Almost half of obese endometrial cancer survivors in a recent study gained weight during 12 months of follow-up, whether or not they participated in a behavioral weight loss intervention.

Of 358 endometrial cancer survivors with a body mass index of at least 30 kg/m² who were approached for participation in the randomized ScaleDown trial, 80 participated and 278 declined. The results of that study, which compared a “high-tech” weight loss intervention to “enhanced usual care,” were reported last year (Gynecol Oncol. 2019 Jun;154[1]:20).

The goal of the ScaleDown trial was to identify a “better mechanism of weight loss encouragement for our patients,” said Abigail Zamorano, MD, of Washington University, St. Louis. “Unfortunately, we found that there was no difference in those two groups. It was rather disappointing.”

Dr. Zamorano and colleagues hypothesized that although the women who participated in the study failed to lose weight, perhaps they gained less weight than women who did not participate. Therefore, the researchers performed a retrospective study comparing the two groups.

The researchers reported results from this study in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
 

Retrospective results

At both 6 months and 12 months of follow-up, there were no significant differences between the ScaleDown participants and nonparticipants with respect to BMI change from baseline (P = .77 and P = .76, respectively).

“In essence, we unfortunately found no difference in BMI change in these two groups either,” Dr. Zamorano said.

At 12 months, rates of weight loss and weight gain were similar in ScaleDown participants and nonparticipants:

• 49.2% and 47%, respectively, gained weight.
• 13.9% and 23.2%, respectively, lost 0% to 2.5% of weight.
• 10.8% and 7.1%, respectively, lost 2.5% to 4% of weight.
• 3.1% and 4.8%, respectively, lost 4% to 5% of weight.
• 23.1% and 17.9%, respectively, lost 5% or more of weight.

Compared with participants, the nonparticipants were significantly more likely to be white and were older (63.4 years vs. 59.3 years), on more medications (median of 7 vs. 4), had a lower median BMI (39.1 kg/m² vs. 41.7 kg/m²), were more likely to have recurrent cancer (15.2% vs. 5.1%), and were less likely to have had genetic counseling (10.8% vs. 20%). There were no differences between the groups in cancer histology, stage, or receipt of initial chemotherapy or radiation therapy.
 

How can oncologists help patients lose weight?

“Overall, I would say that the findings for the primary endpoint were not particularly encouraging,” Dr. Zamorano said.

However, she said an important message emerged from some of the survey results: Patients were very frustrated with their weight loss journey. Many said that, despite having a desire to lose weight, they didn’t know how, and nothing seemed to work. This suggests that, with the right strategies, oncologists are in a position to help, Dr. Zamorano said.

“As their oncologists who see them really regularly for years and years, even after they’ve completed their primary cancer therapy ... we have a unique relationship with them,” she explained. “We have this very unique role that we can play, so we should think a little outside the box about how else we can help our patients potentially lose weight.”

It’s important to try because thousands of women are diagnosed with endometrial cancer in the United States each year, and although many will be “successfully treated from a cancer perspective because they are diagnosed at early stages,” they also can have significant comorbidities – most often obesity, Dr. Zamorano said.

“And in conjunction with that ... diabetes and cardiovascular disease,” she added. “That means they have very high risk of long-term complications of obesity, and even though we are addressing their cancer, we weren’t addressing those other complications.”

One potential solution is bariatric surgery. Weight loss surgery has been shown to improve health care outcomes and reduce mortality rates and costs, yet 89% of ScaleDown participants said they had never considered it, and 67% said they would decline a referral.

This suggests that, despite the available evidence of benefit in patients who are candidates, there is a knowledge gap in awareness of the effectiveness and safety of bariatric surgery in this population, Dr. Zamorano said.

“Given the obesity-related health problems that this population has, we should really address weight as part of the essential cancer management strategy rather than as an afterthought,” she said, adding that it should be incorporated at the start and should potentially include a referral to surgical weight loss.

Dr. Zamorano reported having no disclosures. The research was funded by Washington University.

sworcester@mdedge.com

SOURCE: Zamorano A et al. SGO 2020, Abstract 20.

Almost half of obese endometrial cancer survivors in a recent study gained weight during 12 months of follow-up, whether or not they participated in a behavioral weight loss intervention.

Of 358 endometrial cancer survivors with a body mass index of at least 30 kg/m² who were approached for participation in the randomized ScaleDown trial, 80 participated and 278 declined. The results of that study, which compared a “high-tech” weight loss intervention to “enhanced usual care,” were reported last year (Gynecol Oncol. 2019 Jun;154[1]:20).

The goal of the ScaleDown trial was to identify a “better mechanism of weight loss encouragement for our patients,” said Abigail Zamorano, MD, of Washington University, St. Louis. “Unfortunately, we found that there was no difference in those two groups. It was rather disappointing.”

Dr. Zamorano and colleagues hypothesized that although the women who participated in the study failed to lose weight, perhaps they gained less weight than women who did not participate. Therefore, the researchers performed a retrospective study comparing the two groups.

The researchers reported results from this study in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
 

Retrospective results

At both 6 months and 12 months of follow-up, there were no significant differences between the ScaleDown participants and nonparticipants with respect to BMI change from baseline (P = .77 and P = .76, respectively).

“In essence, we unfortunately found no difference in BMI change in these two groups either,” Dr. Zamorano said.

At 12 months, rates of weight loss and weight gain were similar in ScaleDown participants and nonparticipants:

• 49.2% and 47%, respectively, gained weight.
• 13.9% and 23.2%, respectively, lost 0% to 2.5% of weight.
• 10.8% and 7.1%, respectively, lost 2.5% to 4% of weight.
• 3.1% and 4.8%, respectively, lost 4% to 5% of weight.
• 23.1% and 17.9%, respectively, lost 5% or more of weight.

Compared with participants, the nonparticipants were significantly more likely to be white and were older (63.4 years vs. 59.3 years), on more medications (median of 7 vs. 4), had a lower median BMI (39.1 kg/m² vs. 41.7 kg/m²), were more likely to have recurrent cancer (15.2% vs. 5.1%), and were less likely to have had genetic counseling (10.8% vs. 20%). There were no differences between the groups in cancer histology, stage, or receipt of initial chemotherapy or radiation therapy.
 

How can oncologists help patients lose weight?

“Overall, I would say that the findings for the primary endpoint were not particularly encouraging,” Dr. Zamorano said.

However, she said an important message emerged from some of the survey results: Patients were very frustrated with their weight loss journey. Many said that, despite having a desire to lose weight, they didn’t know how, and nothing seemed to work. This suggests that, with the right strategies, oncologists are in a position to help, Dr. Zamorano said.

“As their oncologists who see them really regularly for years and years, even after they’ve completed their primary cancer therapy ... we have a unique relationship with them,” she explained. “We have this very unique role that we can play, so we should think a little outside the box about how else we can help our patients potentially lose weight.”

It’s important to try because thousands of women are diagnosed with endometrial cancer in the United States each year, and although many will be “successfully treated from a cancer perspective because they are diagnosed at early stages,” they also can have significant comorbidities – most often obesity, Dr. Zamorano said.

“And in conjunction with that ... diabetes and cardiovascular disease,” she added. “That means they have very high risk of long-term complications of obesity, and even though we are addressing their cancer, we weren’t addressing those other complications.”

One potential solution is bariatric surgery. Weight loss surgery has been shown to improve health care outcomes and reduce mortality rates and costs, yet 89% of ScaleDown participants said they had never considered it, and 67% said they would decline a referral.

This suggests that, despite the available evidence of benefit in patients who are candidates, there is a knowledge gap in awareness of the effectiveness and safety of bariatric surgery in this population, Dr. Zamorano said.

“Given the obesity-related health problems that this population has, we should really address weight as part of the essential cancer management strategy rather than as an afterthought,” she said, adding that it should be incorporated at the start and should potentially include a referral to surgical weight loss.

Dr. Zamorano reported having no disclosures. The research was funded by Washington University.

sworcester@mdedge.com

SOURCE: Zamorano A et al. SGO 2020, Abstract 20.

Almost half of obese endometrial cancer survivors in a recent study gained weight during 12 months of follow-up, whether or not they participated in a behavioral weight loss intervention.

Of 358 endometrial cancer survivors with a body mass index of at least 30 kg/m² who were approached for participation in the randomized ScaleDown trial, 80 participated and 278 declined. The results of that study, which compared a “high-tech” weight loss intervention to “enhanced usual care,” were reported last year (Gynecol Oncol. 2019 Jun;154[1]:20).

The goal of the ScaleDown trial was to identify a “better mechanism of weight loss encouragement for our patients,” said Abigail Zamorano, MD, of Washington University, St. Louis. “Unfortunately, we found that there was no difference in those two groups. It was rather disappointing.”

Dr. Zamorano and colleagues hypothesized that although the women who participated in the study failed to lose weight, perhaps they gained less weight than women who did not participate. Therefore, the researchers performed a retrospective study comparing the two groups.

The researchers reported results from this study in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
 

Retrospective results

At both 6 months and 12 months of follow-up, there were no significant differences between the ScaleDown participants and nonparticipants with respect to BMI change from baseline (P = .77 and P = .76, respectively).

“In essence, we unfortunately found no difference in BMI change in these two groups either,” Dr. Zamorano said.

At 12 months, rates of weight loss and weight gain were similar in ScaleDown participants and nonparticipants:

• 49.2% and 47%, respectively, gained weight.
• 13.9% and 23.2%, respectively, lost 0% to 2.5% of weight.
• 10.8% and 7.1%, respectively, lost 2.5% to 4% of weight.
• 3.1% and 4.8%, respectively, lost 4% to 5% of weight.
• 23.1% and 17.9%, respectively, lost 5% or more of weight.

Compared with participants, the nonparticipants were significantly more likely to be white and were older (63.4 years vs. 59.3 years), on more medications (median of 7 vs. 4), had a lower median BMI (39.1 kg/m² vs. 41.7 kg/m²), were more likely to have recurrent cancer (15.2% vs. 5.1%), and were less likely to have had genetic counseling (10.8% vs. 20%). There were no differences between the groups in cancer histology, stage, or receipt of initial chemotherapy or radiation therapy.
 

How can oncologists help patients lose weight?

“Overall, I would say that the findings for the primary endpoint were not particularly encouraging,” Dr. Zamorano said.

However, she said an important message emerged from some of the survey results: Patients were very frustrated with their weight loss journey. Many said that, despite having a desire to lose weight, they didn’t know how, and nothing seemed to work. This suggests that, with the right strategies, oncologists are in a position to help, Dr. Zamorano said.

“As their oncologists who see them really regularly for years and years, even after they’ve completed their primary cancer therapy ... we have a unique relationship with them,” she explained. “We have this very unique role that we can play, so we should think a little outside the box about how else we can help our patients potentially lose weight.”

It’s important to try because thousands of women are diagnosed with endometrial cancer in the United States each year, and although many will be “successfully treated from a cancer perspective because they are diagnosed at early stages,” they also can have significant comorbidities – most often obesity, Dr. Zamorano said.

“And in conjunction with that ... diabetes and cardiovascular disease,” she added. “That means they have very high risk of long-term complications of obesity, and even though we are addressing their cancer, we weren’t addressing those other complications.”

One potential solution is bariatric surgery. Weight loss surgery has been shown to improve health care outcomes and reduce mortality rates and costs, yet 89% of ScaleDown participants said they had never considered it, and 67% said they would decline a referral.

This suggests that, despite the available evidence of benefit in patients who are candidates, there is a knowledge gap in awareness of the effectiveness and safety of bariatric surgery in this population, Dr. Zamorano said.

“Given the obesity-related health problems that this population has, we should really address weight as part of the essential cancer management strategy rather than as an afterthought,” she said, adding that it should be incorporated at the start and should potentially include a referral to surgical weight loss.

Dr. Zamorano reported having no disclosures. The research was funded by Washington University.

sworcester@mdedge.com

SOURCE: Zamorano A et al. SGO 2020, Abstract 20.

For patients with inflammatory bowel disease or other immune-mediated inflammatory diseases, Janus kinase (JAK) inhibitors appear generally safe, though they may increase the risk of herpes zoster infection, according to a large-scale systematic review and meta-analysis.

Data from more than 66,000 patients revealed no significant links between JAK inhibitors and risks of serious infections, malignancy, or major adverse cardiovascular events, reported lead author Pablo Olivera, MD, of Centro de Educación Médica e Investigación Clínica (CEMIC) in Buenos Aires and colleagues.

“To the best of our knowledge, this is the first systematic review evaluating the risk profile of JAK inhibitors in a wide spectrum of immune-mediated inflammatory diseases,” they wrote in Gastroenterology.

The investigators drew studies from the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE from 1990 to 2019 and from conference databases from 2012 to 2018. Out of 973 studies identified, 82 were included in the final analysis, of which two-thirds were randomized clinical trials. In total, 101,925 subjects were included, of whom a majority had rheumatoid arthritis (n = 86,308), followed by psoriasis (n = 9,311), inflammatory bowel disease (n = 5,987), and ankylosing spondylitis (n = 319).

Meta-analysis of JAK inhibitor usage involved 66,159 patients. Four JAK inhibitors were included: tofacitinib, filgotinib, baricitinib, and upadacitinib. The primary outcomes were the incidence rates of adverse events and serious adverse events. The investigators also estimated incidence rates of herpes zoster infection, serious infections, mortality, malignancy, and major adverse cardiovascular events. These rates were compared with those of patients who received placebo or an active comparator in clinical trials.

Analysis showed that almost 9 out of 10 patients (87.16%) who were exposed to a JAK inhibitor received tofacitinib. The investigators described high variability in treatment duration and baseline characteristics of participants. Rates of adverse events and serious adverse events also fell across a broad spectrum, from 10% to 82% and from 0% to 29%, respectively.

“Most [adverse events] were mild, and included worsening of the underlying condition, probably showing lack of efficacy,” the investigators wrote.

Rates of mortality and most adverse events were not significantly associated with JAK inhibitor exposure. In contrast, relative risk of herpes zoster infection was 57% higher in patients who received a JAK inhibitor than in those who received a placebo or comparator (RR, 1.57; 95% confidence interval, 1.01-2.37).

“Regarding the risk of herpes zoster with JAK inhibitors, the largest evidence comes from the use of tofacitinib, but it appears to be a class effect, with a clear dose-dependent effect,” the investigators wrote.

Although risks of herpes zoster may be carried across the drug class, they may not be evenly distributed given that a subgroup analysis revealed that some JAK inhibitors may bring higher risks than others; specifically, tofacitinib and baricitinib were associated with higher relative risks of herpes zoster than were upadacitinib and filgotinib.

“Although this is merely a qualitative comparison, this difference could be related to the fact that both filgotinib and upadacitinib are selective JAK1 inhibitors, whereas tofacitinib is a JAK1/JAK3 inhibitor and baricitinib a JAK1/JAK2 inhibitor,” the investigators wrote. “Further studies are needed to determine if JAK isoform selectivity affects the risk of herpes zoster.”

The investigators emphasized this need for more research. While the present findings help illuminate the safety profile of JAK inhibitors, they are clouded by various other factors, such as disease-specific considerations, a lack of real-world data, and studies that are likely too short to accurately determine risk of malignancy, the investigators wrote.

“More studies with long follow-up and in the real world setting, in different conditions, will be needed to fully elucidate the safety profile of the different JAK inhibitors,” the investigators concluded.

The investigators disclosed relationships with AbbVie, Takeda, Pfizer, and others.

SOURCE: Olivera P et al. Gastroenterology. 2020 Jan 8. doi: 10.1053/j.gastro.2020.01.001.

For patients with inflammatory bowel disease or other immune-mediated inflammatory diseases, Janus kinase (JAK) inhibitors appear generally safe, though they may increase the risk of herpes zoster infection, according to a large-scale systematic review and meta-analysis.

Data from more than 66,000 patients revealed no significant links between JAK inhibitors and risks of serious infections, malignancy, or major adverse cardiovascular events, reported lead author Pablo Olivera, MD, of Centro de Educación Médica e Investigación Clínica (CEMIC) in Buenos Aires and colleagues.

“To the best of our knowledge, this is the first systematic review evaluating the risk profile of JAK inhibitors in a wide spectrum of immune-mediated inflammatory diseases,” they wrote in Gastroenterology.

The investigators drew studies from the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE from 1990 to 2019 and from conference databases from 2012 to 2018. Out of 973 studies identified, 82 were included in the final analysis, of which two-thirds were randomized clinical trials. In total, 101,925 subjects were included, of whom a majority had rheumatoid arthritis (n = 86,308), followed by psoriasis (n = 9,311), inflammatory bowel disease (n = 5,987), and ankylosing spondylitis (n = 319).

Meta-analysis of JAK inhibitor usage involved 66,159 patients. Four JAK inhibitors were included: tofacitinib, filgotinib, baricitinib, and upadacitinib. The primary outcomes were the incidence rates of adverse events and serious adverse events. The investigators also estimated incidence rates of herpes zoster infection, serious infections, mortality, malignancy, and major adverse cardiovascular events. These rates were compared with those of patients who received placebo or an active comparator in clinical trials.

Analysis showed that almost 9 out of 10 patients (87.16%) who were exposed to a JAK inhibitor received tofacitinib. The investigators described high variability in treatment duration and baseline characteristics of participants. Rates of adverse events and serious adverse events also fell across a broad spectrum, from 10% to 82% and from 0% to 29%, respectively.

“Most [adverse events] were mild, and included worsening of the underlying condition, probably showing lack of efficacy,” the investigators wrote.

Rates of mortality and most adverse events were not significantly associated with JAK inhibitor exposure. In contrast, relative risk of herpes zoster infection was 57% higher in patients who received a JAK inhibitor than in those who received a placebo or comparator (RR, 1.57; 95% confidence interval, 1.01-2.37).

“Regarding the risk of herpes zoster with JAK inhibitors, the largest evidence comes from the use of tofacitinib, but it appears to be a class effect, with a clear dose-dependent effect,” the investigators wrote.

Although risks of herpes zoster may be carried across the drug class, they may not be evenly distributed given that a subgroup analysis revealed that some JAK inhibitors may bring higher risks than others; specifically, tofacitinib and baricitinib were associated with higher relative risks of herpes zoster than were upadacitinib and filgotinib.

“Although this is merely a qualitative comparison, this difference could be related to the fact that both filgotinib and upadacitinib are selective JAK1 inhibitors, whereas tofacitinib is a JAK1/JAK3 inhibitor and baricitinib a JAK1/JAK2 inhibitor,” the investigators wrote. “Further studies are needed to determine if JAK isoform selectivity affects the risk of herpes zoster.”

The investigators emphasized this need for more research. While the present findings help illuminate the safety profile of JAK inhibitors, they are clouded by various other factors, such as disease-specific considerations, a lack of real-world data, and studies that are likely too short to accurately determine risk of malignancy, the investigators wrote.

“More studies with long follow-up and in the real world setting, in different conditions, will be needed to fully elucidate the safety profile of the different JAK inhibitors,” the investigators concluded.

The investigators disclosed relationships with AbbVie, Takeda, Pfizer, and others.

SOURCE: Olivera P et al. Gastroenterology. 2020 Jan 8. doi: 10.1053/j.gastro.2020.01.001.

For patients with inflammatory bowel disease or other immune-mediated inflammatory diseases, Janus kinase (JAK) inhibitors appear generally safe, though they may increase the risk of herpes zoster infection, according to a large-scale systematic review and meta-analysis.

Data from more than 66,000 patients revealed no significant links between JAK inhibitors and risks of serious infections, malignancy, or major adverse cardiovascular events, reported lead author Pablo Olivera, MD, of Centro de Educación Médica e Investigación Clínica (CEMIC) in Buenos Aires and colleagues.

“To the best of our knowledge, this is the first systematic review evaluating the risk profile of JAK inhibitors in a wide spectrum of immune-mediated inflammatory diseases,” they wrote in Gastroenterology.

The investigators drew studies from the Cochrane Central Register of Controlled Trials, MEDLINE, and EMBASE from 1990 to 2019 and from conference databases from 2012 to 2018. Out of 973 studies identified, 82 were included in the final analysis, of which two-thirds were randomized clinical trials. In total, 101,925 subjects were included, of whom a majority had rheumatoid arthritis (n = 86,308), followed by psoriasis (n = 9,311), inflammatory bowel disease (n = 5,987), and ankylosing spondylitis (n = 319).

Meta-analysis of JAK inhibitor usage involved 66,159 patients. Four JAK inhibitors were included: tofacitinib, filgotinib, baricitinib, and upadacitinib. The primary outcomes were the incidence rates of adverse events and serious adverse events. The investigators also estimated incidence rates of herpes zoster infection, serious infections, mortality, malignancy, and major adverse cardiovascular events. These rates were compared with those of patients who received placebo or an active comparator in clinical trials.

Analysis showed that almost 9 out of 10 patients (87.16%) who were exposed to a JAK inhibitor received tofacitinib. The investigators described high variability in treatment duration and baseline characteristics of participants. Rates of adverse events and serious adverse events also fell across a broad spectrum, from 10% to 82% and from 0% to 29%, respectively.

“Most [adverse events] were mild, and included worsening of the underlying condition, probably showing lack of efficacy,” the investigators wrote.

Rates of mortality and most adverse events were not significantly associated with JAK inhibitor exposure. In contrast, relative risk of herpes zoster infection was 57% higher in patients who received a JAK inhibitor than in those who received a placebo or comparator (RR, 1.57; 95% confidence interval, 1.01-2.37).

“Regarding the risk of herpes zoster with JAK inhibitors, the largest evidence comes from the use of tofacitinib, but it appears to be a class effect, with a clear dose-dependent effect,” the investigators wrote.

Although risks of herpes zoster may be carried across the drug class, they may not be evenly distributed given that a subgroup analysis revealed that some JAK inhibitors may bring higher risks than others; specifically, tofacitinib and baricitinib were associated with higher relative risks of herpes zoster than were upadacitinib and filgotinib.

“Although this is merely a qualitative comparison, this difference could be related to the fact that both filgotinib and upadacitinib are selective JAK1 inhibitors, whereas tofacitinib is a JAK1/JAK3 inhibitor and baricitinib a JAK1/JAK2 inhibitor,” the investigators wrote. “Further studies are needed to determine if JAK isoform selectivity affects the risk of herpes zoster.”

The investigators emphasized this need for more research. While the present findings help illuminate the safety profile of JAK inhibitors, they are clouded by various other factors, such as disease-specific considerations, a lack of real-world data, and studies that are likely too short to accurately determine risk of malignancy, the investigators wrote.

“More studies with long follow-up and in the real world setting, in different conditions, will be needed to fully elucidate the safety profile of the different JAK inhibitors,” the investigators concluded.

The investigators disclosed relationships with AbbVie, Takeda, Pfizer, and others.

SOURCE: Olivera P et al. Gastroenterology. 2020 Jan 8. doi: 10.1053/j.gastro.2020.01.001.

The Food and Drug Administration has approved nearly two dozen tests for the novel coronavirus through its Emergency Use Authorization (EUA) policy, according to the Infectious Diseases Society of America (IDSA).

“Based on what we know about influenza, it’s unlikely that all of these tests are going to perform exactly the same way,” said Angela M. Caliendo, MD, executive vice chair of the department of medicine at Brown University in Providence, R.I., at a press briefing. Although these tests are good, no test is perfect, she added.

The development and availability of testing has improved over time, but clinical laboratories still face challenges, said Kimberly E. Hanson, MD, associate professor of internal medicine at University of Utah, Salt Lake City. These challenges include shortages of devices for specimen collection, media, test tubes, and reagents. Although the goal is to test all symptomatic patients, these shortages require laboratories to prioritize health care workers and the sickest patients.
 

Tests are being approved through an abbreviated process

Two types of test, rapid tests and serology tests, are in use. Rapid tests use polymerase chain reactions to detect the virus in a clinical specimen. This type of testing is used to diagnose infection. Serology tests measure antibodies to the virus and are more appropriate for indicating whether a patient has been exposed to the virus.

The declaration of a national emergency enabled the FDA to activate its EUA policy, which allows for quicker approval of tests. Normally, a test must be assessed in the laboratory (such as with a mock specimen or an inactivated virus) and in a clinical study of patients. Under the EUA, clinical assessment is not required for the approval of a test. Consequently, the clinical performance of a test approved under EUA is unknown.

Collecting a specimen of good quality is critical to the quality of the test result, said Dr. Caliendo, the secretary of IDSA’s board of directors. Clinicians and investigators have used nasopharyngeal swabs, sputum, and specimens collected from deep within the lung. “We’re still collecting data to determine which is the best specimen type.” As coronavirus testing expands, particularly to drive-through testing sites, “we may be using people who are not as experienced, and so you might not get as high a quality specimen in that situation,” Dr. Caliendo added.

The timing of the test influences the quality of the result, as well, because the amount of virus is lower at the onset of symptoms than it is later. Another factor that affects the quality of the results is the test’s sensitivity.
 

The time to obtain results varies

The value of having several tests available is that it enables many patients to be tested simultaneously, said Dr. Hanson, a member of IDSA’s board of directors. It also helps to reduce potential problems with the supply of test kits. A test manufacturer, however, may supply parts of the test kit but not the whole kit. This requires the hospital or laboratory to obtain the remaining parts from other suppliers. Furthermore, test manufacturers may need to prioritize areas with high rates of infection or transmission when they ship their tests, which limits testing in other areas.

One reason for the lack of a national plan for testing is that the virus has affected different regions at different times, said Dr. Caliendo. Some tests are more difficult to perform than others, and not all laboratories are equally sophisticated, which can limit testing. It is necessary to test not only symptomatic patients who have been hospitalized, but also symptomatic patients in the community, said Dr. Caliendo. “Ideally, we’re going to need to couple acute diagnostics [testing while people are sick] with serologic testing. Serologic testing is going to be important for us to see who has been infected. That will give us an idea of who is left in our community who is at risk for developing infection.”

How quickly test results are available depends on the type of test and where it is administered. Recently established drive-through clinics can provide results in about 30 minutes. Tests performed in hospitals may take between 1 and 6 hours to yield results. “The issue is, do we have reagents that day?” said Dr. Caliendo. “We have to be careful whom we choose to test, and we screen that in the hospital so that we have enough tests to run as we need them.” But many locations have backlogs. “When you have a backlog of testing, you’re going to wait days, unfortunately, to get a result,” said Dr. Caliendo.

Dr. Caliendo and Dr. Hanson did not report disclosures for this briefing.

egreb@mdedge.com

The Food and Drug Administration has approved nearly two dozen tests for the novel coronavirus through its Emergency Use Authorization (EUA) policy, according to the Infectious Diseases Society of America (IDSA).

“Based on what we know about influenza, it’s unlikely that all of these tests are going to perform exactly the same way,” said Angela M. Caliendo, MD, executive vice chair of the department of medicine at Brown University in Providence, R.I., at a press briefing. Although these tests are good, no test is perfect, she added.

The development and availability of testing has improved over time, but clinical laboratories still face challenges, said Kimberly E. Hanson, MD, associate professor of internal medicine at University of Utah, Salt Lake City. These challenges include shortages of devices for specimen collection, media, test tubes, and reagents. Although the goal is to test all symptomatic patients, these shortages require laboratories to prioritize health care workers and the sickest patients.
 

Tests are being approved through an abbreviated process

Two types of test, rapid tests and serology tests, are in use. Rapid tests use polymerase chain reactions to detect the virus in a clinical specimen. This type of testing is used to diagnose infection. Serology tests measure antibodies to the virus and are more appropriate for indicating whether a patient has been exposed to the virus.

The declaration of a national emergency enabled the FDA to activate its EUA policy, which allows for quicker approval of tests. Normally, a test must be assessed in the laboratory (such as with a mock specimen or an inactivated virus) and in a clinical study of patients. Under the EUA, clinical assessment is not required for the approval of a test. Consequently, the clinical performance of a test approved under EUA is unknown.

Collecting a specimen of good quality is critical to the quality of the test result, said Dr. Caliendo, the secretary of IDSA’s board of directors. Clinicians and investigators have used nasopharyngeal swabs, sputum, and specimens collected from deep within the lung. “We’re still collecting data to determine which is the best specimen type.” As coronavirus testing expands, particularly to drive-through testing sites, “we may be using people who are not as experienced, and so you might not get as high a quality specimen in that situation,” Dr. Caliendo added.

The timing of the test influences the quality of the result, as well, because the amount of virus is lower at the onset of symptoms than it is later. Another factor that affects the quality of the results is the test’s sensitivity.
 

The time to obtain results varies

The value of having several tests available is that it enables many patients to be tested simultaneously, said Dr. Hanson, a member of IDSA’s board of directors. It also helps to reduce potential problems with the supply of test kits. A test manufacturer, however, may supply parts of the test kit but not the whole kit. This requires the hospital or laboratory to obtain the remaining parts from other suppliers. Furthermore, test manufacturers may need to prioritize areas with high rates of infection or transmission when they ship their tests, which limits testing in other areas.

One reason for the lack of a national plan for testing is that the virus has affected different regions at different times, said Dr. Caliendo. Some tests are more difficult to perform than others, and not all laboratories are equally sophisticated, which can limit testing. It is necessary to test not only symptomatic patients who have been hospitalized, but also symptomatic patients in the community, said Dr. Caliendo. “Ideally, we’re going to need to couple acute diagnostics [testing while people are sick] with serologic testing. Serologic testing is going to be important for us to see who has been infected. That will give us an idea of who is left in our community who is at risk for developing infection.”

How quickly test results are available depends on the type of test and where it is administered. Recently established drive-through clinics can provide results in about 30 minutes. Tests performed in hospitals may take between 1 and 6 hours to yield results. “The issue is, do we have reagents that day?” said Dr. Caliendo. “We have to be careful whom we choose to test, and we screen that in the hospital so that we have enough tests to run as we need them.” But many locations have backlogs. “When you have a backlog of testing, you’re going to wait days, unfortunately, to get a result,” said Dr. Caliendo.

Dr. Caliendo and Dr. Hanson did not report disclosures for this briefing.

egreb@mdedge.com

The Food and Drug Administration has approved nearly two dozen tests for the novel coronavirus through its Emergency Use Authorization (EUA) policy, according to the Infectious Diseases Society of America (IDSA).

“Based on what we know about influenza, it’s unlikely that all of these tests are going to perform exactly the same way,” said Angela M. Caliendo, MD, executive vice chair of the department of medicine at Brown University in Providence, R.I., at a press briefing. Although these tests are good, no test is perfect, she added.

The development and availability of testing has improved over time, but clinical laboratories still face challenges, said Kimberly E. Hanson, MD, associate professor of internal medicine at University of Utah, Salt Lake City. These challenges include shortages of devices for specimen collection, media, test tubes, and reagents. Although the goal is to test all symptomatic patients, these shortages require laboratories to prioritize health care workers and the sickest patients.
 

Tests are being approved through an abbreviated process

Two types of test, rapid tests and serology tests, are in use. Rapid tests use polymerase chain reactions to detect the virus in a clinical specimen. This type of testing is used to diagnose infection. Serology tests measure antibodies to the virus and are more appropriate for indicating whether a patient has been exposed to the virus.

The declaration of a national emergency enabled the FDA to activate its EUA policy, which allows for quicker approval of tests. Normally, a test must be assessed in the laboratory (such as with a mock specimen or an inactivated virus) and in a clinical study of patients. Under the EUA, clinical assessment is not required for the approval of a test. Consequently, the clinical performance of a test approved under EUA is unknown.

Collecting a specimen of good quality is critical to the quality of the test result, said Dr. Caliendo, the secretary of IDSA’s board of directors. Clinicians and investigators have used nasopharyngeal swabs, sputum, and specimens collected from deep within the lung. “We’re still collecting data to determine which is the best specimen type.” As coronavirus testing expands, particularly to drive-through testing sites, “we may be using people who are not as experienced, and so you might not get as high a quality specimen in that situation,” Dr. Caliendo added.

The timing of the test influences the quality of the result, as well, because the amount of virus is lower at the onset of symptoms than it is later. Another factor that affects the quality of the results is the test’s sensitivity.
 

The time to obtain results varies

The value of having several tests available is that it enables many patients to be tested simultaneously, said Dr. Hanson, a member of IDSA’s board of directors. It also helps to reduce potential problems with the supply of test kits. A test manufacturer, however, may supply parts of the test kit but not the whole kit. This requires the hospital or laboratory to obtain the remaining parts from other suppliers. Furthermore, test manufacturers may need to prioritize areas with high rates of infection or transmission when they ship their tests, which limits testing in other areas.

One reason for the lack of a national plan for testing is that the virus has affected different regions at different times, said Dr. Caliendo. Some tests are more difficult to perform than others, and not all laboratories are equally sophisticated, which can limit testing. It is necessary to test not only symptomatic patients who have been hospitalized, but also symptomatic patients in the community, said Dr. Caliendo. “Ideally, we’re going to need to couple acute diagnostics [testing while people are sick] with serologic testing. Serologic testing is going to be important for us to see who has been infected. That will give us an idea of who is left in our community who is at risk for developing infection.”

How quickly test results are available depends on the type of test and where it is administered. Recently established drive-through clinics can provide results in about 30 minutes. Tests performed in hospitals may take between 1 and 6 hours to yield results. “The issue is, do we have reagents that day?” said Dr. Caliendo. “We have to be careful whom we choose to test, and we screen that in the hospital so that we have enough tests to run as we need them.” But many locations have backlogs. “When you have a backlog of testing, you’re going to wait days, unfortunately, to get a result,” said Dr. Caliendo.

Dr. Caliendo and Dr. Hanson did not report disclosures for this briefing.

egreb@mdedge.com

Patients who experience a rapid response to cognitive processing therapy (CPT) for posttraumatic stress disorder have a greater likelihood of sustained improvement, new research suggests.

A study of 136 veterans with PTSD showed that those who responded quickly to a 3-week CPT program were significantly more likely to report lower symptom scores 3 months post treatment, compared with those participants who responded more slowly.

The results add to previous evidence that intensified, short-term treatment programs can accomplish long-term benefits, noted the investigators, led by Jenna Bagley, Rush University Medical Center, Chicago.

“These findings show promise for the success of condensed evidence-based, trauma-focused interventions,” they added.

Ms. Bagley was scheduled to present the study in March at the Anxiety and Depression Association of America (ADAA) Conference 2020. That conference was canceled because of the coronavirus pandemic.
 

Reducing high dropout rates

PTSD treatments such as CPT and prolonged exposure have been shown to have high efficacy, but they also have been shown to have a nearly 40% dropout rate, the researchers note.

This problem has prompted a focus on shorter-term interventions that can deliver intensified treatment before participants drop out. However, evidence has been lacking as to the sustainability of symptom improvements that occur in a short period.

The researchers evaluated data on 136 veterans (66% men; mean age, 41 years) with PTSD who completed a non–Veterans Affairs, 3-week CPT-based intensive treatment program. Follow-up assessments were carried out at 3 months.

Symptom reduction rates represented the number of days from intake in the program to the first day a reduction was reported of at least 15 points on the PTSD Checklist for DSM-5 (PCL-5), which was indicative of a clinically meaningful improvement.

Results showed the longer that participants took to achieve a 15-point reduction from baseline on the PCL-5, the higher their PCL-5 score at the 3-month follow-up, representing greater ongoing symptoms (P = .04).

The amount of time to reach the 15-point reduction also predicted symptom reductions at the 3-month follow-up, even when controlling for the total change in PCL-5 score during the program (P = .03) and when controlling for type of trauma, such as combat or military sexual trauma.

Another puzzle piece?

Commenting on the study, David C. Rozek, PhD, assistant professor at the University of Central Florida, Orlando, said the findings are encouraging, particularly in terms of improvements seen with shorter treatment programs.

“Sudden gains are important to look at in all treatments,” said Dr. Rozek, who was not involved with the research.

“Seeing that these sudden gains occur in intensive treatment and predict long-term outcome provides another piece of the puzzle and provides additional support to intensive treatments,” he added.

Dr. Rozek noted that he has also observed this with patients. However, they, along with mental health practitioners, often question whether short-term improvements will last.

“There is some concern that a rapid drop in a patient’s symptoms could be an increased risk for a rebound,” he said.

“However, that is when the skills learned in therapy can kick in and provide [patients] tools to use in their everyday life and to help continue recovering,” he added.

Dr. Rozek was scheduled to report results from a pilot study on his own experience at the canceled ADAA meeting. The study was about an even shorter, 7-day intensive CPT program (CPT-7) conducted through the National Center for Veterans Studies.

The program involved one daily individual CPT-7 session with a mental health provider in the morning followed by optional group recreational activities in the afternoon. Twelve military personnel in two cohorts with either PTSD or subthreshold PTSD, defined as having all but one symptom cluster present, were included in the study.

Keep patients engaged

Preliminary results showed reductions in PCL-5 scores from pre- to posttreatment of approximately 40% (P < .001).

“Just over 50% of patients left [the program] with symptoms below probable PTSD diagnosis on a self-report measure,” Dr. Rozek said.

Importantly, none of the participants dropped out of the treatment, but Dr. Rozek said that this was not necessarily surprising because of the nature of the program.

“These patients are brought in as a cohort and form some bonds, as they all have experienced traumatic events, although often [they have had] very different traumas,” he said.

“We’ve found that by doing daily treatment, it is more accessible and removes barriers, as it is often easier to take a week or a few weeks off at a time and participate in treatment than the logistics of weekly treatment,” he added.

Dr. Rozek said he suspects two key factors may predict treatment response in such programs – cognitive flexibility and emotion regulation.

“Patients who come into treatment and are extremely rigid in their thinking and are unable to manage their emotions may be slower to respond to treatment,” he noted.

“That being said, there are a variety of treatments that target these factors in different ways. Now we need to do the work to determine which treatments work for whom.”

The findings on longer-term durability of rapid improvement bode well for the program. “Although the work in treatment is hard, they patients really start to see the gains quickly, within a week or weeks instead of months,” Dr. Rozek said.

“This is rewarding in itself, and I would say is a strong factor for keeping patients engaged,” he concluded.

Dr. Rozek has received research funding from the National Institutes of Health, the Department of Defense, the Bob Woodruff Foundation, and the Boeing Corporation.
 

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

Patients who experience a rapid response to cognitive processing therapy (CPT) for posttraumatic stress disorder have a greater likelihood of sustained improvement, new research suggests.

A study of 136 veterans with PTSD showed that those who responded quickly to a 3-week CPT program were significantly more likely to report lower symptom scores 3 months post treatment, compared with those participants who responded more slowly.

The results add to previous evidence that intensified, short-term treatment programs can accomplish long-term benefits, noted the investigators, led by Jenna Bagley, Rush University Medical Center, Chicago.

“These findings show promise for the success of condensed evidence-based, trauma-focused interventions,” they added.

Ms. Bagley was scheduled to present the study in March at the Anxiety and Depression Association of America (ADAA) Conference 2020. That conference was canceled because of the coronavirus pandemic.
 

Reducing high dropout rates

PTSD treatments such as CPT and prolonged exposure have been shown to have high efficacy, but they also have been shown to have a nearly 40% dropout rate, the researchers note.

This problem has prompted a focus on shorter-term interventions that can deliver intensified treatment before participants drop out. However, evidence has been lacking as to the sustainability of symptom improvements that occur in a short period.

The researchers evaluated data on 136 veterans (66% men; mean age, 41 years) with PTSD who completed a non–Veterans Affairs, 3-week CPT-based intensive treatment program. Follow-up assessments were carried out at 3 months.

Symptom reduction rates represented the number of days from intake in the program to the first day a reduction was reported of at least 15 points on the PTSD Checklist for DSM-5 (PCL-5), which was indicative of a clinically meaningful improvement.

Results showed the longer that participants took to achieve a 15-point reduction from baseline on the PCL-5, the higher their PCL-5 score at the 3-month follow-up, representing greater ongoing symptoms (P = .04).

The amount of time to reach the 15-point reduction also predicted symptom reductions at the 3-month follow-up, even when controlling for the total change in PCL-5 score during the program (P = .03) and when controlling for type of trauma, such as combat or military sexual trauma.

Another puzzle piece?

Commenting on the study, David C. Rozek, PhD, assistant professor at the University of Central Florida, Orlando, said the findings are encouraging, particularly in terms of improvements seen with shorter treatment programs.

“Sudden gains are important to look at in all treatments,” said Dr. Rozek, who was not involved with the research.

“Seeing that these sudden gains occur in intensive treatment and predict long-term outcome provides another piece of the puzzle and provides additional support to intensive treatments,” he added.

Dr. Rozek noted that he has also observed this with patients. However, they, along with mental health practitioners, often question whether short-term improvements will last.

“There is some concern that a rapid drop in a patient’s symptoms could be an increased risk for a rebound,” he said.

“However, that is when the skills learned in therapy can kick in and provide [patients] tools to use in their everyday life and to help continue recovering,” he added.

Dr. Rozek was scheduled to report results from a pilot study on his own experience at the canceled ADAA meeting. The study was about an even shorter, 7-day intensive CPT program (CPT-7) conducted through the National Center for Veterans Studies.

The program involved one daily individual CPT-7 session with a mental health provider in the morning followed by optional group recreational activities in the afternoon. Twelve military personnel in two cohorts with either PTSD or subthreshold PTSD, defined as having all but one symptom cluster present, were included in the study.

Keep patients engaged

Preliminary results showed reductions in PCL-5 scores from pre- to posttreatment of approximately 40% (P < .001).

“Just over 50% of patients left [the program] with symptoms below probable PTSD diagnosis on a self-report measure,” Dr. Rozek said.

Importantly, none of the participants dropped out of the treatment, but Dr. Rozek said that this was not necessarily surprising because of the nature of the program.

“These patients are brought in as a cohort and form some bonds, as they all have experienced traumatic events, although often [they have had] very different traumas,” he said.

“We’ve found that by doing daily treatment, it is more accessible and removes barriers, as it is often easier to take a week or a few weeks off at a time and participate in treatment than the logistics of weekly treatment,” he added.

Dr. Rozek said he suspects two key factors may predict treatment response in such programs – cognitive flexibility and emotion regulation.

“Patients who come into treatment and are extremely rigid in their thinking and are unable to manage their emotions may be slower to respond to treatment,” he noted.

“That being said, there are a variety of treatments that target these factors in different ways. Now we need to do the work to determine which treatments work for whom.”

The findings on longer-term durability of rapid improvement bode well for the program. “Although the work in treatment is hard, they patients really start to see the gains quickly, within a week or weeks instead of months,” Dr. Rozek said.

“This is rewarding in itself, and I would say is a strong factor for keeping patients engaged,” he concluded.

Dr. Rozek has received research funding from the National Institutes of Health, the Department of Defense, the Bob Woodruff Foundation, and the Boeing Corporation.
 

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

Patients who experience a rapid response to cognitive processing therapy (CPT) for posttraumatic stress disorder have a greater likelihood of sustained improvement, new research suggests.

A study of 136 veterans with PTSD showed that those who responded quickly to a 3-week CPT program were significantly more likely to report lower symptom scores 3 months post treatment, compared with those participants who responded more slowly.

The results add to previous evidence that intensified, short-term treatment programs can accomplish long-term benefits, noted the investigators, led by Jenna Bagley, Rush University Medical Center, Chicago.

“These findings show promise for the success of condensed evidence-based, trauma-focused interventions,” they added.

Ms. Bagley was scheduled to present the study in March at the Anxiety and Depression Association of America (ADAA) Conference 2020. That conference was canceled because of the coronavirus pandemic.
 

Reducing high dropout rates

PTSD treatments such as CPT and prolonged exposure have been shown to have high efficacy, but they also have been shown to have a nearly 40% dropout rate, the researchers note.

This problem has prompted a focus on shorter-term interventions that can deliver intensified treatment before participants drop out. However, evidence has been lacking as to the sustainability of symptom improvements that occur in a short period.

The researchers evaluated data on 136 veterans (66% men; mean age, 41 years) with PTSD who completed a non–Veterans Affairs, 3-week CPT-based intensive treatment program. Follow-up assessments were carried out at 3 months.

Symptom reduction rates represented the number of days from intake in the program to the first day a reduction was reported of at least 15 points on the PTSD Checklist for DSM-5 (PCL-5), which was indicative of a clinically meaningful improvement.

Results showed the longer that participants took to achieve a 15-point reduction from baseline on the PCL-5, the higher their PCL-5 score at the 3-month follow-up, representing greater ongoing symptoms (P = .04).

The amount of time to reach the 15-point reduction also predicted symptom reductions at the 3-month follow-up, even when controlling for the total change in PCL-5 score during the program (P = .03) and when controlling for type of trauma, such as combat or military sexual trauma.

Another puzzle piece?

Commenting on the study, David C. Rozek, PhD, assistant professor at the University of Central Florida, Orlando, said the findings are encouraging, particularly in terms of improvements seen with shorter treatment programs.

“Sudden gains are important to look at in all treatments,” said Dr. Rozek, who was not involved with the research.

“Seeing that these sudden gains occur in intensive treatment and predict long-term outcome provides another piece of the puzzle and provides additional support to intensive treatments,” he added.

Dr. Rozek noted that he has also observed this with patients. However, they, along with mental health practitioners, often question whether short-term improvements will last.

“There is some concern that a rapid drop in a patient’s symptoms could be an increased risk for a rebound,” he said.

“However, that is when the skills learned in therapy can kick in and provide [patients] tools to use in their everyday life and to help continue recovering,” he added.

Dr. Rozek was scheduled to report results from a pilot study on his own experience at the canceled ADAA meeting. The study was about an even shorter, 7-day intensive CPT program (CPT-7) conducted through the National Center for Veterans Studies.

The program involved one daily individual CPT-7 session with a mental health provider in the morning followed by optional group recreational activities in the afternoon. Twelve military personnel in two cohorts with either PTSD or subthreshold PTSD, defined as having all but one symptom cluster present, were included in the study.

Keep patients engaged

Preliminary results showed reductions in PCL-5 scores from pre- to posttreatment of approximately 40% (P < .001).

“Just over 50% of patients left [the program] with symptoms below probable PTSD diagnosis on a self-report measure,” Dr. Rozek said.

Importantly, none of the participants dropped out of the treatment, but Dr. Rozek said that this was not necessarily surprising because of the nature of the program.

“These patients are brought in as a cohort and form some bonds, as they all have experienced traumatic events, although often [they have had] very different traumas,” he said.

“We’ve found that by doing daily treatment, it is more accessible and removes barriers, as it is often easier to take a week or a few weeks off at a time and participate in treatment than the logistics of weekly treatment,” he added.

Dr. Rozek said he suspects two key factors may predict treatment response in such programs – cognitive flexibility and emotion regulation.

“Patients who come into treatment and are extremely rigid in their thinking and are unable to manage their emotions may be slower to respond to treatment,” he noted.

“That being said, there are a variety of treatments that target these factors in different ways. Now we need to do the work to determine which treatments work for whom.”

The findings on longer-term durability of rapid improvement bode well for the program. “Although the work in treatment is hard, they patients really start to see the gains quickly, within a week or weeks instead of months,” Dr. Rozek said.

“This is rewarding in itself, and I would say is a strong factor for keeping patients engaged,” he concluded.

Dr. Rozek has received research funding from the National Institutes of Health, the Department of Defense, the Bob Woodruff Foundation, and the Boeing Corporation.
 

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

A large amount of data suggest that mild or severe cytokine storms, accompanied by high expression of interleukin-6 (IL-6), occur in patients with severe coronavirus disease and can be an important cause of death. Blocking the signal transduction pathway of IL-6 is expected to become a new method for the treatment of patients with severe COVID-19, with the IL-6 inhibitor, tocilizumab (Actemra), poised to become an effective drug for these patients, according to the authors of a review published online in the International Journal of Antimicrobial Agents.

Courtesy NIAID-RML

The reviewers from China detailed the metabolic pathways and regulation of cytokine release syndrome, especially with respect to what is known about severe COVID-19, and discussed the results of recent trials with tocilizumab, which is currently used for treatment of CRS in a variety of cancers and other metabolic disorders.

Tocilizumab is a recombinant humanized monoclonal antibody against human IL-6 receptor of immunoglobulin IgG1 subtype and has been approved for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis. The antibody specifically binds soluble- and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits sIL-6R– and mIL-6R–mediated signal transduction. It has been shown to be effective in the treatment of severe CRS patients. In 2017, the U.S. Food and Drug Administration approved tocilizumab for the treatment of CRS caused by CAR-T (chimeric antigen receptor T-cell immunotherapy) therapy.

A small clinical trial in China examined the effectiveness of tocilizumab in 21 patients who met the criteria for severe or critical COVID-19, including respiratory failure requiring mechanical ventilation, shock, or admission to the ICU with other organ failure. After a few days of tocilizumab treatment, the body temperatures returned to normal (initially, all 21 patients had fevers), and all other symptoms were significantly improved, according to the authors. A total of 75% (15/20) of the patients reduced their oxygen intake, and 1 patient did not need oxygen. CT scanning showed that 90.5% (19/21) of the patients had absorption of pulmonary lesions, and lab tests showed that the proportion of peripheral blood lymphocytes and C-reactive protein in the patients returned to normal.

The main deficiency of the study was that only the level of IL-6 in peripheral blood before treatment with tocilizumab was reported (mean value, 132.38 ± 278.54 pg/mL), but the level of IL-6 following treatment was not given, according to the reviewers. Serum levels of IL-6 in normal patients are undetectable or very low.

Based upon their analysis of COVID-19’s possible mechanism and the small samples of clinical data available, tocilizumab appeared effective, and “we suggest that it should be used in critically ill COVID-19 patients with significantly elevated IL-6,” the authors stated.

“CRS occurs in a large number of patients with severe COVID-19, which is also an important cause of death. IL-6 is the key molecule of CRS, so IL-6R antagonist tocilizumab may be an important drug to save patients’ lives,” the researchers concluded.

This study was supported by China Mega-Project for Infectious Diseases and the China Mega-Project for Innovative Drugs. The authors reported that they had no conflicts.

mlesney@mdedge.com

SOURCE: Zhang C et al. Int J Antimicrobial Agents. 2020. doi. org/10.1016/j.ijantimicag.2020.105954.

A large amount of data suggest that mild or severe cytokine storms, accompanied by high expression of interleukin-6 (IL-6), occur in patients with severe coronavirus disease and can be an important cause of death. Blocking the signal transduction pathway of IL-6 is expected to become a new method for the treatment of patients with severe COVID-19, with the IL-6 inhibitor, tocilizumab (Actemra), poised to become an effective drug for these patients, according to the authors of a review published online in the International Journal of Antimicrobial Agents.

Courtesy NIAID-RML

The reviewers from China detailed the metabolic pathways and regulation of cytokine release syndrome, especially with respect to what is known about severe COVID-19, and discussed the results of recent trials with tocilizumab, which is currently used for treatment of CRS in a variety of cancers and other metabolic disorders.

Tocilizumab is a recombinant humanized monoclonal antibody against human IL-6 receptor of immunoglobulin IgG1 subtype and has been approved for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis. The antibody specifically binds soluble- and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits sIL-6R– and mIL-6R–mediated signal transduction. It has been shown to be effective in the treatment of severe CRS patients. In 2017, the U.S. Food and Drug Administration approved tocilizumab for the treatment of CRS caused by CAR-T (chimeric antigen receptor T-cell immunotherapy) therapy.

A small clinical trial in China examined the effectiveness of tocilizumab in 21 patients who met the criteria for severe or critical COVID-19, including respiratory failure requiring mechanical ventilation, shock, or admission to the ICU with other organ failure. After a few days of tocilizumab treatment, the body temperatures returned to normal (initially, all 21 patients had fevers), and all other symptoms were significantly improved, according to the authors. A total of 75% (15/20) of the patients reduced their oxygen intake, and 1 patient did not need oxygen. CT scanning showed that 90.5% (19/21) of the patients had absorption of pulmonary lesions, and lab tests showed that the proportion of peripheral blood lymphocytes and C-reactive protein in the patients returned to normal.

The main deficiency of the study was that only the level of IL-6 in peripheral blood before treatment with tocilizumab was reported (mean value, 132.38 ± 278.54 pg/mL), but the level of IL-6 following treatment was not given, according to the reviewers. Serum levels of IL-6 in normal patients are undetectable or very low.

Based upon their analysis of COVID-19’s possible mechanism and the small samples of clinical data available, tocilizumab appeared effective, and “we suggest that it should be used in critically ill COVID-19 patients with significantly elevated IL-6,” the authors stated.

“CRS occurs in a large number of patients with severe COVID-19, which is also an important cause of death. IL-6 is the key molecule of CRS, so IL-6R antagonist tocilizumab may be an important drug to save patients’ lives,” the researchers concluded.

This study was supported by China Mega-Project for Infectious Diseases and the China Mega-Project for Innovative Drugs. The authors reported that they had no conflicts.

mlesney@mdedge.com

SOURCE: Zhang C et al. Int J Antimicrobial Agents. 2020. doi. org/10.1016/j.ijantimicag.2020.105954.

A large amount of data suggest that mild or severe cytokine storms, accompanied by high expression of interleukin-6 (IL-6), occur in patients with severe coronavirus disease and can be an important cause of death. Blocking the signal transduction pathway of IL-6 is expected to become a new method for the treatment of patients with severe COVID-19, with the IL-6 inhibitor, tocilizumab (Actemra), poised to become an effective drug for these patients, according to the authors of a review published online in the International Journal of Antimicrobial Agents.

Courtesy NIAID-RML

The reviewers from China detailed the metabolic pathways and regulation of cytokine release syndrome, especially with respect to what is known about severe COVID-19, and discussed the results of recent trials with tocilizumab, which is currently used for treatment of CRS in a variety of cancers and other metabolic disorders.

Tocilizumab is a recombinant humanized monoclonal antibody against human IL-6 receptor of immunoglobulin IgG1 subtype and has been approved for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis. The antibody specifically binds soluble- and membrane-bound IL-6 receptors (sIL-6R and mIL-6R) and inhibits sIL-6R– and mIL-6R–mediated signal transduction. It has been shown to be effective in the treatment of severe CRS patients. In 2017, the U.S. Food and Drug Administration approved tocilizumab for the treatment of CRS caused by CAR-T (chimeric antigen receptor T-cell immunotherapy) therapy.

A small clinical trial in China examined the effectiveness of tocilizumab in 21 patients who met the criteria for severe or critical COVID-19, including respiratory failure requiring mechanical ventilation, shock, or admission to the ICU with other organ failure. After a few days of tocilizumab treatment, the body temperatures returned to normal (initially, all 21 patients had fevers), and all other symptoms were significantly improved, according to the authors. A total of 75% (15/20) of the patients reduced their oxygen intake, and 1 patient did not need oxygen. CT scanning showed that 90.5% (19/21) of the patients had absorption of pulmonary lesions, and lab tests showed that the proportion of peripheral blood lymphocytes and C-reactive protein in the patients returned to normal.

The main deficiency of the study was that only the level of IL-6 in peripheral blood before treatment with tocilizumab was reported (mean value, 132.38 ± 278.54 pg/mL), but the level of IL-6 following treatment was not given, according to the reviewers. Serum levels of IL-6 in normal patients are undetectable or very low.

Based upon their analysis of COVID-19’s possible mechanism and the small samples of clinical data available, tocilizumab appeared effective, and “we suggest that it should be used in critically ill COVID-19 patients with significantly elevated IL-6,” the authors stated.

“CRS occurs in a large number of patients with severe COVID-19, which is also an important cause of death. IL-6 is the key molecule of CRS, so IL-6R antagonist tocilizumab may be an important drug to save patients’ lives,” the researchers concluded.

This study was supported by China Mega-Project for Infectious Diseases and the China Mega-Project for Innovative Drugs. The authors reported that they had no conflicts.

mlesney@mdedge.com

SOURCE: Zhang C et al. Int J Antimicrobial Agents. 2020. doi. org/10.1016/j.ijantimicag.2020.105954.

Hospitals across the country encountered severe challenges as the first wave of the COVID-19 pandemic swept over them, and they anticipated much worse to come, according to a new report from the Office of Inspector General of the Department of Health and Human Services (HHS).

From March 23 to 27, the OIG interviewed 323 hospitals of several types in 46 states, the District of Columbia, and Puerto Rico. The report it pulled together from these interviews is intended to help HHS manage the crisis, rather than to review its response to the pandemic, the OIG said.

The most significant hospital challenges, the report states, were testing and caring for patients with known or suspected COVID-19 and protecting staff members. In addition, the hospitals faced challenges in maintaining or expanding their capacities to treat COVID-19 patients and ensuring the adequacy of basic supplies.

The critical shortages of ventilators, personal protective equipment (PPE), and test kits in hospitals have been widely reported by the media. But the OIG report also focused on some areas that have received less press attention.

To begin with, the shortage of tests has not only slowed the national response to the pandemic, but has had a major impact on inpatient care, according to the report’s authors. The limited number of test kits means that only symptomatic staff members and patients can be tested; in some hospitals, there aren’t even enough tests for that, and some facilities subdivided the test kits they had, the report states.

Moreover, the test results often took 7 days or more to come back from commercial or government labs, the report states. In the meantime, symptomatic patients were presumed to have the coronavirus. While awaiting the results, they had to stay in the hospital, using beds and requiring staff who could otherwise have been assigned to other patients.

The doctors and nurse who cared for these presumptive COVID-19 patients also had to take time suiting up in PPE before seeing them; much of that scarce PPE was wasted on those who were later found not to have the illness.

As one administrator explained to OIG, “Sitting with 60 patients with presumed positives in our hospital isn’t healthy for anybody.”

Delayed test results also reduced hospitals’ ability to provide care by sidelining clinicians who reported COVID-19 symptoms. In one hospital, 20% to 25% of staff were determined to be presumptively positive for COVID-19. As a result of their tests not being analyzed promptly, these doctors and nurses were prevented from providing clinical services for longer than necessary.
 

Supply Shortages

The report also described some factors contributing to mask shortages. Because of the fear factor, for example, all staff members in one hospital were wearing masks, instead of just those in designated areas. An administrator said the hospital was using 2,000 masks a day, 10 times the number before the COVID-19 crisis.

Another hospital received 2,300 N95 masks from a state reserve, but they were unusable because the elastic bands had dry-rotted.

Meanwhile, some vendors were profiteering. Masks that used to cost 50 cents now sold for $6 each, one administrator said.

To combat the supply chain disruptions, some facilities were buying PPE from nontraditional sources such as online retailers, home supply stores, paint stores, autobody supply shops, and beauty salons. Other hospitals were using non–medical-grade PPE such as construction masks and handmade masks and gowns.

Other hospitals reported they were conserving and reusing PPE to stretch their supplies. In some cases, they had even changed policies to reduce the extent and frequency of patient interactions with clinicians so the latter would have to change their gear less often.

Shortages of other critical supplies and materials were also reported. Hospitals were running out of supplies that supported patient rooms, such as IV poles, medical gas, linens, toilet paper, and food.

Hospitals across the country were also expecting or experiencing a shortage of ventilators, although none said any patients had been denied access to them. Some institutions were adapting anesthesia machines and single-use emergency transport ventilators.

Also concerning to hospitals was the shortage of intensive-care specialists and nurses to operate the ventilators and care for critically ill patients. Some facilities were training anesthesiologists, hospitalists, and other nonintensivists on how to use the lifesaving equipment.

Meanwhile, patients with COVID-19 symptoms were continuing to show up in droves at emergency departments. Hospitals were concerned about potential shortages of ICU beds, negative-pressure rooms, and isolation units. Given limited bed availability, some administrators said, it was getting hard to separate COVID-19 from non–COVID-19 patients.
 

What Hospitals Want

As the COVID-19 crisis continues to mount, many hospitals are facing financial emergencies as well, the report noted.

“Hospitals described increasing costs and decreasing revenues as a threat to their financial viability. Hospitals reported that ceasing elective procedures and other services decreased revenues at the same time that their costs have increased as they prepare for a potential surge of patients. Many hospitals reported that their cash reserves were quickly depleting, which could disrupt ongoing hospital operations,” the authors write.

This report was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even with the 20% bump in Medicare payments for COVID-19 care that this cash infusion represents, many hospitals will face a cash-flow crunch within 60 to 90 days, as reported by Medscape Medical News.

Besides higher Medicare payments, the OIG report said, hospitals wanted the government to drop the 14-day waiting period for reimbursement and to offer them loans and grants.

Hospitals also want federal and state governments to relax regulations on professional licensing of, and business relationships with, doctors and other clinicians. They’d like the government to:

• Let them reassign licensed professionals within their hospitals and across healthcare networks
• Provide flexibility with respect to licensed professionals practicing across state lines
• Provide relief from regulations that may restrict using contracted staff or physicians based on business relationships

This article first appeared on Medscape.com.

Hospitals across the country encountered severe challenges as the first wave of the COVID-19 pandemic swept over them, and they anticipated much worse to come, according to a new report from the Office of Inspector General of the Department of Health and Human Services (HHS).

From March 23 to 27, the OIG interviewed 323 hospitals of several types in 46 states, the District of Columbia, and Puerto Rico. The report it pulled together from these interviews is intended to help HHS manage the crisis, rather than to review its response to the pandemic, the OIG said.

The most significant hospital challenges, the report states, were testing and caring for patients with known or suspected COVID-19 and protecting staff members. In addition, the hospitals faced challenges in maintaining or expanding their capacities to treat COVID-19 patients and ensuring the adequacy of basic supplies.

The critical shortages of ventilators, personal protective equipment (PPE), and test kits in hospitals have been widely reported by the media. But the OIG report also focused on some areas that have received less press attention.

To begin with, the shortage of tests has not only slowed the national response to the pandemic, but has had a major impact on inpatient care, according to the report’s authors. The limited number of test kits means that only symptomatic staff members and patients can be tested; in some hospitals, there aren’t even enough tests for that, and some facilities subdivided the test kits they had, the report states.

Moreover, the test results often took 7 days or more to come back from commercial or government labs, the report states. In the meantime, symptomatic patients were presumed to have the coronavirus. While awaiting the results, they had to stay in the hospital, using beds and requiring staff who could otherwise have been assigned to other patients.

The doctors and nurse who cared for these presumptive COVID-19 patients also had to take time suiting up in PPE before seeing them; much of that scarce PPE was wasted on those who were later found not to have the illness.

As one administrator explained to OIG, “Sitting with 60 patients with presumed positives in our hospital isn’t healthy for anybody.”

Delayed test results also reduced hospitals’ ability to provide care by sidelining clinicians who reported COVID-19 symptoms. In one hospital, 20% to 25% of staff were determined to be presumptively positive for COVID-19. As a result of their tests not being analyzed promptly, these doctors and nurses were prevented from providing clinical services for longer than necessary.
 

Supply Shortages

The report also described some factors contributing to mask shortages. Because of the fear factor, for example, all staff members in one hospital were wearing masks, instead of just those in designated areas. An administrator said the hospital was using 2,000 masks a day, 10 times the number before the COVID-19 crisis.

Another hospital received 2,300 N95 masks from a state reserve, but they were unusable because the elastic bands had dry-rotted.

Meanwhile, some vendors were profiteering. Masks that used to cost 50 cents now sold for $6 each, one administrator said.

To combat the supply chain disruptions, some facilities were buying PPE from nontraditional sources such as online retailers, home supply stores, paint stores, autobody supply shops, and beauty salons. Other hospitals were using non–medical-grade PPE such as construction masks and handmade masks and gowns.

Other hospitals reported they were conserving and reusing PPE to stretch their supplies. In some cases, they had even changed policies to reduce the extent and frequency of patient interactions with clinicians so the latter would have to change their gear less often.

Shortages of other critical supplies and materials were also reported. Hospitals were running out of supplies that supported patient rooms, such as IV poles, medical gas, linens, toilet paper, and food.

Hospitals across the country were also expecting or experiencing a shortage of ventilators, although none said any patients had been denied access to them. Some institutions were adapting anesthesia machines and single-use emergency transport ventilators.

Also concerning to hospitals was the shortage of intensive-care specialists and nurses to operate the ventilators and care for critically ill patients. Some facilities were training anesthesiologists, hospitalists, and other nonintensivists on how to use the lifesaving equipment.

Meanwhile, patients with COVID-19 symptoms were continuing to show up in droves at emergency departments. Hospitals were concerned about potential shortages of ICU beds, negative-pressure rooms, and isolation units. Given limited bed availability, some administrators said, it was getting hard to separate COVID-19 from non–COVID-19 patients.
 

What Hospitals Want

As the COVID-19 crisis continues to mount, many hospitals are facing financial emergencies as well, the report noted.

“Hospitals described increasing costs and decreasing revenues as a threat to their financial viability. Hospitals reported that ceasing elective procedures and other services decreased revenues at the same time that their costs have increased as they prepare for a potential surge of patients. Many hospitals reported that their cash reserves were quickly depleting, which could disrupt ongoing hospital operations,” the authors write.

This report was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even with the 20% bump in Medicare payments for COVID-19 care that this cash infusion represents, many hospitals will face a cash-flow crunch within 60 to 90 days, as reported by Medscape Medical News.

Besides higher Medicare payments, the OIG report said, hospitals wanted the government to drop the 14-day waiting period for reimbursement and to offer them loans and grants.

Hospitals also want federal and state governments to relax regulations on professional licensing of, and business relationships with, doctors and other clinicians. They’d like the government to:

• Let them reassign licensed professionals within their hospitals and across healthcare networks
• Provide flexibility with respect to licensed professionals practicing across state lines
• Provide relief from regulations that may restrict using contracted staff or physicians based on business relationships

This article first appeared on Medscape.com.

Hospitals across the country encountered severe challenges as the first wave of the COVID-19 pandemic swept over them, and they anticipated much worse to come, according to a new report from the Office of Inspector General of the Department of Health and Human Services (HHS).

From March 23 to 27, the OIG interviewed 323 hospitals of several types in 46 states, the District of Columbia, and Puerto Rico. The report it pulled together from these interviews is intended to help HHS manage the crisis, rather than to review its response to the pandemic, the OIG said.

The most significant hospital challenges, the report states, were testing and caring for patients with known or suspected COVID-19 and protecting staff members. In addition, the hospitals faced challenges in maintaining or expanding their capacities to treat COVID-19 patients and ensuring the adequacy of basic supplies.

The critical shortages of ventilators, personal protective equipment (PPE), and test kits in hospitals have been widely reported by the media. But the OIG report also focused on some areas that have received less press attention.

To begin with, the shortage of tests has not only slowed the national response to the pandemic, but has had a major impact on inpatient care, according to the report’s authors. The limited number of test kits means that only symptomatic staff members and patients can be tested; in some hospitals, there aren’t even enough tests for that, and some facilities subdivided the test kits they had, the report states.

Moreover, the test results often took 7 days or more to come back from commercial or government labs, the report states. In the meantime, symptomatic patients were presumed to have the coronavirus. While awaiting the results, they had to stay in the hospital, using beds and requiring staff who could otherwise have been assigned to other patients.

The doctors and nurse who cared for these presumptive COVID-19 patients also had to take time suiting up in PPE before seeing them; much of that scarce PPE was wasted on those who were later found not to have the illness.

As one administrator explained to OIG, “Sitting with 60 patients with presumed positives in our hospital isn’t healthy for anybody.”

Delayed test results also reduced hospitals’ ability to provide care by sidelining clinicians who reported COVID-19 symptoms. In one hospital, 20% to 25% of staff were determined to be presumptively positive for COVID-19. As a result of their tests not being analyzed promptly, these doctors and nurses were prevented from providing clinical services for longer than necessary.
 

Supply Shortages

The report also described some factors contributing to mask shortages. Because of the fear factor, for example, all staff members in one hospital were wearing masks, instead of just those in designated areas. An administrator said the hospital was using 2,000 masks a day, 10 times the number before the COVID-19 crisis.

Another hospital received 2,300 N95 masks from a state reserve, but they were unusable because the elastic bands had dry-rotted.

Meanwhile, some vendors were profiteering. Masks that used to cost 50 cents now sold for $6 each, one administrator said.

To combat the supply chain disruptions, some facilities were buying PPE from nontraditional sources such as online retailers, home supply stores, paint stores, autobody supply shops, and beauty salons. Other hospitals were using non–medical-grade PPE such as construction masks and handmade masks and gowns.

Other hospitals reported they were conserving and reusing PPE to stretch their supplies. In some cases, they had even changed policies to reduce the extent and frequency of patient interactions with clinicians so the latter would have to change their gear less often.

Shortages of other critical supplies and materials were also reported. Hospitals were running out of supplies that supported patient rooms, such as IV poles, medical gas, linens, toilet paper, and food.

Hospitals across the country were also expecting or experiencing a shortage of ventilators, although none said any patients had been denied access to them. Some institutions were adapting anesthesia machines and single-use emergency transport ventilators.

Also concerning to hospitals was the shortage of intensive-care specialists and nurses to operate the ventilators and care for critically ill patients. Some facilities were training anesthesiologists, hospitalists, and other nonintensivists on how to use the lifesaving equipment.

Meanwhile, patients with COVID-19 symptoms were continuing to show up in droves at emergency departments. Hospitals were concerned about potential shortages of ICU beds, negative-pressure rooms, and isolation units. Given limited bed availability, some administrators said, it was getting hard to separate COVID-19 from non–COVID-19 patients.
 

What Hospitals Want

As the COVID-19 crisis continues to mount, many hospitals are facing financial emergencies as well, the report noted.

“Hospitals described increasing costs and decreasing revenues as a threat to their financial viability. Hospitals reported that ceasing elective procedures and other services decreased revenues at the same time that their costs have increased as they prepare for a potential surge of patients. Many hospitals reported that their cash reserves were quickly depleting, which could disrupt ongoing hospital operations,” the authors write.

This report was conducted a few days before the passage of the CURES Act, which earmarked $100 billion for hospitals on the frontline of the crisis. As a recent analysis of financial hospital data revealed, however, even with the 20% bump in Medicare payments for COVID-19 care that this cash infusion represents, many hospitals will face a cash-flow crunch within 60 to 90 days, as reported by Medscape Medical News.

Besides higher Medicare payments, the OIG report said, hospitals wanted the government to drop the 14-day waiting period for reimbursement and to offer them loans and grants.

Hospitals also want federal and state governments to relax regulations on professional licensing of, and business relationships with, doctors and other clinicians. They’d like the government to:

• Let them reassign licensed professionals within their hospitals and across healthcare networks
• Provide flexibility with respect to licensed professionals practicing across state lines
• Provide relief from regulations that may restrict using contracted staff or physicians based on business relationships

This article first appeared on Medscape.com.

A team of radiation oncologists has devised recommendations and a framework for managing radiotherapy in prostate cancer patients during the COVID-19 pandemic.

The framework involves using remote visits via telemedicine, avoiding radiotherapy in applicable cases, deferring radiotherapy as appropriate, and shortening the fractionation schedule of treatment based on safety and efficacy parameters.

Nicholas G. Zaorsky, MD, of Penn State Cancer Institute in Hershey, Pennsylvania, and colleagues described the framework and recommendations in Advances in Radiation Oncology.

The authors systematically reviewed the body of literature for evidence pertaining to the safe use of telemedicine, avoidance or deferral of radiotherapy, and optimal use of androgen deprivation therapy for patients with prostate cancer. The team also reviewed best practices for patients undergoing radiotherapy based on disease risk.

Based on their findings, Dr. Zaorsky and colleagues recommended that, during the pandemic, all consultations and return visits become telehealth visits. “Very few prostate cancer patients require an in-person visit during a pandemic,” the authors wrote.
 

Lower-risk disease

Dr. Zaorsky and colleagues recommended avoiding radiotherapy in patients with very-low-, low-, and favorable intermediate-risk disease. The authors said data suggest that, in general, treatment can be safely deferred in these patients “until after pandemic-related restrictions have been lifted.” However, this recommendation presumes the pandemic will wane over the next 12 months.

“I reassure my patients with very-low- and low-risk prostate cancer that the preferred, evidence-based treatment for patients in these categories is active surveillance,” said study author Amar U. Kishan, MD, of the University of California, Los Angeles.

“If surveillance is an option, then delaying treatment must be reasonable [during the pandemic],” he added. “For favorable intermediate-risk disease, I [review] the data supporting this approach and discuss that short delays are very unlikely to compromise outcomes.”
 

Higher-risk disease

The authors recommended deferral of radiotherapy for 4-6 months in patients with higher-risk disease, which includes those with unfavorable intermediate-risk, high-risk, very-high-risk, clinical node-positive, oligometastatic, and low-volume M1 disease, as well as patients who have undergone prostatectomy.

The authors noted that in-person consultations and return visits should be converted to “timely remote telehealth visits” for these patients. After these patients have started treatment, androgen deprivation therapy “can allow for further deferral of radiotherapy as necessary based on the nature of the ongoing epidemic.”

In cases where radiotherapy cannot be deferred safely, “the shortest fractionation schedule should be adopted that has evidence of safety and efficacy,” the authors wrote.

They acknowledged that these recommendations are only applicable to patients not infected with COVID-19. In cases of suspected or confirmed COVID-19, local institutional policies and practices should be followed.

The authors further explained that, due to the rapidly evolving nature of the COVID-19 pandemic, state and federal guidelines should be followed when made available.

The authors reported having no conflicts of interest. No funding sources were reported.

SOURCE: Zaorsky NG et al. Adv Radiat Oncol. 2020 Apr 1. doi: 10.1016/j.adro.2020.03.010.

A team of radiation oncologists has devised recommendations and a framework for managing radiotherapy in prostate cancer patients during the COVID-19 pandemic.

The framework involves using remote visits via telemedicine, avoiding radiotherapy in applicable cases, deferring radiotherapy as appropriate, and shortening the fractionation schedule of treatment based on safety and efficacy parameters.

Nicholas G. Zaorsky, MD, of Penn State Cancer Institute in Hershey, Pennsylvania, and colleagues described the framework and recommendations in Advances in Radiation Oncology.

The authors systematically reviewed the body of literature for evidence pertaining to the safe use of telemedicine, avoidance or deferral of radiotherapy, and optimal use of androgen deprivation therapy for patients with prostate cancer. The team also reviewed best practices for patients undergoing radiotherapy based on disease risk.

Based on their findings, Dr. Zaorsky and colleagues recommended that, during the pandemic, all consultations and return visits become telehealth visits. “Very few prostate cancer patients require an in-person visit during a pandemic,” the authors wrote.
 

Lower-risk disease

Dr. Zaorsky and colleagues recommended avoiding radiotherapy in patients with very-low-, low-, and favorable intermediate-risk disease. The authors said data suggest that, in general, treatment can be safely deferred in these patients “until after pandemic-related restrictions have been lifted.” However, this recommendation presumes the pandemic will wane over the next 12 months.

“I reassure my patients with very-low- and low-risk prostate cancer that the preferred, evidence-based treatment for patients in these categories is active surveillance,” said study author Amar U. Kishan, MD, of the University of California, Los Angeles.

“If surveillance is an option, then delaying treatment must be reasonable [during the pandemic],” he added. “For favorable intermediate-risk disease, I [review] the data supporting this approach and discuss that short delays are very unlikely to compromise outcomes.”
 

Higher-risk disease

The authors recommended deferral of radiotherapy for 4-6 months in patients with higher-risk disease, which includes those with unfavorable intermediate-risk, high-risk, very-high-risk, clinical node-positive, oligometastatic, and low-volume M1 disease, as well as patients who have undergone prostatectomy.

The authors noted that in-person consultations and return visits should be converted to “timely remote telehealth visits” for these patients. After these patients have started treatment, androgen deprivation therapy “can allow for further deferral of radiotherapy as necessary based on the nature of the ongoing epidemic.”

In cases where radiotherapy cannot be deferred safely, “the shortest fractionation schedule should be adopted that has evidence of safety and efficacy,” the authors wrote.

They acknowledged that these recommendations are only applicable to patients not infected with COVID-19. In cases of suspected or confirmed COVID-19, local institutional policies and practices should be followed.

The authors further explained that, due to the rapidly evolving nature of the COVID-19 pandemic, state and federal guidelines should be followed when made available.

The authors reported having no conflicts of interest. No funding sources were reported.

SOURCE: Zaorsky NG et al. Adv Radiat Oncol. 2020 Apr 1. doi: 10.1016/j.adro.2020.03.010.

A team of radiation oncologists has devised recommendations and a framework for managing radiotherapy in prostate cancer patients during the COVID-19 pandemic.

The framework involves using remote visits via telemedicine, avoiding radiotherapy in applicable cases, deferring radiotherapy as appropriate, and shortening the fractionation schedule of treatment based on safety and efficacy parameters.

Nicholas G. Zaorsky, MD, of Penn State Cancer Institute in Hershey, Pennsylvania, and colleagues described the framework and recommendations in Advances in Radiation Oncology.

The authors systematically reviewed the body of literature for evidence pertaining to the safe use of telemedicine, avoidance or deferral of radiotherapy, and optimal use of androgen deprivation therapy for patients with prostate cancer. The team also reviewed best practices for patients undergoing radiotherapy based on disease risk.

Based on their findings, Dr. Zaorsky and colleagues recommended that, during the pandemic, all consultations and return visits become telehealth visits. “Very few prostate cancer patients require an in-person visit during a pandemic,” the authors wrote.
 

Lower-risk disease

Dr. Zaorsky and colleagues recommended avoiding radiotherapy in patients with very-low-, low-, and favorable intermediate-risk disease. The authors said data suggest that, in general, treatment can be safely deferred in these patients “until after pandemic-related restrictions have been lifted.” However, this recommendation presumes the pandemic will wane over the next 12 months.

“I reassure my patients with very-low- and low-risk prostate cancer that the preferred, evidence-based treatment for patients in these categories is active surveillance,” said study author Amar U. Kishan, MD, of the University of California, Los Angeles.

“If surveillance is an option, then delaying treatment must be reasonable [during the pandemic],” he added. “For favorable intermediate-risk disease, I [review] the data supporting this approach and discuss that short delays are very unlikely to compromise outcomes.”
 

Higher-risk disease

The authors recommended deferral of radiotherapy for 4-6 months in patients with higher-risk disease, which includes those with unfavorable intermediate-risk, high-risk, very-high-risk, clinical node-positive, oligometastatic, and low-volume M1 disease, as well as patients who have undergone prostatectomy.

The authors noted that in-person consultations and return visits should be converted to “timely remote telehealth visits” for these patients. After these patients have started treatment, androgen deprivation therapy “can allow for further deferral of radiotherapy as necessary based on the nature of the ongoing epidemic.”

In cases where radiotherapy cannot be deferred safely, “the shortest fractionation schedule should be adopted that has evidence of safety and efficacy,” the authors wrote.

They acknowledged that these recommendations are only applicable to patients not infected with COVID-19. In cases of suspected or confirmed COVID-19, local institutional policies and practices should be followed.

The authors further explained that, due to the rapidly evolving nature of the COVID-19 pandemic, state and federal guidelines should be followed when made available.

The authors reported having no conflicts of interest. No funding sources were reported.

SOURCE: Zaorsky NG et al. Adv Radiat Oncol. 2020 Apr 1. doi: 10.1016/j.adro.2020.03.010.

When I started at SHM in 2000, there were fewer than 1,000 hospitalists in the US, and now there are more than 60,000. SHM (back then, we were the National Association of Inpatient Physicians) had about 300 members; now, we have more than 20,000.

Today, hospitalists are part of the medical staff at virtually every hospital in the country, and hospital medicine is recognized as a unique medical specialty with our own knowledge base, textbooks, competencies, meetings, and medical professional society. In a health care environment swirling with change, we are one of the few specialties forged with the ability to adapt and, at times, lead this change. Yet there is so much disruption and instability that there are still many twists and turns in the road that will affect hospitalists’ ability to carve out an even brighter future.

Consolidation has come to health care on a large scale. Hospitals are merging. Health insurers are combining, and even large hospital medicine companies like TeamHealth, Sound, Envision, and others are merging, growing, and acquiring.

At the same time, outside forces from industries not usually associated with health care or inpatient care are swarming into our world: CVS acquires Aetna and aims to reshape primary care; Amazon dominates health care supply chains and moves into pharmacy benefits, and even gets into health care delivery via their partnership with Berkshire Hathaway and JP Morgan; Walmart merges with Humana to create one of the biggest players in Medicare; and Apple expands their inroads into wearables and chronic disease management.

Employment of clinicians has grown logarithmically, especially with inpatient physicians, reshaping the medical staff compensation and accountability. At the same time, payers, both government and private, are evolving into population health with an emphasis not so much on transactions (visits and procedures), but more aligned with outcomes, effectiveness, and efficiency.

All of this leads to a new paradigm of what is important and a new set of values that seems at times more like corporate America where the loyalty of employees can be torn between their employer and the patient. This is especially troublesome in a field traditionally based on the primacy of the doctor-patient relationship. This can put the hospitalist right in the middle at the time when the patient can be most vulnerable.

This has led to new ways to deliver the care that hospitalists provide. First as a pilot and now moving more mainstream, patients with several diagnoses (e.g., heart failure, dehydration, or pneumonia) are now managed not in bricks and mortar hospitals, but in “hospitals at home.” The last few days of a typical hospitalization now take place outside the hospital in a skilled nursing facility (SNF). Fear of uncompensated and unnecessary readmissions leads hospitals to engage hospitalists to handle the first few post-discharge outpatient visits.

This is just a small part of the expanding scope for hospitalists. In addition to managing SNFs and the discharge clinic, hospitalists are now the major providers of perioperative care and play a growing role in palliative care, especially for inpatients. As other specialties that abut hospital medicine have increasing demands and yet fewer new specialists, hospitalists are taking on more critical care and geriatrics, providing procedures, and occupy an evolving role in the emergency room.

There is a lot of work coming towards hospital medicine, and to expand our workforce, hospital medicine groups have incorporated advanced practice providers, including nurse practitioners and physician assistants. But building a true team of health professionals is not seamless or easy with each constituency having a unique scope of practice, limits on their licensure, their own culture, and a distinct training background.

But wait. There will be more new players on the hospital medicine team going forward – some we cannot even anticipate at the present time. In the future, the hospitalist may not even touch the electronic health record (EHR). Clinicians have never excelled at data entry or analysis, and it is time to use a combination of artificial intelligence (AI), voice-activated gathering of history into the record, and staff trained to manage the EHR on both the input and the output sides.

While there may be cheering for this new approach to the EHR – especially because it is a major factor in hospitalist burnout – this will refocus the role and work of the hospitalist to be more of a reviewer and integrator of data, and a strategist and decision-maker overseeing 30 or more patients. As Amazon, CVS, and Walmart move into health care, they will look for the best way to utilize the $300-400/hour hospitalist to the top of our skill level.

In the end, this all comes back to how hospitalists add value, how we can create a career that is rewarding, and how we can help hospitalists be resilient and avoid burnout.

The good news is that hospitalists will not be replaced by AI, nor should we expect to have our incomes cut as less well-trained alternatives replace highly compensated physicians in other specialties. This is a real prospect for many other specialties like dermatology, radiology, pathology, anesthesiology, and even cardiology. But hospitalists will need to adapt to changes in what is valued (i.e., how you can be the most effective and efficient) and to a new job description (i.e., overseeing more patients and managing a team that does more of the H&P, data collecting, and bedside work).

After 20 years of coming out of nowhere to being in the middle of everything in health care, I am confident that hospitalists, with the help of SHM, can continue to forge a path where we can be key difference makers and where we can create a rewarding and sustainable career. It won’t “just happen.” It is not inevitable. But if the past 20 years is any example, we are well-positioned to make the adaptation to succeed in the next 20 years. It is up to all of us to make it happen.
 

Dr. Wellikson is the CEO of SHM and is retiring from his role in 2020. This article is the second in a series celebrating Dr. Wellikson’s tenure as CEO.

When I started at SHM in 2000, there were fewer than 1,000 hospitalists in the US, and now there are more than 60,000. SHM (back then, we were the National Association of Inpatient Physicians) had about 300 members; now, we have more than 20,000.

Today, hospitalists are part of the medical staff at virtually every hospital in the country, and hospital medicine is recognized as a unique medical specialty with our own knowledge base, textbooks, competencies, meetings, and medical professional society. In a health care environment swirling with change, we are one of the few specialties forged with the ability to adapt and, at times, lead this change. Yet there is so much disruption and instability that there are still many twists and turns in the road that will affect hospitalists’ ability to carve out an even brighter future.

Consolidation has come to health care on a large scale. Hospitals are merging. Health insurers are combining, and even large hospital medicine companies like TeamHealth, Sound, Envision, and others are merging, growing, and acquiring.

At the same time, outside forces from industries not usually associated with health care or inpatient care are swarming into our world: CVS acquires Aetna and aims to reshape primary care; Amazon dominates health care supply chains and moves into pharmacy benefits, and even gets into health care delivery via their partnership with Berkshire Hathaway and JP Morgan; Walmart merges with Humana to create one of the biggest players in Medicare; and Apple expands their inroads into wearables and chronic disease management.

Employment of clinicians has grown logarithmically, especially with inpatient physicians, reshaping the medical staff compensation and accountability. At the same time, payers, both government and private, are evolving into population health with an emphasis not so much on transactions (visits and procedures), but more aligned with outcomes, effectiveness, and efficiency.

All of this leads to a new paradigm of what is important and a new set of values that seems at times more like corporate America where the loyalty of employees can be torn between their employer and the patient. This is especially troublesome in a field traditionally based on the primacy of the doctor-patient relationship. This can put the hospitalist right in the middle at the time when the patient can be most vulnerable.

This has led to new ways to deliver the care that hospitalists provide. First as a pilot and now moving more mainstream, patients with several diagnoses (e.g., heart failure, dehydration, or pneumonia) are now managed not in bricks and mortar hospitals, but in “hospitals at home.” The last few days of a typical hospitalization now take place outside the hospital in a skilled nursing facility (SNF). Fear of uncompensated and unnecessary readmissions leads hospitals to engage hospitalists to handle the first few post-discharge outpatient visits.

This is just a small part of the expanding scope for hospitalists. In addition to managing SNFs and the discharge clinic, hospitalists are now the major providers of perioperative care and play a growing role in palliative care, especially for inpatients. As other specialties that abut hospital medicine have increasing demands and yet fewer new specialists, hospitalists are taking on more critical care and geriatrics, providing procedures, and occupy an evolving role in the emergency room.

There is a lot of work coming towards hospital medicine, and to expand our workforce, hospital medicine groups have incorporated advanced practice providers, including nurse practitioners and physician assistants. But building a true team of health professionals is not seamless or easy with each constituency having a unique scope of practice, limits on their licensure, their own culture, and a distinct training background.

But wait. There will be more new players on the hospital medicine team going forward – some we cannot even anticipate at the present time. In the future, the hospitalist may not even touch the electronic health record (EHR). Clinicians have never excelled at data entry or analysis, and it is time to use a combination of artificial intelligence (AI), voice-activated gathering of history into the record, and staff trained to manage the EHR on both the input and the output sides.

While there may be cheering for this new approach to the EHR – especially because it is a major factor in hospitalist burnout – this will refocus the role and work of the hospitalist to be more of a reviewer and integrator of data, and a strategist and decision-maker overseeing 30 or more patients. As Amazon, CVS, and Walmart move into health care, they will look for the best way to utilize the $300-400/hour hospitalist to the top of our skill level.

In the end, this all comes back to how hospitalists add value, how we can create a career that is rewarding, and how we can help hospitalists be resilient and avoid burnout.

The good news is that hospitalists will not be replaced by AI, nor should we expect to have our incomes cut as less well-trained alternatives replace highly compensated physicians in other specialties. This is a real prospect for many other specialties like dermatology, radiology, pathology, anesthesiology, and even cardiology. But hospitalists will need to adapt to changes in what is valued (i.e., how you can be the most effective and efficient) and to a new job description (i.e., overseeing more patients and managing a team that does more of the H&P, data collecting, and bedside work).

After 20 years of coming out of nowhere to being in the middle of everything in health care, I am confident that hospitalists, with the help of SHM, can continue to forge a path where we can be key difference makers and where we can create a rewarding and sustainable career. It won’t “just happen.” It is not inevitable. But if the past 20 years is any example, we are well-positioned to make the adaptation to succeed in the next 20 years. It is up to all of us to make it happen.
 

Dr. Wellikson is the CEO of SHM and is retiring from his role in 2020. This article is the second in a series celebrating Dr. Wellikson’s tenure as CEO.

When I started at SHM in 2000, there were fewer than 1,000 hospitalists in the US, and now there are more than 60,000. SHM (back then, we were the National Association of Inpatient Physicians) had about 300 members; now, we have more than 20,000.

Today, hospitalists are part of the medical staff at virtually every hospital in the country, and hospital medicine is recognized as a unique medical specialty with our own knowledge base, textbooks, competencies, meetings, and medical professional society. In a health care environment swirling with change, we are one of the few specialties forged with the ability to adapt and, at times, lead this change. Yet there is so much disruption and instability that there are still many twists and turns in the road that will affect hospitalists’ ability to carve out an even brighter future.

Consolidation has come to health care on a large scale. Hospitals are merging. Health insurers are combining, and even large hospital medicine companies like TeamHealth, Sound, Envision, and others are merging, growing, and acquiring.

At the same time, outside forces from industries not usually associated with health care or inpatient care are swarming into our world: CVS acquires Aetna and aims to reshape primary care; Amazon dominates health care supply chains and moves into pharmacy benefits, and even gets into health care delivery via their partnership with Berkshire Hathaway and JP Morgan; Walmart merges with Humana to create one of the biggest players in Medicare; and Apple expands their inroads into wearables and chronic disease management.

Employment of clinicians has grown logarithmically, especially with inpatient physicians, reshaping the medical staff compensation and accountability. At the same time, payers, both government and private, are evolving into population health with an emphasis not so much on transactions (visits and procedures), but more aligned with outcomes, effectiveness, and efficiency.

All of this leads to a new paradigm of what is important and a new set of values that seems at times more like corporate America where the loyalty of employees can be torn between their employer and the patient. This is especially troublesome in a field traditionally based on the primacy of the doctor-patient relationship. This can put the hospitalist right in the middle at the time when the patient can be most vulnerable.

This has led to new ways to deliver the care that hospitalists provide. First as a pilot and now moving more mainstream, patients with several diagnoses (e.g., heart failure, dehydration, or pneumonia) are now managed not in bricks and mortar hospitals, but in “hospitals at home.” The last few days of a typical hospitalization now take place outside the hospital in a skilled nursing facility (SNF). Fear of uncompensated and unnecessary readmissions leads hospitals to engage hospitalists to handle the first few post-discharge outpatient visits.

This is just a small part of the expanding scope for hospitalists. In addition to managing SNFs and the discharge clinic, hospitalists are now the major providers of perioperative care and play a growing role in palliative care, especially for inpatients. As other specialties that abut hospital medicine have increasing demands and yet fewer new specialists, hospitalists are taking on more critical care and geriatrics, providing procedures, and occupy an evolving role in the emergency room.

There is a lot of work coming towards hospital medicine, and to expand our workforce, hospital medicine groups have incorporated advanced practice providers, including nurse practitioners and physician assistants. But building a true team of health professionals is not seamless or easy with each constituency having a unique scope of practice, limits on their licensure, their own culture, and a distinct training background.

But wait. There will be more new players on the hospital medicine team going forward – some we cannot even anticipate at the present time. In the future, the hospitalist may not even touch the electronic health record (EHR). Clinicians have never excelled at data entry or analysis, and it is time to use a combination of artificial intelligence (AI), voice-activated gathering of history into the record, and staff trained to manage the EHR on both the input and the output sides.

While there may be cheering for this new approach to the EHR – especially because it is a major factor in hospitalist burnout – this will refocus the role and work of the hospitalist to be more of a reviewer and integrator of data, and a strategist and decision-maker overseeing 30 or more patients. As Amazon, CVS, and Walmart move into health care, they will look for the best way to utilize the $300-400/hour hospitalist to the top of our skill level.

In the end, this all comes back to how hospitalists add value, how we can create a career that is rewarding, and how we can help hospitalists be resilient and avoid burnout.

The good news is that hospitalists will not be replaced by AI, nor should we expect to have our incomes cut as less well-trained alternatives replace highly compensated physicians in other specialties. This is a real prospect for many other specialties like dermatology, radiology, pathology, anesthesiology, and even cardiology. But hospitalists will need to adapt to changes in what is valued (i.e., how you can be the most effective and efficient) and to a new job description (i.e., overseeing more patients and managing a team that does more of the H&P, data collecting, and bedside work).

After 20 years of coming out of nowhere to being in the middle of everything in health care, I am confident that hospitalists, with the help of SHM, can continue to forge a path where we can be key difference makers and where we can create a rewarding and sustainable career. It won’t “just happen.” It is not inevitable. But if the past 20 years is any example, we are well-positioned to make the adaptation to succeed in the next 20 years. It is up to all of us to make it happen.
 

Dr. Wellikson is the CEO of SHM and is retiring from his role in 2020. This article is the second in a series celebrating Dr. Wellikson’s tenure as CEO.

Beyond asthma and chronic obstructive pulmonary disease (COPD), inhalation therapy is a mainstay in the management of bronchiectasis, cystic fibrosis, and pulmonary artery hypertension. Several US Food and Drug Administration off-label indications for inhalational medications include hypoxia secondary to acute respiratory distress syndrome (ARDS) and intraoperative and postoperative pulmonary hypertension during and following cardiac surgery, respectively.^1-11 Therapeutic delivery of aerosols to the lung may be provided via nebulization, pressurized metered-dose inhalers (pMDI), and other devices (eg, dry powder inhalers, soft-mist inhalers, and smart inhalers).¹² The most common aerosolized medications given in the clinical setting are bronchodilators.¹²

Product selection is often guided by practice guidelines (Table 1), consideration of the formulation’s advantages and disadvantages (Table 2), and/or formulary considerations. For example, current guidelines for COPD state that there is no evidence for superiority of nebulized bronchodilator therapy over handheld devices in patients who can use them properly.² Due to equivalence, nebulized formulations are commonly used in hospitals, emergency departments (EDs) and ambulatory clinics based on the drug’s unit cost. In contrast, a pMDI is often more cost-effective for use in ambulatory patients who are administering multiple doses from the same canister.

The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) recommend droplet and contact precautions for all patients suspected or diagnosed with novel coronavirus-19 (COVID-19).^13,14 Airborne precautions must be applied when performing aerosol-generating medical procedures (AGMPs), including but not limited to, open suctioning of the respiratory tract, intubation, bronchoscopy, and cardiopulmonary resuscitation (CPR). Data from the severe acute respiratory syndrome (SARS-CoV) epidemic suggest that nebulization of medication is also an AGMP.^15-17

Institutions must ensure that their health care workers (HCWs) are wearing appropriate personal protective equipment (PPE) including gloves, long-sleeved gowns, eye protection, and fit-tested particulate respirators (N95 mask) for airborne procedures and are carefully discarding PPE after use.^13,14 Due to severe shortages in available respirators in the US supply chain, the CDC has temporarily modified WHO recommendations. Face masks are now an acceptable alternative to protect HCWs from splashes and sprays from procedures not likely to generate aerosols and for cleaning of rooms, although there is no evidence to support this decision.

Internationally, HCWs are falling ill with COVID-19. Data from Italy and Spain show that about 9% to 13% of these countries’ cases are HCWs.^18,19 Within the US, the Ohio health department reports approximately 16% of cases are HCWs.²⁰ It is possible that 20% of frontline HCWs will become infected.²¹ Evolving laboratory research shows that COVID-19 remains viable in aerosols for up to 3 hours postaerosolization, thus making aerosol transmission plausible.²² Nebulizers convert liquids into aerosols and during dispersal may potentially cause secondary inhalation of fugitive emissions.²³ Since interim CDC infection control guidance is to allow only essential personnel to enter the room of patients with COVID-19, many facilities will rely on their frontline nursing staff to clean and disinfect high-touch surfaces following routine care activities.²⁴

Achieving adequate fomite disinfection following viral aerosolization may pose a significant problem for any patient receiving scheduled doses of nebulized medications. Additionally, for personnel who clean rooms following intermittent drug nebulization while wearing PPE that includes a face mask, protection from aerosolized virus may be inadequate. Subsequently, fugitive emissions from nebulized medications may potentially contribute to both nosocomial COVID-19 transmission and viral infections in the medical staff until proven otherwise by studies conducted outside of the laboratory. Prevention of infection in the medical staff is imperative since federal health care systems cannot sustain a significant loss of its workforce.

Recommendations

We recommend that health care systems stop business as usual and adopt public health recommendations issued by Canadian and Hong Kong health care authorities for the management of suspected or confirmed COVID-19 disease.^25-28 We have further clarified and expanded on these interventions. During viral pandemics, prescribers and health care systems should:

1. Deprescribe nebulized therapies on medical wards and intensive care units as an infection control measure. Also avoid use in any outpatient health care setting (eg, community-based clinics, EDs, triage).
2. Avoid initiation of nebulized unproven therapies (eg, n-acetylcysteine, hypertonic saline).¹
3. Use alternative bronchodilator formulations as appropriate (eg, oral β-2 agonist, recognizing its slower onset) before prescribing nebulized agents to patients who are uncooperative or unable to follow directions needed to use a pMDI with a spacer or have experienced a prior poor response to a pMDI with spacer (eg, OptiChamber Diamond, Philips).^25,27
4.  Limit nebulized drug utilization (eg, bronchodilators, epoprostenol) to patients who are on mechanical ventilation and will receive nebulized therapies via a closed system or to patients housed in negative pressure hospital rooms.²² Use a viral filter (eg, Salter Labs system) to decrease the spread of infection for those receiving epoprostenol via face mask.²⁵
5. Adjust procurement practices (eg, pharmacy, logistics) to address the transition from nebulized drugs to alternatives.
6. Add a safety net to the drug-ordering process by restricting new orders for nebulized therapies to the prior authorization process.²⁷ Apply the exclusion criterion of suspected or definite COVID-19.
7. Add a safety net to environmental service practices. Nursing staff should track patients who received ≥ 1 nebulizations via open (before diagnosis) or closed systems so that staff wear suitable PPE to include a N-95 mask while cleaning the room.

Conclusions

To implement the aggressive infection control guidance promulgated here, we recommend collaboration with infection control, pharmacy service (eg, prior authorization team, clinical pharmacy team, and procurement team), respiratory therapy, pulmonary and other critical care physicians, EDs, CPR committee, and other stakeholders. When making significant transitions in clinical care during a viral pandemic, guidelines must be timely, use imperative wording, and consist of easily identifiable education and/or instructions for the affected frontline staff in order to change attitudes.²⁹ Additionally, when transitioning from nebulized bronchodilators to pMDI, educational in-services should be provided to frontline staff to avoid misconceptions regarding pMDI treatment efficacy and patients’ ability to use their pMDI with spacer.³⁰

Acknowledgments

This material is the result of work supported with resources and the use of facilities at the VA Tennessee Valley Healthcare System in Nashville.

Beyond asthma and chronic obstructive pulmonary disease (COPD), inhalation therapy is a mainstay in the management of bronchiectasis, cystic fibrosis, and pulmonary artery hypertension. Several US Food and Drug Administration off-label indications for inhalational medications include hypoxia secondary to acute respiratory distress syndrome (ARDS) and intraoperative and postoperative pulmonary hypertension during and following cardiac surgery, respectively.^1-11 Therapeutic delivery of aerosols to the lung may be provided via nebulization, pressurized metered-dose inhalers (pMDI), and other devices (eg, dry powder inhalers, soft-mist inhalers, and smart inhalers).¹² The most common aerosolized medications given in the clinical setting are bronchodilators.¹²

Product selection is often guided by practice guidelines (Table 1), consideration of the formulation’s advantages and disadvantages (Table 2), and/or formulary considerations. For example, current guidelines for COPD state that there is no evidence for superiority of nebulized bronchodilator therapy over handheld devices in patients who can use them properly.² Due to equivalence, nebulized formulations are commonly used in hospitals, emergency departments (EDs) and ambulatory clinics based on the drug’s unit cost. In contrast, a pMDI is often more cost-effective for use in ambulatory patients who are administering multiple doses from the same canister.

The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) recommend droplet and contact precautions for all patients suspected or diagnosed with novel coronavirus-19 (COVID-19).^13,14 Airborne precautions must be applied when performing aerosol-generating medical procedures (AGMPs), including but not limited to, open suctioning of the respiratory tract, intubation, bronchoscopy, and cardiopulmonary resuscitation (CPR). Data from the severe acute respiratory syndrome (SARS-CoV) epidemic suggest that nebulization of medication is also an AGMP.^15-17

Institutions must ensure that their health care workers (HCWs) are wearing appropriate personal protective equipment (PPE) including gloves, long-sleeved gowns, eye protection, and fit-tested particulate respirators (N95 mask) for airborne procedures and are carefully discarding PPE after use.^13,14 Due to severe shortages in available respirators in the US supply chain, the CDC has temporarily modified WHO recommendations. Face masks are now an acceptable alternative to protect HCWs from splashes and sprays from procedures not likely to generate aerosols and for cleaning of rooms, although there is no evidence to support this decision.

Internationally, HCWs are falling ill with COVID-19. Data from Italy and Spain show that about 9% to 13% of these countries’ cases are HCWs.^18,19 Within the US, the Ohio health department reports approximately 16% of cases are HCWs.²⁰ It is possible that 20% of frontline HCWs will become infected.²¹ Evolving laboratory research shows that COVID-19 remains viable in aerosols for up to 3 hours postaerosolization, thus making aerosol transmission plausible.²² Nebulizers convert liquids into aerosols and during dispersal may potentially cause secondary inhalation of fugitive emissions.²³ Since interim CDC infection control guidance is to allow only essential personnel to enter the room of patients with COVID-19, many facilities will rely on their frontline nursing staff to clean and disinfect high-touch surfaces following routine care activities.²⁴

Achieving adequate fomite disinfection following viral aerosolization may pose a significant problem for any patient receiving scheduled doses of nebulized medications. Additionally, for personnel who clean rooms following intermittent drug nebulization while wearing PPE that includes a face mask, protection from aerosolized virus may be inadequate. Subsequently, fugitive emissions from nebulized medications may potentially contribute to both nosocomial COVID-19 transmission and viral infections in the medical staff until proven otherwise by studies conducted outside of the laboratory. Prevention of infection in the medical staff is imperative since federal health care systems cannot sustain a significant loss of its workforce.

Recommendations

We recommend that health care systems stop business as usual and adopt public health recommendations issued by Canadian and Hong Kong health care authorities for the management of suspected or confirmed COVID-19 disease.^25-28 We have further clarified and expanded on these interventions. During viral pandemics, prescribers and health care systems should:

1. Deprescribe nebulized therapies on medical wards and intensive care units as an infection control measure. Also avoid use in any outpatient health care setting (eg, community-based clinics, EDs, triage).
2. Avoid initiation of nebulized unproven therapies (eg, n-acetylcysteine, hypertonic saline).¹
3. Use alternative bronchodilator formulations as appropriate (eg, oral β-2 agonist, recognizing its slower onset) before prescribing nebulized agents to patients who are uncooperative or unable to follow directions needed to use a pMDI with a spacer or have experienced a prior poor response to a pMDI with spacer (eg, OptiChamber Diamond, Philips).^25,27
4.  Limit nebulized drug utilization (eg, bronchodilators, epoprostenol) to patients who are on mechanical ventilation and will receive nebulized therapies via a closed system or to patients housed in negative pressure hospital rooms.²² Use a viral filter (eg, Salter Labs system) to decrease the spread of infection for those receiving epoprostenol via face mask.²⁵
5. Adjust procurement practices (eg, pharmacy, logistics) to address the transition from nebulized drugs to alternatives.
6. Add a safety net to the drug-ordering process by restricting new orders for nebulized therapies to the prior authorization process.²⁷ Apply the exclusion criterion of suspected or definite COVID-19.
7. Add a safety net to environmental service practices. Nursing staff should track patients who received ≥ 1 nebulizations via open (before diagnosis) or closed systems so that staff wear suitable PPE to include a N-95 mask while cleaning the room.

Conclusions

To implement the aggressive infection control guidance promulgated here, we recommend collaboration with infection control, pharmacy service (eg, prior authorization team, clinical pharmacy team, and procurement team), respiratory therapy, pulmonary and other critical care physicians, EDs, CPR committee, and other stakeholders. When making significant transitions in clinical care during a viral pandemic, guidelines must be timely, use imperative wording, and consist of easily identifiable education and/or instructions for the affected frontline staff in order to change attitudes.²⁹ Additionally, when transitioning from nebulized bronchodilators to pMDI, educational in-services should be provided to frontline staff to avoid misconceptions regarding pMDI treatment efficacy and patients’ ability to use their pMDI with spacer.³⁰

Acknowledgments

This material is the result of work supported with resources and the use of facilities at the VA Tennessee Valley Healthcare System in Nashville.

Beyond asthma and chronic obstructive pulmonary disease (COPD), inhalation therapy is a mainstay in the management of bronchiectasis, cystic fibrosis, and pulmonary artery hypertension. Several US Food and Drug Administration off-label indications for inhalational medications include hypoxia secondary to acute respiratory distress syndrome (ARDS) and intraoperative and postoperative pulmonary hypertension during and following cardiac surgery, respectively.^1-11 Therapeutic delivery of aerosols to the lung may be provided via nebulization, pressurized metered-dose inhalers (pMDI), and other devices (eg, dry powder inhalers, soft-mist inhalers, and smart inhalers).¹² The most common aerosolized medications given in the clinical setting are bronchodilators.¹²

Product selection is often guided by practice guidelines (Table 1), consideration of the formulation’s advantages and disadvantages (Table 2), and/or formulary considerations. For example, current guidelines for COPD state that there is no evidence for superiority of nebulized bronchodilator therapy over handheld devices in patients who can use them properly.² Due to equivalence, nebulized formulations are commonly used in hospitals, emergency departments (EDs) and ambulatory clinics based on the drug’s unit cost. In contrast, a pMDI is often more cost-effective for use in ambulatory patients who are administering multiple doses from the same canister.

The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) recommend droplet and contact precautions for all patients suspected or diagnosed with novel coronavirus-19 (COVID-19).^13,14 Airborne precautions must be applied when performing aerosol-generating medical procedures (AGMPs), including but not limited to, open suctioning of the respiratory tract, intubation, bronchoscopy, and cardiopulmonary resuscitation (CPR). Data from the severe acute respiratory syndrome (SARS-CoV) epidemic suggest that nebulization of medication is also an AGMP.^15-17

Institutions must ensure that their health care workers (HCWs) are wearing appropriate personal protective equipment (PPE) including gloves, long-sleeved gowns, eye protection, and fit-tested particulate respirators (N95 mask) for airborne procedures and are carefully discarding PPE after use.^13,14 Due to severe shortages in available respirators in the US supply chain, the CDC has temporarily modified WHO recommendations. Face masks are now an acceptable alternative to protect HCWs from splashes and sprays from procedures not likely to generate aerosols and for cleaning of rooms, although there is no evidence to support this decision.

Internationally, HCWs are falling ill with COVID-19. Data from Italy and Spain show that about 9% to 13% of these countries’ cases are HCWs.^18,19 Within the US, the Ohio health department reports approximately 16% of cases are HCWs.²⁰ It is possible that 20% of frontline HCWs will become infected.²¹ Evolving laboratory research shows that COVID-19 remains viable in aerosols for up to 3 hours postaerosolization, thus making aerosol transmission plausible.²² Nebulizers convert liquids into aerosols and during dispersal may potentially cause secondary inhalation of fugitive emissions.²³ Since interim CDC infection control guidance is to allow only essential personnel to enter the room of patients with COVID-19, many facilities will rely on their frontline nursing staff to clean and disinfect high-touch surfaces following routine care activities.²⁴

Achieving adequate fomite disinfection following viral aerosolization may pose a significant problem for any patient receiving scheduled doses of nebulized medications. Additionally, for personnel who clean rooms following intermittent drug nebulization while wearing PPE that includes a face mask, protection from aerosolized virus may be inadequate. Subsequently, fugitive emissions from nebulized medications may potentially contribute to both nosocomial COVID-19 transmission and viral infections in the medical staff until proven otherwise by studies conducted outside of the laboratory. Prevention of infection in the medical staff is imperative since federal health care systems cannot sustain a significant loss of its workforce.

Recommendations

We recommend that health care systems stop business as usual and adopt public health recommendations issued by Canadian and Hong Kong health care authorities for the management of suspected or confirmed COVID-19 disease.^25-28 We have further clarified and expanded on these interventions. During viral pandemics, prescribers and health care systems should:

1. Deprescribe nebulized therapies on medical wards and intensive care units as an infection control measure. Also avoid use in any outpatient health care setting (eg, community-based clinics, EDs, triage).
2. Avoid initiation of nebulized unproven therapies (eg, n-acetylcysteine, hypertonic saline).¹
3. Use alternative bronchodilator formulations as appropriate (eg, oral β-2 agonist, recognizing its slower onset) before prescribing nebulized agents to patients who are uncooperative or unable to follow directions needed to use a pMDI with a spacer or have experienced a prior poor response to a pMDI with spacer (eg, OptiChamber Diamond, Philips).^25,27
4.  Limit nebulized drug utilization (eg, bronchodilators, epoprostenol) to patients who are on mechanical ventilation and will receive nebulized therapies via a closed system or to patients housed in negative pressure hospital rooms.²² Use a viral filter (eg, Salter Labs system) to decrease the spread of infection for those receiving epoprostenol via face mask.²⁵
5. Adjust procurement practices (eg, pharmacy, logistics) to address the transition from nebulized drugs to alternatives.
6. Add a safety net to the drug-ordering process by restricting new orders for nebulized therapies to the prior authorization process.²⁷ Apply the exclusion criterion of suspected or definite COVID-19.
7. Add a safety net to environmental service practices. Nursing staff should track patients who received ≥ 1 nebulizations via open (before diagnosis) or closed systems so that staff wear suitable PPE to include a N-95 mask while cleaning the room.

Conclusions

To implement the aggressive infection control guidance promulgated here, we recommend collaboration with infection control, pharmacy service (eg, prior authorization team, clinical pharmacy team, and procurement team), respiratory therapy, pulmonary and other critical care physicians, EDs, CPR committee, and other stakeholders. When making significant transitions in clinical care during a viral pandemic, guidelines must be timely, use imperative wording, and consist of easily identifiable education and/or instructions for the affected frontline staff in order to change attitudes.²⁹ Additionally, when transitioning from nebulized bronchodilators to pMDI, educational in-services should be provided to frontline staff to avoid misconceptions regarding pMDI treatment efficacy and patients’ ability to use their pMDI with spacer.³⁰

Acknowledgments

This material is the result of work supported with resources and the use of facilities at the VA Tennessee Valley Healthcare System in Nashville.