this disease. Among those studies is a National Institutes of Health–sponsored adaptive, randomized, placebo-controlled trial that will provide data on the use of remdesivir versus supportive care.
“As the results from randomized controlled trials are anticipated, inclusion of this agent for treatment of COVID-19 may be considered,” Dr. Sanders and colleagues wrote in their report. To date, remdesivir remains investigational and needs to be obtained via compassionate use, through expanded access, or by participating in a clinical trial, they added.
Hydroxychloroquine and chloroquine
Among the published hydroxychloroquine studies is a “promising” 36-patient open-label nonrandomized French study, in which the antimalarial agent given every 8 hours improved virologic clearance by day 6 versus controls (70% vs. 12.5%, respectively), the review authors said. Moreover, viral clearance was 100% for 6 patients who received hydroxychloroquine plus azithromycin, compared to 57% (8 of 14) for patients treated with hydroxychloroquine alone. However, that study had several important limitations, including the small sample size, variable viral loads at baseline between groups, and a lack of safety and clinical outcomes reporting, according to the investigators. Moreover, six patients in the hydroxychloroquine group were taken out of the analysis because of early treatment stoppage due to medical intolerance or critical illness, the authors noted.
One prospective study including 30 patients in China demonstrated no difference in virologic outcomes for patients randomized to hydroxychloroquine plus standard of care versus standard of care alone, they added. There is also a case series of more than 100 patients with COVID-19 that reportedly improved viral clearance and reduced disease progression, though they said results haven’t been published or presented beyond a news briefing in China.
Randomized, controlled trials of chloroquine and hydroxychloroquine for COVID-19 treatment are underway, and studies are planned or enrolling to look at chloroquine prophylaxis in health care personnel and hydroxychloroquine for postexposure prophylaxis, authors said.
In results from one of those randomized trials, just reported, a higher dose of chloroquine was associated with a cardiac adverse event and an increased mortality risk, leading to the closure of that study arm. In the parallel, double-blinded, phase IIb clinical trial, patients in Brazil with SARS-CoV-2 infection received low or high doses of chloroquine plus ceftriaxone and azithromycin. According to the preprint publication, a higher rate of heart rate–corrected QT interval (QTc) prolongation and a “trend toward higher lethality” was observed in the high-dose group, leading investigators to “strongly recommend” the higher dose be abandoned.
“No apparent benefit of chloroquine was seen regarding lethality in our patients so far, but we will still enroll patients in the low chloroquine dose group to complete the originally planned sample size,” said investigators of the study, which at the time of the report had enrolled 81 out of an anticipated 440 patients.
Other COVID-19 pharmacologic therapies under study
Treatments of note in the review included the following:
- Tocilizumab. This monoclonal antibody IL-6 receptor antagonist, approved by the FDA for treatment of rheumatoid arthritis and for cytokine release syndrome related to chimeric antigen receptor (CAR) T-cell therapy, has yielded success in small series of patients with severe cases of COVID-19, according to authors. In one 21-patient report, 91% had clinical improvement, usually after a single dose. In China, tocilizumab is included in COVID-19 treatment guidelines, and several randomized clinical trials are underway in China including patients with COVID-19 with severe pneumonia.
- Immunoglobulin therapy. Antibodies from recovered COVID-19 patients could help with free virus and infected cell immune clearance, the authors said, adding that further studies are warranted beyond a few small published case series that suggest promise. Furthermore, on March 24 the FDA released guidance for screening donors for COVID-19 convalescent plasma and on emergency investigational new drug applications based on this modality.
- Lopinavir/ritonavir. Despite demonstrated in vitro activity against other novel coronaviruses, there is no published in vitro data for lopinavir/ritonavir in SARS-CoV-2, and likely a “limited role” for this combination anticipated in treating COVID-19, according to the review authors. In an open-label randomized clinical trial published in the New England Journal of Medicine (2020 Mar 18. doi: 10.1056/NEJMoa2001282), there were no differences in clinical improvement, viral clearance, or mortality for antiviral treatment versus standard care. Delayed treatment initiation may explain the ineffectiveness, though a subgroup analysis didn’t show a shorter time to clinical improvement for those who got the treatment earlier.
- Ribavirin. Likewise, this antiviral medication has efficacy and safety data suggesting “limited value” for treatment of COVID-19. Treatment of SARS yielded “inconclusive results” for ribavirin, which was also associated with substantial toxicity that included hemolytic anemia in 60% of SARS patients.
- Oseltamivir. While it may treat influenza, it has no documented activity against SARS-CoV-2 in vitro: “This agent has no role in the management of COVID-19 once influenza has been excluded,” said Dr. Sanders and coauthors.
- Corticosteroids. They could decrease inflammatory responses in the lung, but they could also lead to delays in viral clearance and increases in secondary infection risk. Guidelines for COVID-19 say to avoid corticosteroids, and the authors of the review concur, saying that potential harms and lack of proven benefit mean they usually should not be used outside of a randomized clinical trial setting.
- Vaccines. Clearly, vaccines represent the “most effective long-term strategy” to prevent future COVID-19 outbreaks, though at least 12-18 months would be required until vaccines can be widely deployed, authors said.
Dr. Sanders reported no potential conflicts. Senior author James B. Cutrell, MD, also of the University of Texas Southwestern Medical Center, reported nonfinancial support from Gilead and Regeneron outside of the study. No other authors reported disclosures.
, according to authors of a recent review covering nearly 300 active clinical treatment trials underway for the disease.
Remdesivir, which has potent in vitro activity against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is not approved by the Food and Drug Administration and is currently being tested in randomized trials, according to the review authors, led by James M. Sanders, PhD, of the department of pharmacy at University of Texas Southwestern Medical Center in Dallas.
By contrast, oseltamivir has not demonstrated efficacy against the virus, corticosteroids are not recommended, and promising data from a small French hydroxychloroquine study are balanced by “several major limitations” including small sample size and exclusion of early dropouts from the analysis, among others, Dr. Sanders and coauthors said in their report.
“These limitations coupled with concerns of additive cardiotoxicity with combination therapy [i.e., hydroxychloroquine with azithromycin] do not support adoption of this regimen without additional studies,” the researchers wrote. Their report is in JAMA.
Dr. Sanders and colleagues identified 291 COVID-19–specific studies listed in ClinicalTrials.gov through April 2, including 29 placebo-controlled trials.
This might represent just a sliver of the treatments that could combat COVID-19, according to the researchers, who said more than 3,000 small-molecule drug candidates with potential activity against human coronaviruses have been identified.
“This large amount of potential agents will hopefully yield more candidate therapeutics in the race to find effective treatments or preventive strategies against COVID-19,” said Dr. Sanders and coauthors.
Remdesivir for COVID-19
Remdesivir, an investigational nucleotide analog, is one promising agent because of its broad-spectrum and potent activity against SARS-CoV-2 and other novel coronaviruses, they said, adding that phase 1 trials demonstrated the drug was well tolerated without observed liver or kidney toxicity.
There have been “successful” case reports of remdesivir use in COVID-19, and at least five ongoing clinical trials are evaluating the drug’s safety and antiviral activity in this disease. Among those studies is a National Institutes of Health–sponsored adaptive, randomized, placebo-controlled trial that will provide data on the use of remdesivir versus supportive care.
“As the results from randomized controlled trials are anticipated, inclusion of this agent for treatment of COVID-19 may be considered,” Dr. Sanders and colleagues wrote in their report. To date, remdesivir remains investigational and needs to be obtained via compassionate use, through expanded access, or by participating in a clinical trial, they added.
Hydroxychloroquine and chloroquine
Among the published hydroxychloroquine studies is a “promising” 36-patient open-label nonrandomized French study, in which the antimalarial agent given every 8 hours improved virologic clearance by day 6 versus controls (70% vs. 12.5%, respectively), the review authors said. Moreover, viral clearance was 100% for 6 patients who received hydroxychloroquine plus azithromycin, compared to 57% (8 of 14) for patients treated with hydroxychloroquine alone. However, that study had several important limitations, including the small sample size, variable viral loads at baseline between groups, and a lack of safety and clinical outcomes reporting, according to the investigators. Moreover, six patients in the hydroxychloroquine group were taken out of the analysis because of early treatment stoppage due to medical intolerance or critical illness, the authors noted.
One prospective study including 30 patients in China demonstrated no difference in virologic outcomes for patients randomized to hydroxychloroquine plus standard of care versus standard of care alone, they added. There is also a case series of more than 100 patients with COVID-19 that reportedly improved viral clearance and reduced disease progression, though they said results haven’t been published or presented beyond a news briefing in China.
Randomized, controlled trials of chloroquine and hydroxychloroquine for COVID-19 treatment are underway, and studies are planned or enrolling to look at chloroquine prophylaxis in health care personnel and hydroxychloroquine for postexposure prophylaxis, authors said.
In results from one of those randomized trials, just reported, a higher dose of chloroquine was associated with a cardiac adverse event and an increased mortality risk, leading to the closure of that study arm. In the parallel, double-blinded, phase IIb clinical trial, patients in Brazil with SARS-CoV-2 infection received low or high doses of chloroquine plus ceftriaxone and azithromycin. According to the preprint publication, a higher rate of heart rate–corrected QT interval (QTc) prolongation and a “trend toward higher lethality” was observed in the high-dose group, leading investigators to “strongly recommend” the higher dose be abandoned.
“No apparent benefit of chloroquine was seen regarding lethality in our patients so far, but we will still enroll patients in the low chloroquine dose group to complete the originally planned sample size,” said investigators of the study, which at the time of the report had enrolled 81 out of an anticipated 440 patients.
Other COVID-19 pharmacologic therapies under study
Treatments of note in the review included the following:
- Tocilizumab. This monoclonal antibody IL-6 receptor antagonist, approved by the FDA for treatment of rheumatoid arthritis and for cytokine release syndrome related to chimeric antigen receptor (CAR) T-cell therapy, has yielded success in small series of patients with severe cases of COVID-19, according to authors. In one 21-patient report, 91% had clinical improvement, usually after a single dose. In China, tocilizumab is included in COVID-19 treatment guidelines, and several randomized clinical trials are underway in China including patients with COVID-19 with severe pneumonia.
- Immunoglobulin therapy. Antibodies from recovered COVID-19 patients could help with free virus and infected cell immune clearance, the authors said, adding that further studies are warranted beyond a few small published case series that suggest promise. Furthermore, on March 24 the FDA released guidance for screening donors for COVID-19 convalescent plasma and on emergency investigational new drug applications based on this modality.
- Lopinavir/ritonavir. Despite demonstrated in vitro activity against other novel coronaviruses, there is no published in vitro data for lopinavir/ritonavir in SARS-CoV-2, and likely a “limited role” for this combination anticipated in treating COVID-19, according to the review authors. In an open-label randomized clinical trial published in the New England Journal of Medicine (2020 Mar 18. doi: 10.1056/NEJMoa2001282), there were no differences in clinical improvement, viral clearance, or mortality for antiviral treatment versus standard care. Delayed treatment initiation may explain the ineffectiveness, though a subgroup analysis didn’t show a shorter time to clinical improvement for those who got the treatment earlier.
- Ribavirin. Likewise, this antiviral medication has efficacy and safety data suggesting “limited value” for treatment of COVID-19. Treatment of SARS yielded “inconclusive results” for ribavirin, which was also associated with substantial toxicity that included hemolytic anemia in 60% of SARS patients.
- Oseltamivir. While it may treat influenza, it has no documented activity against SARS-CoV-2 in vitro: “This agent has no role in the management of COVID-19 once influenza has been excluded,” said Dr. Sanders and coauthors.
- Corticosteroids. They could decrease inflammatory responses in the lung, but they could also lead to delays in viral clearance and increases in secondary infection risk. Guidelines for COVID-19 say to avoid corticosteroids, and the authors of the review concur, saying that potential harms and lack of proven benefit mean they usually should not be used outside of a randomized clinical trial setting.
- Vaccines. Clearly, vaccines represent the “most effective long-term strategy” to prevent future COVID-19 outbreaks, though at least 12-18 months would be required until vaccines can be widely deployed, authors said.
Dr. Sanders reported no potential conflicts. Senior author James B. Cutrell, MD, also of the University of Texas Southwestern Medical Center, reported nonfinancial support from Gilead and Regeneron outside of the study. No other authors reported disclosures.
FROM JAMA
Troponins touted as ‘ally’ in COVID-19 triage, but message is nuanced
, cardiologists in the United Kingdom advise in a recently published viewpoint.
The tests can be used to “inform the triage of patients to critical care, guide the use of supportive treatments, and facilitate targeted cardiac investigations in those most likely to benefit,” Nicholas Mills, MD, PhD, University of Edinburgh, United Kingdom, told theheart.org | Medscape Cardiology. He is senior author on the viewpoint published online April 6 in the journal Circulation.
Older adults and those with a history of underlying cardiovascular disease appear to be at greatest risk of dying from COVID-19. “From early reports it is clear that elevated cardiac troponin concentrations predict in-hospital mortality,” said Mills.
In a recent report on hospitalized patients with COVID-19 in Wuhan, China, for example, cardiac injury (hs-cTn above the 99th-percentile upper reference limit) was seen in 1 in 5 patients and was an independent predictor of dying in the hospital. Mortality was 10-fold higher in those with cardiac injury on presentation.
Elevated cardiac troponin in the setting of COVID-19, Mills said, “may reflect illness severity with myocardial injury arising due to myocardial oxygen supply–demand imbalance. Or it may be due to direct cardiac involvement through viral myocarditis or stress cardiomyopathy, or where the prothrombotic and proinflammatory state is precipitating acute coronary syndromes.”
In their viewpoint, the authors note that circulating cTn is a marker of myocardial injury, “including but not limited to myocardial infarction or myocarditis, and the clinical relevance of this distinction has never been so clear.”
Therefore, the consequence of not measuring cardiac troponin may be to “ignore the plethora of ischemic and nonischemic causes” of myocardial injury related to COVID-19. “Clinicians who have used troponin measurement as a binary test for myocardial infarction independent of clinical context and those who consider an elevated cardiac troponin concentration to be a mandate for invasive coronary angiography must recalibrate,” they write.
“Rather than encouraging avoidance of troponin testing, we must harness the unheralded engagement from the cardiovascular community due to COVID-19 to better understand the utility of this essential biomarker and to educate clinicians on its interpretation and implications for prognosis and clinical decision making.”
Based on “same logic” as recent ACC guidance
The viewpoint was to some extent a response to a recent informal guidance from the American College of Cardiology (ACC) that advised caution in use of troponin and natriuretic peptide tests in patients with COVID-19.
Even so, that ACC guidance and the new viewpoint in Circulation are based on the “same logic,” James Januzzi Jr, MD, Massachusetts General Hospital, Boston, told theheart.org | Medscape Cardiology. Both documents:
- Point out that troponins are frequently abnormal in patients with severe cases of COVID-19
- Caution that clinicians should not equate an abnormal hs-cTn with acute myocardial infarction
- Note that, in most cases, hs-cTn elevations are a result of noncoronary mechanisms
- Recognize the potential risk to caregivers and the continued unchecked spread of SARS-CoV-2 related to downstream testing that might not be needed
“The Circulation opinion piece states that clinicians often use troponin as a binary test for myocardial infarction and a mandate for downstream testing, suggesting clinicians will need to recalibrate that approach, something I agree with and which is the central message of the ACC position,” Januzzi said.
Probably the biggest difference between the two documents, he said, is in the Circulation authors’ apparent enthusiasm to use hs-cTn as a tool to judge disease severity in patients with COVID-19.
It’s been known for more than a decade that myocardial injury is “an important risk predictor” in critical illness, Januzzi explained. “So the link between cardiac injury and outcomes in critical illness is nothing new. The difference is the fact we are seeing so many patients with COVID-19 all at once, and the authors suggest that using troponin might help in triage decision making.”
“There may be [such] a role here, but the data have not been systematically collected, and whether troponin truly adds something beyond information already available at the bedside — for example, does it add anything not already obvious at the bedside? — has not yet been conclusively proven,” Januzzi cautioned.
“As well, there are no prospective data supporting troponin as a trigger for ICU triage or for deciding on specific treatments.”
Positive cTn status “common” in COVID-19 patients
In his experience, Barry Cohen, MD, Morristown Medical Center, New Jersey, told theheart.org | Medscape Cardiology, that positive cTn status is “common in COVID-19 patients and appears to have prognostic value, not only in type 1 MI due to atherothrombotic disease (related to a proinflammatory and prothrombotic state), but more frequently type 2 MI (supply–demand mismatch), viral myocarditis, coronary microvascular ischemia, stress cardiomyopathy or tachyarrhythmias.”
Moreover, Cohen said, hs-cTn “has identified patients at increased risk for ventilation support (invasive and noninvasive), acute respiratory distress syndrome, acute kidney injury, and mortality.”
Echoing both the ACC document and the Circulation report, Cohen also said hs-cTn measurements “appear to help risk stratify COVID-19 patients, but clearly do not mean that a troponin-positive patient needs to go to the cath lab and be treated as having acute coronary syndrome. Only a minority of these patients require this intervention.”
Mills discloses receiving honoraria from Abbott Diagnostics, Roche Diagnostics, Siemens Healthineers, and LumiraDx. Januzzi has previously disclosed receiving personal fees from the American College of Cardiology, Pfizer, Merck, AbbVie, Amgen, Boehringer Ingelheim, and Takeda; grants and personal fees from Novartis, Roche, Abbott, and Janssen; and grants from Singulex and Prevencio. Cohen has disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
, cardiologists in the United Kingdom advise in a recently published viewpoint.
The tests can be used to “inform the triage of patients to critical care, guide the use of supportive treatments, and facilitate targeted cardiac investigations in those most likely to benefit,” Nicholas Mills, MD, PhD, University of Edinburgh, United Kingdom, told theheart.org | Medscape Cardiology. He is senior author on the viewpoint published online April 6 in the journal Circulation.
Older adults and those with a history of underlying cardiovascular disease appear to be at greatest risk of dying from COVID-19. “From early reports it is clear that elevated cardiac troponin concentrations predict in-hospital mortality,” said Mills.
In a recent report on hospitalized patients with COVID-19 in Wuhan, China, for example, cardiac injury (hs-cTn above the 99th-percentile upper reference limit) was seen in 1 in 5 patients and was an independent predictor of dying in the hospital. Mortality was 10-fold higher in those with cardiac injury on presentation.
Elevated cardiac troponin in the setting of COVID-19, Mills said, “may reflect illness severity with myocardial injury arising due to myocardial oxygen supply–demand imbalance. Or it may be due to direct cardiac involvement through viral myocarditis or stress cardiomyopathy, or where the prothrombotic and proinflammatory state is precipitating acute coronary syndromes.”
In their viewpoint, the authors note that circulating cTn is a marker of myocardial injury, “including but not limited to myocardial infarction or myocarditis, and the clinical relevance of this distinction has never been so clear.”
Therefore, the consequence of not measuring cardiac troponin may be to “ignore the plethora of ischemic and nonischemic causes” of myocardial injury related to COVID-19. “Clinicians who have used troponin measurement as a binary test for myocardial infarction independent of clinical context and those who consider an elevated cardiac troponin concentration to be a mandate for invasive coronary angiography must recalibrate,” they write.
“Rather than encouraging avoidance of troponin testing, we must harness the unheralded engagement from the cardiovascular community due to COVID-19 to better understand the utility of this essential biomarker and to educate clinicians on its interpretation and implications for prognosis and clinical decision making.”
Based on “same logic” as recent ACC guidance
The viewpoint was to some extent a response to a recent informal guidance from the American College of Cardiology (ACC) that advised caution in use of troponin and natriuretic peptide tests in patients with COVID-19.
Even so, that ACC guidance and the new viewpoint in Circulation are based on the “same logic,” James Januzzi Jr, MD, Massachusetts General Hospital, Boston, told theheart.org | Medscape Cardiology. Both documents:
- Point out that troponins are frequently abnormal in patients with severe cases of COVID-19
- Caution that clinicians should not equate an abnormal hs-cTn with acute myocardial infarction
- Note that, in most cases, hs-cTn elevations are a result of noncoronary mechanisms
- Recognize the potential risk to caregivers and the continued unchecked spread of SARS-CoV-2 related to downstream testing that might not be needed
“The Circulation opinion piece states that clinicians often use troponin as a binary test for myocardial infarction and a mandate for downstream testing, suggesting clinicians will need to recalibrate that approach, something I agree with and which is the central message of the ACC position,” Januzzi said.
Probably the biggest difference between the two documents, he said, is in the Circulation authors’ apparent enthusiasm to use hs-cTn as a tool to judge disease severity in patients with COVID-19.
It’s been known for more than a decade that myocardial injury is “an important risk predictor” in critical illness, Januzzi explained. “So the link between cardiac injury and outcomes in critical illness is nothing new. The difference is the fact we are seeing so many patients with COVID-19 all at once, and the authors suggest that using troponin might help in triage decision making.”
“There may be [such] a role here, but the data have not been systematically collected, and whether troponin truly adds something beyond information already available at the bedside — for example, does it add anything not already obvious at the bedside? — has not yet been conclusively proven,” Januzzi cautioned.
“As well, there are no prospective data supporting troponin as a trigger for ICU triage or for deciding on specific treatments.”
Positive cTn status “common” in COVID-19 patients
In his experience, Barry Cohen, MD, Morristown Medical Center, New Jersey, told theheart.org | Medscape Cardiology, that positive cTn status is “common in COVID-19 patients and appears to have prognostic value, not only in type 1 MI due to atherothrombotic disease (related to a proinflammatory and prothrombotic state), but more frequently type 2 MI (supply–demand mismatch), viral myocarditis, coronary microvascular ischemia, stress cardiomyopathy or tachyarrhythmias.”
Moreover, Cohen said, hs-cTn “has identified patients at increased risk for ventilation support (invasive and noninvasive), acute respiratory distress syndrome, acute kidney injury, and mortality.”
Echoing both the ACC document and the Circulation report, Cohen also said hs-cTn measurements “appear to help risk stratify COVID-19 patients, but clearly do not mean that a troponin-positive patient needs to go to the cath lab and be treated as having acute coronary syndrome. Only a minority of these patients require this intervention.”
Mills discloses receiving honoraria from Abbott Diagnostics, Roche Diagnostics, Siemens Healthineers, and LumiraDx. Januzzi has previously disclosed receiving personal fees from the American College of Cardiology, Pfizer, Merck, AbbVie, Amgen, Boehringer Ingelheim, and Takeda; grants and personal fees from Novartis, Roche, Abbott, and Janssen; and grants from Singulex and Prevencio. Cohen has disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
, cardiologists in the United Kingdom advise in a recently published viewpoint.
The tests can be used to “inform the triage of patients to critical care, guide the use of supportive treatments, and facilitate targeted cardiac investigations in those most likely to benefit,” Nicholas Mills, MD, PhD, University of Edinburgh, United Kingdom, told theheart.org | Medscape Cardiology. He is senior author on the viewpoint published online April 6 in the journal Circulation.
Older adults and those with a history of underlying cardiovascular disease appear to be at greatest risk of dying from COVID-19. “From early reports it is clear that elevated cardiac troponin concentrations predict in-hospital mortality,” said Mills.
In a recent report on hospitalized patients with COVID-19 in Wuhan, China, for example, cardiac injury (hs-cTn above the 99th-percentile upper reference limit) was seen in 1 in 5 patients and was an independent predictor of dying in the hospital. Mortality was 10-fold higher in those with cardiac injury on presentation.
Elevated cardiac troponin in the setting of COVID-19, Mills said, “may reflect illness severity with myocardial injury arising due to myocardial oxygen supply–demand imbalance. Or it may be due to direct cardiac involvement through viral myocarditis or stress cardiomyopathy, or where the prothrombotic and proinflammatory state is precipitating acute coronary syndromes.”
In their viewpoint, the authors note that circulating cTn is a marker of myocardial injury, “including but not limited to myocardial infarction or myocarditis, and the clinical relevance of this distinction has never been so clear.”
Therefore, the consequence of not measuring cardiac troponin may be to “ignore the plethora of ischemic and nonischemic causes” of myocardial injury related to COVID-19. “Clinicians who have used troponin measurement as a binary test for myocardial infarction independent of clinical context and those who consider an elevated cardiac troponin concentration to be a mandate for invasive coronary angiography must recalibrate,” they write.
“Rather than encouraging avoidance of troponin testing, we must harness the unheralded engagement from the cardiovascular community due to COVID-19 to better understand the utility of this essential biomarker and to educate clinicians on its interpretation and implications for prognosis and clinical decision making.”
Based on “same logic” as recent ACC guidance
The viewpoint was to some extent a response to a recent informal guidance from the American College of Cardiology (ACC) that advised caution in use of troponin and natriuretic peptide tests in patients with COVID-19.
Even so, that ACC guidance and the new viewpoint in Circulation are based on the “same logic,” James Januzzi Jr, MD, Massachusetts General Hospital, Boston, told theheart.org | Medscape Cardiology. Both documents:
- Point out that troponins are frequently abnormal in patients with severe cases of COVID-19
- Caution that clinicians should not equate an abnormal hs-cTn with acute myocardial infarction
- Note that, in most cases, hs-cTn elevations are a result of noncoronary mechanisms
- Recognize the potential risk to caregivers and the continued unchecked spread of SARS-CoV-2 related to downstream testing that might not be needed
“The Circulation opinion piece states that clinicians often use troponin as a binary test for myocardial infarction and a mandate for downstream testing, suggesting clinicians will need to recalibrate that approach, something I agree with and which is the central message of the ACC position,” Januzzi said.
Probably the biggest difference between the two documents, he said, is in the Circulation authors’ apparent enthusiasm to use hs-cTn as a tool to judge disease severity in patients with COVID-19.
It’s been known for more than a decade that myocardial injury is “an important risk predictor” in critical illness, Januzzi explained. “So the link between cardiac injury and outcomes in critical illness is nothing new. The difference is the fact we are seeing so many patients with COVID-19 all at once, and the authors suggest that using troponin might help in triage decision making.”
“There may be [such] a role here, but the data have not been systematically collected, and whether troponin truly adds something beyond information already available at the bedside — for example, does it add anything not already obvious at the bedside? — has not yet been conclusively proven,” Januzzi cautioned.
“As well, there are no prospective data supporting troponin as a trigger for ICU triage or for deciding on specific treatments.”
Positive cTn status “common” in COVID-19 patients
In his experience, Barry Cohen, MD, Morristown Medical Center, New Jersey, told theheart.org | Medscape Cardiology, that positive cTn status is “common in COVID-19 patients and appears to have prognostic value, not only in type 1 MI due to atherothrombotic disease (related to a proinflammatory and prothrombotic state), but more frequently type 2 MI (supply–demand mismatch), viral myocarditis, coronary microvascular ischemia, stress cardiomyopathy or tachyarrhythmias.”
Moreover, Cohen said, hs-cTn “has identified patients at increased risk for ventilation support (invasive and noninvasive), acute respiratory distress syndrome, acute kidney injury, and mortality.”
Echoing both the ACC document and the Circulation report, Cohen also said hs-cTn measurements “appear to help risk stratify COVID-19 patients, but clearly do not mean that a troponin-positive patient needs to go to the cath lab and be treated as having acute coronary syndrome. Only a minority of these patients require this intervention.”
Mills discloses receiving honoraria from Abbott Diagnostics, Roche Diagnostics, Siemens Healthineers, and LumiraDx. Januzzi has previously disclosed receiving personal fees from the American College of Cardiology, Pfizer, Merck, AbbVie, Amgen, Boehringer Ingelheim, and Takeda; grants and personal fees from Novartis, Roche, Abbott, and Janssen; and grants from Singulex and Prevencio. Cohen has disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
COVID-19 pandemic brings unexpected pediatric consequences
As physicians and advanced practitioners, we have been preparing to face COVID-19 – anticipating increasing volumes of patients with fevers, cough, and shortness of breath, and potential surges in emergency departments (EDs) and primary care offices. Fortunately, while COVID-19 has demonstrated more mild symptoms in pediatric patients, the heightened public health fears and mandated social isolation have created some unforeseen consequences for pediatric patients. This article presents cases encountered over the course of 2 weeks in our ED that shed light on the unexpected ramifications of living in the time of a pandemic. These encounters should remind us as providers to be diligent and thorough in giving guidance to families during a time when face-to-face medicine has become increasingly difficult and limited.
These stories have been modified to protect patient confidentiality.
Case 1
A 2-week-old full-term infant arrived in the ED after having a fever for 48 hours. The patient’s mother reported that she had called the pediatrician yesterday to ask for advice on treating the fever and was instructed to give acetaminophen and bring the infant into the ED for testing.
When we asked mom why she did not bring the infant in yesterday, she stated that the fever went down with acetaminophen, and the baby was drinking well and urinating normally. Mostly, she was afraid to bring the child into the ED given concern for COVID-19; however, when the fever persisted today, she came in. During the work-up, the infant was noted to have focal seizures and was ultimately diagnosed with bacterial meningitis.
Takeaway: Families may be hesitant to follow pediatrician’s advice to seek medical attention at an ED or doctor’s office because of the fear of being exposed to COVID-19.
- If something is urgent or emergent, be sure to stress the importance to families that the advice is non-negotiable for their child’s health.
- Attempt to call ahead for patients who might be more vulnerable in waiting rooms or overcrowded hospitals.
Case 2
A 5-month-old baby presented to the ED with new-onset seizures. Immediate bedside blood work performed demonstrated a normal blood glucose, but the baby was profoundly hyponatremic. Upon asking the mother if the baby has had any vomiting, diarrhea, or difficulty tolerating feeds, she says that she has been diluting formula because all the stores were out of formula. Today, she gave the baby plain water because they were completely out of formula.
Takeaway: With economists estimating unemployment rates in the United States at 13% at press time (the worst since the Great Depression), many families may lack resources to purchase necessities.
- Even if families have the ability to purchase necessities, they may be difficult to find or unavailable (e.g., formula, medications, diapers).
- Consider reaching out to patients in your practice to ask about their ability to find essentials and with advice on what to do if they run out of formula or diapers, or who they should contact if they cannot refill a medication.
- Are you in a position to speak with your mayor or local council to ensure there are regulations on the hoarding of essential items?
- In a time when breast milk or formula is not available for children younger than 1 year of age, what will you recommend for families? There are no current American Academy of Pediatrics’ guidelines.
Case 3
A school-aged girl was helping her mother sanitize the home during the COVID-19 pandemic. She had her gloves on, her commercial antiseptic cleaner ready to go, but it was not spraying. She turned the bottle around to check the nozzle and sprayed herself in the eyes. The family presented to the ED for alkaline burn to her eyes, which required copious irrigation.
Takeaway: Children are spending more time in the house with access to button batteries, choking hazards, and cleaning supplies.
- Cleaning products can cause chemical burns. These products should not be used by young children.
Case 4
A school-aged boy arrived via emergency medical services (EMS) for altered mental status. He told his father he was feeling dizzy and then lost consciousness. EMS noticed that he had some tonic movements of his lower extremities, and when he arrived in the ED, he had eye deviation and was unresponsive.
Work-up ultimately demonstrated that this patient had a seizure and a dangerously elevated ethanol level from drinking an entire bottle of hand sanitizer. Hand sanitizer may contain high concentrations of ethyl alcohol or isopropyl alcohol, which when ingested can cause intoxication or poisoning.
Takeaway: Many products that we may view as harmless can be toxic if ingested in large amounts.
- Consider making a list of products that families may have acquired and have around the home during this COVID-19 pandemic and instruct families to make sure dangerous items (e.g., acetaminophen, aspirin, hand sanitizer, lighters, firearms, batteries) are locked up and/or out of reach of children.
- Make sure families know the Poison Control phone number (800-222-1222).
Case 5
An adolescent female currently being treated with immunosuppressants arrived from home with fever. Her medical history revealed that the patient’s guardian recently passed away from suspected COVID-19. The patient was tested and is herself found to be positive for COVID-19. The patient is currently being cared for by relatives who also live in the same home. They require extensive education and teaching regarding the patient’s medication regimen, while also dealing with the loss of their loved one and the fear of personal exposure.
Takeaway: Communicate with families – especially those with special health care needs – about issues of guardianship in case a child’s primary caretaker falls ill.
- Discuss with families about having easily accessible lists of medications and medical conditions.
- Involve social work and child life specialists to help children and their families deal with life-altering changes and losses suffered during this time, as well as fears related to mortality and exposure.
Case 6
A 3-year-old boy arrived covered in bruises and complaining of stomachache. While the mother denies any known abuse, she states that her significant other has been getting more and more “worked up having to deal with the child’s behavior all day every day.” The preschool the child previously attended has closed due to the pandemic.
Takeaway: Abuse is more common when the parents perceive that there is little community support and when families feel a lack of connection to the community.1 Huang et al. examined the relationship between the economy and nonaccidental trauma, showing a doubling in the rate of nonaccidental head trauma during economic recession.2
- Allow families to know that they are not alone and that child care is difficult
- Offer advice on what caretakers can do if they feel alone or at their mental or physical limit.
- Provide strategies on your practice’s website if a situation at home becomes tense and strained.
Case 7
An adolescent female arrived to the ED with increased suicidality. She normally follows with her psychiatrist once a month and her therapist once a week. Since the beginning of COVID-19 restrictions, she has been using telemedicine for her therapy visits. While previously doing well, she reports that her suicidal ideations have worsened because of feeling isolated from her friends now that school is out and she is not allowed to see them. Although compliant with her medications, her thoughts have increased to the point where she has to be admitted to inpatient psychiatry.
Takeaway: Anxiety, depression, and suicide may increase in a down economy. After the 2008 global economic crisis, rates of suicide drastically increased.3
- Recognize the limitations of telemedicine (technology limitations, patient cooperation, etc.)
- Social isolation may contribute to worsening mental health
- Know when to advise patients to seek in-person evaluation and care for medical and mental health concerns.
Pediatricians are at the forefront of preventative medicine. Families rely on pediatricians for trustworthy and accurate anticipatory guidance, a need that is only heightened during times of local and national stress. The social isolation, fear, and lack of resources accompanying this pandemic have serious consequences for our families. What can you and your practice do to keep children safe in the time of COVID-19?
Dr. Angelica DesPain is a pediatric emergency medicine fellow at Children’s National Hospital in Washington. Dr. Rachel Hatcliffe is an attending physician at the hospital. Neither physician had any relevant financial disclosures. Email Dr. DesPain and/or Dr. Hatcliffe at [email protected].
References
1. Child Dev. 1978;49:604-16.
2. J Neurosurg Pediatr 2011 Aug;8(2):171-6.
3. BMJ 2013;347:f5239.
As physicians and advanced practitioners, we have been preparing to face COVID-19 – anticipating increasing volumes of patients with fevers, cough, and shortness of breath, and potential surges in emergency departments (EDs) and primary care offices. Fortunately, while COVID-19 has demonstrated more mild symptoms in pediatric patients, the heightened public health fears and mandated social isolation have created some unforeseen consequences for pediatric patients. This article presents cases encountered over the course of 2 weeks in our ED that shed light on the unexpected ramifications of living in the time of a pandemic. These encounters should remind us as providers to be diligent and thorough in giving guidance to families during a time when face-to-face medicine has become increasingly difficult and limited.
These stories have been modified to protect patient confidentiality.
Case 1
A 2-week-old full-term infant arrived in the ED after having a fever for 48 hours. The patient’s mother reported that she had called the pediatrician yesterday to ask for advice on treating the fever and was instructed to give acetaminophen and bring the infant into the ED for testing.
When we asked mom why she did not bring the infant in yesterday, she stated that the fever went down with acetaminophen, and the baby was drinking well and urinating normally. Mostly, she was afraid to bring the child into the ED given concern for COVID-19; however, when the fever persisted today, she came in. During the work-up, the infant was noted to have focal seizures and was ultimately diagnosed with bacterial meningitis.
Takeaway: Families may be hesitant to follow pediatrician’s advice to seek medical attention at an ED or doctor’s office because of the fear of being exposed to COVID-19.
- If something is urgent or emergent, be sure to stress the importance to families that the advice is non-negotiable for their child’s health.
- Attempt to call ahead for patients who might be more vulnerable in waiting rooms or overcrowded hospitals.
Case 2
A 5-month-old baby presented to the ED with new-onset seizures. Immediate bedside blood work performed demonstrated a normal blood glucose, but the baby was profoundly hyponatremic. Upon asking the mother if the baby has had any vomiting, diarrhea, or difficulty tolerating feeds, she says that she has been diluting formula because all the stores were out of formula. Today, she gave the baby plain water because they were completely out of formula.
Takeaway: With economists estimating unemployment rates in the United States at 13% at press time (the worst since the Great Depression), many families may lack resources to purchase necessities.
- Even if families have the ability to purchase necessities, they may be difficult to find or unavailable (e.g., formula, medications, diapers).
- Consider reaching out to patients in your practice to ask about their ability to find essentials and with advice on what to do if they run out of formula or diapers, or who they should contact if they cannot refill a medication.
- Are you in a position to speak with your mayor or local council to ensure there are regulations on the hoarding of essential items?
- In a time when breast milk or formula is not available for children younger than 1 year of age, what will you recommend for families? There are no current American Academy of Pediatrics’ guidelines.
Case 3
A school-aged girl was helping her mother sanitize the home during the COVID-19 pandemic. She had her gloves on, her commercial antiseptic cleaner ready to go, but it was not spraying. She turned the bottle around to check the nozzle and sprayed herself in the eyes. The family presented to the ED for alkaline burn to her eyes, which required copious irrigation.
Takeaway: Children are spending more time in the house with access to button batteries, choking hazards, and cleaning supplies.
- Cleaning products can cause chemical burns. These products should not be used by young children.
Case 4
A school-aged boy arrived via emergency medical services (EMS) for altered mental status. He told his father he was feeling dizzy and then lost consciousness. EMS noticed that he had some tonic movements of his lower extremities, and when he arrived in the ED, he had eye deviation and was unresponsive.
Work-up ultimately demonstrated that this patient had a seizure and a dangerously elevated ethanol level from drinking an entire bottle of hand sanitizer. Hand sanitizer may contain high concentrations of ethyl alcohol or isopropyl alcohol, which when ingested can cause intoxication or poisoning.
Takeaway: Many products that we may view as harmless can be toxic if ingested in large amounts.
- Consider making a list of products that families may have acquired and have around the home during this COVID-19 pandemic and instruct families to make sure dangerous items (e.g., acetaminophen, aspirin, hand sanitizer, lighters, firearms, batteries) are locked up and/or out of reach of children.
- Make sure families know the Poison Control phone number (800-222-1222).
Case 5
An adolescent female currently being treated with immunosuppressants arrived from home with fever. Her medical history revealed that the patient’s guardian recently passed away from suspected COVID-19. The patient was tested and is herself found to be positive for COVID-19. The patient is currently being cared for by relatives who also live in the same home. They require extensive education and teaching regarding the patient’s medication regimen, while also dealing with the loss of their loved one and the fear of personal exposure.
Takeaway: Communicate with families – especially those with special health care needs – about issues of guardianship in case a child’s primary caretaker falls ill.
- Discuss with families about having easily accessible lists of medications and medical conditions.
- Involve social work and child life specialists to help children and their families deal with life-altering changes and losses suffered during this time, as well as fears related to mortality and exposure.
Case 6
A 3-year-old boy arrived covered in bruises and complaining of stomachache. While the mother denies any known abuse, she states that her significant other has been getting more and more “worked up having to deal with the child’s behavior all day every day.” The preschool the child previously attended has closed due to the pandemic.
Takeaway: Abuse is more common when the parents perceive that there is little community support and when families feel a lack of connection to the community.1 Huang et al. examined the relationship between the economy and nonaccidental trauma, showing a doubling in the rate of nonaccidental head trauma during economic recession.2
- Allow families to know that they are not alone and that child care is difficult
- Offer advice on what caretakers can do if they feel alone or at their mental or physical limit.
- Provide strategies on your practice’s website if a situation at home becomes tense and strained.
Case 7
An adolescent female arrived to the ED with increased suicidality. She normally follows with her psychiatrist once a month and her therapist once a week. Since the beginning of COVID-19 restrictions, she has been using telemedicine for her therapy visits. While previously doing well, she reports that her suicidal ideations have worsened because of feeling isolated from her friends now that school is out and she is not allowed to see them. Although compliant with her medications, her thoughts have increased to the point where she has to be admitted to inpatient psychiatry.
Takeaway: Anxiety, depression, and suicide may increase in a down economy. After the 2008 global economic crisis, rates of suicide drastically increased.3
- Recognize the limitations of telemedicine (technology limitations, patient cooperation, etc.)
- Social isolation may contribute to worsening mental health
- Know when to advise patients to seek in-person evaluation and care for medical and mental health concerns.
Pediatricians are at the forefront of preventative medicine. Families rely on pediatricians for trustworthy and accurate anticipatory guidance, a need that is only heightened during times of local and national stress. The social isolation, fear, and lack of resources accompanying this pandemic have serious consequences for our families. What can you and your practice do to keep children safe in the time of COVID-19?
Dr. Angelica DesPain is a pediatric emergency medicine fellow at Children’s National Hospital in Washington. Dr. Rachel Hatcliffe is an attending physician at the hospital. Neither physician had any relevant financial disclosures. Email Dr. DesPain and/or Dr. Hatcliffe at [email protected].
References
1. Child Dev. 1978;49:604-16.
2. J Neurosurg Pediatr 2011 Aug;8(2):171-6.
3. BMJ 2013;347:f5239.
As physicians and advanced practitioners, we have been preparing to face COVID-19 – anticipating increasing volumes of patients with fevers, cough, and shortness of breath, and potential surges in emergency departments (EDs) and primary care offices. Fortunately, while COVID-19 has demonstrated more mild symptoms in pediatric patients, the heightened public health fears and mandated social isolation have created some unforeseen consequences for pediatric patients. This article presents cases encountered over the course of 2 weeks in our ED that shed light on the unexpected ramifications of living in the time of a pandemic. These encounters should remind us as providers to be diligent and thorough in giving guidance to families during a time when face-to-face medicine has become increasingly difficult and limited.
These stories have been modified to protect patient confidentiality.
Case 1
A 2-week-old full-term infant arrived in the ED after having a fever for 48 hours. The patient’s mother reported that she had called the pediatrician yesterday to ask for advice on treating the fever and was instructed to give acetaminophen and bring the infant into the ED for testing.
When we asked mom why she did not bring the infant in yesterday, she stated that the fever went down with acetaminophen, and the baby was drinking well and urinating normally. Mostly, she was afraid to bring the child into the ED given concern for COVID-19; however, when the fever persisted today, she came in. During the work-up, the infant was noted to have focal seizures and was ultimately diagnosed with bacterial meningitis.
Takeaway: Families may be hesitant to follow pediatrician’s advice to seek medical attention at an ED or doctor’s office because of the fear of being exposed to COVID-19.
- If something is urgent or emergent, be sure to stress the importance to families that the advice is non-negotiable for their child’s health.
- Attempt to call ahead for patients who might be more vulnerable in waiting rooms or overcrowded hospitals.
Case 2
A 5-month-old baby presented to the ED with new-onset seizures. Immediate bedside blood work performed demonstrated a normal blood glucose, but the baby was profoundly hyponatremic. Upon asking the mother if the baby has had any vomiting, diarrhea, or difficulty tolerating feeds, she says that she has been diluting formula because all the stores were out of formula. Today, she gave the baby plain water because they were completely out of formula.
Takeaway: With economists estimating unemployment rates in the United States at 13% at press time (the worst since the Great Depression), many families may lack resources to purchase necessities.
- Even if families have the ability to purchase necessities, they may be difficult to find or unavailable (e.g., formula, medications, diapers).
- Consider reaching out to patients in your practice to ask about their ability to find essentials and with advice on what to do if they run out of formula or diapers, or who they should contact if they cannot refill a medication.
- Are you in a position to speak with your mayor or local council to ensure there are regulations on the hoarding of essential items?
- In a time when breast milk or formula is not available for children younger than 1 year of age, what will you recommend for families? There are no current American Academy of Pediatrics’ guidelines.
Case 3
A school-aged girl was helping her mother sanitize the home during the COVID-19 pandemic. She had her gloves on, her commercial antiseptic cleaner ready to go, but it was not spraying. She turned the bottle around to check the nozzle and sprayed herself in the eyes. The family presented to the ED for alkaline burn to her eyes, which required copious irrigation.
Takeaway: Children are spending more time in the house with access to button batteries, choking hazards, and cleaning supplies.
- Cleaning products can cause chemical burns. These products should not be used by young children.
Case 4
A school-aged boy arrived via emergency medical services (EMS) for altered mental status. He told his father he was feeling dizzy and then lost consciousness. EMS noticed that he had some tonic movements of his lower extremities, and when he arrived in the ED, he had eye deviation and was unresponsive.
Work-up ultimately demonstrated that this patient had a seizure and a dangerously elevated ethanol level from drinking an entire bottle of hand sanitizer. Hand sanitizer may contain high concentrations of ethyl alcohol or isopropyl alcohol, which when ingested can cause intoxication or poisoning.
Takeaway: Many products that we may view as harmless can be toxic if ingested in large amounts.
- Consider making a list of products that families may have acquired and have around the home during this COVID-19 pandemic and instruct families to make sure dangerous items (e.g., acetaminophen, aspirin, hand sanitizer, lighters, firearms, batteries) are locked up and/or out of reach of children.
- Make sure families know the Poison Control phone number (800-222-1222).
Case 5
An adolescent female currently being treated with immunosuppressants arrived from home with fever. Her medical history revealed that the patient’s guardian recently passed away from suspected COVID-19. The patient was tested and is herself found to be positive for COVID-19. The patient is currently being cared for by relatives who also live in the same home. They require extensive education and teaching regarding the patient’s medication regimen, while also dealing with the loss of their loved one and the fear of personal exposure.
Takeaway: Communicate with families – especially those with special health care needs – about issues of guardianship in case a child’s primary caretaker falls ill.
- Discuss with families about having easily accessible lists of medications and medical conditions.
- Involve social work and child life specialists to help children and their families deal with life-altering changes and losses suffered during this time, as well as fears related to mortality and exposure.
Case 6
A 3-year-old boy arrived covered in bruises and complaining of stomachache. While the mother denies any known abuse, she states that her significant other has been getting more and more “worked up having to deal with the child’s behavior all day every day.” The preschool the child previously attended has closed due to the pandemic.
Takeaway: Abuse is more common when the parents perceive that there is little community support and when families feel a lack of connection to the community.1 Huang et al. examined the relationship between the economy and nonaccidental trauma, showing a doubling in the rate of nonaccidental head trauma during economic recession.2
- Allow families to know that they are not alone and that child care is difficult
- Offer advice on what caretakers can do if they feel alone or at their mental or physical limit.
- Provide strategies on your practice’s website if a situation at home becomes tense and strained.
Case 7
An adolescent female arrived to the ED with increased suicidality. She normally follows with her psychiatrist once a month and her therapist once a week. Since the beginning of COVID-19 restrictions, she has been using telemedicine for her therapy visits. While previously doing well, she reports that her suicidal ideations have worsened because of feeling isolated from her friends now that school is out and she is not allowed to see them. Although compliant with her medications, her thoughts have increased to the point where she has to be admitted to inpatient psychiatry.
Takeaway: Anxiety, depression, and suicide may increase in a down economy. After the 2008 global economic crisis, rates of suicide drastically increased.3
- Recognize the limitations of telemedicine (technology limitations, patient cooperation, etc.)
- Social isolation may contribute to worsening mental health
- Know when to advise patients to seek in-person evaluation and care for medical and mental health concerns.
Pediatricians are at the forefront of preventative medicine. Families rely on pediatricians for trustworthy and accurate anticipatory guidance, a need that is only heightened during times of local and national stress. The social isolation, fear, and lack of resources accompanying this pandemic have serious consequences for our families. What can you and your practice do to keep children safe in the time of COVID-19?
Dr. Angelica DesPain is a pediatric emergency medicine fellow at Children’s National Hospital in Washington. Dr. Rachel Hatcliffe is an attending physician at the hospital. Neither physician had any relevant financial disclosures. Email Dr. DesPain and/or Dr. Hatcliffe at [email protected].
References
1. Child Dev. 1978;49:604-16.
2. J Neurosurg Pediatr 2011 Aug;8(2):171-6.
3. BMJ 2013;347:f5239.
ASH tackles COVID-19 with hematology-related FAQ, promotes new registries
The American Society of Hematology has committed a portion of its website to providing continually updated information addressing specific hematologic disorders in relation to COVID-19.
“As the world grapples with the novel coronavirus, ASH believes that we can help each other be as knowledgeable and prepared as possible,” wrote the society’s president, Stephanie J. Lee, MD, MPH.
On its website, ASH provides relevant COVID-19 information in a series of FAQ divided into malignant and nonmalignant hematologic diseases and disorders. In the malignant category, the various lymphomas and leukemias are individually addressed, as well as other conditions such as myelodysplastic syndromes, myeloproliferative neoplasms, and multiple myeloma. In the nonmalignant category, ASH has provided FAQ on aplastic anemia, thalassemia, sickle cell disease, pulmonary embolism, venous thromboembolism/anticoagulation, coagulopathy, and immune as well as thrombotic thrombocytopenic purpura.
In addition to the continually updated series of relevant FAQ, as part of its response to the pandemic ASH is promoting two unique COVID-19 registries for physicians: the ASH Research Collaborative’s (ASH RC) Data Hub COVID-19 Registry and the Surveillance Epidemiology of Coronavirus (COVID-19) Under Research Exclusion Sickle Cell Disease (SECURE-SCD) Registry.
“The ASH Research Collaborative’s (ASH RC) Data Hub launched the COVID-19 Registry and is currently capturing data on people who test positive for COVID-19 and have been or are currently being treated for hematologic malignancy,” according to the website. The intention is to provide “near real-time observational data summaries,” which will hopefully provide useful information to clinicians treating hematologic malignancies in patients in the midst of the COVID-19 pandemic.
The registry allows clinicians to enter their own cases in a specified format to allow data analysis on clinical practice and patient outcomes that will be aggregated to provide rapid insights for clinicians to help them care for their patients, according to ASH.
The second registry specifically deals with COVID-19 cases in patients with sickle cell disease. It also allows clinicians to add cases with a similar intention of aggregating data to provide near real-time insights into patient care. “We are asking providers caring for these patients to report all of their cases of COVID-19 to this registry,” according to the registry website. The registry is for reporting COVID-19 cases in sickle cell disease patients “after sufficient time has passed to observe the disease course through resolution of acute illness and/or death.”
ASH also provides more generalized information for hematology practitioners dealing with COVID-19 on the topics of conducting their practice and using telemedicine, among others.
Correction, April 15, 2020: This story originally said incorrectly that ASH developed the 2 new registries. The registries are merely being promoted on the ASH website.
The American Society of Hematology has committed a portion of its website to providing continually updated information addressing specific hematologic disorders in relation to COVID-19.
“As the world grapples with the novel coronavirus, ASH believes that we can help each other be as knowledgeable and prepared as possible,” wrote the society’s president, Stephanie J. Lee, MD, MPH.
On its website, ASH provides relevant COVID-19 information in a series of FAQ divided into malignant and nonmalignant hematologic diseases and disorders. In the malignant category, the various lymphomas and leukemias are individually addressed, as well as other conditions such as myelodysplastic syndromes, myeloproliferative neoplasms, and multiple myeloma. In the nonmalignant category, ASH has provided FAQ on aplastic anemia, thalassemia, sickle cell disease, pulmonary embolism, venous thromboembolism/anticoagulation, coagulopathy, and immune as well as thrombotic thrombocytopenic purpura.
In addition to the continually updated series of relevant FAQ, as part of its response to the pandemic ASH is promoting two unique COVID-19 registries for physicians: the ASH Research Collaborative’s (ASH RC) Data Hub COVID-19 Registry and the Surveillance Epidemiology of Coronavirus (COVID-19) Under Research Exclusion Sickle Cell Disease (SECURE-SCD) Registry.
“The ASH Research Collaborative’s (ASH RC) Data Hub launched the COVID-19 Registry and is currently capturing data on people who test positive for COVID-19 and have been or are currently being treated for hematologic malignancy,” according to the website. The intention is to provide “near real-time observational data summaries,” which will hopefully provide useful information to clinicians treating hematologic malignancies in patients in the midst of the COVID-19 pandemic.
The registry allows clinicians to enter their own cases in a specified format to allow data analysis on clinical practice and patient outcomes that will be aggregated to provide rapid insights for clinicians to help them care for their patients, according to ASH.
The second registry specifically deals with COVID-19 cases in patients with sickle cell disease. It also allows clinicians to add cases with a similar intention of aggregating data to provide near real-time insights into patient care. “We are asking providers caring for these patients to report all of their cases of COVID-19 to this registry,” according to the registry website. The registry is for reporting COVID-19 cases in sickle cell disease patients “after sufficient time has passed to observe the disease course through resolution of acute illness and/or death.”
ASH also provides more generalized information for hematology practitioners dealing with COVID-19 on the topics of conducting their practice and using telemedicine, among others.
Correction, April 15, 2020: This story originally said incorrectly that ASH developed the 2 new registries. The registries are merely being promoted on the ASH website.
The American Society of Hematology has committed a portion of its website to providing continually updated information addressing specific hematologic disorders in relation to COVID-19.
“As the world grapples with the novel coronavirus, ASH believes that we can help each other be as knowledgeable and prepared as possible,” wrote the society’s president, Stephanie J. Lee, MD, MPH.
On its website, ASH provides relevant COVID-19 information in a series of FAQ divided into malignant and nonmalignant hematologic diseases and disorders. In the malignant category, the various lymphomas and leukemias are individually addressed, as well as other conditions such as myelodysplastic syndromes, myeloproliferative neoplasms, and multiple myeloma. In the nonmalignant category, ASH has provided FAQ on aplastic anemia, thalassemia, sickle cell disease, pulmonary embolism, venous thromboembolism/anticoagulation, coagulopathy, and immune as well as thrombotic thrombocytopenic purpura.
In addition to the continually updated series of relevant FAQ, as part of its response to the pandemic ASH is promoting two unique COVID-19 registries for physicians: the ASH Research Collaborative’s (ASH RC) Data Hub COVID-19 Registry and the Surveillance Epidemiology of Coronavirus (COVID-19) Under Research Exclusion Sickle Cell Disease (SECURE-SCD) Registry.
“The ASH Research Collaborative’s (ASH RC) Data Hub launched the COVID-19 Registry and is currently capturing data on people who test positive for COVID-19 and have been or are currently being treated for hematologic malignancy,” according to the website. The intention is to provide “near real-time observational data summaries,” which will hopefully provide useful information to clinicians treating hematologic malignancies in patients in the midst of the COVID-19 pandemic.
The registry allows clinicians to enter their own cases in a specified format to allow data analysis on clinical practice and patient outcomes that will be aggregated to provide rapid insights for clinicians to help them care for their patients, according to ASH.
The second registry specifically deals with COVID-19 cases in patients with sickle cell disease. It also allows clinicians to add cases with a similar intention of aggregating data to provide near real-time insights into patient care. “We are asking providers caring for these patients to report all of their cases of COVID-19 to this registry,” according to the registry website. The registry is for reporting COVID-19 cases in sickle cell disease patients “after sufficient time has passed to observe the disease course through resolution of acute illness and/or death.”
ASH also provides more generalized information for hematology practitioners dealing with COVID-19 on the topics of conducting their practice and using telemedicine, among others.
Correction, April 15, 2020: This story originally said incorrectly that ASH developed the 2 new registries. The registries are merely being promoted on the ASH website.
Low plasma sodium levels can predict complications in acute painful episodes of SCD
Although a low blood sodium level has been shown to be a prognostic factor for a number of disorders, it has not been reported on for sickle cell disease, according to French researchers Jean-Simon Rech, MD, and colleagues.
They found that hyponatremia at hospital admission was predictive of complications in initially uncomplicated episodes of painful episodes of sickle cell disease (SCD), according to their study published online in the American Journal of Medicine. Dr. Rech is with the department of internal medicine, Sickle Cell Disease Reference Center, Tenon Hospital, Assistance Publique-Hôpitaux de Paris.
The study assessed 1,218 stays (406 patients) admitted to a single center and the analyses were adjusted for age, sex, hemoglobin genotype and concentration, LDH concentration, and white blood cell count.
The researchers found that hyponatremia (defined as plasma sodium ≤ 135 mmol/L) was significantly associated with the primary endpoint of a composite criterion including acute chest syndrome, intensive care unit transfer, red blood cell transfusion, or inpatient death (P = .001).
With regard to the components of the primary endpoint, hyponatremia was significantly associated with acute chest syndrome (P = .008), as well as with receiving a red blood cell transfusion (P < .001) However, hyponatremia at admission was not significantly associated with intensive care unit transfer (P = .074) and there were no patient deaths.
In addition, hyponatremia was significantly associated with longer stays: 1.1 days adjusted mean length of stay (P < .001).
“Hyponatremia may lead to direct clinical consequences in the management of sickle cell disease patients. Indeed, a plasma sodium concentration ≤ 135mmol/L at admission or a decreasing natremia over the first days of an acute painful episode could be regarded as early signs of incipient acute chest syndrome, prompting clinicians to closely monitor the clinical status of their patients,” the researchers concluded.
The authors declared that they had no conflicts and that there was no funding source.
SOURCE: Rech JS et al. Am J Med. 2020 Mar 18. doi.org/10.1016/j.amjmed.2020.02.017.
Although a low blood sodium level has been shown to be a prognostic factor for a number of disorders, it has not been reported on for sickle cell disease, according to French researchers Jean-Simon Rech, MD, and colleagues.
They found that hyponatremia at hospital admission was predictive of complications in initially uncomplicated episodes of painful episodes of sickle cell disease (SCD), according to their study published online in the American Journal of Medicine. Dr. Rech is with the department of internal medicine, Sickle Cell Disease Reference Center, Tenon Hospital, Assistance Publique-Hôpitaux de Paris.
The study assessed 1,218 stays (406 patients) admitted to a single center and the analyses were adjusted for age, sex, hemoglobin genotype and concentration, LDH concentration, and white blood cell count.
The researchers found that hyponatremia (defined as plasma sodium ≤ 135 mmol/L) was significantly associated with the primary endpoint of a composite criterion including acute chest syndrome, intensive care unit transfer, red blood cell transfusion, or inpatient death (P = .001).
With regard to the components of the primary endpoint, hyponatremia was significantly associated with acute chest syndrome (P = .008), as well as with receiving a red blood cell transfusion (P < .001) However, hyponatremia at admission was not significantly associated with intensive care unit transfer (P = .074) and there were no patient deaths.
In addition, hyponatremia was significantly associated with longer stays: 1.1 days adjusted mean length of stay (P < .001).
“Hyponatremia may lead to direct clinical consequences in the management of sickle cell disease patients. Indeed, a plasma sodium concentration ≤ 135mmol/L at admission or a decreasing natremia over the first days of an acute painful episode could be regarded as early signs of incipient acute chest syndrome, prompting clinicians to closely monitor the clinical status of their patients,” the researchers concluded.
The authors declared that they had no conflicts and that there was no funding source.
SOURCE: Rech JS et al. Am J Med. 2020 Mar 18. doi.org/10.1016/j.amjmed.2020.02.017.
Although a low blood sodium level has been shown to be a prognostic factor for a number of disorders, it has not been reported on for sickle cell disease, according to French researchers Jean-Simon Rech, MD, and colleagues.
They found that hyponatremia at hospital admission was predictive of complications in initially uncomplicated episodes of painful episodes of sickle cell disease (SCD), according to their study published online in the American Journal of Medicine. Dr. Rech is with the department of internal medicine, Sickle Cell Disease Reference Center, Tenon Hospital, Assistance Publique-Hôpitaux de Paris.
The study assessed 1,218 stays (406 patients) admitted to a single center and the analyses were adjusted for age, sex, hemoglobin genotype and concentration, LDH concentration, and white blood cell count.
The researchers found that hyponatremia (defined as plasma sodium ≤ 135 mmol/L) was significantly associated with the primary endpoint of a composite criterion including acute chest syndrome, intensive care unit transfer, red blood cell transfusion, or inpatient death (P = .001).
With regard to the components of the primary endpoint, hyponatremia was significantly associated with acute chest syndrome (P = .008), as well as with receiving a red blood cell transfusion (P < .001) However, hyponatremia at admission was not significantly associated with intensive care unit transfer (P = .074) and there were no patient deaths.
In addition, hyponatremia was significantly associated with longer stays: 1.1 days adjusted mean length of stay (P < .001).
“Hyponatremia may lead to direct clinical consequences in the management of sickle cell disease patients. Indeed, a plasma sodium concentration ≤ 135mmol/L at admission or a decreasing natremia over the first days of an acute painful episode could be regarded as early signs of incipient acute chest syndrome, prompting clinicians to closely monitor the clinical status of their patients,” the researchers concluded.
The authors declared that they had no conflicts and that there was no funding source.
SOURCE: Rech JS et al. Am J Med. 2020 Mar 18. doi.org/10.1016/j.amjmed.2020.02.017.
FROM THE AMERICAN JOURNAL OF MEDICINE
ABIM grants MOC extension
Physicians will not lose their certification if they are unable to complete maintenance of certification requirements in 2020, the American Board of Internal Medicine announced.
ABIM President Richard Baron, MD, said in a letter sent to all diplomates.
Additionally, physicians “currently in their grace year will also be afforded an additional grace year in 2021,” the letter continued.
ABIM noted that many assessments were planned for the fall of 2020 and the organization will continue to offer them as planned for physicians who are able to take them. It added that more assessment dates for 2020 and 2021 will be sent out later this year.
“The next few weeks and months will challenge our health care system and country like never before,” Dr. Baron stated. “Our many internal medicine colleagues – and the clinical teams that support them – have been heroic in their response, often selflessly putting their own personal safety at risk while using their superb skills to provide care for others. They have inspired all of us.”
Physicians will not lose their certification if they are unable to complete maintenance of certification requirements in 2020, the American Board of Internal Medicine announced.
ABIM President Richard Baron, MD, said in a letter sent to all diplomates.
Additionally, physicians “currently in their grace year will also be afforded an additional grace year in 2021,” the letter continued.
ABIM noted that many assessments were planned for the fall of 2020 and the organization will continue to offer them as planned for physicians who are able to take them. It added that more assessment dates for 2020 and 2021 will be sent out later this year.
“The next few weeks and months will challenge our health care system and country like never before,” Dr. Baron stated. “Our many internal medicine colleagues – and the clinical teams that support them – have been heroic in their response, often selflessly putting their own personal safety at risk while using their superb skills to provide care for others. They have inspired all of us.”
Physicians will not lose their certification if they are unable to complete maintenance of certification requirements in 2020, the American Board of Internal Medicine announced.
ABIM President Richard Baron, MD, said in a letter sent to all diplomates.
Additionally, physicians “currently in their grace year will also be afforded an additional grace year in 2021,” the letter continued.
ABIM noted that many assessments were planned for the fall of 2020 and the organization will continue to offer them as planned for physicians who are able to take them. It added that more assessment dates for 2020 and 2021 will be sent out later this year.
“The next few weeks and months will challenge our health care system and country like never before,” Dr. Baron stated. “Our many internal medicine colleagues – and the clinical teams that support them – have been heroic in their response, often selflessly putting their own personal safety at risk while using their superb skills to provide care for others. They have inspired all of us.”
COVID 19: Confessions of an outpatient psychiatrist during the pandemic
It seems that some glitches would be inevitable. With a sudden shift to videoconferencing in private psychiatric practices, there were bound to be issues with both technology and privacy. One friend told me of such a glitch on the very first day she started telemental health: She was meeting with a patient who was sitting at her kitchen table. Unbeknownst to the patient, her husband walked into the kitchen behind her, fully naked, to get something from the refrigerator. “There was a full moon shot!” my friend said, initially quite shocked, and then eventually amused. As we all cope with a national tragedy and the total upheaval to our personal and professional lives, the stories just keep coming.
I left work on Friday, March 13, with plans to return on the following Monday to see patients. I had no idea that, by Sunday evening, I would be persuaded that for the safety of all I would need to shut down my real-life psychiatric practice and switch to a videoconferencing venue. I, along with many psychiatrists in Maryland, made this decision after Amy Huberman, MD, posted the following on the Maryland Psychiatric Society (MPS) listserv on Sunday, March 15:
“I want to make a case for starting video sessions with all your patients NOW. There is increasing evidence that the spread of coronavirus is driven primarily by asymptomatic or mildly ill people infected with the virus. Because of this, it’s not good enough to tell your patients not to come in if they have symptoms, or for you not to come into work if you have no symptoms. Even after I sent out a letter two weeks ago warning people not to come in if they had symptoms or had potentially come in contact with someone with COVID-19, several patients with coughs still came to my office, as well as several people who had just been on trips to New York City.
If we want to help slow the spread of this illness so that our health system has a better chance of being able to offer ventilators to the people who need them, we must limit all contacts as much as possible – even of asymptomatic people, given the emerging data.
I am planning to send out a message to all my patients today that they should do the same. Without the president or the media giving clear advice to people about what to do, it’s our job as physicians to do it.”
By that night, I had set up a home office with a blank wall behind me, windows in front of me, and books propping my computer at a height that would not have my patients looking up my nose. For the first time in over 20 years, I dusted my son’s Little League trophies, moved them and a 40,000 baseball card collection against the wall, carried a desk, chair, rug, houseplant, and a small Buddha into a room in which I would have some privacy, and my telepsychiatry practice found a home.
After some research, I registered for a free site called Doxy.me because it was HIPAA compliant and did not require patients to download an application; anyone with a camera on any Internet-enabled phone, computer, or tablet, could click on a link and enter my virtual waiting room. I soon discovered that images on the Doxy.me site are sometimes grainy and sometimes freeze up; in some sessions, we ended up switching to FaceTime, and as government mandates for HIPAA compliance relaxed, I offered to meet on any site that my patients might be comfortable with: if not Doxy.me (which remains my starting place for most sessions), Facetime, Skype, Zoom, or Whatsapp. I have not offered Bluejeans, Google Hangouts, or WebEx, and no one has requested those applications. I keep the phone next to the computer, and some sessions include a few minutes of tech support as I help patients (or they help me) navigate the various sites. In a few sessions, we could not get the audio to work and we used video on one venue while we talked on the phone. I haven’t figured out if the variations in the quality of the connection has to do with my Comcast connection, the fact that these websites are overloaded with users, or that my household now consists of three people, two large monitors, three laptops, two tablets, three cell phone lines (not to mention one dog and a transplanted cat), all going at the same time. The pets do not require any bandwidth, but all the people are talking to screens throughout the workday.
As my colleagues embarked on the same journey, the listserv questions and comments came quickly. What were the best platforms? Was it a good thing or a bad thing to suddenly be in people’s homes? Some felt the extraneous background to be helpful, others found it distracting and intrusive.
How do these sessions get coded for the purpose of billing? There was a tremendous amount of confusion over that, with the initial verdict being that Medicare wanted the place of service changed to “02” and that private insurers want one of two modifiers, and it was anyone’s guess which company wanted which modifier. Then there was the concern that Medicare was paying 25% less, until the MPS staff clarified that full fees would be paid, but the place of service should be filled in as “11” – not “02” – as with regular office visits, and the modifier “95” should be added on the Health Care Finance Administration claim form. We were left to wait and see what gets reimbursed and for what fees.
Could new patients be seen by videoconferencing? Could patients from other states be seen this way if the psychiatrist was not licensed in the state where the patient was calling from? One psychiatrist reported he had a patient in an adjacent state drive over the border into Maryland, but the patient brought her mother and the evaluation included unwanted input from the mom as the session consisted of the patient and her mother yelling at both each other in the car and at the psychiatrist on the screen!
Psychiatrists on the listserv began to comment that treatment sessions were intense and exhausting. I feel the literal face-to-face contact of another person’s head just inches from my own, with full eye contact, often gets to be a lot. No one asks why I’ve moved a trinket (ah, there are no trinkets) or gazes off around the room. I sometimes sit for long periods of time as I don’t even stand to see the patients to the door. Other patients move about or bounce their devices on their laps, and my stomach starts to feel queasy until I ask to have the device adjusted. In some sessions, I find I’m talking to partial heads, or that computer icons cover the patient’s mouth.
Being in people’s lives via screen has been interesting. Unlike my colleague, I have not had any streaking spouses, but I’ve greeted a few family members – often those serving as technical support – and I’ve toured part of a farm, met dogs, guinea pigs, and even a goat. I’ve made brief daily “visits” to a frightened patient in isolation on a COVID hospital unit and had the joy of celebrating the discharge to home. It’s odd to be in a bedroom with a patient, even virtually, and it is interesting to note where they choose to hold their sessions; I’ve had several patients hold sessions from their cars. Seeing my own image in the corner of the screen is also a bit distracting, and in one session, as I saw my own reaction, my patient said, “I knew you were going to make that face!”
The pandemic has usurped most of the activities of all of our lives, and without social interactions, travel, and work in the usual way, life does not hold its usual richness. In a few cases, I have ended the session after half the time as the patient insisted there was nothing to talk about. Many talk about the medical problems they can’t be seen for, what they are doing to keep safe (or not), how they are washing down their groceries, and who they are meeting with by Zoom. Of those who were terribly anxious before, some feel oddly calmer – the world has ramped up to meet their level of anxiety and they feel vindicated. No one thinks they are odd for worrying about germs on door knobs or elevator buttons. What were once neurotic fears are now our real-life reality. Others have been triggered by a paralyzing fear, often with panic attacks, and these sessions are certainly challenging as I figure out which medications will best help, while responding to requests for reassurance. And there is the troublesome aspect of trying to care for others who are fearful while living with the reality that these fears are not extraneous to our own lives: We, too, are scared for ourselves and our families.
For some people, stay-at-home mandates have been easier than for others. People who are naturally introverted, or those with social anxiety, have told me they find this time at home to be a relief. They no longer feel pressured to go out; there is permission to be alone, to read, or watch Netflix. No one is pressuring them to go to parties or look for a Tinder date. For others, the isolation and loneliness have been devastating, causing a range of emotions from being “stir crazy,” to triggering episodes of major depression and severe anxiety.
Health care workers in therapy talk about their fears of being contaminated with coronavirus, about the exposures they’ve had, their fears of bringing the virus home to family, and about the anger – sometimes rage – that their employers are not doing more to protect them.
Few people these past weeks are looking for insight into their patterns of behavior and emotion. Most of life has come to be about survival and not about personal striving. Students who are driven to excel are disappointed to have their scholastic worlds have switched to pass/fail. And for those struggling with milder forms of depression and anxiety, both the patients and I have all been a bit perplexed by losing the usual measures of what feelings are normal in a tragic world and we no longer use socializing as the hallmark that heralds a return to normalcy after a period of withdrawal.
In some aspects, it is not all been bad. I’ve enjoyed watching my neighbors walk by with their dogs through the window behind my computer screen and I’ve felt part of the daily evolution as the cherry tree outside that same window turns from dead brown wood to vibrant pink blossoms. I like the flexibility of my schedule and the sensation I always carry of being rushed has quelled. I take more walks and spend more time with the family members who are held captive with me. The dog, who no longer is left alone for hours each day, is certainly a winner.
Some of my colleagues tell me they are overwhelmed – patients they have not seen for years have returned, people are asking for more frequent sessions, and they are suddenly trying to work at home while homeschooling children. I have had only a few of those requests for crisis care, while new referrals are much quieter than normal. Some of my patients have even said that they simply aren’t comfortable meeting this way and they will see me at the other end of the pandemic. A few people I would have expected to hear from I have not, and I fear that those who have lost their jobs may avoiding the cost of treatment – this group I will reach out to in the coming weeks. A little extra time, however, has given me the opportunity to join the Johns Hopkins COVID-19 Mental Health team. And my first attempt at teaching a resident seminar by Zoom has gone well.
For some in the medical field, this has been a horrible and traumatic time; they are worked to exhaustion, and surrounded by distress, death, and personal fear with every shift. For others, life has come to a standstill as the elective procedures that fill their days have virtually stopped. For outpatient psychiatry, it’s been a bit of an in-between, we may feel an odd mix of relevant and useless all at the same time, as our services are appreciated by our patients, but as actual soldiers caring for the ill COVID patients, we are leaving that to our colleagues in the EDs, COVID units, and ICUs. As a physician who has not treated a patient in an ICU for decades, I wish I had something more concrete to contribute to the effort, and at the same time, I’m relieved that I don’t.
And what about the patients? How are they doing with remote psychiatry? Some are clearly flustered or frustrated by the technology issues. Other times sessions go smoothly, and the fact that we are talking through screens gets forgotten. Some like the convenience of not having to drive a far distance and no one misses my crowded parking lot.
Kristen, another doctor’s patient in Illinois, commented: “I appreciate the continuity in care, especially if the alternative is delaying appointments. I think that’s most important. The interaction helps manage added anxiety from isolating as well. I don’t think it diminishes the care I receive; it makes me feel that my doctor is still accessible. One other point, since I have had both telemedicine and in-person appointments with my current psychiatrist, is that during in-person meetings, he is usually on his computer and rarely looks at me or makes eye contact. In virtual meetings, I feel he is much more engaged with me.”
In normal times, I spend a good deal of time encouraging patients to work on building their relationships and community – these connections lead people to healthy and fulfilling lives – and now we talk about how to best be socially distant. We see each other as vectors of disease and to greet a friend with a handshake, much less a hug, would be unthinkable. Will our collective psyches ever recover? For those of us who will survive, that remains to be seen. In the meantime, perhaps we are all being forced to be more flexible and innovative.
Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.
It seems that some glitches would be inevitable. With a sudden shift to videoconferencing in private psychiatric practices, there were bound to be issues with both technology and privacy. One friend told me of such a glitch on the very first day she started telemental health: She was meeting with a patient who was sitting at her kitchen table. Unbeknownst to the patient, her husband walked into the kitchen behind her, fully naked, to get something from the refrigerator. “There was a full moon shot!” my friend said, initially quite shocked, and then eventually amused. As we all cope with a national tragedy and the total upheaval to our personal and professional lives, the stories just keep coming.
I left work on Friday, March 13, with plans to return on the following Monday to see patients. I had no idea that, by Sunday evening, I would be persuaded that for the safety of all I would need to shut down my real-life psychiatric practice and switch to a videoconferencing venue. I, along with many psychiatrists in Maryland, made this decision after Amy Huberman, MD, posted the following on the Maryland Psychiatric Society (MPS) listserv on Sunday, March 15:
“I want to make a case for starting video sessions with all your patients NOW. There is increasing evidence that the spread of coronavirus is driven primarily by asymptomatic or mildly ill people infected with the virus. Because of this, it’s not good enough to tell your patients not to come in if they have symptoms, or for you not to come into work if you have no symptoms. Even after I sent out a letter two weeks ago warning people not to come in if they had symptoms or had potentially come in contact with someone with COVID-19, several patients with coughs still came to my office, as well as several people who had just been on trips to New York City.
If we want to help slow the spread of this illness so that our health system has a better chance of being able to offer ventilators to the people who need them, we must limit all contacts as much as possible – even of asymptomatic people, given the emerging data.
I am planning to send out a message to all my patients today that they should do the same. Without the president or the media giving clear advice to people about what to do, it’s our job as physicians to do it.”
By that night, I had set up a home office with a blank wall behind me, windows in front of me, and books propping my computer at a height that would not have my patients looking up my nose. For the first time in over 20 years, I dusted my son’s Little League trophies, moved them and a 40,000 baseball card collection against the wall, carried a desk, chair, rug, houseplant, and a small Buddha into a room in which I would have some privacy, and my telepsychiatry practice found a home.
After some research, I registered for a free site called Doxy.me because it was HIPAA compliant and did not require patients to download an application; anyone with a camera on any Internet-enabled phone, computer, or tablet, could click on a link and enter my virtual waiting room. I soon discovered that images on the Doxy.me site are sometimes grainy and sometimes freeze up; in some sessions, we ended up switching to FaceTime, and as government mandates for HIPAA compliance relaxed, I offered to meet on any site that my patients might be comfortable with: if not Doxy.me (which remains my starting place for most sessions), Facetime, Skype, Zoom, or Whatsapp. I have not offered Bluejeans, Google Hangouts, or WebEx, and no one has requested those applications. I keep the phone next to the computer, and some sessions include a few minutes of tech support as I help patients (or they help me) navigate the various sites. In a few sessions, we could not get the audio to work and we used video on one venue while we talked on the phone. I haven’t figured out if the variations in the quality of the connection has to do with my Comcast connection, the fact that these websites are overloaded with users, or that my household now consists of three people, two large monitors, three laptops, two tablets, three cell phone lines (not to mention one dog and a transplanted cat), all going at the same time. The pets do not require any bandwidth, but all the people are talking to screens throughout the workday.
As my colleagues embarked on the same journey, the listserv questions and comments came quickly. What were the best platforms? Was it a good thing or a bad thing to suddenly be in people’s homes? Some felt the extraneous background to be helpful, others found it distracting and intrusive.
How do these sessions get coded for the purpose of billing? There was a tremendous amount of confusion over that, with the initial verdict being that Medicare wanted the place of service changed to “02” and that private insurers want one of two modifiers, and it was anyone’s guess which company wanted which modifier. Then there was the concern that Medicare was paying 25% less, until the MPS staff clarified that full fees would be paid, but the place of service should be filled in as “11” – not “02” – as with regular office visits, and the modifier “95” should be added on the Health Care Finance Administration claim form. We were left to wait and see what gets reimbursed and for what fees.
Could new patients be seen by videoconferencing? Could patients from other states be seen this way if the psychiatrist was not licensed in the state where the patient was calling from? One psychiatrist reported he had a patient in an adjacent state drive over the border into Maryland, but the patient brought her mother and the evaluation included unwanted input from the mom as the session consisted of the patient and her mother yelling at both each other in the car and at the psychiatrist on the screen!
Psychiatrists on the listserv began to comment that treatment sessions were intense and exhausting. I feel the literal face-to-face contact of another person’s head just inches from my own, with full eye contact, often gets to be a lot. No one asks why I’ve moved a trinket (ah, there are no trinkets) or gazes off around the room. I sometimes sit for long periods of time as I don’t even stand to see the patients to the door. Other patients move about or bounce their devices on their laps, and my stomach starts to feel queasy until I ask to have the device adjusted. In some sessions, I find I’m talking to partial heads, or that computer icons cover the patient’s mouth.
Being in people’s lives via screen has been interesting. Unlike my colleague, I have not had any streaking spouses, but I’ve greeted a few family members – often those serving as technical support – and I’ve toured part of a farm, met dogs, guinea pigs, and even a goat. I’ve made brief daily “visits” to a frightened patient in isolation on a COVID hospital unit and had the joy of celebrating the discharge to home. It’s odd to be in a bedroom with a patient, even virtually, and it is interesting to note where they choose to hold their sessions; I’ve had several patients hold sessions from their cars. Seeing my own image in the corner of the screen is also a bit distracting, and in one session, as I saw my own reaction, my patient said, “I knew you were going to make that face!”
The pandemic has usurped most of the activities of all of our lives, and without social interactions, travel, and work in the usual way, life does not hold its usual richness. In a few cases, I have ended the session after half the time as the patient insisted there was nothing to talk about. Many talk about the medical problems they can’t be seen for, what they are doing to keep safe (or not), how they are washing down their groceries, and who they are meeting with by Zoom. Of those who were terribly anxious before, some feel oddly calmer – the world has ramped up to meet their level of anxiety and they feel vindicated. No one thinks they are odd for worrying about germs on door knobs or elevator buttons. What were once neurotic fears are now our real-life reality. Others have been triggered by a paralyzing fear, often with panic attacks, and these sessions are certainly challenging as I figure out which medications will best help, while responding to requests for reassurance. And there is the troublesome aspect of trying to care for others who are fearful while living with the reality that these fears are not extraneous to our own lives: We, too, are scared for ourselves and our families.
For some people, stay-at-home mandates have been easier than for others. People who are naturally introverted, or those with social anxiety, have told me they find this time at home to be a relief. They no longer feel pressured to go out; there is permission to be alone, to read, or watch Netflix. No one is pressuring them to go to parties or look for a Tinder date. For others, the isolation and loneliness have been devastating, causing a range of emotions from being “stir crazy,” to triggering episodes of major depression and severe anxiety.
Health care workers in therapy talk about their fears of being contaminated with coronavirus, about the exposures they’ve had, their fears of bringing the virus home to family, and about the anger – sometimes rage – that their employers are not doing more to protect them.
Few people these past weeks are looking for insight into their patterns of behavior and emotion. Most of life has come to be about survival and not about personal striving. Students who are driven to excel are disappointed to have their scholastic worlds have switched to pass/fail. And for those struggling with milder forms of depression and anxiety, both the patients and I have all been a bit perplexed by losing the usual measures of what feelings are normal in a tragic world and we no longer use socializing as the hallmark that heralds a return to normalcy after a period of withdrawal.
In some aspects, it is not all been bad. I’ve enjoyed watching my neighbors walk by with their dogs through the window behind my computer screen and I’ve felt part of the daily evolution as the cherry tree outside that same window turns from dead brown wood to vibrant pink blossoms. I like the flexibility of my schedule and the sensation I always carry of being rushed has quelled. I take more walks and spend more time with the family members who are held captive with me. The dog, who no longer is left alone for hours each day, is certainly a winner.
Some of my colleagues tell me they are overwhelmed – patients they have not seen for years have returned, people are asking for more frequent sessions, and they are suddenly trying to work at home while homeschooling children. I have had only a few of those requests for crisis care, while new referrals are much quieter than normal. Some of my patients have even said that they simply aren’t comfortable meeting this way and they will see me at the other end of the pandemic. A few people I would have expected to hear from I have not, and I fear that those who have lost their jobs may avoiding the cost of treatment – this group I will reach out to in the coming weeks. A little extra time, however, has given me the opportunity to join the Johns Hopkins COVID-19 Mental Health team. And my first attempt at teaching a resident seminar by Zoom has gone well.
For some in the medical field, this has been a horrible and traumatic time; they are worked to exhaustion, and surrounded by distress, death, and personal fear with every shift. For others, life has come to a standstill as the elective procedures that fill their days have virtually stopped. For outpatient psychiatry, it’s been a bit of an in-between, we may feel an odd mix of relevant and useless all at the same time, as our services are appreciated by our patients, but as actual soldiers caring for the ill COVID patients, we are leaving that to our colleagues in the EDs, COVID units, and ICUs. As a physician who has not treated a patient in an ICU for decades, I wish I had something more concrete to contribute to the effort, and at the same time, I’m relieved that I don’t.
And what about the patients? How are they doing with remote psychiatry? Some are clearly flustered or frustrated by the technology issues. Other times sessions go smoothly, and the fact that we are talking through screens gets forgotten. Some like the convenience of not having to drive a far distance and no one misses my crowded parking lot.
Kristen, another doctor’s patient in Illinois, commented: “I appreciate the continuity in care, especially if the alternative is delaying appointments. I think that’s most important. The interaction helps manage added anxiety from isolating as well. I don’t think it diminishes the care I receive; it makes me feel that my doctor is still accessible. One other point, since I have had both telemedicine and in-person appointments with my current psychiatrist, is that during in-person meetings, he is usually on his computer and rarely looks at me or makes eye contact. In virtual meetings, I feel he is much more engaged with me.”
In normal times, I spend a good deal of time encouraging patients to work on building their relationships and community – these connections lead people to healthy and fulfilling lives – and now we talk about how to best be socially distant. We see each other as vectors of disease and to greet a friend with a handshake, much less a hug, would be unthinkable. Will our collective psyches ever recover? For those of us who will survive, that remains to be seen. In the meantime, perhaps we are all being forced to be more flexible and innovative.
Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.
It seems that some glitches would be inevitable. With a sudden shift to videoconferencing in private psychiatric practices, there were bound to be issues with both technology and privacy. One friend told me of such a glitch on the very first day she started telemental health: She was meeting with a patient who was sitting at her kitchen table. Unbeknownst to the patient, her husband walked into the kitchen behind her, fully naked, to get something from the refrigerator. “There was a full moon shot!” my friend said, initially quite shocked, and then eventually amused. As we all cope with a national tragedy and the total upheaval to our personal and professional lives, the stories just keep coming.
I left work on Friday, March 13, with plans to return on the following Monday to see patients. I had no idea that, by Sunday evening, I would be persuaded that for the safety of all I would need to shut down my real-life psychiatric practice and switch to a videoconferencing venue. I, along with many psychiatrists in Maryland, made this decision after Amy Huberman, MD, posted the following on the Maryland Psychiatric Society (MPS) listserv on Sunday, March 15:
“I want to make a case for starting video sessions with all your patients NOW. There is increasing evidence that the spread of coronavirus is driven primarily by asymptomatic or mildly ill people infected with the virus. Because of this, it’s not good enough to tell your patients not to come in if they have symptoms, or for you not to come into work if you have no symptoms. Even after I sent out a letter two weeks ago warning people not to come in if they had symptoms or had potentially come in contact with someone with COVID-19, several patients with coughs still came to my office, as well as several people who had just been on trips to New York City.
If we want to help slow the spread of this illness so that our health system has a better chance of being able to offer ventilators to the people who need them, we must limit all contacts as much as possible – even of asymptomatic people, given the emerging data.
I am planning to send out a message to all my patients today that they should do the same. Without the president or the media giving clear advice to people about what to do, it’s our job as physicians to do it.”
By that night, I had set up a home office with a blank wall behind me, windows in front of me, and books propping my computer at a height that would not have my patients looking up my nose. For the first time in over 20 years, I dusted my son’s Little League trophies, moved them and a 40,000 baseball card collection against the wall, carried a desk, chair, rug, houseplant, and a small Buddha into a room in which I would have some privacy, and my telepsychiatry practice found a home.
After some research, I registered for a free site called Doxy.me because it was HIPAA compliant and did not require patients to download an application; anyone with a camera on any Internet-enabled phone, computer, or tablet, could click on a link and enter my virtual waiting room. I soon discovered that images on the Doxy.me site are sometimes grainy and sometimes freeze up; in some sessions, we ended up switching to FaceTime, and as government mandates for HIPAA compliance relaxed, I offered to meet on any site that my patients might be comfortable with: if not Doxy.me (which remains my starting place for most sessions), Facetime, Skype, Zoom, or Whatsapp. I have not offered Bluejeans, Google Hangouts, or WebEx, and no one has requested those applications. I keep the phone next to the computer, and some sessions include a few minutes of tech support as I help patients (or they help me) navigate the various sites. In a few sessions, we could not get the audio to work and we used video on one venue while we talked on the phone. I haven’t figured out if the variations in the quality of the connection has to do with my Comcast connection, the fact that these websites are overloaded with users, or that my household now consists of three people, two large monitors, three laptops, two tablets, three cell phone lines (not to mention one dog and a transplanted cat), all going at the same time. The pets do not require any bandwidth, but all the people are talking to screens throughout the workday.
As my colleagues embarked on the same journey, the listserv questions and comments came quickly. What were the best platforms? Was it a good thing or a bad thing to suddenly be in people’s homes? Some felt the extraneous background to be helpful, others found it distracting and intrusive.
How do these sessions get coded for the purpose of billing? There was a tremendous amount of confusion over that, with the initial verdict being that Medicare wanted the place of service changed to “02” and that private insurers want one of two modifiers, and it was anyone’s guess which company wanted which modifier. Then there was the concern that Medicare was paying 25% less, until the MPS staff clarified that full fees would be paid, but the place of service should be filled in as “11” – not “02” – as with regular office visits, and the modifier “95” should be added on the Health Care Finance Administration claim form. We were left to wait and see what gets reimbursed and for what fees.
Could new patients be seen by videoconferencing? Could patients from other states be seen this way if the psychiatrist was not licensed in the state where the patient was calling from? One psychiatrist reported he had a patient in an adjacent state drive over the border into Maryland, but the patient brought her mother and the evaluation included unwanted input from the mom as the session consisted of the patient and her mother yelling at both each other in the car and at the psychiatrist on the screen!
Psychiatrists on the listserv began to comment that treatment sessions were intense and exhausting. I feel the literal face-to-face contact of another person’s head just inches from my own, with full eye contact, often gets to be a lot. No one asks why I’ve moved a trinket (ah, there are no trinkets) or gazes off around the room. I sometimes sit for long periods of time as I don’t even stand to see the patients to the door. Other patients move about or bounce their devices on their laps, and my stomach starts to feel queasy until I ask to have the device adjusted. In some sessions, I find I’m talking to partial heads, or that computer icons cover the patient’s mouth.
Being in people’s lives via screen has been interesting. Unlike my colleague, I have not had any streaking spouses, but I’ve greeted a few family members – often those serving as technical support – and I’ve toured part of a farm, met dogs, guinea pigs, and even a goat. I’ve made brief daily “visits” to a frightened patient in isolation on a COVID hospital unit and had the joy of celebrating the discharge to home. It’s odd to be in a bedroom with a patient, even virtually, and it is interesting to note where they choose to hold their sessions; I’ve had several patients hold sessions from their cars. Seeing my own image in the corner of the screen is also a bit distracting, and in one session, as I saw my own reaction, my patient said, “I knew you were going to make that face!”
The pandemic has usurped most of the activities of all of our lives, and without social interactions, travel, and work in the usual way, life does not hold its usual richness. In a few cases, I have ended the session after half the time as the patient insisted there was nothing to talk about. Many talk about the medical problems they can’t be seen for, what they are doing to keep safe (or not), how they are washing down their groceries, and who they are meeting with by Zoom. Of those who were terribly anxious before, some feel oddly calmer – the world has ramped up to meet their level of anxiety and they feel vindicated. No one thinks they are odd for worrying about germs on door knobs or elevator buttons. What were once neurotic fears are now our real-life reality. Others have been triggered by a paralyzing fear, often with panic attacks, and these sessions are certainly challenging as I figure out which medications will best help, while responding to requests for reassurance. And there is the troublesome aspect of trying to care for others who are fearful while living with the reality that these fears are not extraneous to our own lives: We, too, are scared for ourselves and our families.
For some people, stay-at-home mandates have been easier than for others. People who are naturally introverted, or those with social anxiety, have told me they find this time at home to be a relief. They no longer feel pressured to go out; there is permission to be alone, to read, or watch Netflix. No one is pressuring them to go to parties or look for a Tinder date. For others, the isolation and loneliness have been devastating, causing a range of emotions from being “stir crazy,” to triggering episodes of major depression and severe anxiety.
Health care workers in therapy talk about their fears of being contaminated with coronavirus, about the exposures they’ve had, their fears of bringing the virus home to family, and about the anger – sometimes rage – that their employers are not doing more to protect them.
Few people these past weeks are looking for insight into their patterns of behavior and emotion. Most of life has come to be about survival and not about personal striving. Students who are driven to excel are disappointed to have their scholastic worlds have switched to pass/fail. And for those struggling with milder forms of depression and anxiety, both the patients and I have all been a bit perplexed by losing the usual measures of what feelings are normal in a tragic world and we no longer use socializing as the hallmark that heralds a return to normalcy after a period of withdrawal.
In some aspects, it is not all been bad. I’ve enjoyed watching my neighbors walk by with their dogs through the window behind my computer screen and I’ve felt part of the daily evolution as the cherry tree outside that same window turns from dead brown wood to vibrant pink blossoms. I like the flexibility of my schedule and the sensation I always carry of being rushed has quelled. I take more walks and spend more time with the family members who are held captive with me. The dog, who no longer is left alone for hours each day, is certainly a winner.
Some of my colleagues tell me they are overwhelmed – patients they have not seen for years have returned, people are asking for more frequent sessions, and they are suddenly trying to work at home while homeschooling children. I have had only a few of those requests for crisis care, while new referrals are much quieter than normal. Some of my patients have even said that they simply aren’t comfortable meeting this way and they will see me at the other end of the pandemic. A few people I would have expected to hear from I have not, and I fear that those who have lost their jobs may avoiding the cost of treatment – this group I will reach out to in the coming weeks. A little extra time, however, has given me the opportunity to join the Johns Hopkins COVID-19 Mental Health team. And my first attempt at teaching a resident seminar by Zoom has gone well.
For some in the medical field, this has been a horrible and traumatic time; they are worked to exhaustion, and surrounded by distress, death, and personal fear with every shift. For others, life has come to a standstill as the elective procedures that fill their days have virtually stopped. For outpatient psychiatry, it’s been a bit of an in-between, we may feel an odd mix of relevant and useless all at the same time, as our services are appreciated by our patients, but as actual soldiers caring for the ill COVID patients, we are leaving that to our colleagues in the EDs, COVID units, and ICUs. As a physician who has not treated a patient in an ICU for decades, I wish I had something more concrete to contribute to the effort, and at the same time, I’m relieved that I don’t.
And what about the patients? How are they doing with remote psychiatry? Some are clearly flustered or frustrated by the technology issues. Other times sessions go smoothly, and the fact that we are talking through screens gets forgotten. Some like the convenience of not having to drive a far distance and no one misses my crowded parking lot.
Kristen, another doctor’s patient in Illinois, commented: “I appreciate the continuity in care, especially if the alternative is delaying appointments. I think that’s most important. The interaction helps manage added anxiety from isolating as well. I don’t think it diminishes the care I receive; it makes me feel that my doctor is still accessible. One other point, since I have had both telemedicine and in-person appointments with my current psychiatrist, is that during in-person meetings, he is usually on his computer and rarely looks at me or makes eye contact. In virtual meetings, I feel he is much more engaged with me.”
In normal times, I spend a good deal of time encouraging patients to work on building their relationships and community – these connections lead people to healthy and fulfilling lives – and now we talk about how to best be socially distant. We see each other as vectors of disease and to greet a friend with a handshake, much less a hug, would be unthinkable. Will our collective psyches ever recover? For those of us who will survive, that remains to be seen. In the meantime, perhaps we are all being forced to be more flexible and innovative.
Dr. Miller is coauthor with Annette Hanson, MD, of “Committed: The Battle Over Involuntary Psychiatric Care” (Baltimore: Johns Hopkins University, 2016). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins, both in Baltimore.
ASCO announces its own COVID-19 and cancer registry
Data will not be commercialized, unlike CancerLinQ
The American Society of Clinical Oncology (ASCO) has launched a registry to collect data on cancer patients with COVID-19 and is asking oncology practices across the United States to share information about their patients with the infection for educational purposes.
The new registry joins at least two other cancer and COVID-19 patient registries already underway in the U.S.
In a statement, ASCO President Howard “Skip” Burris III, MD said there is a need to know “how the virus is impacting our patients, their cancer treatment, and outcomes to inform current cancer care” and future care.
The web-based registry, known as the American Society of Clinical Oncology (ASCO) Survey on COVID-19 in Oncology Registry, is open to all U.S. oncology practices. Participating practices will receive an unspecified “nominal” payment for their data entry efforts.
The registry patient information will be stored on ASCO’s “Big Data” platform, known as CancerLinQ, but is being held apart from that pool of data. The registry information will not be available for commercial purposes, ASCO spokesperson Rachel Martin recently told Medscape Medical News.
Separately, CancerLinQ, which is a wholly owned subsidiary of ASCO, will continue to collect data from its participant oncology practices (as usual), including COVID-19 information.
CancerLinQ has been criticized by ethicists for allowing partner companies to sell access to its data (after stripping off patient identifiers), but without asking for patients’ permission, as reported last year by Medscape Medical News.
Eleven practices, including academic enterprises, have so far expressed interested in participating in the ASCO COVID-19 Registry.
Participating practices are requested to send in details about cancer patients with a confirmed COVID-19 diagnosis. As well as a baseline data capture form, they will need to provide details of subsequent status, treatment, and outcomes. Some patient-identifying data, including zip code, date of birth, gender, race, ethnicity, type of cancer, and comorbidities, will be collected for the purposes of analysis.
ASCO hopes to learn about characteristics of patients with cancer most impacted by COVID-19; estimates of disease severity; treatment modifications or delays; implementation of telemedicine in the cancer treatment setting; and clinical outcomes related to both COVID-19 and cancer.
ASCO says it will deliver periodic reports to the cancer community and the broader public on these and other “key learnings.” It also says that the registry is designed to capture point-in-time data as well as longitudinal data on how the virus will impact care and outcomes into 2021.
ASCO is not alone in its data collection efforts.
The COVID-19 and Cancer Consortium is already collecting information from more than 50 cancer centers and organizations on COVID-19 in patients with cancer. The American Society of Hematology (ASH) Research Collaborative COVID-19 Registry for Hematologic Malignancy is doing the same but with a focus on hematologic malignancies.
This article first appeared on Medscape.com.
Data will not be commercialized, unlike CancerLinQ
Data will not be commercialized, unlike CancerLinQ
The American Society of Clinical Oncology (ASCO) has launched a registry to collect data on cancer patients with COVID-19 and is asking oncology practices across the United States to share information about their patients with the infection for educational purposes.
The new registry joins at least two other cancer and COVID-19 patient registries already underway in the U.S.
In a statement, ASCO President Howard “Skip” Burris III, MD said there is a need to know “how the virus is impacting our patients, their cancer treatment, and outcomes to inform current cancer care” and future care.
The web-based registry, known as the American Society of Clinical Oncology (ASCO) Survey on COVID-19 in Oncology Registry, is open to all U.S. oncology practices. Participating practices will receive an unspecified “nominal” payment for their data entry efforts.
The registry patient information will be stored on ASCO’s “Big Data” platform, known as CancerLinQ, but is being held apart from that pool of data. The registry information will not be available for commercial purposes, ASCO spokesperson Rachel Martin recently told Medscape Medical News.
Separately, CancerLinQ, which is a wholly owned subsidiary of ASCO, will continue to collect data from its participant oncology practices (as usual), including COVID-19 information.
CancerLinQ has been criticized by ethicists for allowing partner companies to sell access to its data (after stripping off patient identifiers), but without asking for patients’ permission, as reported last year by Medscape Medical News.
Eleven practices, including academic enterprises, have so far expressed interested in participating in the ASCO COVID-19 Registry.
Participating practices are requested to send in details about cancer patients with a confirmed COVID-19 diagnosis. As well as a baseline data capture form, they will need to provide details of subsequent status, treatment, and outcomes. Some patient-identifying data, including zip code, date of birth, gender, race, ethnicity, type of cancer, and comorbidities, will be collected for the purposes of analysis.
ASCO hopes to learn about characteristics of patients with cancer most impacted by COVID-19; estimates of disease severity; treatment modifications or delays; implementation of telemedicine in the cancer treatment setting; and clinical outcomes related to both COVID-19 and cancer.
ASCO says it will deliver periodic reports to the cancer community and the broader public on these and other “key learnings.” It also says that the registry is designed to capture point-in-time data as well as longitudinal data on how the virus will impact care and outcomes into 2021.
ASCO is not alone in its data collection efforts.
The COVID-19 and Cancer Consortium is already collecting information from more than 50 cancer centers and organizations on COVID-19 in patients with cancer. The American Society of Hematology (ASH) Research Collaborative COVID-19 Registry for Hematologic Malignancy is doing the same but with a focus on hematologic malignancies.
This article first appeared on Medscape.com.
The American Society of Clinical Oncology (ASCO) has launched a registry to collect data on cancer patients with COVID-19 and is asking oncology practices across the United States to share information about their patients with the infection for educational purposes.
The new registry joins at least two other cancer and COVID-19 patient registries already underway in the U.S.
In a statement, ASCO President Howard “Skip” Burris III, MD said there is a need to know “how the virus is impacting our patients, their cancer treatment, and outcomes to inform current cancer care” and future care.
The web-based registry, known as the American Society of Clinical Oncology (ASCO) Survey on COVID-19 in Oncology Registry, is open to all U.S. oncology practices. Participating practices will receive an unspecified “nominal” payment for their data entry efforts.
The registry patient information will be stored on ASCO’s “Big Data” platform, known as CancerLinQ, but is being held apart from that pool of data. The registry information will not be available for commercial purposes, ASCO spokesperson Rachel Martin recently told Medscape Medical News.
Separately, CancerLinQ, which is a wholly owned subsidiary of ASCO, will continue to collect data from its participant oncology practices (as usual), including COVID-19 information.
CancerLinQ has been criticized by ethicists for allowing partner companies to sell access to its data (after stripping off patient identifiers), but without asking for patients’ permission, as reported last year by Medscape Medical News.
Eleven practices, including academic enterprises, have so far expressed interested in participating in the ASCO COVID-19 Registry.
Participating practices are requested to send in details about cancer patients with a confirmed COVID-19 diagnosis. As well as a baseline data capture form, they will need to provide details of subsequent status, treatment, and outcomes. Some patient-identifying data, including zip code, date of birth, gender, race, ethnicity, type of cancer, and comorbidities, will be collected for the purposes of analysis.
ASCO hopes to learn about characteristics of patients with cancer most impacted by COVID-19; estimates of disease severity; treatment modifications or delays; implementation of telemedicine in the cancer treatment setting; and clinical outcomes related to both COVID-19 and cancer.
ASCO says it will deliver periodic reports to the cancer community and the broader public on these and other “key learnings.” It also says that the registry is designed to capture point-in-time data as well as longitudinal data on how the virus will impact care and outcomes into 2021.
ASCO is not alone in its data collection efforts.
The COVID-19 and Cancer Consortium is already collecting information from more than 50 cancer centers and organizations on COVID-19 in patients with cancer. The American Society of Hematology (ASH) Research Collaborative COVID-19 Registry for Hematologic Malignancy is doing the same but with a focus on hematologic malignancies.
This article first appeared on Medscape.com.
TWILIGHT-COMPLEX: Tap ticagrelor monotherapy early after complex PCI
Patients who underwent complex PCI for acute coronary syndrome followed by 3 months of dual-antiplatelet therapy (DAPT) with ticagrelor plus aspirin fared significantly better by dropping aspirin at that point in favor of long-term ticagrelor monotherapy than with continued dual-antiplatelet therapy in the TWILIGHT-COMPLEX study.
The rate of clinically relevant bleeding was significantly lower at 12 months of follow-up in the ticagrelor monotherapy group than it was in patients randomized to continued DAPT. Moreover, this major benefit came at no cost in terms of ischemic events, which were actually numerically less frequent in the ticagrelor plus placebo group, George D. Dangas, MD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.
“We found that the aspirin just doesn’t add that much, even in complex patients – just bleeding complications, for the most part,” explained Dr. Dangas, professor of medicine and of surgery at the Icahn School of Medicine at Mount Sinai, New York.
The TWILIGHT-COMPLEX study was a secondary post hoc analysis of outcomes in 2,342 participants in the previously reported larger parent TWILIGHT randomized trial who underwent complex PCI. The main TWILIGHT trial included 7,119 patients in 11 countries who underwent PCI for acute coronary syndrome, successfully completed 3 months of DAPT with ticagrelor plus aspirin without incident, and were then randomized double blind to 12 months of ticagrelor plus placebo or to another 12 months of ticagrelor and aspirin.
In the overall TWILIGHT trial, ticagrelor alone resulted in a significantly lower clinically relevant bleeding rate than did long-term ticagrelor plus aspirin, with no increase in the risk of death, MI, or stroke (N Engl J Med 2019; 381:2032-42). But the results left many interventional cardiologists wondering if a ticagrelor monotherapy strategy was really applicable to their more challenging patients undergoing complex PCI given that the risk of ischemic events is known to climb with PCI complexity. The TWILIGHT-COMPLEX study was specifically designed to address that concern.
To be eligible for TWILIGHT-COMPLEX, patients had to meet one or more prespecified angiographic or procedural criteria for complex PCI, such as a total stent length in excess of 60 mm, three or more treated lesions, use of an atherectomy device, or PCI of a left main lesion, a chronic total occlusion, or a bifurcation lesion with two stents. These complex PCI patients accounted for one-third of the total study population in TWILIGHT; 36% of them met more than one criteria for complex PCI.
TWILIGHT-COMPLEX findings
In the 12 months after randomization, patients who received ticagrelor plus placebo had a 4.2% incidence of clinically significant Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding, which was significantly lower than the 7.7% rate in the group on long-term DAPT and represented a 46% relative risk reduction. Severe or fatal bleeding – that is, BARC type 3 or 5 – occurred in 1.1% of those on ticagrelor monotherapy and 2.6% of the DAPT group, for a significant 59% relative risk reduction.
The composite ischemic endpoint comprising cardiovascular death, MI, or ischemic stroke occurred in 3.6% of the ticagrelor monotherapy group and 4.8% of patients on long-term DAPT, a trend that didn’t achieve statistical significance. The all-cause mortality rate was 0.9% in the ticagrelor monotherapy group and 1.5% with extended DAPT, again a nonsignificant difference. Similarly, the rate of definite or probable stent thrombosis was numerically lower with ticagrelor monotherapy, by a margin of 0.4% versus 0.8%, a nonsignificant difference.
The results were consistent regardless of which specific criteria for complex PCI a patient had or how many of them.
Results are ‘reassuring’
At a press conference where Dr. Dangas presented the TWILIGHT-COMPLEX results, discussant Claire S. Duvernoy, MD, said she was “very impressed” with just how complex the PCIs were in the study participants.
“Really, these are the patients that in my own practice we’ve always been the most cautious about, the most worried about thrombotic risk, and the ones where we get down on our house staff when they drop an antiplatelet agent. So this study is very reassuring,” said Dr. Duvernoy, professor of medicine at the University of Michigan, Ann Arbor.
She identified two key differences between TWILIGHT-COMPLEX and earlier studies that showed a benefit for extended DAPT in higher-risk patients. In the earlier studies, it was the P2Y12 inhibitor that was dropped; TWILIGHT was the first major randomized trial to discontinue the aspirin instead. And patients in the TWILIGHT study received second-generation drug-eluting stents.
“That makes a huge difference,” Dr. Duvernoy said. “We have stents now that are much safer than the old ones were, and that’s what allows us to gain this incredible benefit of reduced bleeding.”
Dr. Dangas cautioned that since this was a secondary post hoc analysis, the TWILIGHT-COMPLEX study must be viewed as hypothesis-generating.
The TWILIGHT trial was funded by AstraZeneca. Dr. Dangas reported receiving institutional research grants from that company as well as Bayer and Daichi-Sankyo. He also served as a paid consultant to Abbott Vascular, Boston Scientific, and Biosensors.
Simultaneous with his presentation at ACC 2020, the TWILIGHT-COMPLEX results were published online (J Am Coll Cardiol. 2020 Mar 13. doi: 10.1016/j.jacc.2020.03.011).
SOURCE: Dangas GD. ACC 20, Abstract 410-09.
Patients who underwent complex PCI for acute coronary syndrome followed by 3 months of dual-antiplatelet therapy (DAPT) with ticagrelor plus aspirin fared significantly better by dropping aspirin at that point in favor of long-term ticagrelor monotherapy than with continued dual-antiplatelet therapy in the TWILIGHT-COMPLEX study.
The rate of clinically relevant bleeding was significantly lower at 12 months of follow-up in the ticagrelor monotherapy group than it was in patients randomized to continued DAPT. Moreover, this major benefit came at no cost in terms of ischemic events, which were actually numerically less frequent in the ticagrelor plus placebo group, George D. Dangas, MD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.
“We found that the aspirin just doesn’t add that much, even in complex patients – just bleeding complications, for the most part,” explained Dr. Dangas, professor of medicine and of surgery at the Icahn School of Medicine at Mount Sinai, New York.
The TWILIGHT-COMPLEX study was a secondary post hoc analysis of outcomes in 2,342 participants in the previously reported larger parent TWILIGHT randomized trial who underwent complex PCI. The main TWILIGHT trial included 7,119 patients in 11 countries who underwent PCI for acute coronary syndrome, successfully completed 3 months of DAPT with ticagrelor plus aspirin without incident, and were then randomized double blind to 12 months of ticagrelor plus placebo or to another 12 months of ticagrelor and aspirin.
In the overall TWILIGHT trial, ticagrelor alone resulted in a significantly lower clinically relevant bleeding rate than did long-term ticagrelor plus aspirin, with no increase in the risk of death, MI, or stroke (N Engl J Med 2019; 381:2032-42). But the results left many interventional cardiologists wondering if a ticagrelor monotherapy strategy was really applicable to their more challenging patients undergoing complex PCI given that the risk of ischemic events is known to climb with PCI complexity. The TWILIGHT-COMPLEX study was specifically designed to address that concern.
To be eligible for TWILIGHT-COMPLEX, patients had to meet one or more prespecified angiographic or procedural criteria for complex PCI, such as a total stent length in excess of 60 mm, three or more treated lesions, use of an atherectomy device, or PCI of a left main lesion, a chronic total occlusion, or a bifurcation lesion with two stents. These complex PCI patients accounted for one-third of the total study population in TWILIGHT; 36% of them met more than one criteria for complex PCI.
TWILIGHT-COMPLEX findings
In the 12 months after randomization, patients who received ticagrelor plus placebo had a 4.2% incidence of clinically significant Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding, which was significantly lower than the 7.7% rate in the group on long-term DAPT and represented a 46% relative risk reduction. Severe or fatal bleeding – that is, BARC type 3 or 5 – occurred in 1.1% of those on ticagrelor monotherapy and 2.6% of the DAPT group, for a significant 59% relative risk reduction.
The composite ischemic endpoint comprising cardiovascular death, MI, or ischemic stroke occurred in 3.6% of the ticagrelor monotherapy group and 4.8% of patients on long-term DAPT, a trend that didn’t achieve statistical significance. The all-cause mortality rate was 0.9% in the ticagrelor monotherapy group and 1.5% with extended DAPT, again a nonsignificant difference. Similarly, the rate of definite or probable stent thrombosis was numerically lower with ticagrelor monotherapy, by a margin of 0.4% versus 0.8%, a nonsignificant difference.
The results were consistent regardless of which specific criteria for complex PCI a patient had or how many of them.
Results are ‘reassuring’
At a press conference where Dr. Dangas presented the TWILIGHT-COMPLEX results, discussant Claire S. Duvernoy, MD, said she was “very impressed” with just how complex the PCIs were in the study participants.
“Really, these are the patients that in my own practice we’ve always been the most cautious about, the most worried about thrombotic risk, and the ones where we get down on our house staff when they drop an antiplatelet agent. So this study is very reassuring,” said Dr. Duvernoy, professor of medicine at the University of Michigan, Ann Arbor.
She identified two key differences between TWILIGHT-COMPLEX and earlier studies that showed a benefit for extended DAPT in higher-risk patients. In the earlier studies, it was the P2Y12 inhibitor that was dropped; TWILIGHT was the first major randomized trial to discontinue the aspirin instead. And patients in the TWILIGHT study received second-generation drug-eluting stents.
“That makes a huge difference,” Dr. Duvernoy said. “We have stents now that are much safer than the old ones were, and that’s what allows us to gain this incredible benefit of reduced bleeding.”
Dr. Dangas cautioned that since this was a secondary post hoc analysis, the TWILIGHT-COMPLEX study must be viewed as hypothesis-generating.
The TWILIGHT trial was funded by AstraZeneca. Dr. Dangas reported receiving institutional research grants from that company as well as Bayer and Daichi-Sankyo. He also served as a paid consultant to Abbott Vascular, Boston Scientific, and Biosensors.
Simultaneous with his presentation at ACC 2020, the TWILIGHT-COMPLEX results were published online (J Am Coll Cardiol. 2020 Mar 13. doi: 10.1016/j.jacc.2020.03.011).
SOURCE: Dangas GD. ACC 20, Abstract 410-09.
Patients who underwent complex PCI for acute coronary syndrome followed by 3 months of dual-antiplatelet therapy (DAPT) with ticagrelor plus aspirin fared significantly better by dropping aspirin at that point in favor of long-term ticagrelor monotherapy than with continued dual-antiplatelet therapy in the TWILIGHT-COMPLEX study.
The rate of clinically relevant bleeding was significantly lower at 12 months of follow-up in the ticagrelor monotherapy group than it was in patients randomized to continued DAPT. Moreover, this major benefit came at no cost in terms of ischemic events, which were actually numerically less frequent in the ticagrelor plus placebo group, George D. Dangas, MD, reported at the joint scientific sessions of the American College of Cardiology and the World Heart Federation. ACC organizers chose to present parts of the meeting virtually after COVID-19 concerns caused them to cancel the meeting.
“We found that the aspirin just doesn’t add that much, even in complex patients – just bleeding complications, for the most part,” explained Dr. Dangas, professor of medicine and of surgery at the Icahn School of Medicine at Mount Sinai, New York.
The TWILIGHT-COMPLEX study was a secondary post hoc analysis of outcomes in 2,342 participants in the previously reported larger parent TWILIGHT randomized trial who underwent complex PCI. The main TWILIGHT trial included 7,119 patients in 11 countries who underwent PCI for acute coronary syndrome, successfully completed 3 months of DAPT with ticagrelor plus aspirin without incident, and were then randomized double blind to 12 months of ticagrelor plus placebo or to another 12 months of ticagrelor and aspirin.
In the overall TWILIGHT trial, ticagrelor alone resulted in a significantly lower clinically relevant bleeding rate than did long-term ticagrelor plus aspirin, with no increase in the risk of death, MI, or stroke (N Engl J Med 2019; 381:2032-42). But the results left many interventional cardiologists wondering if a ticagrelor monotherapy strategy was really applicable to their more challenging patients undergoing complex PCI given that the risk of ischemic events is known to climb with PCI complexity. The TWILIGHT-COMPLEX study was specifically designed to address that concern.
To be eligible for TWILIGHT-COMPLEX, patients had to meet one or more prespecified angiographic or procedural criteria for complex PCI, such as a total stent length in excess of 60 mm, three or more treated lesions, use of an atherectomy device, or PCI of a left main lesion, a chronic total occlusion, or a bifurcation lesion with two stents. These complex PCI patients accounted for one-third of the total study population in TWILIGHT; 36% of them met more than one criteria for complex PCI.
TWILIGHT-COMPLEX findings
In the 12 months after randomization, patients who received ticagrelor plus placebo had a 4.2% incidence of clinically significant Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding, which was significantly lower than the 7.7% rate in the group on long-term DAPT and represented a 46% relative risk reduction. Severe or fatal bleeding – that is, BARC type 3 or 5 – occurred in 1.1% of those on ticagrelor monotherapy and 2.6% of the DAPT group, for a significant 59% relative risk reduction.
The composite ischemic endpoint comprising cardiovascular death, MI, or ischemic stroke occurred in 3.6% of the ticagrelor monotherapy group and 4.8% of patients on long-term DAPT, a trend that didn’t achieve statistical significance. The all-cause mortality rate was 0.9% in the ticagrelor monotherapy group and 1.5% with extended DAPT, again a nonsignificant difference. Similarly, the rate of definite or probable stent thrombosis was numerically lower with ticagrelor monotherapy, by a margin of 0.4% versus 0.8%, a nonsignificant difference.
The results were consistent regardless of which specific criteria for complex PCI a patient had or how many of them.
Results are ‘reassuring’
At a press conference where Dr. Dangas presented the TWILIGHT-COMPLEX results, discussant Claire S. Duvernoy, MD, said she was “very impressed” with just how complex the PCIs were in the study participants.
“Really, these are the patients that in my own practice we’ve always been the most cautious about, the most worried about thrombotic risk, and the ones where we get down on our house staff when they drop an antiplatelet agent. So this study is very reassuring,” said Dr. Duvernoy, professor of medicine at the University of Michigan, Ann Arbor.
She identified two key differences between TWILIGHT-COMPLEX and earlier studies that showed a benefit for extended DAPT in higher-risk patients. In the earlier studies, it was the P2Y12 inhibitor that was dropped; TWILIGHT was the first major randomized trial to discontinue the aspirin instead. And patients in the TWILIGHT study received second-generation drug-eluting stents.
“That makes a huge difference,” Dr. Duvernoy said. “We have stents now that are much safer than the old ones were, and that’s what allows us to gain this incredible benefit of reduced bleeding.”
Dr. Dangas cautioned that since this was a secondary post hoc analysis, the TWILIGHT-COMPLEX study must be viewed as hypothesis-generating.
The TWILIGHT trial was funded by AstraZeneca. Dr. Dangas reported receiving institutional research grants from that company as well as Bayer and Daichi-Sankyo. He also served as a paid consultant to Abbott Vascular, Boston Scientific, and Biosensors.
Simultaneous with his presentation at ACC 2020, the TWILIGHT-COMPLEX results were published online (J Am Coll Cardiol. 2020 Mar 13. doi: 10.1016/j.jacc.2020.03.011).
SOURCE: Dangas GD. ACC 20, Abstract 410-09.
FROM ACC 2020
