Dermatology News

Real-world survival outcomes for cancer patients on immune checkpoint inhibitors (ICIs) are inferior to outcomes reported in patients on clinical trials of ICIs, according to research published in JCO Clinical Cancer Informatics.

However, the research also suggests that real-world patients who receive ICIs achieve longer survival than patients on standard-of-care medications.

“Patients receiving ICIs in real-world practice may differ from those enrolled in trials in a variety of ways, including age, race, performance status, and comorbidity burden,” said study author Jerry S.H. Lee, PhD, of the University of Southern California, Los Angeles.

Dr. Lee noted that only 3%-4% of cancer patients participate in clinical trials. In fact, more than half of patients with melanoma and nearly three-quarters of those with non–small cell lung cancer (NSCLC) do not meet criteria for eligibility in clinical trials, he said.

To examine the discrepancies between real-world practice and clinical trials and to better understand which patients receive ICIs in clinical practice, Dr. Lee and colleagues conducted a retrospective analysis using electronic health record data from Veterans Administration (VA) facilities nationwide.

The researchers identified 11,888 cancer patients who were treated with ICIs. The cohort included patients who are underrepresented in pivotal clinical trials, including older, non-White, and/or higher disease-burdened patients.

The majority of patients were treated for NSCLC (51.1%), followed by melanoma (14.4%), renal cell carcinoma (RCC; 8.1%), squamous cell carcinoma of the head and neck (6.8%), urothelial cancer (6.4%), hepatocellular carcinoma (4.5%), and other less common cancer types (8.8%).
 

Overall survival by indication

In general, median overall survival (OS) in the VA cohort was inferior to median OS reported in clinical trials. However, patients treated with first-line nivolumab for melanoma and second-line pembrolizumab or nivolumab for NSCLC had similar OS in the real-world and trial data.

The researchers did not report exact OS numbers from clinical trials. However, they did report the exact numbers from the VA cohort and show OS differences between the VA cohort and clinical trials graphically.

Among patients in the VA cohort, the median OS was:

• 25.5 months in melanoma patients on first-line nivolumab
• 16.3 months in RCC patients receiving nivolumab in the second line or higher
• 14 months in RCC patients on first-line ipilimumab and nivolumab
• 10.6 months in NSCLC patients on first-line pembrolizumab
• 9.9 months in NSCLC patients receiving pembrolizumab or nivolumab in the second line or higher
• 9.1 months in NSCLC patients on first-line pembrolizumab and platinum-based chemotherapy
• 6.7 months in urothelial cancer patients receiving ICIs in the second line or higher.

A number of factors may have contributed to the shorter OS observed in the VA cohort, according to the researchers. The VA cohort is predominantly male, is older, and has a higher degree of comorbidity, compared with patients in clinical trials.

In addition, no data are available to determine the cause for discontinuation of therapy, and VA patients may have received ICIs after failing multiple lines of previous therapy, while clinical trials may limit patients to only one or two previous lines of therapy.

After stratifying VA patients by frailty status, the OS among non-frail patients was more similar to the OS reported in clinical trials.

“Real-world outcomes from the VA were more similar when adjusted for frailty, which shows the importance of patient diversity in clinical trials,” Dr. Lee said. He added that the definition of frailty among VA patients included potential injury during combat and therefore differs from a generic frailty definition.
 

ICIs vs. standard care

The researchers also found that VA patients treated with ICIs had longer OS, compared with a cohort of VA patients receiving standard-of-care therapies.

The median OS was as follows:

• In melanoma patients on first-line treatment – 39.29 months with nivolumab and 5.75 months with chemotherapy (P < .001).
• In RCC patients on first-line treatment – 14.01 months with ipilimumab plus nivolumab and 8.63 months with targeted therapy (P = .051).
• In RCC patients on second-line or greater treatment – 12.43 months with nivolumab and 8.09 months with everolimus (P < .001).
• In NSCLC patients on first-line therapy – 8.88 months with pembrolizumab and 6.38 months with a platinum doublet (P < .001).
• In NSCLC patients on first-line combination therapy – 10.59 months with pembrolizumab plus platinum chemotherapy and 6.38 months with a platinum doublet (P < .001).
• In NSCLC patients on second-line or greater therapy – 10.06 months with pembrolizumab or nivolumab and 6.41 months with docetaxel (P < .001).
• In urothelial cancer patients on second-line or greater therapy – 7.66 months with an ICI and 6.31 months with chemotherapy (P = .043).
   

Help for treatment decisions

“The real-world survival outcomes not only indicate the breadth of indications but also represent patients who tend not to be eligible for immunotherapy trials, based on their health status,” Dr. Lee said. “We hope this dataset of national-level experience provides practicing oncologists evidence to help patients and family members in the process of decision-making about therapy.”

Real-world data can also inform oncologists who face decisions on whether to prescribe or withhold ICIs and patients who face the financial burden of paying for ICIs, he said.

This dataset will be continually updated. The researchers have already added another 10,000 VA patients who have received immunotherapies in the year since the trial began.

“In a longitudinal way, we plan to examine what causes differences in outcomes and continue to find ways to extend care to veterans with a balance of high quality of life,” Dr. Lee said.

“Patients who participate in clinical trials are, on average, younger and healthier than the general population,” said Bora Youn, PhD, a senior biostatistician at Biogen in Cambridge, Mass., who was not involved in this study.

“In the case of immunotherapies, those with poor performance status and autoimmune conditions are often excluded from trials,” Dr. Youn added. “In the real world, these patients can also receive treatments, and clinicians often need to extrapolate the results from clinical trials. It is therefore important to collect real-world data to understand the effectiveness and safety of these therapies in patients with limited evidence.”

Dr. Youn led a real-world study, published in Cancer, of 1,256 Medicare recipients who were diagnosed with NSCLC and received ICI therapy.

“We found that factors associated with poor prognosis in general, such as squamous histology and failure of aggressive prior treatment, are also predictive of decreased survival among those who initiated immunotherapies. Yet, OS of older patients was relatively comparable to those observed in clinical trials,” Dr. Youn said.

“Understanding the real-world effectiveness of these treatments will help improve the evidence base, especially for those underrepresented in clinical trials. These studies can also help identify patients who are most likely to benefit from immunotherapies,” Dr. Youn added.

This study was supported by the VA Office of Research and Development Cooperative Studies Program. Dr. Lee and Dr. Youn disclosed no conflicts of interest.

SOURCE: Jennifer La et al. JCO Clinical Cancer Informatics. 2020:4:918-28.

Real-world survival outcomes for cancer patients on immune checkpoint inhibitors (ICIs) are inferior to outcomes reported in patients on clinical trials of ICIs, according to research published in JCO Clinical Cancer Informatics.

However, the research also suggests that real-world patients who receive ICIs achieve longer survival than patients on standard-of-care medications.

“Patients receiving ICIs in real-world practice may differ from those enrolled in trials in a variety of ways, including age, race, performance status, and comorbidity burden,” said study author Jerry S.H. Lee, PhD, of the University of Southern California, Los Angeles.

Dr. Lee noted that only 3%-4% of cancer patients participate in clinical trials. In fact, more than half of patients with melanoma and nearly three-quarters of those with non–small cell lung cancer (NSCLC) do not meet criteria for eligibility in clinical trials, he said.

To examine the discrepancies between real-world practice and clinical trials and to better understand which patients receive ICIs in clinical practice, Dr. Lee and colleagues conducted a retrospective analysis using electronic health record data from Veterans Administration (VA) facilities nationwide.

The researchers identified 11,888 cancer patients who were treated with ICIs. The cohort included patients who are underrepresented in pivotal clinical trials, including older, non-White, and/or higher disease-burdened patients.

The majority of patients were treated for NSCLC (51.1%), followed by melanoma (14.4%), renal cell carcinoma (RCC; 8.1%), squamous cell carcinoma of the head and neck (6.8%), urothelial cancer (6.4%), hepatocellular carcinoma (4.5%), and other less common cancer types (8.8%).
 

Overall survival by indication

In general, median overall survival (OS) in the VA cohort was inferior to median OS reported in clinical trials. However, patients treated with first-line nivolumab for melanoma and second-line pembrolizumab or nivolumab for NSCLC had similar OS in the real-world and trial data.

The researchers did not report exact OS numbers from clinical trials. However, they did report the exact numbers from the VA cohort and show OS differences between the VA cohort and clinical trials graphically.

Among patients in the VA cohort, the median OS was:

• 25.5 months in melanoma patients on first-line nivolumab
• 16.3 months in RCC patients receiving nivolumab in the second line or higher
• 14 months in RCC patients on first-line ipilimumab and nivolumab
• 10.6 months in NSCLC patients on first-line pembrolizumab
• 9.9 months in NSCLC patients receiving pembrolizumab or nivolumab in the second line or higher
• 9.1 months in NSCLC patients on first-line pembrolizumab and platinum-based chemotherapy
• 6.7 months in urothelial cancer patients receiving ICIs in the second line or higher.

A number of factors may have contributed to the shorter OS observed in the VA cohort, according to the researchers. The VA cohort is predominantly male, is older, and has a higher degree of comorbidity, compared with patients in clinical trials.

In addition, no data are available to determine the cause for discontinuation of therapy, and VA patients may have received ICIs after failing multiple lines of previous therapy, while clinical trials may limit patients to only one or two previous lines of therapy.

After stratifying VA patients by frailty status, the OS among non-frail patients was more similar to the OS reported in clinical trials.

“Real-world outcomes from the VA were more similar when adjusted for frailty, which shows the importance of patient diversity in clinical trials,” Dr. Lee said. He added that the definition of frailty among VA patients included potential injury during combat and therefore differs from a generic frailty definition.
 

ICIs vs. standard care

The researchers also found that VA patients treated with ICIs had longer OS, compared with a cohort of VA patients receiving standard-of-care therapies.

The median OS was as follows:

• In melanoma patients on first-line treatment – 39.29 months with nivolumab and 5.75 months with chemotherapy (P < .001).
• In RCC patients on first-line treatment – 14.01 months with ipilimumab plus nivolumab and 8.63 months with targeted therapy (P = .051).
• In RCC patients on second-line or greater treatment – 12.43 months with nivolumab and 8.09 months with everolimus (P < .001).
• In NSCLC patients on first-line therapy – 8.88 months with pembrolizumab and 6.38 months with a platinum doublet (P < .001).
• In NSCLC patients on first-line combination therapy – 10.59 months with pembrolizumab plus platinum chemotherapy and 6.38 months with a platinum doublet (P < .001).
• In NSCLC patients on second-line or greater therapy – 10.06 months with pembrolizumab or nivolumab and 6.41 months with docetaxel (P < .001).
• In urothelial cancer patients on second-line or greater therapy – 7.66 months with an ICI and 6.31 months with chemotherapy (P = .043).
   

Help for treatment decisions

“The real-world survival outcomes not only indicate the breadth of indications but also represent patients who tend not to be eligible for immunotherapy trials, based on their health status,” Dr. Lee said. “We hope this dataset of national-level experience provides practicing oncologists evidence to help patients and family members in the process of decision-making about therapy.”

Real-world data can also inform oncologists who face decisions on whether to prescribe or withhold ICIs and patients who face the financial burden of paying for ICIs, he said.

This dataset will be continually updated. The researchers have already added another 10,000 VA patients who have received immunotherapies in the year since the trial began.

“In a longitudinal way, we plan to examine what causes differences in outcomes and continue to find ways to extend care to veterans with a balance of high quality of life,” Dr. Lee said.

“Patients who participate in clinical trials are, on average, younger and healthier than the general population,” said Bora Youn, PhD, a senior biostatistician at Biogen in Cambridge, Mass., who was not involved in this study.

“In the case of immunotherapies, those with poor performance status and autoimmune conditions are often excluded from trials,” Dr. Youn added. “In the real world, these patients can also receive treatments, and clinicians often need to extrapolate the results from clinical trials. It is therefore important to collect real-world data to understand the effectiveness and safety of these therapies in patients with limited evidence.”

Dr. Youn led a real-world study, published in Cancer, of 1,256 Medicare recipients who were diagnosed with NSCLC and received ICI therapy.

“We found that factors associated with poor prognosis in general, such as squamous histology and failure of aggressive prior treatment, are also predictive of decreased survival among those who initiated immunotherapies. Yet, OS of older patients was relatively comparable to those observed in clinical trials,” Dr. Youn said.

“Understanding the real-world effectiveness of these treatments will help improve the evidence base, especially for those underrepresented in clinical trials. These studies can also help identify patients who are most likely to benefit from immunotherapies,” Dr. Youn added.

This study was supported by the VA Office of Research and Development Cooperative Studies Program. Dr. Lee and Dr. Youn disclosed no conflicts of interest.

SOURCE: Jennifer La et al. JCO Clinical Cancer Informatics. 2020:4:918-28.

Real-world survival outcomes for cancer patients on immune checkpoint inhibitors (ICIs) are inferior to outcomes reported in patients on clinical trials of ICIs, according to research published in JCO Clinical Cancer Informatics.

However, the research also suggests that real-world patients who receive ICIs achieve longer survival than patients on standard-of-care medications.

“Patients receiving ICIs in real-world practice may differ from those enrolled in trials in a variety of ways, including age, race, performance status, and comorbidity burden,” said study author Jerry S.H. Lee, PhD, of the University of Southern California, Los Angeles.

Dr. Lee noted that only 3%-4% of cancer patients participate in clinical trials. In fact, more than half of patients with melanoma and nearly three-quarters of those with non–small cell lung cancer (NSCLC) do not meet criteria for eligibility in clinical trials, he said.

To examine the discrepancies between real-world practice and clinical trials and to better understand which patients receive ICIs in clinical practice, Dr. Lee and colleagues conducted a retrospective analysis using electronic health record data from Veterans Administration (VA) facilities nationwide.

The researchers identified 11,888 cancer patients who were treated with ICIs. The cohort included patients who are underrepresented in pivotal clinical trials, including older, non-White, and/or higher disease-burdened patients.

The majority of patients were treated for NSCLC (51.1%), followed by melanoma (14.4%), renal cell carcinoma (RCC; 8.1%), squamous cell carcinoma of the head and neck (6.8%), urothelial cancer (6.4%), hepatocellular carcinoma (4.5%), and other less common cancer types (8.8%).
 

Overall survival by indication

In general, median overall survival (OS) in the VA cohort was inferior to median OS reported in clinical trials. However, patients treated with first-line nivolumab for melanoma and second-line pembrolizumab or nivolumab for NSCLC had similar OS in the real-world and trial data.

The researchers did not report exact OS numbers from clinical trials. However, they did report the exact numbers from the VA cohort and show OS differences between the VA cohort and clinical trials graphically.

Among patients in the VA cohort, the median OS was:

• 25.5 months in melanoma patients on first-line nivolumab
• 16.3 months in RCC patients receiving nivolumab in the second line or higher
• 14 months in RCC patients on first-line ipilimumab and nivolumab
• 10.6 months in NSCLC patients on first-line pembrolizumab
• 9.9 months in NSCLC patients receiving pembrolizumab or nivolumab in the second line or higher
• 9.1 months in NSCLC patients on first-line pembrolizumab and platinum-based chemotherapy
• 6.7 months in urothelial cancer patients receiving ICIs in the second line or higher.

A number of factors may have contributed to the shorter OS observed in the VA cohort, according to the researchers. The VA cohort is predominantly male, is older, and has a higher degree of comorbidity, compared with patients in clinical trials.

In addition, no data are available to determine the cause for discontinuation of therapy, and VA patients may have received ICIs after failing multiple lines of previous therapy, while clinical trials may limit patients to only one or two previous lines of therapy.

After stratifying VA patients by frailty status, the OS among non-frail patients was more similar to the OS reported in clinical trials.

“Real-world outcomes from the VA were more similar when adjusted for frailty, which shows the importance of patient diversity in clinical trials,” Dr. Lee said. He added that the definition of frailty among VA patients included potential injury during combat and therefore differs from a generic frailty definition.
 

ICIs vs. standard care

The researchers also found that VA patients treated with ICIs had longer OS, compared with a cohort of VA patients receiving standard-of-care therapies.

The median OS was as follows:

• In melanoma patients on first-line treatment – 39.29 months with nivolumab and 5.75 months with chemotherapy (P < .001).
• In RCC patients on first-line treatment – 14.01 months with ipilimumab plus nivolumab and 8.63 months with targeted therapy (P = .051).
• In RCC patients on second-line or greater treatment – 12.43 months with nivolumab and 8.09 months with everolimus (P < .001).
• In NSCLC patients on first-line therapy – 8.88 months with pembrolizumab and 6.38 months with a platinum doublet (P < .001).
• In NSCLC patients on first-line combination therapy – 10.59 months with pembrolizumab plus platinum chemotherapy and 6.38 months with a platinum doublet (P < .001).
• In NSCLC patients on second-line or greater therapy – 10.06 months with pembrolizumab or nivolumab and 6.41 months with docetaxel (P < .001).
• In urothelial cancer patients on second-line or greater therapy – 7.66 months with an ICI and 6.31 months with chemotherapy (P = .043).
   

Help for treatment decisions

“The real-world survival outcomes not only indicate the breadth of indications but also represent patients who tend not to be eligible for immunotherapy trials, based on their health status,” Dr. Lee said. “We hope this dataset of national-level experience provides practicing oncologists evidence to help patients and family members in the process of decision-making about therapy.”

Real-world data can also inform oncologists who face decisions on whether to prescribe or withhold ICIs and patients who face the financial burden of paying for ICIs, he said.

This dataset will be continually updated. The researchers have already added another 10,000 VA patients who have received immunotherapies in the year since the trial began.

“In a longitudinal way, we plan to examine what causes differences in outcomes and continue to find ways to extend care to veterans with a balance of high quality of life,” Dr. Lee said.

“Patients who participate in clinical trials are, on average, younger and healthier than the general population,” said Bora Youn, PhD, a senior biostatistician at Biogen in Cambridge, Mass., who was not involved in this study.

“In the case of immunotherapies, those with poor performance status and autoimmune conditions are often excluded from trials,” Dr. Youn added. “In the real world, these patients can also receive treatments, and clinicians often need to extrapolate the results from clinical trials. It is therefore important to collect real-world data to understand the effectiveness and safety of these therapies in patients with limited evidence.”

Dr. Youn led a real-world study, published in Cancer, of 1,256 Medicare recipients who were diagnosed with NSCLC and received ICI therapy.

“We found that factors associated with poor prognosis in general, such as squamous histology and failure of aggressive prior treatment, are also predictive of decreased survival among those who initiated immunotherapies. Yet, OS of older patients was relatively comparable to those observed in clinical trials,” Dr. Youn said.

“Understanding the real-world effectiveness of these treatments will help improve the evidence base, especially for those underrepresented in clinical trials. These studies can also help identify patients who are most likely to benefit from immunotherapies,” Dr. Youn added.

This study was supported by the VA Office of Research and Development Cooperative Studies Program. Dr. Lee and Dr. Youn disclosed no conflicts of interest.

SOURCE: Jennifer La et al. JCO Clinical Cancer Informatics. 2020:4:918-28.

Physician practices nationwide lost 32% of their revenue, on average, from February to the summer, according to a new American Medical Association survey of 3,500 physicians, conducted from mid-July to August. That period coincided with the second wave of the coronavirus pandemic in the United States.

A third of practices reported a revenue drop of 25%-49%; 15% said their volume had fallen by 50%-74%, and 4% saw a decrease of 75% or more.

Because of the pandemic, 81% of physicians were providing fewer in-person visits than in February. In-person visits dropped by 50% or more for more than one-third of physicians. The average number of in-person visits fell from 95 to 57 per week.

Physicians who responded to the survey held an average of six weekly telehealth visits before the pandemic, 29 at the height of the pandemic in the spring, and 16 the week they were surveyed. About 20% of respondents with any telehealth visits had conducted them before the pandemic, 77% at the height of the crisis, and 68% in the survey week.

Among the doctors who weren’t involved in telehealth visits before the pandemic, only 23% conducted them at the pandemic’s peak; 12% conducted them in the survey week.

Despite the telehealth increase, almost 70% of physicians were providing fewer total visits, including in-person and virtual encounters, than before the pandemic, the survey showed. About 21% saw a decrease of 25%-49%; 11%, a drop of 50%-74%; and 10%, a falloff of at least 75%. On average, total visits fell from 101 to 72 per week.
 

Other surveys more upbeat

A larger survey by Harvard University, the Commonwealth Fund, and the technology company Phreesia found that total outpatient visits in early October had rebounded to the level of March 1. This was a major turnaround from late March, when visits had plunged by nearly 60%.

According to the Harvard/Commonwealth Fund’s ongoing survey, visits started recovering in late June, although they were still off by 10%. They began rising further around Labor Day. The AMA researchers began conducting their survey in mid-June. The summertime surge in COVID-19 likely accounted for their finding that practice revenues were off by a third from the February baseline.

If so, the return to normalcy early this month may not represent the current situation as the virus sweeps across the country for a third time. In any case, even if patient visits and revenues have recovered more than the AMA data indicate, most practices will not have recovered from their losses earlier in the year.

A third survey more closely mirrors the AMA results. At the end of June, according to data from the Medical Group Management Association, revenues for the association’s members were 76% of what they had been in June 2019, and patient volume was 78% of that in the previous year.
 

Practice expenses rise

The AMA survey also found that, since February, practice spending on personal protective equipment (PPE) had increased by 57% or more, on average. About 64% of practice owners said their PPE expenditures were up from what they had been before the pandemic. For nearly 40% of practice owners, this expense had increased by 50% or more.

About 36% of the respondents said that acquiring PPE was very or extremely difficult. This was an especially big challenge for smaller practices, which do not have the purchasing power to compete with big health care systems for masks, gowns, and gloves, the AMA noted.

About 41% of doctors in practices with one to five physicians said they had difficulty getting PPE, compared with 30% of those in practices of 50 or more doctors. Only 25% of respondents in practices owned by hospitals and health systems said this was a problem.

Acquiring sufficient PPE is just one factor in the increase in practice expenses attributable to COVID-19. Still, it is indicative of the financial woes affecting physicians during the pandemic.

Nearly all respondents agreed that federal financial relief early in the pandemic was helpful and was appreciated. Among these programs was the CARES Act, which authorized the Provider Relief Fund, which accepted applications through Aug.28; the Medicare Accelerated and Advance Payment Program, which was suspended in April; and the SBA Paycheck Protection Program, which ended on Aug. 8.

To date, Congress had not approved the renewal of any these programs.

“Physician practices continue to be under significant financial stress due to reductions in patient volume and revenue, in addition to higher expenses for supplies that are scarce for some physicians,” said AMA President Susan R. Bailey, MD, in a news release on the survey’s findings. “More economic relief is needed now from Congress as some medical practices contemplate the brink of viability, particularly smaller practices that are facing a difficult road to recovery.”

A version of this article originally appeared on Medscape.com.

Physician practices nationwide lost 32% of their revenue, on average, from February to the summer, according to a new American Medical Association survey of 3,500 physicians, conducted from mid-July to August. That period coincided with the second wave of the coronavirus pandemic in the United States.

A third of practices reported a revenue drop of 25%-49%; 15% said their volume had fallen by 50%-74%, and 4% saw a decrease of 75% or more.

Because of the pandemic, 81% of physicians were providing fewer in-person visits than in February. In-person visits dropped by 50% or more for more than one-third of physicians. The average number of in-person visits fell from 95 to 57 per week.

Physicians who responded to the survey held an average of six weekly telehealth visits before the pandemic, 29 at the height of the pandemic in the spring, and 16 the week they were surveyed. About 20% of respondents with any telehealth visits had conducted them before the pandemic, 77% at the height of the crisis, and 68% in the survey week.

Among the doctors who weren’t involved in telehealth visits before the pandemic, only 23% conducted them at the pandemic’s peak; 12% conducted them in the survey week.

Despite the telehealth increase, almost 70% of physicians were providing fewer total visits, including in-person and virtual encounters, than before the pandemic, the survey showed. About 21% saw a decrease of 25%-49%; 11%, a drop of 50%-74%; and 10%, a falloff of at least 75%. On average, total visits fell from 101 to 72 per week.
 

Other surveys more upbeat

A larger survey by Harvard University, the Commonwealth Fund, and the technology company Phreesia found that total outpatient visits in early October had rebounded to the level of March 1. This was a major turnaround from late March, when visits had plunged by nearly 60%.

According to the Harvard/Commonwealth Fund’s ongoing survey, visits started recovering in late June, although they were still off by 10%. They began rising further around Labor Day. The AMA researchers began conducting their survey in mid-June. The summertime surge in COVID-19 likely accounted for their finding that practice revenues were off by a third from the February baseline.

If so, the return to normalcy early this month may not represent the current situation as the virus sweeps across the country for a third time. In any case, even if patient visits and revenues have recovered more than the AMA data indicate, most practices will not have recovered from their losses earlier in the year.

A third survey more closely mirrors the AMA results. At the end of June, according to data from the Medical Group Management Association, revenues for the association’s members were 76% of what they had been in June 2019, and patient volume was 78% of that in the previous year.
 

Practice expenses rise

The AMA survey also found that, since February, practice spending on personal protective equipment (PPE) had increased by 57% or more, on average. About 64% of practice owners said their PPE expenditures were up from what they had been before the pandemic. For nearly 40% of practice owners, this expense had increased by 50% or more.

About 36% of the respondents said that acquiring PPE was very or extremely difficult. This was an especially big challenge for smaller practices, which do not have the purchasing power to compete with big health care systems for masks, gowns, and gloves, the AMA noted.

About 41% of doctors in practices with one to five physicians said they had difficulty getting PPE, compared with 30% of those in practices of 50 or more doctors. Only 25% of respondents in practices owned by hospitals and health systems said this was a problem.

Acquiring sufficient PPE is just one factor in the increase in practice expenses attributable to COVID-19. Still, it is indicative of the financial woes affecting physicians during the pandemic.

Nearly all respondents agreed that federal financial relief early in the pandemic was helpful and was appreciated. Among these programs was the CARES Act, which authorized the Provider Relief Fund, which accepted applications through Aug.28; the Medicare Accelerated and Advance Payment Program, which was suspended in April; and the SBA Paycheck Protection Program, which ended on Aug. 8.

To date, Congress had not approved the renewal of any these programs.

“Physician practices continue to be under significant financial stress due to reductions in patient volume and revenue, in addition to higher expenses for supplies that are scarce for some physicians,” said AMA President Susan R. Bailey, MD, in a news release on the survey’s findings. “More economic relief is needed now from Congress as some medical practices contemplate the brink of viability, particularly smaller practices that are facing a difficult road to recovery.”

A version of this article originally appeared on Medscape.com.

Physician practices nationwide lost 32% of their revenue, on average, from February to the summer, according to a new American Medical Association survey of 3,500 physicians, conducted from mid-July to August. That period coincided with the second wave of the coronavirus pandemic in the United States.

A third of practices reported a revenue drop of 25%-49%; 15% said their volume had fallen by 50%-74%, and 4% saw a decrease of 75% or more.

Because of the pandemic, 81% of physicians were providing fewer in-person visits than in February. In-person visits dropped by 50% or more for more than one-third of physicians. The average number of in-person visits fell from 95 to 57 per week.

Physicians who responded to the survey held an average of six weekly telehealth visits before the pandemic, 29 at the height of the pandemic in the spring, and 16 the week they were surveyed. About 20% of respondents with any telehealth visits had conducted them before the pandemic, 77% at the height of the crisis, and 68% in the survey week.

Among the doctors who weren’t involved in telehealth visits before the pandemic, only 23% conducted them at the pandemic’s peak; 12% conducted them in the survey week.

Despite the telehealth increase, almost 70% of physicians were providing fewer total visits, including in-person and virtual encounters, than before the pandemic, the survey showed. About 21% saw a decrease of 25%-49%; 11%, a drop of 50%-74%; and 10%, a falloff of at least 75%. On average, total visits fell from 101 to 72 per week.
 

Other surveys more upbeat

A larger survey by Harvard University, the Commonwealth Fund, and the technology company Phreesia found that total outpatient visits in early October had rebounded to the level of March 1. This was a major turnaround from late March, when visits had plunged by nearly 60%.

According to the Harvard/Commonwealth Fund’s ongoing survey, visits started recovering in late June, although they were still off by 10%. They began rising further around Labor Day. The AMA researchers began conducting their survey in mid-June. The summertime surge in COVID-19 likely accounted for their finding that practice revenues were off by a third from the February baseline.

If so, the return to normalcy early this month may not represent the current situation as the virus sweeps across the country for a third time. In any case, even if patient visits and revenues have recovered more than the AMA data indicate, most practices will not have recovered from their losses earlier in the year.

A third survey more closely mirrors the AMA results. At the end of June, according to data from the Medical Group Management Association, revenues for the association’s members were 76% of what they had been in June 2019, and patient volume was 78% of that in the previous year.
 

Practice expenses rise

The AMA survey also found that, since February, practice spending on personal protective equipment (PPE) had increased by 57% or more, on average. About 64% of practice owners said their PPE expenditures were up from what they had been before the pandemic. For nearly 40% of practice owners, this expense had increased by 50% or more.

About 36% of the respondents said that acquiring PPE was very or extremely difficult. This was an especially big challenge for smaller practices, which do not have the purchasing power to compete with big health care systems for masks, gowns, and gloves, the AMA noted.

About 41% of doctors in practices with one to five physicians said they had difficulty getting PPE, compared with 30% of those in practices of 50 or more doctors. Only 25% of respondents in practices owned by hospitals and health systems said this was a problem.

Acquiring sufficient PPE is just one factor in the increase in practice expenses attributable to COVID-19. Still, it is indicative of the financial woes affecting physicians during the pandemic.

Nearly all respondents agreed that federal financial relief early in the pandemic was helpful and was appreciated. Among these programs was the CARES Act, which authorized the Provider Relief Fund, which accepted applications through Aug.28; the Medicare Accelerated and Advance Payment Program, which was suspended in April; and the SBA Paycheck Protection Program, which ended on Aug. 8.

To date, Congress had not approved the renewal of any these programs.

“Physician practices continue to be under significant financial stress due to reductions in patient volume and revenue, in addition to higher expenses for supplies that are scarce for some physicians,” said AMA President Susan R. Bailey, MD, in a news release on the survey’s findings. “More economic relief is needed now from Congress as some medical practices contemplate the brink of viability, particularly smaller practices that are facing a difficult road to recovery.”

A version of this article originally appeared on Medscape.com.

If you’re looking for ways to boost revenue and patient compliance to recommended treatment intervals for aesthetic procedures, consider offering subscription-based services.

According to W. Grant Stevens, MD, an estimated 73% of aesthetic patients fall short when it comes to compliance with recommended treatment intervals for toxins, fillers, and other procedures.

“When we talk about how often the average patient should be treated with Botox, for instance, we say every 3-4 months,” Dr. Stevens, founder and CEO of Marina Plastic Surgery in Marina Del Rey, Calif., said during the virtual annual Masters of Aesthetics Symposium. But in reality, he added, “it’s more like every 7 months.” A 2015 survey of 23 Bay Area aesthetic practices conducted by HintMD found that 73% of patients were noncompliant and that they came in fewer than 3-4 times per year for treatments. “Not only did they come in infrequently, but they oftentimes were undercorrected and the revenue was being left on the table because of discounting and undercorrection,” said Dr. Stevens, who is also a professor of surgery in the division of plastic surgery at the University of Southern California, Los Angeles.

On average, each patient from the 23 practices surveyed spent $601.88 on treatments 1.44 times per year, yet the industry standard for neuromodulators is 3-4 times per year and every 2 months for HydraFacials and med spa facials. “What’s the problem?” he asked “Why are we falling off? For our practices, noncompliance leads to unhappy, undertreated patients, so they may write negative reviews. In addition to that, we lose revenue.” He cited results from a 2016 focus group of aesthetic patients who were asked about the perceived barriers to treatment compliance. More than two-thirds (68%) said cost was the issue, followed by the number of treatments required (43%) and effectiveness (16%).

Three years ago, Dr. Stevens used the HintMD platform to implement a treatment plan subscription service to 472 active members of his practice. Prior to implementation, patients were coming in for treatment with toxins an average of 1.8 times per year. After implementation, that rose to an average of 3.1 times per year. “That was almost an $800 incremental average increase spent on toxins alone,” Dr. Stevens said. “More importantly, the patients were therapeutic all year long.” With toxin and filler services combined, the average increased income grew to more than $1,100 per patient, which translated into increased annual revenue of $519,200.

Dr. Stevens said that many of his patients favor subscription services because most use them in other aspects of their lives, such as with Amazon Prime, Blue Apron, and Netflix. “They like it because it is personalized and customized,” he said. “If we want to adjust the amount of toxin or filler, we can do it that very day, and it’s customized for them. It’s not a one-size-fits-all program. It also allows them to have convenient, smaller monthly payments. That’s the key. That way, they budget. So, if they’re spending $200 a month or $500 a month or $1,000 a month, it’s a convenient monthly payment.”

Dr. Stevens disclosed that he is an adviser to Viveve, Venus, Aesthetics Biomedical, Alastin, Cypris Medical, Allergan, CoolSculpting, HydraFacial, Revance, Ampersand, and HintMD.

[email protected]

If you’re looking for ways to boost revenue and patient compliance to recommended treatment intervals for aesthetic procedures, consider offering subscription-based services.

According to W. Grant Stevens, MD, an estimated 73% of aesthetic patients fall short when it comes to compliance with recommended treatment intervals for toxins, fillers, and other procedures.

“When we talk about how often the average patient should be treated with Botox, for instance, we say every 3-4 months,” Dr. Stevens, founder and CEO of Marina Plastic Surgery in Marina Del Rey, Calif., said during the virtual annual Masters of Aesthetics Symposium. But in reality, he added, “it’s more like every 7 months.” A 2015 survey of 23 Bay Area aesthetic practices conducted by HintMD found that 73% of patients were noncompliant and that they came in fewer than 3-4 times per year for treatments. “Not only did they come in infrequently, but they oftentimes were undercorrected and the revenue was being left on the table because of discounting and undercorrection,” said Dr. Stevens, who is also a professor of surgery in the division of plastic surgery at the University of Southern California, Los Angeles.

On average, each patient from the 23 practices surveyed spent $601.88 on treatments 1.44 times per year, yet the industry standard for neuromodulators is 3-4 times per year and every 2 months for HydraFacials and med spa facials. “What’s the problem?” he asked “Why are we falling off? For our practices, noncompliance leads to unhappy, undertreated patients, so they may write negative reviews. In addition to that, we lose revenue.” He cited results from a 2016 focus group of aesthetic patients who were asked about the perceived barriers to treatment compliance. More than two-thirds (68%) said cost was the issue, followed by the number of treatments required (43%) and effectiveness (16%).

Three years ago, Dr. Stevens used the HintMD platform to implement a treatment plan subscription service to 472 active members of his practice. Prior to implementation, patients were coming in for treatment with toxins an average of 1.8 times per year. After implementation, that rose to an average of 3.1 times per year. “That was almost an $800 incremental average increase spent on toxins alone,” Dr. Stevens said. “More importantly, the patients were therapeutic all year long.” With toxin and filler services combined, the average increased income grew to more than $1,100 per patient, which translated into increased annual revenue of $519,200.

Dr. Stevens said that many of his patients favor subscription services because most use them in other aspects of their lives, such as with Amazon Prime, Blue Apron, and Netflix. “They like it because it is personalized and customized,” he said. “If we want to adjust the amount of toxin or filler, we can do it that very day, and it’s customized for them. It’s not a one-size-fits-all program. It also allows them to have convenient, smaller monthly payments. That’s the key. That way, they budget. So, if they’re spending $200 a month or $500 a month or $1,000 a month, it’s a convenient monthly payment.”

Dr. Stevens disclosed that he is an adviser to Viveve, Venus, Aesthetics Biomedical, Alastin, Cypris Medical, Allergan, CoolSculpting, HydraFacial, Revance, Ampersand, and HintMD.

[email protected]

If you’re looking for ways to boost revenue and patient compliance to recommended treatment intervals for aesthetic procedures, consider offering subscription-based services.

According to W. Grant Stevens, MD, an estimated 73% of aesthetic patients fall short when it comes to compliance with recommended treatment intervals for toxins, fillers, and other procedures.

“When we talk about how often the average patient should be treated with Botox, for instance, we say every 3-4 months,” Dr. Stevens, founder and CEO of Marina Plastic Surgery in Marina Del Rey, Calif., said during the virtual annual Masters of Aesthetics Symposium. But in reality, he added, “it’s more like every 7 months.” A 2015 survey of 23 Bay Area aesthetic practices conducted by HintMD found that 73% of patients were noncompliant and that they came in fewer than 3-4 times per year for treatments. “Not only did they come in infrequently, but they oftentimes were undercorrected and the revenue was being left on the table because of discounting and undercorrection,” said Dr. Stevens, who is also a professor of surgery in the division of plastic surgery at the University of Southern California, Los Angeles.

On average, each patient from the 23 practices surveyed spent $601.88 on treatments 1.44 times per year, yet the industry standard for neuromodulators is 3-4 times per year and every 2 months for HydraFacials and med spa facials. “What’s the problem?” he asked “Why are we falling off? For our practices, noncompliance leads to unhappy, undertreated patients, so they may write negative reviews. In addition to that, we lose revenue.” He cited results from a 2016 focus group of aesthetic patients who were asked about the perceived barriers to treatment compliance. More than two-thirds (68%) said cost was the issue, followed by the number of treatments required (43%) and effectiveness (16%).

Three years ago, Dr. Stevens used the HintMD platform to implement a treatment plan subscription service to 472 active members of his practice. Prior to implementation, patients were coming in for treatment with toxins an average of 1.8 times per year. After implementation, that rose to an average of 3.1 times per year. “That was almost an $800 incremental average increase spent on toxins alone,” Dr. Stevens said. “More importantly, the patients were therapeutic all year long.” With toxin and filler services combined, the average increased income grew to more than $1,100 per patient, which translated into increased annual revenue of $519,200.

Dr. Stevens said that many of his patients favor subscription services because most use them in other aspects of their lives, such as with Amazon Prime, Blue Apron, and Netflix. “They like it because it is personalized and customized,” he said. “If we want to adjust the amount of toxin or filler, we can do it that very day, and it’s customized for them. It’s not a one-size-fits-all program. It also allows them to have convenient, smaller monthly payments. That’s the key. That way, they budget. So, if they’re spending $200 a month or $500 a month or $1,000 a month, it’s a convenient monthly payment.”

Dr. Stevens disclosed that he is an adviser to Viveve, Venus, Aesthetics Biomedical, Alastin, Cypris Medical, Allergan, CoolSculpting, HydraFacial, Revance, Ampersand, and HintMD.

[email protected]

The Department of Health & Human Services on Oct. 29 extended the deadline for health care groups to provide patients with immediate electronic access to their doctors’ clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, and will now go into effect April 5.

The announcement comes just 4 days before the previously established Nov. 2 deadline and gives the pandemic as the reason for the delay.

“We are hearing that, while there is strong support for advancing patient access … stakeholders also must manage the needs being experienced during the current pandemic,” Don Rucker, MD, national coordinator for health information technology at HHS, said in a press statement.

“To be clear, the Office of the National Coordinator is not removing the requirements advancing patient access to their health information,” he added.
 

‘What you make of it’

Scott MacDonald, MD, electronic health record medical director at the University of California, Davis, said his organization is proceeding anyway. “UC Davis is going to start releasing notes and test results on Nov. 12,” he said in an interview.

Other organizations and practices now have more time, he said, but the law stays the same. “There’s no change to the what or why – only to the when,” Dr. MacDonald pointed out.

Vanderbilt University Medical Center in Nashville, Tenn., will take advantage of the extra time, Trent Rosenbloom, MD, MPH, director of patient portals, said in an interview.

“Given the super-short time frame we had to work under as this emerged out from dealing with COVID, we feel that we have not addressed all the potential legal-edge cases such as dealing with adolescent medicine and child abuse,” he said.

On Oct. 21, this news organization reported on the then-imminent start of the new law, which irked many readers. They cited, among other things, the likelihood of patient confusion with fast patient access to all clinical notes.

“To me, the biggest issue is that we speak a foreign language that most outside of medicine don’t speak. Our job is to explain it to the patient at a level they can understand. What will 100% happen now is that a patient will not be able to reconcile what is in the note to what they’ve been told,” Andrew White, MD, wrote in a reader comment.

But benefits of open notes outweigh the risks, say proponents, who claim that doctor-patient communication and trust actually improve with information access and that research indicates other benefits such as improved medication adherence.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot open-notes program for 3 years.

“I actually end all of my appointments with: ‘Don’t forget to read your note later,’ ” she said in an interview.

Dr. Millen feared open notes initially but, within the first 3 months of usage, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”

Dr. MacDonald and Dr. Millen disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

The Department of Health & Human Services on Oct. 29 extended the deadline for health care groups to provide patients with immediate electronic access to their doctors’ clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, and will now go into effect April 5.

The announcement comes just 4 days before the previously established Nov. 2 deadline and gives the pandemic as the reason for the delay.

“We are hearing that, while there is strong support for advancing patient access … stakeholders also must manage the needs being experienced during the current pandemic,” Don Rucker, MD, national coordinator for health information technology at HHS, said in a press statement.

“To be clear, the Office of the National Coordinator is not removing the requirements advancing patient access to their health information,” he added.
 

‘What you make of it’

Scott MacDonald, MD, electronic health record medical director at the University of California, Davis, said his organization is proceeding anyway. “UC Davis is going to start releasing notes and test results on Nov. 12,” he said in an interview.

Other organizations and practices now have more time, he said, but the law stays the same. “There’s no change to the what or why – only to the when,” Dr. MacDonald pointed out.

Vanderbilt University Medical Center in Nashville, Tenn., will take advantage of the extra time, Trent Rosenbloom, MD, MPH, director of patient portals, said in an interview.

“Given the super-short time frame we had to work under as this emerged out from dealing with COVID, we feel that we have not addressed all the potential legal-edge cases such as dealing with adolescent medicine and child abuse,” he said.

On Oct. 21, this news organization reported on the then-imminent start of the new law, which irked many readers. They cited, among other things, the likelihood of patient confusion with fast patient access to all clinical notes.

“To me, the biggest issue is that we speak a foreign language that most outside of medicine don’t speak. Our job is to explain it to the patient at a level they can understand. What will 100% happen now is that a patient will not be able to reconcile what is in the note to what they’ve been told,” Andrew White, MD, wrote in a reader comment.

But benefits of open notes outweigh the risks, say proponents, who claim that doctor-patient communication and trust actually improve with information access and that research indicates other benefits such as improved medication adherence.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot open-notes program for 3 years.

“I actually end all of my appointments with: ‘Don’t forget to read your note later,’ ” she said in an interview.

Dr. Millen feared open notes initially but, within the first 3 months of usage, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”

Dr. MacDonald and Dr. Millen disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

The Department of Health & Human Services on Oct. 29 extended the deadline for health care groups to provide patients with immediate electronic access to their doctors’ clinical notes as well as test results and reports from pathology and imaging.

The mandate, called “open notes” by many, is part of the 21st Century Cures Act, and will now go into effect April 5.

The announcement comes just 4 days before the previously established Nov. 2 deadline and gives the pandemic as the reason for the delay.

“We are hearing that, while there is strong support for advancing patient access … stakeholders also must manage the needs being experienced during the current pandemic,” Don Rucker, MD, national coordinator for health information technology at HHS, said in a press statement.

“To be clear, the Office of the National Coordinator is not removing the requirements advancing patient access to their health information,” he added.
 

‘What you make of it’

Scott MacDonald, MD, electronic health record medical director at the University of California, Davis, said his organization is proceeding anyway. “UC Davis is going to start releasing notes and test results on Nov. 12,” he said in an interview.

Other organizations and practices now have more time, he said, but the law stays the same. “There’s no change to the what or why – only to the when,” Dr. MacDonald pointed out.

Vanderbilt University Medical Center in Nashville, Tenn., will take advantage of the extra time, Trent Rosenbloom, MD, MPH, director of patient portals, said in an interview.

“Given the super-short time frame we had to work under as this emerged out from dealing with COVID, we feel that we have not addressed all the potential legal-edge cases such as dealing with adolescent medicine and child abuse,” he said.

On Oct. 21, this news organization reported on the then-imminent start of the new law, which irked many readers. They cited, among other things, the likelihood of patient confusion with fast patient access to all clinical notes.

“To me, the biggest issue is that we speak a foreign language that most outside of medicine don’t speak. Our job is to explain it to the patient at a level they can understand. What will 100% happen now is that a patient will not be able to reconcile what is in the note to what they’ve been told,” Andrew White, MD, wrote in a reader comment.

But benefits of open notes outweigh the risks, say proponents, who claim that doctor-patient communication and trust actually improve with information access and that research indicates other benefits such as improved medication adherence.

Open notes are “what you make of it,” said Marlene Millen, MD, an internist at UC San Diego Health, which has had a pilot open-notes program for 3 years.

“I actually end all of my appointments with: ‘Don’t forget to read your note later,’ ” she said in an interview.

Dr. Millen feared open notes initially but, within the first 3 months of usage, about 15 patients gave her direct feedback on how much they appreciated her notes. “It seemed to really reassure them that they were getting good care.”

Dr. MacDonald and Dr. Millen disclosed no relevant financial relationships.
 

A version of this article originally appeared on Medscape.com.

A routine scan used to evaluate some acute stroke patients can also detect SARS-CoV-2 infection in the upper lungs, a new study shows.

“As part of the stroke evaluation workup process, we were able to diagnose COVID-19 at the same time at no extra cost or additional workload,” lead author Charles Esenwa, MD, commented to Medscape Medical News. “This is an objective way to screen for COVID-19 in the acute stroke setting,” he added.

Esenwa is an assistant professor and a stroke neurologist at the Montefiore Medical Center/Albert Einstein College of Medicine in New York City.

He explained that, during the COVID-19 surge earlier this year, assessment of patients with severe acute stroke using computed tomography angiogram (CTA) scans – used to evaluate suitability for endovascular stroke therapy – also showed findings in the upper lung consistent with viral infection in some patients.

“We then assumed that these patients had COVID-19 and took extra precautions to keep them isolated and to protect staff involved in their care. It also allowed us to triage these patients more quickly than waiting for the COVID-19 swab test and arrange the most appropriate care for them,” Esenwa said.

The researchers have now gone back and analyzed their data on acute stroke patients who underwent CTA at their institution during the COVID-19 surge. They found that the changes identified in the lungs were highly specific for diagnosing SARS-CoV-2 infection.

The study was published online on Oct. 29 in Stroke.

“Stroke patients are normally screened for COVID-19 on hospitalization, but the swab test result can take several hours or longer to come back, and it is very useful for us to know if a patient could be infected,” Esenwa noted.

“When we do a CTA, we look at the blood vessels supplying the brain, but the scan also covers the top of the lung, as it starts at the aortic arch. We don’t normally look closely at that area, but we started to notice signs of active lung infection which could have been COVID-19,” he said. “For this paper, we went back to assess how accurate this approach actually was vs. the COVID-19 PCR test.”

The researchers report on 57 patients who presented to three Montefiore Health System hospitals in the Bronx, in New York City, with acute ischemic stroke and who underwent CTA of the head and neck in March and April 2020, the peak of the COVID-19 outbreak there. The patients also underwent PCR testing for COVID-19.

Results showed that 30 patients had a positive COVID-19 test result and that 27 had a negative result. Lung findings highly or very highly suspicious for COVID-19 pneumonia were identified during the CTA scan in 20 (67%) of the COVID-19–positive patients and in two (7%) of the COVID-19–negative patients.

These findings, when used in isolation, yielded a sensitivity of 0.67 and a specificity of 0.93. They had a positive predictive value of 0.19, a negative predictive value of 0.99, and accuracy of 0.92 for the diagnosis of COVID-19.

When apical lung assessment was combined with self-reported clinical symptoms of cough or dyspnea, sensitivity for the diagnosis of COVID-19 for patients presenting to the hospital for acute ischemic stroke increased to 0.83.

“We wondered whether looking at the whole lung would have found better results, but other studies which have done this actually found similar numbers to ours, so we think actually just looking at the top of the lungs, which can be seen in a stroke CTA, may be sufficient,” Esenwa said.

He emphasized the importance of establishing whether an acute stroke patient has COVID-19. “If we had a high suspicion of COVID-19 infection, we would take more precautions during any procedures, such as thrombectomy, and make sure to keep the patient isolated afterwards. It doesn’t necessarily affect the treatment given for stroke, but it affects the safety of the patients and everyone caring for them,” he commented.

Esenwa explained that intubation – which is sometime necessary during thrombectomy – can expose everyone in the room to aerosolized droplets. “So we would take much higher safety precautions if we thought the patient was COVID-19 positive,” he said.

“Early COVID-19 diagnosis also means patients can be given supportive treatment more quickly, admitted to ICU if appropriate, and we can all keep a close eye on pulmonary issues. So having that information is important in many ways,” he added.

Esenwa advises that any medical center that evaluates acute stroke patients for thrombectomy and is experiencing a COVID-19 surge can use this technique as a screening method for COVID-19.

He pointed out that the Montefiore Health System had a very high rate of COVID-19. That part of New York City was one of the worst hit areas of the world, and the CTA approach for identifying COVID-19 has been validated only in areas with such a high local incidence of COVID. If used in an area of lower prevalence, the accuracy would likely be less.

“We don’t know if this approach would work as well at times of low COVID-19 infection, where any lung findings would be more likely to be caused by other conditions, such as pneumonia due to other causes or congestive heart failure. So there would be more false positives,” Esenwa said.

“But when COVID-19 prevalence is high, the lung findings are much more likely to be a sign of COVID-19 infection. As COVID-19 numbers are now rising for a second time, it is likely to become a useful strategy again.”

The study was approved by the Albert Einstein College of Medicine/Montefiore Medical Center Institutional Review Board and had no external funding. Esenwa has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

A routine scan used to evaluate some acute stroke patients can also detect SARS-CoV-2 infection in the upper lungs, a new study shows.

“As part of the stroke evaluation workup process, we were able to diagnose COVID-19 at the same time at no extra cost or additional workload,” lead author Charles Esenwa, MD, commented to Medscape Medical News. “This is an objective way to screen for COVID-19 in the acute stroke setting,” he added.

Esenwa is an assistant professor and a stroke neurologist at the Montefiore Medical Center/Albert Einstein College of Medicine in New York City.

He explained that, during the COVID-19 surge earlier this year, assessment of patients with severe acute stroke using computed tomography angiogram (CTA) scans – used to evaluate suitability for endovascular stroke therapy – also showed findings in the upper lung consistent with viral infection in some patients.

“We then assumed that these patients had COVID-19 and took extra precautions to keep them isolated and to protect staff involved in their care. It also allowed us to triage these patients more quickly than waiting for the COVID-19 swab test and arrange the most appropriate care for them,” Esenwa said.

The researchers have now gone back and analyzed their data on acute stroke patients who underwent CTA at their institution during the COVID-19 surge. They found that the changes identified in the lungs were highly specific for diagnosing SARS-CoV-2 infection.

The study was published online on Oct. 29 in Stroke.

“Stroke patients are normally screened for COVID-19 on hospitalization, but the swab test result can take several hours or longer to come back, and it is very useful for us to know if a patient could be infected,” Esenwa noted.

“When we do a CTA, we look at the blood vessels supplying the brain, but the scan also covers the top of the lung, as it starts at the aortic arch. We don’t normally look closely at that area, but we started to notice signs of active lung infection which could have been COVID-19,” he said. “For this paper, we went back to assess how accurate this approach actually was vs. the COVID-19 PCR test.”

The researchers report on 57 patients who presented to three Montefiore Health System hospitals in the Bronx, in New York City, with acute ischemic stroke and who underwent CTA of the head and neck in March and April 2020, the peak of the COVID-19 outbreak there. The patients also underwent PCR testing for COVID-19.

Results showed that 30 patients had a positive COVID-19 test result and that 27 had a negative result. Lung findings highly or very highly suspicious for COVID-19 pneumonia were identified during the CTA scan in 20 (67%) of the COVID-19–positive patients and in two (7%) of the COVID-19–negative patients.

These findings, when used in isolation, yielded a sensitivity of 0.67 and a specificity of 0.93. They had a positive predictive value of 0.19, a negative predictive value of 0.99, and accuracy of 0.92 for the diagnosis of COVID-19.

When apical lung assessment was combined with self-reported clinical symptoms of cough or dyspnea, sensitivity for the diagnosis of COVID-19 for patients presenting to the hospital for acute ischemic stroke increased to 0.83.

“We wondered whether looking at the whole lung would have found better results, but other studies which have done this actually found similar numbers to ours, so we think actually just looking at the top of the lungs, which can be seen in a stroke CTA, may be sufficient,” Esenwa said.

He emphasized the importance of establishing whether an acute stroke patient has COVID-19. “If we had a high suspicion of COVID-19 infection, we would take more precautions during any procedures, such as thrombectomy, and make sure to keep the patient isolated afterwards. It doesn’t necessarily affect the treatment given for stroke, but it affects the safety of the patients and everyone caring for them,” he commented.

Esenwa explained that intubation – which is sometime necessary during thrombectomy – can expose everyone in the room to aerosolized droplets. “So we would take much higher safety precautions if we thought the patient was COVID-19 positive,” he said.

“Early COVID-19 diagnosis also means patients can be given supportive treatment more quickly, admitted to ICU if appropriate, and we can all keep a close eye on pulmonary issues. So having that information is important in many ways,” he added.

Esenwa advises that any medical center that evaluates acute stroke patients for thrombectomy and is experiencing a COVID-19 surge can use this technique as a screening method for COVID-19.

He pointed out that the Montefiore Health System had a very high rate of COVID-19. That part of New York City was one of the worst hit areas of the world, and the CTA approach for identifying COVID-19 has been validated only in areas with such a high local incidence of COVID. If used in an area of lower prevalence, the accuracy would likely be less.

“We don’t know if this approach would work as well at times of low COVID-19 infection, where any lung findings would be more likely to be caused by other conditions, such as pneumonia due to other causes or congestive heart failure. So there would be more false positives,” Esenwa said.

“But when COVID-19 prevalence is high, the lung findings are much more likely to be a sign of COVID-19 infection. As COVID-19 numbers are now rising for a second time, it is likely to become a useful strategy again.”

The study was approved by the Albert Einstein College of Medicine/Montefiore Medical Center Institutional Review Board and had no external funding. Esenwa has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

A routine scan used to evaluate some acute stroke patients can also detect SARS-CoV-2 infection in the upper lungs, a new study shows.

“As part of the stroke evaluation workup process, we were able to diagnose COVID-19 at the same time at no extra cost or additional workload,” lead author Charles Esenwa, MD, commented to Medscape Medical News. “This is an objective way to screen for COVID-19 in the acute stroke setting,” he added.

Esenwa is an assistant professor and a stroke neurologist at the Montefiore Medical Center/Albert Einstein College of Medicine in New York City.

He explained that, during the COVID-19 surge earlier this year, assessment of patients with severe acute stroke using computed tomography angiogram (CTA) scans – used to evaluate suitability for endovascular stroke therapy – also showed findings in the upper lung consistent with viral infection in some patients.

“We then assumed that these patients had COVID-19 and took extra precautions to keep them isolated and to protect staff involved in their care. It also allowed us to triage these patients more quickly than waiting for the COVID-19 swab test and arrange the most appropriate care for them,” Esenwa said.

The researchers have now gone back and analyzed their data on acute stroke patients who underwent CTA at their institution during the COVID-19 surge. They found that the changes identified in the lungs were highly specific for diagnosing SARS-CoV-2 infection.

The study was published online on Oct. 29 in Stroke.

“Stroke patients are normally screened for COVID-19 on hospitalization, but the swab test result can take several hours or longer to come back, and it is very useful for us to know if a patient could be infected,” Esenwa noted.

“When we do a CTA, we look at the blood vessels supplying the brain, but the scan also covers the top of the lung, as it starts at the aortic arch. We don’t normally look closely at that area, but we started to notice signs of active lung infection which could have been COVID-19,” he said. “For this paper, we went back to assess how accurate this approach actually was vs. the COVID-19 PCR test.”

The researchers report on 57 patients who presented to three Montefiore Health System hospitals in the Bronx, in New York City, with acute ischemic stroke and who underwent CTA of the head and neck in March and April 2020, the peak of the COVID-19 outbreak there. The patients also underwent PCR testing for COVID-19.

Results showed that 30 patients had a positive COVID-19 test result and that 27 had a negative result. Lung findings highly or very highly suspicious for COVID-19 pneumonia were identified during the CTA scan in 20 (67%) of the COVID-19–positive patients and in two (7%) of the COVID-19–negative patients.

These findings, when used in isolation, yielded a sensitivity of 0.67 and a specificity of 0.93. They had a positive predictive value of 0.19, a negative predictive value of 0.99, and accuracy of 0.92 for the diagnosis of COVID-19.

When apical lung assessment was combined with self-reported clinical symptoms of cough or dyspnea, sensitivity for the diagnosis of COVID-19 for patients presenting to the hospital for acute ischemic stroke increased to 0.83.

“We wondered whether looking at the whole lung would have found better results, but other studies which have done this actually found similar numbers to ours, so we think actually just looking at the top of the lungs, which can be seen in a stroke CTA, may be sufficient,” Esenwa said.

He emphasized the importance of establishing whether an acute stroke patient has COVID-19. “If we had a high suspicion of COVID-19 infection, we would take more precautions during any procedures, such as thrombectomy, and make sure to keep the patient isolated afterwards. It doesn’t necessarily affect the treatment given for stroke, but it affects the safety of the patients and everyone caring for them,” he commented.

Esenwa explained that intubation – which is sometime necessary during thrombectomy – can expose everyone in the room to aerosolized droplets. “So we would take much higher safety precautions if we thought the patient was COVID-19 positive,” he said.

“Early COVID-19 diagnosis also means patients can be given supportive treatment more quickly, admitted to ICU if appropriate, and we can all keep a close eye on pulmonary issues. So having that information is important in many ways,” he added.

Esenwa advises that any medical center that evaluates acute stroke patients for thrombectomy and is experiencing a COVID-19 surge can use this technique as a screening method for COVID-19.

He pointed out that the Montefiore Health System had a very high rate of COVID-19. That part of New York City was one of the worst hit areas of the world, and the CTA approach for identifying COVID-19 has been validated only in areas with such a high local incidence of COVID. If used in an area of lower prevalence, the accuracy would likely be less.

“We don’t know if this approach would work as well at times of low COVID-19 infection, where any lung findings would be more likely to be caused by other conditions, such as pneumonia due to other causes or congestive heart failure. So there would be more false positives,” Esenwa said.

“But when COVID-19 prevalence is high, the lung findings are much more likely to be a sign of COVID-19 infection. As COVID-19 numbers are now rising for a second time, it is likely to become a useful strategy again.”

The study was approved by the Albert Einstein College of Medicine/Montefiore Medical Center Institutional Review Board and had no external funding. Esenwa has disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

A cumulative 511,000 lives could be lost from COVID-19 in the United States by the end of February 2021, a new prediction study reveals.

However, if universal mask wearing is adopted — defined as 95% of Americans complying with the protective measure — along with social distancing mandates as warranted, nearly 130,000 of those lives could be saved.

And if even 85% of Americans comply, an additional 95,800 lives would be spared before March of next year, researchers at the University of Washington Institute for Health Metrics and Evaluation (IHME) report.

The study was published online October 23 in Nature Medicine.

“The study is sound and makes the case for mandatory mask policies,” said Arthur L. Caplan, PhD, a professor of bioethics at NYU Langone Health in New York City, who frequently provides commentary for Medscape.

Without mandatory mask requirements, he added, “we will see a pandemic slaughter and an overwhelmed healthcare system and workforce.”

The IHME team evaluated COVID-19 data for cases and related deaths between February 1 and September 21. Based on this data, they predicted the likely future of SARS-CoV-2 infections on a state level from September 22, 2020, to February 2021.

An Optimistic Projection

Lead author Robert C. Reiner Jr and colleagues looked at five scenarios. For example, they calculated likely deaths associated with COVID-19 if adoption of mask and social distancing recommendations were nearly universal. They note that Singapore achieved a 95% compliance rate with masks and used this as their “best-case scenario” model.

An estimated 129,574 (range, 85,284–170,867) additional lives could be saved if 95% of Americans wore masks in public, their research reveals. This optimistic scenario includes a “plausible reference” in which any US state reaching 8 COVID-19 deaths per 1 million residents would enact 6 weeks of social distancing mandates (SDMs).

Achieving this level of mask compliance in the United States “could be sufficient to ameliorate the worst effects of epidemic resurgences in many states,” the researchers note.

In contrast, the proportion of Americans wearing masks in public as of September 22 was 49%, according to IHME data.
 

Universal mask use unlikely

“I’m not a modeling expert, but it is an interesting, and as far as I can judge, well-conducted study which looks, state by state, at what might happen in various scenarios around masking policies going forward — and in particular the effect that mandated masking might have,” Trish Greenhalgh, MD, told Medscape Medical News.  

“However, the scenario is a thought experiment. Near-universal mask use is not going to happen in the USA, nor indeed in any individual state, right now, given how emotive the issue has become,” added Greenhalgh, professor in the Nuffield Department of Primary Care Health Sciences at Oxford University, UK. She was not affiliated with the study.

“Hence, whilst I am broadly supportive of the science,” she said, “I’m not confident that this paper will be able to change policy.”
 

Other ‘What if?’ scenarios

The authors also predicted the mortality implications associated with lower adherence to masks, the presence or absence of SDMs, and what could happen if mandates continue to ease at their current rate.

For example, they considered a scenario with less-than-universal mask use in public, 85%, along with SDMs being reinstated based on the mortality rate threshold. In this instance, they found an additional 95,814 (range, 60,731–133,077) lives could be spared by February 28.

Another calculation looked at outcomes if 95% of Americans wore masks going forward without states instituting SDMs at any point. In this case, the researchers predict that 490,437 Americans would die from COVID-19 by February 2021.

A fourth analysis revealed what would happen without greater mask use if the mortality threshold triggered 6 weeks of SDMs as warranted. Under this ‘plausible reference’ calculation, a total 511,373 Americans would die from COVID-19 by the end of February.

A fifth scenario predicted potential mortality if states continue easing SDMs at the current pace. “This is an alternative scenario to the more probable situation where states are expected to respond to an impending health crisis by reinstating some SDMs,” the authors note. The predicted number of American deaths appears more dire in this calculation. The investigators predict cumulative total deaths could reach 1,053,206 (range, 759,693–1,452,397) by the end of February 2021.

The death toll would likely vary among states in this scenario. California, Florida, and Pennsylvania would like account for approximately one third of all deaths.

All the modeling scenarios considered other factors including pneumonia seasonality, mobility, testing rates, and mask use per capita.
 

“I have seen the IHME study and I agree with the broad conclusions,” Richard Stutt, PhD, of the Epidemiology and Modelling Group at the University of Cambridge, UK, told Medscape Medical News.

“Case numbers are climbing in the US, and without further intervention, there will be a significant number of deaths over the coming months,” he said.

Masks are low cost and widely available, Stutt said. “I am hopeful that even if masks are not widely adopted, we will not see as many deaths as predicted here, as these outbreaks can be significantly reduced by increased social distancing or lockdowns.”

“However this comes at a far higher economic cost than the use of masks, and still requires action,” added Stutt, who authored a study in June that modeled facemasks in combination with “lock-down” measures for managing the COVID-19 pandemic.

Modeling study results depend on the assumptions researchers make, and the IHME team rightly tested a number of different assumptions, Greenhalgh said.

“The key conclusion,” she added, “is here: ‘The implementation of SDMs as soon as individual states reach a threshold of 8 daily deaths per million could dramatically ameliorate the effects of the disease; achieving near-universal mask use could delay, or in many states, possibly prevent, this threshold from being reached and has the potential to save the most lives while minimizing damage to the economy.’ “

“This is a useful piece of information and I think is borne out by their data,” added Greenhalgh, lead author of an April study on face masks for the public during the pandemic.

You can visit the IHME website for the most current mortality projections.

Caplan, Greenhalgh, and Stutt have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A cumulative 511,000 lives could be lost from COVID-19 in the United States by the end of February 2021, a new prediction study reveals.

However, if universal mask wearing is adopted — defined as 95% of Americans complying with the protective measure — along with social distancing mandates as warranted, nearly 130,000 of those lives could be saved.

And if even 85% of Americans comply, an additional 95,800 lives would be spared before March of next year, researchers at the University of Washington Institute for Health Metrics and Evaluation (IHME) report.

The study was published online October 23 in Nature Medicine.

“The study is sound and makes the case for mandatory mask policies,” said Arthur L. Caplan, PhD, a professor of bioethics at NYU Langone Health in New York City, who frequently provides commentary for Medscape.

Without mandatory mask requirements, he added, “we will see a pandemic slaughter and an overwhelmed healthcare system and workforce.”

The IHME team evaluated COVID-19 data for cases and related deaths between February 1 and September 21. Based on this data, they predicted the likely future of SARS-CoV-2 infections on a state level from September 22, 2020, to February 2021.

An Optimistic Projection

Lead author Robert C. Reiner Jr and colleagues looked at five scenarios. For example, they calculated likely deaths associated with COVID-19 if adoption of mask and social distancing recommendations were nearly universal. They note that Singapore achieved a 95% compliance rate with masks and used this as their “best-case scenario” model.

An estimated 129,574 (range, 85,284–170,867) additional lives could be saved if 95% of Americans wore masks in public, their research reveals. This optimistic scenario includes a “plausible reference” in which any US state reaching 8 COVID-19 deaths per 1 million residents would enact 6 weeks of social distancing mandates (SDMs).

Achieving this level of mask compliance in the United States “could be sufficient to ameliorate the worst effects of epidemic resurgences in many states,” the researchers note.

In contrast, the proportion of Americans wearing masks in public as of September 22 was 49%, according to IHME data.
 

Universal mask use unlikely

“I’m not a modeling expert, but it is an interesting, and as far as I can judge, well-conducted study which looks, state by state, at what might happen in various scenarios around masking policies going forward — and in particular the effect that mandated masking might have,” Trish Greenhalgh, MD, told Medscape Medical News.  

“However, the scenario is a thought experiment. Near-universal mask use is not going to happen in the USA, nor indeed in any individual state, right now, given how emotive the issue has become,” added Greenhalgh, professor in the Nuffield Department of Primary Care Health Sciences at Oxford University, UK. She was not affiliated with the study.

“Hence, whilst I am broadly supportive of the science,” she said, “I’m not confident that this paper will be able to change policy.”
 

Other ‘What if?’ scenarios

The authors also predicted the mortality implications associated with lower adherence to masks, the presence or absence of SDMs, and what could happen if mandates continue to ease at their current rate.

For example, they considered a scenario with less-than-universal mask use in public, 85%, along with SDMs being reinstated based on the mortality rate threshold. In this instance, they found an additional 95,814 (range, 60,731–133,077) lives could be spared by February 28.

Another calculation looked at outcomes if 95% of Americans wore masks going forward without states instituting SDMs at any point. In this case, the researchers predict that 490,437 Americans would die from COVID-19 by February 2021.

A fourth analysis revealed what would happen without greater mask use if the mortality threshold triggered 6 weeks of SDMs as warranted. Under this ‘plausible reference’ calculation, a total 511,373 Americans would die from COVID-19 by the end of February.

A fifth scenario predicted potential mortality if states continue easing SDMs at the current pace. “This is an alternative scenario to the more probable situation where states are expected to respond to an impending health crisis by reinstating some SDMs,” the authors note. The predicted number of American deaths appears more dire in this calculation. The investigators predict cumulative total deaths could reach 1,053,206 (range, 759,693–1,452,397) by the end of February 2021.

The death toll would likely vary among states in this scenario. California, Florida, and Pennsylvania would like account for approximately one third of all deaths.

All the modeling scenarios considered other factors including pneumonia seasonality, mobility, testing rates, and mask use per capita.
 

“I have seen the IHME study and I agree with the broad conclusions,” Richard Stutt, PhD, of the Epidemiology and Modelling Group at the University of Cambridge, UK, told Medscape Medical News.

“Case numbers are climbing in the US, and without further intervention, there will be a significant number of deaths over the coming months,” he said.

Masks are low cost and widely available, Stutt said. “I am hopeful that even if masks are not widely adopted, we will not see as many deaths as predicted here, as these outbreaks can be significantly reduced by increased social distancing or lockdowns.”

“However this comes at a far higher economic cost than the use of masks, and still requires action,” added Stutt, who authored a study in June that modeled facemasks in combination with “lock-down” measures for managing the COVID-19 pandemic.

Modeling study results depend on the assumptions researchers make, and the IHME team rightly tested a number of different assumptions, Greenhalgh said.

“The key conclusion,” she added, “is here: ‘The implementation of SDMs as soon as individual states reach a threshold of 8 daily deaths per million could dramatically ameliorate the effects of the disease; achieving near-universal mask use could delay, or in many states, possibly prevent, this threshold from being reached and has the potential to save the most lives while minimizing damage to the economy.’ “

“This is a useful piece of information and I think is borne out by their data,” added Greenhalgh, lead author of an April study on face masks for the public during the pandemic.

You can visit the IHME website for the most current mortality projections.

Caplan, Greenhalgh, and Stutt have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A cumulative 511,000 lives could be lost from COVID-19 in the United States by the end of February 2021, a new prediction study reveals.

However, if universal mask wearing is adopted — defined as 95% of Americans complying with the protective measure — along with social distancing mandates as warranted, nearly 130,000 of those lives could be saved.

And if even 85% of Americans comply, an additional 95,800 lives would be spared before March of next year, researchers at the University of Washington Institute for Health Metrics and Evaluation (IHME) report.

The study was published online October 23 in Nature Medicine.

“The study is sound and makes the case for mandatory mask policies,” said Arthur L. Caplan, PhD, a professor of bioethics at NYU Langone Health in New York City, who frequently provides commentary for Medscape.

Without mandatory mask requirements, he added, “we will see a pandemic slaughter and an overwhelmed healthcare system and workforce.”

The IHME team evaluated COVID-19 data for cases and related deaths between February 1 and September 21. Based on this data, they predicted the likely future of SARS-CoV-2 infections on a state level from September 22, 2020, to February 2021.

An Optimistic Projection

Lead author Robert C. Reiner Jr and colleagues looked at five scenarios. For example, they calculated likely deaths associated with COVID-19 if adoption of mask and social distancing recommendations were nearly universal. They note that Singapore achieved a 95% compliance rate with masks and used this as their “best-case scenario” model.

An estimated 129,574 (range, 85,284–170,867) additional lives could be saved if 95% of Americans wore masks in public, their research reveals. This optimistic scenario includes a “plausible reference” in which any US state reaching 8 COVID-19 deaths per 1 million residents would enact 6 weeks of social distancing mandates (SDMs).

Achieving this level of mask compliance in the United States “could be sufficient to ameliorate the worst effects of epidemic resurgences in many states,” the researchers note.

In contrast, the proportion of Americans wearing masks in public as of September 22 was 49%, according to IHME data.
 

Universal mask use unlikely

“I’m not a modeling expert, but it is an interesting, and as far as I can judge, well-conducted study which looks, state by state, at what might happen in various scenarios around masking policies going forward — and in particular the effect that mandated masking might have,” Trish Greenhalgh, MD, told Medscape Medical News.  

“However, the scenario is a thought experiment. Near-universal mask use is not going to happen in the USA, nor indeed in any individual state, right now, given how emotive the issue has become,” added Greenhalgh, professor in the Nuffield Department of Primary Care Health Sciences at Oxford University, UK. She was not affiliated with the study.

“Hence, whilst I am broadly supportive of the science,” she said, “I’m not confident that this paper will be able to change policy.”
 

Other ‘What if?’ scenarios

The authors also predicted the mortality implications associated with lower adherence to masks, the presence or absence of SDMs, and what could happen if mandates continue to ease at their current rate.

For example, they considered a scenario with less-than-universal mask use in public, 85%, along with SDMs being reinstated based on the mortality rate threshold. In this instance, they found an additional 95,814 (range, 60,731–133,077) lives could be spared by February 28.

Another calculation looked at outcomes if 95% of Americans wore masks going forward without states instituting SDMs at any point. In this case, the researchers predict that 490,437 Americans would die from COVID-19 by February 2021.

A fourth analysis revealed what would happen without greater mask use if the mortality threshold triggered 6 weeks of SDMs as warranted. Under this ‘plausible reference’ calculation, a total 511,373 Americans would die from COVID-19 by the end of February.

A fifth scenario predicted potential mortality if states continue easing SDMs at the current pace. “This is an alternative scenario to the more probable situation where states are expected to respond to an impending health crisis by reinstating some SDMs,” the authors note. The predicted number of American deaths appears more dire in this calculation. The investigators predict cumulative total deaths could reach 1,053,206 (range, 759,693–1,452,397) by the end of February 2021.

The death toll would likely vary among states in this scenario. California, Florida, and Pennsylvania would like account for approximately one third of all deaths.

All the modeling scenarios considered other factors including pneumonia seasonality, mobility, testing rates, and mask use per capita.
 

“I have seen the IHME study and I agree with the broad conclusions,” Richard Stutt, PhD, of the Epidemiology and Modelling Group at the University of Cambridge, UK, told Medscape Medical News.

“Case numbers are climbing in the US, and without further intervention, there will be a significant number of deaths over the coming months,” he said.

Masks are low cost and widely available, Stutt said. “I am hopeful that even if masks are not widely adopted, we will not see as many deaths as predicted here, as these outbreaks can be significantly reduced by increased social distancing or lockdowns.”

“However this comes at a far higher economic cost than the use of masks, and still requires action,” added Stutt, who authored a study in June that modeled facemasks in combination with “lock-down” measures for managing the COVID-19 pandemic.

Modeling study results depend on the assumptions researchers make, and the IHME team rightly tested a number of different assumptions, Greenhalgh said.

“The key conclusion,” she added, “is here: ‘The implementation of SDMs as soon as individual states reach a threshold of 8 daily deaths per million could dramatically ameliorate the effects of the disease; achieving near-universal mask use could delay, or in many states, possibly prevent, this threshold from being reached and has the potential to save the most lives while minimizing damage to the economy.’ “

“This is a useful piece of information and I think is borne out by their data,” added Greenhalgh, lead author of an April study on face masks for the public during the pandemic.

You can visit the IHME website for the most current mortality projections.

Caplan, Greenhalgh, and Stutt have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Half of Chinese American parents and their children report having experienced an in-person episode of racial discrimination related to the COVID-19 pandemic, according to results from a survey study.

In the United States, where public officials continue to refer to SARS-CoV-2 as the “China virus” and have often sought to draw attention to its origins in Wuhan, China, “the associations between discrimination triggered by the racialization of this acute public health crisis and mental health are unknown,” Charissa S.L. Cheah, PhD, of the University of Maryland, Baltimore County, and colleagues wrote.

For their research published Oct. 29 in Pediatrics, Dr. Cheah and colleagues recruited a cohort of 543 Chinese American parents of school-age children, and 230 of their children aged 10-18 years, to complete online surveys between mid-March and late May 2020. Parents in the cohort were largely foreign born, with all identifying as ethnically Chinese, while their children were mostly U.S. born.
 

Evidence of discrimination against Chinese Americans

Half of parents and their children (51% of parents and 50% of youth) reported experiencing at least one in-person incident of direct discrimination (assessed using questions derived from a validated scale of racial aggression) related to the pandemic. Dr. Cheah and colleagues also reported a high incidence of direct discrimination online (32% of parents and 46% of youth). Additionally, the researchers measured reports of vicarious or indirect discrimination – such as hearing jokes or disparaging remarks about one’s ethnic group – which they used a different adapted scale to capture. More than three-quarters of the cohort reported such experiences.

The experiences of discrimination likely bore on the mental health of both parents and youth. Using a series of instruments designed to measure overall psychological well-being as well as symptoms of depression, anxiety, and certain emotional and behavioral outcomes, Dr. Cheah and colleagues reported significant negative associations between direct online or in-person discrimination and psychological health. For parents and children alike, anxiety and depressive symptoms were positively associated with all varieties of discrimination experiences measured in the study.

About a fifth of the youth in the study were deemed, based on the symptom scales used in the study, to have an elevated risk of clinically significant mental health problems, higher than the 10%-15% that would be expected for these age groups in the United States.

“This study revealed that a high percentage of Chinese American parents and their children personally experienced or witnessed anti-Chinese or anti–Asian American racial discrimination both online and in person due to the COVID-19 pandemic,” the investigators wrote. “Most respondents reported directly experiencing or witnessing racial discrimination against other Chinese or Asian American individuals due to COVID-19 at least once.”

Dr. Cheah and colleagues noted that their cross-sectional study did not lend itself to causal interpretations and was vulnerable to certain types of reporting bias. Nonetheless, they argued, as the pandemic continues, “pediatricians should be sensitive to the potential mental health needs of Chinese American youth and their parents related to various forms of racism, in addition to other stressors, as the foundations of perceptions of racial-ethnic discrimination and their consequences may be set during this period.”
 

COVID-19 didn’t only bring infection

In an accompanying editorial, Tina L. Cheng, MD, of Johns Hopkins University, Baltimore, and her daughter Alison M. Conca-Cheng, a medical student at Brown University, Providence, R.I., remarked that the study’s findings were consistent with recent research that found “4 in 10 Americans reported that it has become more common since COVID-19 for people to express racist views about Asian Americans,” and also described an increase in complaints of discriminatory experiences by Asian Americans.

In this context, a link to poor mental health “should be no surprise,” Dr. Cheng and Ms. Conca-Cheng argued, and urged pediatricians to consult the American Academy of Pediatrics’ 2019 policy statement on racism and on child and adolescent health. “It calls for us to optimize clinical practice, improve workforce development and professional education, strengthen research, and deploy systems through community engagement, advocacy, and public policy.”

David Rettew, MD, a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington, called the study’s main points “clear and disturbing.”

“While it is difficult to find much in the way here of a silver lining, these alarming reports have helped people working in health care and mental health to understand racism as another form of trauma and abuse which, like other types, can have real negative effects on health,” Dr. Rettew said in an interview. “The more we as mental health professions ask about racism and offer resources for people who have experienced it, just as we would people who have endured other types of trauma, the more we can help people heal. That said, it would be better just to stop this from happening in the first place.”

Dr. Cheah and colleagues’ study was supported by a National Science Foundation grant. The investigators disclosed no conflicts of interest. Dr. Cheng and Ms. Conca-Cheng disclosed no financial conflicts of interest related to their editorial. Dr. Rettew said he had no relevant financial disclosures.

SOURCE: Cheah CSL et al. Pediatrics. 2020;146(5):e2020021816.

Half of Chinese American parents and their children report having experienced an in-person episode of racial discrimination related to the COVID-19 pandemic, according to results from a survey study.

In the United States, where public officials continue to refer to SARS-CoV-2 as the “China virus” and have often sought to draw attention to its origins in Wuhan, China, “the associations between discrimination triggered by the racialization of this acute public health crisis and mental health are unknown,” Charissa S.L. Cheah, PhD, of the University of Maryland, Baltimore County, and colleagues wrote.

For their research published Oct. 29 in Pediatrics, Dr. Cheah and colleagues recruited a cohort of 543 Chinese American parents of school-age children, and 230 of their children aged 10-18 years, to complete online surveys between mid-March and late May 2020. Parents in the cohort were largely foreign born, with all identifying as ethnically Chinese, while their children were mostly U.S. born.
 

Evidence of discrimination against Chinese Americans

Half of parents and their children (51% of parents and 50% of youth) reported experiencing at least one in-person incident of direct discrimination (assessed using questions derived from a validated scale of racial aggression) related to the pandemic. Dr. Cheah and colleagues also reported a high incidence of direct discrimination online (32% of parents and 46% of youth). Additionally, the researchers measured reports of vicarious or indirect discrimination – such as hearing jokes or disparaging remarks about one’s ethnic group – which they used a different adapted scale to capture. More than three-quarters of the cohort reported such experiences.

The experiences of discrimination likely bore on the mental health of both parents and youth. Using a series of instruments designed to measure overall psychological well-being as well as symptoms of depression, anxiety, and certain emotional and behavioral outcomes, Dr. Cheah and colleagues reported significant negative associations between direct online or in-person discrimination and psychological health. For parents and children alike, anxiety and depressive symptoms were positively associated with all varieties of discrimination experiences measured in the study.

About a fifth of the youth in the study were deemed, based on the symptom scales used in the study, to have an elevated risk of clinically significant mental health problems, higher than the 10%-15% that would be expected for these age groups in the United States.

“This study revealed that a high percentage of Chinese American parents and their children personally experienced or witnessed anti-Chinese or anti–Asian American racial discrimination both online and in person due to the COVID-19 pandemic,” the investigators wrote. “Most respondents reported directly experiencing or witnessing racial discrimination against other Chinese or Asian American individuals due to COVID-19 at least once.”

Dr. Cheah and colleagues noted that their cross-sectional study did not lend itself to causal interpretations and was vulnerable to certain types of reporting bias. Nonetheless, they argued, as the pandemic continues, “pediatricians should be sensitive to the potential mental health needs of Chinese American youth and their parents related to various forms of racism, in addition to other stressors, as the foundations of perceptions of racial-ethnic discrimination and their consequences may be set during this period.”
 

COVID-19 didn’t only bring infection

In an accompanying editorial, Tina L. Cheng, MD, of Johns Hopkins University, Baltimore, and her daughter Alison M. Conca-Cheng, a medical student at Brown University, Providence, R.I., remarked that the study’s findings were consistent with recent research that found “4 in 10 Americans reported that it has become more common since COVID-19 for people to express racist views about Asian Americans,” and also described an increase in complaints of discriminatory experiences by Asian Americans.

In this context, a link to poor mental health “should be no surprise,” Dr. Cheng and Ms. Conca-Cheng argued, and urged pediatricians to consult the American Academy of Pediatrics’ 2019 policy statement on racism and on child and adolescent health. “It calls for us to optimize clinical practice, improve workforce development and professional education, strengthen research, and deploy systems through community engagement, advocacy, and public policy.”

David Rettew, MD, a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington, called the study’s main points “clear and disturbing.”

“While it is difficult to find much in the way here of a silver lining, these alarming reports have helped people working in health care and mental health to understand racism as another form of trauma and abuse which, like other types, can have real negative effects on health,” Dr. Rettew said in an interview. “The more we as mental health professions ask about racism and offer resources for people who have experienced it, just as we would people who have endured other types of trauma, the more we can help people heal. That said, it would be better just to stop this from happening in the first place.”

Dr. Cheah and colleagues’ study was supported by a National Science Foundation grant. The investigators disclosed no conflicts of interest. Dr. Cheng and Ms. Conca-Cheng disclosed no financial conflicts of interest related to their editorial. Dr. Rettew said he had no relevant financial disclosures.

SOURCE: Cheah CSL et al. Pediatrics. 2020;146(5):e2020021816.

Half of Chinese American parents and their children report having experienced an in-person episode of racial discrimination related to the COVID-19 pandemic, according to results from a survey study.

In the United States, where public officials continue to refer to SARS-CoV-2 as the “China virus” and have often sought to draw attention to its origins in Wuhan, China, “the associations between discrimination triggered by the racialization of this acute public health crisis and mental health are unknown,” Charissa S.L. Cheah, PhD, of the University of Maryland, Baltimore County, and colleagues wrote.

For their research published Oct. 29 in Pediatrics, Dr. Cheah and colleagues recruited a cohort of 543 Chinese American parents of school-age children, and 230 of their children aged 10-18 years, to complete online surveys between mid-March and late May 2020. Parents in the cohort were largely foreign born, with all identifying as ethnically Chinese, while their children were mostly U.S. born.
 

Evidence of discrimination against Chinese Americans

Half of parents and their children (51% of parents and 50% of youth) reported experiencing at least one in-person incident of direct discrimination (assessed using questions derived from a validated scale of racial aggression) related to the pandemic. Dr. Cheah and colleagues also reported a high incidence of direct discrimination online (32% of parents and 46% of youth). Additionally, the researchers measured reports of vicarious or indirect discrimination – such as hearing jokes or disparaging remarks about one’s ethnic group – which they used a different adapted scale to capture. More than three-quarters of the cohort reported such experiences.

The experiences of discrimination likely bore on the mental health of both parents and youth. Using a series of instruments designed to measure overall psychological well-being as well as symptoms of depression, anxiety, and certain emotional and behavioral outcomes, Dr. Cheah and colleagues reported significant negative associations between direct online or in-person discrimination and psychological health. For parents and children alike, anxiety and depressive symptoms were positively associated with all varieties of discrimination experiences measured in the study.

About a fifth of the youth in the study were deemed, based on the symptom scales used in the study, to have an elevated risk of clinically significant mental health problems, higher than the 10%-15% that would be expected for these age groups in the United States.

“This study revealed that a high percentage of Chinese American parents and their children personally experienced or witnessed anti-Chinese or anti–Asian American racial discrimination both online and in person due to the COVID-19 pandemic,” the investigators wrote. “Most respondents reported directly experiencing or witnessing racial discrimination against other Chinese or Asian American individuals due to COVID-19 at least once.”

Dr. Cheah and colleagues noted that their cross-sectional study did not lend itself to causal interpretations and was vulnerable to certain types of reporting bias. Nonetheless, they argued, as the pandemic continues, “pediatricians should be sensitive to the potential mental health needs of Chinese American youth and their parents related to various forms of racism, in addition to other stressors, as the foundations of perceptions of racial-ethnic discrimination and their consequences may be set during this period.”
 

COVID-19 didn’t only bring infection

In an accompanying editorial, Tina L. Cheng, MD, of Johns Hopkins University, Baltimore, and her daughter Alison M. Conca-Cheng, a medical student at Brown University, Providence, R.I., remarked that the study’s findings were consistent with recent research that found “4 in 10 Americans reported that it has become more common since COVID-19 for people to express racist views about Asian Americans,” and also described an increase in complaints of discriminatory experiences by Asian Americans.

In this context, a link to poor mental health “should be no surprise,” Dr. Cheng and Ms. Conca-Cheng argued, and urged pediatricians to consult the American Academy of Pediatrics’ 2019 policy statement on racism and on child and adolescent health. “It calls for us to optimize clinical practice, improve workforce development and professional education, strengthen research, and deploy systems through community engagement, advocacy, and public policy.”

David Rettew, MD, a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington, called the study’s main points “clear and disturbing.”

“While it is difficult to find much in the way here of a silver lining, these alarming reports have helped people working in health care and mental health to understand racism as another form of trauma and abuse which, like other types, can have real negative effects on health,” Dr. Rettew said in an interview. “The more we as mental health professions ask about racism and offer resources for people who have experienced it, just as we would people who have endured other types of trauma, the more we can help people heal. That said, it would be better just to stop this from happening in the first place.”

Dr. Cheah and colleagues’ study was supported by a National Science Foundation grant. The investigators disclosed no conflicts of interest. Dr. Cheng and Ms. Conca-Cheng disclosed no financial conflicts of interest related to their editorial. Dr. Rettew said he had no relevant financial disclosures.

SOURCE: Cheah CSL et al. Pediatrics. 2020;146(5):e2020021816.

Tocilizumab (Actemra/RoActemra) was not found to have any clear role as a treatment for COVID-19 in four new studies.

Three randomized controlled trials showed that the drug either had no benefit or only a modest one, contradicting a large retrospective study that had hinted at a more robust effect.

“This is not a blockbuster,” said David Cennimo, MD, an infectious disease expert at Rutgers New Jersey Medical School, Newark, New Jersey. “This is not something that’s going to revolutionize our treatment of COVID-19.”

But some researchers still regard these studies as showing evidence that the drug benefits certain patients with severe inflammation.

The immune response to SARS-CoV-2 includes elevated levels of the cytokine interleukin-6 (IL-6). In some patients, this response becomes a nonspecific inflammation, a “cytokine storm,” involving edema and inflammatory cell infiltration in the lungs. These cases are among the most severe.

Dexamethasone has proved effective in controlling this inflammation in some patients. Researchers have theorized that a more targeted suppression of IL-6 could be even more effective or work in cases that don’t respond to dexamethasone.

A recombinant monoclonal antibody, tocilizumab blocks IL-6 receptors. It is approved by the US Food and Drug Administration for use in patients with rheumatologic disorders and cytokine release syndrome induced by chimeric antigen receptor T-cell therapy.

Current National Institutes of Health (NIH) guidelines recommend against the use of tocilizumab as a treatment for COVID-19, despite earlier observational studies that suggested the drug might help patients with moderate to severe disease. Controlled trials were lacking until now.

The most hopeful results in this batch came from the CORIMUNO-19 platform of open-label, randomized controlled trials of immune modulatory treatments for moderate or severe COVID-19 in France.

Published in JAMA Internal Medicine , the trial recruited patients from nine French hospitals. Patients were eligible if they required at least 3 L/min of oxygen without ventilation or admission to the intensive care unit.

The investigators randomly assigned 64 patients to receive tocilizumab 8 mg/kg body weight intravenously plus usual care and 67 patients to usual care alone. Usual care included antibiotic agents, antiviral agents, corticosteroids, vasopressor support, and anticoagulants.

After 4 days, the investigators scored patients on the World Health Organization 10-point Clinical Progression Scale. Twelve of the patients who received tocilizumab scored higher than 5 vs 19 of the patients in the usual care group, with higher scores indicating clinical deterioration.

After 14 days, 24% of the patients taking tocilizumab required either noninvasive ventilation or mechanical ventilation or had died, vs 36% in the usual care group (median posterior hazard ratio [HR], 0.58; 90% credible interval, 0.33 – 1.00).

“We reduced the risk of dying or requiring mechanical ventilation, so for me, the study was positive,” said Olivier Hermine, MD, PhD, a professor of hematology at Paris Descartes University in Paris, France.

However, there was no difference in mortality at 28 days. Hermine hopes to have longer-term outcomes soon, he told Medscape Medical News.

A second randomized controlled trial, also published in JAMA Internal Medicine , provided less hope. In this RCT-TCZ-COVID-19 Study Group trial, conducted at 24 Italian centers, patients were enrolled if their partial pressure of arterial oxygen to fraction of inspired oxygen (PaO₂/FiO₂) ratios were between 200 and 300 mm Hg and if their inflammatory phenotypes were defined by fever and elevated C-reactive protein level.

The investigators randomly assigned 60 patients to receive tocilizumab 8 mg/kg up to a maximum of 800 mg within 8 hours of randomization, followed by a second dose after 12 hours. They assigned 66 patients to a control group that received supportive care until clinical worsening, at which point patients could receive tocilizumab as a rescue therapy.

Of the patients who received tocilizumab, 28.3% showed clinical worsening within 14 days, compared to 27.0% in the control group (rate ratio, 1.05; 95% CI, 0.59 – 1.86). There was no significant difference between the groups in terms of the proportion admitted to intensive care. The researchers stopped the trial prematurely because tocilizumab did not seem to be making a difference.

The BACC Bay Tocilizumab Trial was conducted at seven Boston hospitals. The results, which were published in The New England Journal of Medicine, were also discouraging.

In that trial, enrolled patients met two sets of parameters. First, the patients had at least one of the following signs: C-reactive protein level higher than 50 mg/L, ferritin level higher than 500 ng/mL, D-dimer level higher than 1000 ng/mL, or a lactate dehydrogenase level higher than 250 U/L. Second, the patients had to have at least two of the following signs: body temperature >38° C, pulmonary infiltrates, or the need for supplemental oxygen to maintain an oxygen saturation greater than 92%.

The investigators randomly assigned 161 patients to receive intravenous tocilizumab 8 mg/kg up to 800 mg and 81 to receive a placebo.

They didn’t find a statistically significant difference between the groups. The hazard ratio for intubation or death in the tocilizumab group as compared with the placebo group was 0.83 (95% CI, 0.38 – 1.81; P = .64). The hazard ratio for disease worsening was 1.11 (95% CI, 0.59 – 2.10; P = .73). At 14 days, the conditions of 18.0% of the patients who received tocilizumab and 14.9% of the patients who received the placebo worsened.

In contrast to these randomized trials, STOP-COVID, a retrospective analysis of 3924 patients, also published in JAMA Internal Medicine, found that the risk for death was lower for patients treated with tocilizumab compared with those not treated with tocilizumab (HR, 0.71; 95% CI, 0.56 – 0.92) over a median follow-up period of 27 days.

Also on the bright side, none of the new studies showed significant adverse reactions to tocilizumab.

More randomized clinical trials are underway. In press releases announcing topline data, Roche reported mostly negative results in its phase 3 COVACTA trial but noted a 44% reduction in the risk for progression to death or ventilation in its phase 3 IMPACTA trial. Roche did not comment on the ethnicity of its COVACTA patients; it said IMPACTA enrolled a majority of Hispanic patients and included large representations of Native American and Black patients.
 

Results don’t support routine use

Commenting on the new studies, editorialists in both JAMA Internal Medicine and The New England Journal of Medicine concluded that the tocilizumab results were not strong enough to support routine use.

“My take-home point from looking at all of these together is that, even if it does help, it’s most likely in a small subset of the population and/or a small effect,” Cennimo told Medscape Medical News.

But the NIH recommendation against tocilizumab goes too far, argued Cristina Mussini, MD, a professor of infectious diseases at the University of Modena and Reggio Emilia in Italy, who is a coauthor of a cohort study of tocilizumab and served on the CORIMUNO-19 Data Safety and Monitoring Board.

“I really think it’s too early to recommend against it because at least two clinical trials showed protection against mechanical ventilation and death,” she said.

She prescribes tocilizumab for patients who have not been helped by dexamethasone. “It’s just a rescue drug,” she told Medscape Medical News. “It’s not something you use for everybody, but it’s the only weapon we have now when the patient is really going to the intensive care unit.”

The BACC Bay Tocilizumab Trial was funded by Genentech/Roche. Genentech/Roche provided the drug for the CORIMUNO and RCT-TCZ-COVID-19 trials. The STOP-COVID study was supported by grants from the NIH and by the Frankel Cardiovascular Center COVID-19: Impact Research Ignitor. Cennimo, Hermine, and Mussini have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Tocilizumab (Actemra/RoActemra) was not found to have any clear role as a treatment for COVID-19 in four new studies.

Three randomized controlled trials showed that the drug either had no benefit or only a modest one, contradicting a large retrospective study that had hinted at a more robust effect.

“This is not a blockbuster,” said David Cennimo, MD, an infectious disease expert at Rutgers New Jersey Medical School, Newark, New Jersey. “This is not something that’s going to revolutionize our treatment of COVID-19.”

But some researchers still regard these studies as showing evidence that the drug benefits certain patients with severe inflammation.

The immune response to SARS-CoV-2 includes elevated levels of the cytokine interleukin-6 (IL-6). In some patients, this response becomes a nonspecific inflammation, a “cytokine storm,” involving edema and inflammatory cell infiltration in the lungs. These cases are among the most severe.

Dexamethasone has proved effective in controlling this inflammation in some patients. Researchers have theorized that a more targeted suppression of IL-6 could be even more effective or work in cases that don’t respond to dexamethasone.

A recombinant monoclonal antibody, tocilizumab blocks IL-6 receptors. It is approved by the US Food and Drug Administration for use in patients with rheumatologic disorders and cytokine release syndrome induced by chimeric antigen receptor T-cell therapy.

Current National Institutes of Health (NIH) guidelines recommend against the use of tocilizumab as a treatment for COVID-19, despite earlier observational studies that suggested the drug might help patients with moderate to severe disease. Controlled trials were lacking until now.

The most hopeful results in this batch came from the CORIMUNO-19 platform of open-label, randomized controlled trials of immune modulatory treatments for moderate or severe COVID-19 in France.

Published in JAMA Internal Medicine , the trial recruited patients from nine French hospitals. Patients were eligible if they required at least 3 L/min of oxygen without ventilation or admission to the intensive care unit.

The investigators randomly assigned 64 patients to receive tocilizumab 8 mg/kg body weight intravenously plus usual care and 67 patients to usual care alone. Usual care included antibiotic agents, antiviral agents, corticosteroids, vasopressor support, and anticoagulants.

After 4 days, the investigators scored patients on the World Health Organization 10-point Clinical Progression Scale. Twelve of the patients who received tocilizumab scored higher than 5 vs 19 of the patients in the usual care group, with higher scores indicating clinical deterioration.

After 14 days, 24% of the patients taking tocilizumab required either noninvasive ventilation or mechanical ventilation or had died, vs 36% in the usual care group (median posterior hazard ratio [HR], 0.58; 90% credible interval, 0.33 – 1.00).

“We reduced the risk of dying or requiring mechanical ventilation, so for me, the study was positive,” said Olivier Hermine, MD, PhD, a professor of hematology at Paris Descartes University in Paris, France.

However, there was no difference in mortality at 28 days. Hermine hopes to have longer-term outcomes soon, he told Medscape Medical News.

A second randomized controlled trial, also published in JAMA Internal Medicine , provided less hope. In this RCT-TCZ-COVID-19 Study Group trial, conducted at 24 Italian centers, patients were enrolled if their partial pressure of arterial oxygen to fraction of inspired oxygen (PaO₂/FiO₂) ratios were between 200 and 300 mm Hg and if their inflammatory phenotypes were defined by fever and elevated C-reactive protein level.

The investigators randomly assigned 60 patients to receive tocilizumab 8 mg/kg up to a maximum of 800 mg within 8 hours of randomization, followed by a second dose after 12 hours. They assigned 66 patients to a control group that received supportive care until clinical worsening, at which point patients could receive tocilizumab as a rescue therapy.

Of the patients who received tocilizumab, 28.3% showed clinical worsening within 14 days, compared to 27.0% in the control group (rate ratio, 1.05; 95% CI, 0.59 – 1.86). There was no significant difference between the groups in terms of the proportion admitted to intensive care. The researchers stopped the trial prematurely because tocilizumab did not seem to be making a difference.

The BACC Bay Tocilizumab Trial was conducted at seven Boston hospitals. The results, which were published in The New England Journal of Medicine, were also discouraging.

In that trial, enrolled patients met two sets of parameters. First, the patients had at least one of the following signs: C-reactive protein level higher than 50 mg/L, ferritin level higher than 500 ng/mL, D-dimer level higher than 1000 ng/mL, or a lactate dehydrogenase level higher than 250 U/L. Second, the patients had to have at least two of the following signs: body temperature >38° C, pulmonary infiltrates, or the need for supplemental oxygen to maintain an oxygen saturation greater than 92%.

The investigators randomly assigned 161 patients to receive intravenous tocilizumab 8 mg/kg up to 800 mg and 81 to receive a placebo.

They didn’t find a statistically significant difference between the groups. The hazard ratio for intubation or death in the tocilizumab group as compared with the placebo group was 0.83 (95% CI, 0.38 – 1.81; P = .64). The hazard ratio for disease worsening was 1.11 (95% CI, 0.59 – 2.10; P = .73). At 14 days, the conditions of 18.0% of the patients who received tocilizumab and 14.9% of the patients who received the placebo worsened.

In contrast to these randomized trials, STOP-COVID, a retrospective analysis of 3924 patients, also published in JAMA Internal Medicine, found that the risk for death was lower for patients treated with tocilizumab compared with those not treated with tocilizumab (HR, 0.71; 95% CI, 0.56 – 0.92) over a median follow-up period of 27 days.

Also on the bright side, none of the new studies showed significant adverse reactions to tocilizumab.

More randomized clinical trials are underway. In press releases announcing topline data, Roche reported mostly negative results in its phase 3 COVACTA trial but noted a 44% reduction in the risk for progression to death or ventilation in its phase 3 IMPACTA trial. Roche did not comment on the ethnicity of its COVACTA patients; it said IMPACTA enrolled a majority of Hispanic patients and included large representations of Native American and Black patients.
 

Results don’t support routine use

Commenting on the new studies, editorialists in both JAMA Internal Medicine and The New England Journal of Medicine concluded that the tocilizumab results were not strong enough to support routine use.

“My take-home point from looking at all of these together is that, even if it does help, it’s most likely in a small subset of the population and/or a small effect,” Cennimo told Medscape Medical News.

But the NIH recommendation against tocilizumab goes too far, argued Cristina Mussini, MD, a professor of infectious diseases at the University of Modena and Reggio Emilia in Italy, who is a coauthor of a cohort study of tocilizumab and served on the CORIMUNO-19 Data Safety and Monitoring Board.

“I really think it’s too early to recommend against it because at least two clinical trials showed protection against mechanical ventilation and death,” she said.

She prescribes tocilizumab for patients who have not been helped by dexamethasone. “It’s just a rescue drug,” she told Medscape Medical News. “It’s not something you use for everybody, but it’s the only weapon we have now when the patient is really going to the intensive care unit.”

The BACC Bay Tocilizumab Trial was funded by Genentech/Roche. Genentech/Roche provided the drug for the CORIMUNO and RCT-TCZ-COVID-19 trials. The STOP-COVID study was supported by grants from the NIH and by the Frankel Cardiovascular Center COVID-19: Impact Research Ignitor. Cennimo, Hermine, and Mussini have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Tocilizumab (Actemra/RoActemra) was not found to have any clear role as a treatment for COVID-19 in four new studies.

Three randomized controlled trials showed that the drug either had no benefit or only a modest one, contradicting a large retrospective study that had hinted at a more robust effect.

“This is not a blockbuster,” said David Cennimo, MD, an infectious disease expert at Rutgers New Jersey Medical School, Newark, New Jersey. “This is not something that’s going to revolutionize our treatment of COVID-19.”

But some researchers still regard these studies as showing evidence that the drug benefits certain patients with severe inflammation.

The immune response to SARS-CoV-2 includes elevated levels of the cytokine interleukin-6 (IL-6). In some patients, this response becomes a nonspecific inflammation, a “cytokine storm,” involving edema and inflammatory cell infiltration in the lungs. These cases are among the most severe.

Dexamethasone has proved effective in controlling this inflammation in some patients. Researchers have theorized that a more targeted suppression of IL-6 could be even more effective or work in cases that don’t respond to dexamethasone.

A recombinant monoclonal antibody, tocilizumab blocks IL-6 receptors. It is approved by the US Food and Drug Administration for use in patients with rheumatologic disorders and cytokine release syndrome induced by chimeric antigen receptor T-cell therapy.

Current National Institutes of Health (NIH) guidelines recommend against the use of tocilizumab as a treatment for COVID-19, despite earlier observational studies that suggested the drug might help patients with moderate to severe disease. Controlled trials were lacking until now.

The most hopeful results in this batch came from the CORIMUNO-19 platform of open-label, randomized controlled trials of immune modulatory treatments for moderate or severe COVID-19 in France.

Published in JAMA Internal Medicine , the trial recruited patients from nine French hospitals. Patients were eligible if they required at least 3 L/min of oxygen without ventilation or admission to the intensive care unit.

The investigators randomly assigned 64 patients to receive tocilizumab 8 mg/kg body weight intravenously plus usual care and 67 patients to usual care alone. Usual care included antibiotic agents, antiviral agents, corticosteroids, vasopressor support, and anticoagulants.

After 4 days, the investigators scored patients on the World Health Organization 10-point Clinical Progression Scale. Twelve of the patients who received tocilizumab scored higher than 5 vs 19 of the patients in the usual care group, with higher scores indicating clinical deterioration.

After 14 days, 24% of the patients taking tocilizumab required either noninvasive ventilation or mechanical ventilation or had died, vs 36% in the usual care group (median posterior hazard ratio [HR], 0.58; 90% credible interval, 0.33 – 1.00).

“We reduced the risk of dying or requiring mechanical ventilation, so for me, the study was positive,” said Olivier Hermine, MD, PhD, a professor of hematology at Paris Descartes University in Paris, France.

However, there was no difference in mortality at 28 days. Hermine hopes to have longer-term outcomes soon, he told Medscape Medical News.

A second randomized controlled trial, also published in JAMA Internal Medicine , provided less hope. In this RCT-TCZ-COVID-19 Study Group trial, conducted at 24 Italian centers, patients were enrolled if their partial pressure of arterial oxygen to fraction of inspired oxygen (PaO₂/FiO₂) ratios were between 200 and 300 mm Hg and if their inflammatory phenotypes were defined by fever and elevated C-reactive protein level.

The investigators randomly assigned 60 patients to receive tocilizumab 8 mg/kg up to a maximum of 800 mg within 8 hours of randomization, followed by a second dose after 12 hours. They assigned 66 patients to a control group that received supportive care until clinical worsening, at which point patients could receive tocilizumab as a rescue therapy.

Of the patients who received tocilizumab, 28.3% showed clinical worsening within 14 days, compared to 27.0% in the control group (rate ratio, 1.05; 95% CI, 0.59 – 1.86). There was no significant difference between the groups in terms of the proportion admitted to intensive care. The researchers stopped the trial prematurely because tocilizumab did not seem to be making a difference.

The BACC Bay Tocilizumab Trial was conducted at seven Boston hospitals. The results, which were published in The New England Journal of Medicine, were also discouraging.

In that trial, enrolled patients met two sets of parameters. First, the patients had at least one of the following signs: C-reactive protein level higher than 50 mg/L, ferritin level higher than 500 ng/mL, D-dimer level higher than 1000 ng/mL, or a lactate dehydrogenase level higher than 250 U/L. Second, the patients had to have at least two of the following signs: body temperature >38° C, pulmonary infiltrates, or the need for supplemental oxygen to maintain an oxygen saturation greater than 92%.

The investigators randomly assigned 161 patients to receive intravenous tocilizumab 8 mg/kg up to 800 mg and 81 to receive a placebo.

They didn’t find a statistically significant difference between the groups. The hazard ratio for intubation or death in the tocilizumab group as compared with the placebo group was 0.83 (95% CI, 0.38 – 1.81; P = .64). The hazard ratio for disease worsening was 1.11 (95% CI, 0.59 – 2.10; P = .73). At 14 days, the conditions of 18.0% of the patients who received tocilizumab and 14.9% of the patients who received the placebo worsened.

In contrast to these randomized trials, STOP-COVID, a retrospective analysis of 3924 patients, also published in JAMA Internal Medicine, found that the risk for death was lower for patients treated with tocilizumab compared with those not treated with tocilizumab (HR, 0.71; 95% CI, 0.56 – 0.92) over a median follow-up period of 27 days.

Also on the bright side, none of the new studies showed significant adverse reactions to tocilizumab.

More randomized clinical trials are underway. In press releases announcing topline data, Roche reported mostly negative results in its phase 3 COVACTA trial but noted a 44% reduction in the risk for progression to death or ventilation in its phase 3 IMPACTA trial. Roche did not comment on the ethnicity of its COVACTA patients; it said IMPACTA enrolled a majority of Hispanic patients and included large representations of Native American and Black patients.
 

Results don’t support routine use

Commenting on the new studies, editorialists in both JAMA Internal Medicine and The New England Journal of Medicine concluded that the tocilizumab results were not strong enough to support routine use.

“My take-home point from looking at all of these together is that, even if it does help, it’s most likely in a small subset of the population and/or a small effect,” Cennimo told Medscape Medical News.

But the NIH recommendation against tocilizumab goes too far, argued Cristina Mussini, MD, a professor of infectious diseases at the University of Modena and Reggio Emilia in Italy, who is a coauthor of a cohort study of tocilizumab and served on the CORIMUNO-19 Data Safety and Monitoring Board.

“I really think it’s too early to recommend against it because at least two clinical trials showed protection against mechanical ventilation and death,” she said.

She prescribes tocilizumab for patients who have not been helped by dexamethasone. “It’s just a rescue drug,” she told Medscape Medical News. “It’s not something you use for everybody, but it’s the only weapon we have now when the patient is really going to the intensive care unit.”

The BACC Bay Tocilizumab Trial was funded by Genentech/Roche. Genentech/Roche provided the drug for the CORIMUNO and RCT-TCZ-COVID-19 trials. The STOP-COVID study was supported by grants from the NIH and by the Frankel Cardiovascular Center COVID-19: Impact Research Ignitor. Cennimo, Hermine, and Mussini have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

Eli Lilly announced it will halt its ACTIV-3 trial evaluating the antibody bamlanivimab in combination with remdesivir for people hospitalized with COVID-19, after new evidence regarding efficacy emerged.

The new data from the National Institutes of Health suggest that the experimental neutralizing antibody therapy does not offer significant clinical benefit for people with more advanced COVID-19 illness, according to a company statement.

Eli Lilly also announced it plans to continue its other trials evaluating the antibody, including those assessing a potential role in treating people in the earlier stages of COVID-19.

“While there was insufficient evidence that bamlanivimab improved clinical outcomes when added to other treatments in hospitalized patients with COVID-19, we remain confident based on data from Lilly’s BLAZE-1 study that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19,” the statement reads.

The ACTIV-3 trial was paused on October 13 after a data and safety monitoring board cited safety concerns.

The most recent data update that triggered an end to the trial did not reveal any significant differences in safety, though.  
 

This article first appeared on Medscape.com.

Eli Lilly announced it will halt its ACTIV-3 trial evaluating the antibody bamlanivimab in combination with remdesivir for people hospitalized with COVID-19, after new evidence regarding efficacy emerged.

The new data from the National Institutes of Health suggest that the experimental neutralizing antibody therapy does not offer significant clinical benefit for people with more advanced COVID-19 illness, according to a company statement.

Eli Lilly also announced it plans to continue its other trials evaluating the antibody, including those assessing a potential role in treating people in the earlier stages of COVID-19.

“While there was insufficient evidence that bamlanivimab improved clinical outcomes when added to other treatments in hospitalized patients with COVID-19, we remain confident based on data from Lilly’s BLAZE-1 study that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19,” the statement reads.

The ACTIV-3 trial was paused on October 13 after a data and safety monitoring board cited safety concerns.

The most recent data update that triggered an end to the trial did not reveal any significant differences in safety, though.  
 

This article first appeared on Medscape.com.

Eli Lilly announced it will halt its ACTIV-3 trial evaluating the antibody bamlanivimab in combination with remdesivir for people hospitalized with COVID-19, after new evidence regarding efficacy emerged.

The new data from the National Institutes of Health suggest that the experimental neutralizing antibody therapy does not offer significant clinical benefit for people with more advanced COVID-19 illness, according to a company statement.

Eli Lilly also announced it plans to continue its other trials evaluating the antibody, including those assessing a potential role in treating people in the earlier stages of COVID-19.

“While there was insufficient evidence that bamlanivimab improved clinical outcomes when added to other treatments in hospitalized patients with COVID-19, we remain confident based on data from Lilly’s BLAZE-1 study that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19,” the statement reads.

The ACTIV-3 trial was paused on October 13 after a data and safety monitoring board cited safety concerns.

The most recent data update that triggered an end to the trial did not reveal any significant differences in safety, though.  
 

This article first appeared on Medscape.com.

Vertebral fractures appear to be common in people with severe COVID-19, and also raise the mortality risk, findings from a retrospective cohort suggest.

Among 114 patients with COVID-19 who underwent lateral chest x-rays at the San Raffaele Hospital ED in Milan, more than a third were found to have thoracic vertebral fractures. And, those individuals were more than twice as likely to die as were those without vertebral fractures.

“Morphometric vertebral fractures are one of the most common comorbidities among adults hospitalized with COVID-19, and the presence of such fractures may predict the severity of disease outcomes,” lead investigator Andrea Giustina, MD, said in an interview.

This is the first study to examine vertebral fracture prevalence in any coronavirus disease, but such fractures have been linked to an increased risk of pneumonia and impaired respiratory function, including restrictive pulmonary dysfunction. One possible mechanism may be that they cause anatomical changes, such as kyphosis, which negatively impact respiratory function by decreasing vital capacity, forced expiratory volume in 1 second, and inspiratory time, explained Dr. Giustina, professor of endocrinology, San Raffaele Vita Salute University, Milan, and president of the European Society of Endocrinology. The results were published in the Journal of Clinical Endocrinology and Metabolism.

Clinically, the findings suggest that all patients with COVID-19 who are undergoing chest x-rays should have morphometric vertebral x-ray evaluation, said Dr. Giustina.

“One interesting aspect of the study is that without morphometry, approximatively two thirds of vertebral fractures [would have been] missed. Therefore, they are largely underestimated in clinical practice,” he noted.
 

Thoracic vertebral fractures assessed via lateral chest x-rays

The 114 study subjects included were those whose lateral chest x-rays allowed for a high-quality assessment and in which all the thoracic tract of T4-T12 were viewable and assessable. None had been using glucocorticoids and only 3% had a prior diagnosis of osteoporosis.

The majority (75%) were male, and median age was 57 years. Most (79%) were hospitalized after evaluation in the ED. Of those, 12% (13) were admitted to the ICU and 15% (16) died.

Thoracic vertebral fractures were detected on the lateral chest x-rays in 36% (41) of the patients. In contrast, in studies of women aged 50 years and older from the general European population, morphometric vertebral fracture prevalence ranged from 18% to 26%, the investigators noted.

Of the total 65 vertebral fractures detected, 60% were classified as mild (height ratio decrease <25%), 33.3% as moderate (25%-40% decrease) and 7.7% as severe (>40%). Patients with more than one vertebral fracture were classified by their most severe one.

Those with versus without vertebral fractures didn’t differ by sex, body mass index, or clinical or biological parameters evaluated in the ED. But, compared with those without vertebral fractures, those with them were significantly older (68 vs. 54 years) and were more likely to have arterial hypertension (56% vs. 30%) and coronary artery disease (22% vs. 7%).

In multivariate analysis, age was the only statistically significant predictor of vertebral fractures (odds ratio, 1.04; P < .001).

Mortality doubled, though not significantly

Those with vertebral fractures were more likely to be hospitalized, although not significantly (88% vs. 74%). There was no significant difference in ICU admission (11% vs. 12.5%).

However, those with vertebral fractures required noninvasive mechanical ventilation significantly more often (48.8% vs. 27.4%; P = .02), and were more than twice as likely to die (22% vs. 10%; P = .07). While the difference in overall mortality wasn’t quite statistically significant, those with severe vertebral fractures were significantly more likely to die, compared with those with mild or moderate fractures (60%, 7%, 24%, respectively, for severe, moderate, and mild; P = .04), despite no significant differences in clinical or laboratory parameters.

“Our data from the field reinforce the need of implementing previously published recommendations concerning the importance of bone fragility care during the COVID pandemic with at least those patients already treated with antiosteoporotic drugs maintaining their adherence to treatments including vitamin D, which have also been suggested very recently to have no relevant predisposing effect on COVID-19,” Dr. Giustina and colleagues wrote.

Moreover, they added, “continuity of care should also include bone density monitoring despite very restricted access to clinical facilities, during the COVID-19 pandemic. Finally, all patients with fractures should start antiresorptive treatment right away, even during hospital stay.”

The authors reported having no disclosures.

SOURCE: Giustina A et al. J Clin Endocrinol Metab. 2020 Oct 21. doi: 10.1210/clinem/dgaa738.

Vertebral fractures appear to be common in people with severe COVID-19, and also raise the mortality risk, findings from a retrospective cohort suggest.

Among 114 patients with COVID-19 who underwent lateral chest x-rays at the San Raffaele Hospital ED in Milan, more than a third were found to have thoracic vertebral fractures. And, those individuals were more than twice as likely to die as were those without vertebral fractures.

“Morphometric vertebral fractures are one of the most common comorbidities among adults hospitalized with COVID-19, and the presence of such fractures may predict the severity of disease outcomes,” lead investigator Andrea Giustina, MD, said in an interview.

This is the first study to examine vertebral fracture prevalence in any coronavirus disease, but such fractures have been linked to an increased risk of pneumonia and impaired respiratory function, including restrictive pulmonary dysfunction. One possible mechanism may be that they cause anatomical changes, such as kyphosis, which negatively impact respiratory function by decreasing vital capacity, forced expiratory volume in 1 second, and inspiratory time, explained Dr. Giustina, professor of endocrinology, San Raffaele Vita Salute University, Milan, and president of the European Society of Endocrinology. The results were published in the Journal of Clinical Endocrinology and Metabolism.

Clinically, the findings suggest that all patients with COVID-19 who are undergoing chest x-rays should have morphometric vertebral x-ray evaluation, said Dr. Giustina.

“One interesting aspect of the study is that without morphometry, approximatively two thirds of vertebral fractures [would have been] missed. Therefore, they are largely underestimated in clinical practice,” he noted.
 

Thoracic vertebral fractures assessed via lateral chest x-rays

The 114 study subjects included were those whose lateral chest x-rays allowed for a high-quality assessment and in which all the thoracic tract of T4-T12 were viewable and assessable. None had been using glucocorticoids and only 3% had a prior diagnosis of osteoporosis.

The majority (75%) were male, and median age was 57 years. Most (79%) were hospitalized after evaluation in the ED. Of those, 12% (13) were admitted to the ICU and 15% (16) died.

Thoracic vertebral fractures were detected on the lateral chest x-rays in 36% (41) of the patients. In contrast, in studies of women aged 50 years and older from the general European population, morphometric vertebral fracture prevalence ranged from 18% to 26%, the investigators noted.

Of the total 65 vertebral fractures detected, 60% were classified as mild (height ratio decrease <25%), 33.3% as moderate (25%-40% decrease) and 7.7% as severe (>40%). Patients with more than one vertebral fracture were classified by their most severe one.

Those with versus without vertebral fractures didn’t differ by sex, body mass index, or clinical or biological parameters evaluated in the ED. But, compared with those without vertebral fractures, those with them were significantly older (68 vs. 54 years) and were more likely to have arterial hypertension (56% vs. 30%) and coronary artery disease (22% vs. 7%).

In multivariate analysis, age was the only statistically significant predictor of vertebral fractures (odds ratio, 1.04; P < .001).

Mortality doubled, though not significantly

Those with vertebral fractures were more likely to be hospitalized, although not significantly (88% vs. 74%). There was no significant difference in ICU admission (11% vs. 12.5%).

However, those with vertebral fractures required noninvasive mechanical ventilation significantly more often (48.8% vs. 27.4%; P = .02), and were more than twice as likely to die (22% vs. 10%; P = .07). While the difference in overall mortality wasn’t quite statistically significant, those with severe vertebral fractures were significantly more likely to die, compared with those with mild or moderate fractures (60%, 7%, 24%, respectively, for severe, moderate, and mild; P = .04), despite no significant differences in clinical or laboratory parameters.

“Our data from the field reinforce the need of implementing previously published recommendations concerning the importance of bone fragility care during the COVID pandemic with at least those patients already treated with antiosteoporotic drugs maintaining their adherence to treatments including vitamin D, which have also been suggested very recently to have no relevant predisposing effect on COVID-19,” Dr. Giustina and colleagues wrote.

Moreover, they added, “continuity of care should also include bone density monitoring despite very restricted access to clinical facilities, during the COVID-19 pandemic. Finally, all patients with fractures should start antiresorptive treatment right away, even during hospital stay.”

The authors reported having no disclosures.

SOURCE: Giustina A et al. J Clin Endocrinol Metab. 2020 Oct 21. doi: 10.1210/clinem/dgaa738.

Vertebral fractures appear to be common in people with severe COVID-19, and also raise the mortality risk, findings from a retrospective cohort suggest.

Among 114 patients with COVID-19 who underwent lateral chest x-rays at the San Raffaele Hospital ED in Milan, more than a third were found to have thoracic vertebral fractures. And, those individuals were more than twice as likely to die as were those without vertebral fractures.

“Morphometric vertebral fractures are one of the most common comorbidities among adults hospitalized with COVID-19, and the presence of such fractures may predict the severity of disease outcomes,” lead investigator Andrea Giustina, MD, said in an interview.

This is the first study to examine vertebral fracture prevalence in any coronavirus disease, but such fractures have been linked to an increased risk of pneumonia and impaired respiratory function, including restrictive pulmonary dysfunction. One possible mechanism may be that they cause anatomical changes, such as kyphosis, which negatively impact respiratory function by decreasing vital capacity, forced expiratory volume in 1 second, and inspiratory time, explained Dr. Giustina, professor of endocrinology, San Raffaele Vita Salute University, Milan, and president of the European Society of Endocrinology. The results were published in the Journal of Clinical Endocrinology and Metabolism.

Clinically, the findings suggest that all patients with COVID-19 who are undergoing chest x-rays should have morphometric vertebral x-ray evaluation, said Dr. Giustina.

“One interesting aspect of the study is that without morphometry, approximatively two thirds of vertebral fractures [would have been] missed. Therefore, they are largely underestimated in clinical practice,” he noted.
 

Thoracic vertebral fractures assessed via lateral chest x-rays

The 114 study subjects included were those whose lateral chest x-rays allowed for a high-quality assessment and in which all the thoracic tract of T4-T12 were viewable and assessable. None had been using glucocorticoids and only 3% had a prior diagnosis of osteoporosis.

The majority (75%) were male, and median age was 57 years. Most (79%) were hospitalized after evaluation in the ED. Of those, 12% (13) were admitted to the ICU and 15% (16) died.

Thoracic vertebral fractures were detected on the lateral chest x-rays in 36% (41) of the patients. In contrast, in studies of women aged 50 years and older from the general European population, morphometric vertebral fracture prevalence ranged from 18% to 26%, the investigators noted.

Of the total 65 vertebral fractures detected, 60% were classified as mild (height ratio decrease <25%), 33.3% as moderate (25%-40% decrease) and 7.7% as severe (>40%). Patients with more than one vertebral fracture were classified by their most severe one.

Those with versus without vertebral fractures didn’t differ by sex, body mass index, or clinical or biological parameters evaluated in the ED. But, compared with those without vertebral fractures, those with them were significantly older (68 vs. 54 years) and were more likely to have arterial hypertension (56% vs. 30%) and coronary artery disease (22% vs. 7%).

In multivariate analysis, age was the only statistically significant predictor of vertebral fractures (odds ratio, 1.04; P < .001).

Mortality doubled, though not significantly

Those with vertebral fractures were more likely to be hospitalized, although not significantly (88% vs. 74%). There was no significant difference in ICU admission (11% vs. 12.5%).

However, those with vertebral fractures required noninvasive mechanical ventilation significantly more often (48.8% vs. 27.4%; P = .02), and were more than twice as likely to die (22% vs. 10%; P = .07). While the difference in overall mortality wasn’t quite statistically significant, those with severe vertebral fractures were significantly more likely to die, compared with those with mild or moderate fractures (60%, 7%, 24%, respectively, for severe, moderate, and mild; P = .04), despite no significant differences in clinical or laboratory parameters.

“Our data from the field reinforce the need of implementing previously published recommendations concerning the importance of bone fragility care during the COVID pandemic with at least those patients already treated with antiosteoporotic drugs maintaining their adherence to treatments including vitamin D, which have also been suggested very recently to have no relevant predisposing effect on COVID-19,” Dr. Giustina and colleagues wrote.

Moreover, they added, “continuity of care should also include bone density monitoring despite very restricted access to clinical facilities, during the COVID-19 pandemic. Finally, all patients with fractures should start antiresorptive treatment right away, even during hospital stay.”

The authors reported having no disclosures.

SOURCE: Giustina A et al. J Clin Endocrinol Metab. 2020 Oct 21. doi: 10.1210/clinem/dgaa738.