In a webinar designed to guide physicians in the care of hematology patients during the COVID-19 pandemic, three world experts on thalassemia and sickle cell disease (SCD) provided on-the-ground information from physicians who were dealing with the height of the crisis in their countries.

The webinar was organized by the European Hematology Association (EHA) and the Thalassemia International Federation (TIF).

Moderator Francesco Cerisoli, MD, head of research and mentoring at EHA, led the discussion with three guest speakers: Maria-Domenica Cappellini, MD, PhD, professor of hematology at the University of Milan; Androulla Eleftheriou, MD, executive director of TIF in Cyprus; and Raffaella Colombatti , MD, of the University of Padova in Italy, coordinator of the Red Cell Reserve Working Group of the Italian Association of Pediatric Hematology and Oncology.
 

Italian experience with thalassemia and COVID-19

Dr. Cappellini discussed the Italian experience with 11 thalassemia patients followed by a network survey who developed COVID-19 in the northern part of Italy, where the pandemic has been most widespread.

There are no published data focusing specifically on SARS-CoV-2 infection in patients with thalassemic syndromes, but patients with preexisting comorbidities are likely to be more severely affected by SARS-CoV-2, according to Dr. Cappellini.

Of particular concern is the fact that patients with thalassemia, especially older ones, are frequently splenectomized, which renders them more vulnerable to bacterial infections and can trigger life-threatening sepsis. However, splenectomy is not known to increase the risk of viral infection or severe viral illness. Of additional concern is the fact that many thalassemia patients need routine and frequent transfusions.

Overall, the 11 thalassemia patients who developed COVID-19 experienced only mild to moderate symptoms. This is despite the fact that 72% of the patients were splenectomized, which did not appear to affect the clinical course, and all of the patients had thalassemia-related comorbidities.

Around half of the patients were hospitalized, but none of them required transfer to the ICU. One patient who was treated with chemotherapy for diffuse large B-cell lymphoma in 2019 but is now in remission required more intense ventilation support with the use of continuous positive airway pressure.

Only three patients received specific treatment for COVID-19: one with hydroxychloroquine (HCQ) alone, one with HCQ plus anakinra, and one with HCQ plus ritonavir/darunavir.

Overall, “the number of infected thalassemia patients was lower than expected, likely due to earlier and more vigilant self-isolation compared to the general population,” Dr. Cappellini said. She pointed out that the first early response in February by thalassemia physicians was to warn their patients via email and phone calls about the need for self-isolation and precautions against the pandemic.

Physicians “rapidly reorganized activities, postponing nonessential ones” and managed to provide patients “a safe track at the hospital to receive their life-saving treatment in COVID-19–free areas with health care personnel wearing protective equipment” and assessment of all entering patients for COVID-19 infection, Dr. Cappellini said.
 

Results in additional thalassemia patients and SCD patients

Dr. Eleftheriou described 51 cases of thalassemia patients with SARS-CoV-2 infection reported to TIF as of April 16. Patients were from Cyprus, Italy, the United Kingdom, France, Turkey, Iran, Pakistan, and Indonesia.

Of the 51 patients, 46 presented with mild to moderate symptoms. Five patients had severe respiratory symptoms and required hospitalization, two were hospitalized and discharged, and three died between day 5 and day 15 post hospitalization.

Dr. Colombatti followed with a brief presentation of the intersection of COVID-19 with SCD patients. She presented anecdotal data involving 32 SCD patients who exhibited COVID-19 symptoms. Dr. Colombatti obtained the data via personal communication with Pablo Bartolucci, of Hôpitaux Universitaires Henri Mondor in Créteil, France.

All 32 SCD patients were screened and treated for COVID-19, and 17 of them continued treatment for 10 days. In all, 22 patients were hospitalized, 11 were transferred to the ICU, and 1 died.
 

Ensuring adequate blood supply

Dr. Eleftheriou also discussed the TIF response to the COVID-19 pandemic, which focused on the adequacy of blood supplies for these patients who so often need transfusions.

Dr. Eleftheriou stated that a shortage of blood was reported in 75% of the 62 member countries of the TIF, with 58% reporting severe shortages and 35% reporting moderate to severe shortages.

The shortages resulted in many countries returning to older family/friends donation practices, rare use of whole blood transfusions, and the use of older blood transfusions (older than 28 days).

In addition, physicians have modified their transfusion strategy. They have reduced the amount of blood given to thalassemia patients from two units to one unit during any transfusion, while making arrangements for more frequent transfusions; for example, one transfusion per week but with precautions made to “limit the time spent in the clinic and to control blood supplies while safeguarding that all [thalassemia] patients will be able to get their transfusion,” Dr. Eleftheriou said.

The information in the webinar was provided with the caveat that “no general evidence-based guidance can be derived from this discussion.” There were no other disclosures given.

[email protected]

In a webinar designed to guide physicians in the care of hematology patients during the COVID-19 pandemic, three world experts on thalassemia and sickle cell disease (SCD) provided on-the-ground information from physicians who were dealing with the height of the crisis in their countries.

The webinar was organized by the European Hematology Association (EHA) and the Thalassemia International Federation (TIF).

Moderator Francesco Cerisoli, MD, head of research and mentoring at EHA, led the discussion with three guest speakers: Maria-Domenica Cappellini, MD, PhD, professor of hematology at the University of Milan; Androulla Eleftheriou, MD, executive director of TIF in Cyprus; and Raffaella Colombatti , MD, of the University of Padova in Italy, coordinator of the Red Cell Reserve Working Group of the Italian Association of Pediatric Hematology and Oncology.
 

Italian experience with thalassemia and COVID-19

Dr. Cappellini discussed the Italian experience with 11 thalassemia patients followed by a network survey who developed COVID-19 in the northern part of Italy, where the pandemic has been most widespread.

There are no published data focusing specifically on SARS-CoV-2 infection in patients with thalassemic syndromes, but patients with preexisting comorbidities are likely to be more severely affected by SARS-CoV-2, according to Dr. Cappellini.

Of particular concern is the fact that patients with thalassemia, especially older ones, are frequently splenectomized, which renders them more vulnerable to bacterial infections and can trigger life-threatening sepsis. However, splenectomy is not known to increase the risk of viral infection or severe viral illness. Of additional concern is the fact that many thalassemia patients need routine and frequent transfusions.

Overall, the 11 thalassemia patients who developed COVID-19 experienced only mild to moderate symptoms. This is despite the fact that 72% of the patients were splenectomized, which did not appear to affect the clinical course, and all of the patients had thalassemia-related comorbidities.

Around half of the patients were hospitalized, but none of them required transfer to the ICU. One patient who was treated with chemotherapy for diffuse large B-cell lymphoma in 2019 but is now in remission required more intense ventilation support with the use of continuous positive airway pressure.

Only three patients received specific treatment for COVID-19: one with hydroxychloroquine (HCQ) alone, one with HCQ plus anakinra, and one with HCQ plus ritonavir/darunavir.

Overall, “the number of infected thalassemia patients was lower than expected, likely due to earlier and more vigilant self-isolation compared to the general population,” Dr. Cappellini said. She pointed out that the first early response in February by thalassemia physicians was to warn their patients via email and phone calls about the need for self-isolation and precautions against the pandemic.

Physicians “rapidly reorganized activities, postponing nonessential ones” and managed to provide patients “a safe track at the hospital to receive their life-saving treatment in COVID-19–free areas with health care personnel wearing protective equipment” and assessment of all entering patients for COVID-19 infection, Dr. Cappellini said.
 

Results in additional thalassemia patients and SCD patients

Dr. Eleftheriou described 51 cases of thalassemia patients with SARS-CoV-2 infection reported to TIF as of April 16. Patients were from Cyprus, Italy, the United Kingdom, France, Turkey, Iran, Pakistan, and Indonesia.

Of the 51 patients, 46 presented with mild to moderate symptoms. Five patients had severe respiratory symptoms and required hospitalization, two were hospitalized and discharged, and three died between day 5 and day 15 post hospitalization.

Dr. Colombatti followed with a brief presentation of the intersection of COVID-19 with SCD patients. She presented anecdotal data involving 32 SCD patients who exhibited COVID-19 symptoms. Dr. Colombatti obtained the data via personal communication with Pablo Bartolucci, of Hôpitaux Universitaires Henri Mondor in Créteil, France.

All 32 SCD patients were screened and treated for COVID-19, and 17 of them continued treatment for 10 days. In all, 22 patients were hospitalized, 11 were transferred to the ICU, and 1 died.
 

Ensuring adequate blood supply

Dr. Eleftheriou also discussed the TIF response to the COVID-19 pandemic, which focused on the adequacy of blood supplies for these patients who so often need transfusions.

Dr. Eleftheriou stated that a shortage of blood was reported in 75% of the 62 member countries of the TIF, with 58% reporting severe shortages and 35% reporting moderate to severe shortages.

The shortages resulted in many countries returning to older family/friends donation practices, rare use of whole blood transfusions, and the use of older blood transfusions (older than 28 days).

In addition, physicians have modified their transfusion strategy. They have reduced the amount of blood given to thalassemia patients from two units to one unit during any transfusion, while making arrangements for more frequent transfusions; for example, one transfusion per week but with precautions made to “limit the time spent in the clinic and to control blood supplies while safeguarding that all [thalassemia] patients will be able to get their transfusion,” Dr. Eleftheriou said.

The information in the webinar was provided with the caveat that “no general evidence-based guidance can be derived from this discussion.” There were no other disclosures given.

[email protected]

In a webinar designed to guide physicians in the care of hematology patients during the COVID-19 pandemic, three world experts on thalassemia and sickle cell disease (SCD) provided on-the-ground information from physicians who were dealing with the height of the crisis in their countries.

The webinar was organized by the European Hematology Association (EHA) and the Thalassemia International Federation (TIF).

Moderator Francesco Cerisoli, MD, head of research and mentoring at EHA, led the discussion with three guest speakers: Maria-Domenica Cappellini, MD, PhD, professor of hematology at the University of Milan; Androulla Eleftheriou, MD, executive director of TIF in Cyprus; and Raffaella Colombatti , MD, of the University of Padova in Italy, coordinator of the Red Cell Reserve Working Group of the Italian Association of Pediatric Hematology and Oncology.
 

Italian experience with thalassemia and COVID-19

Dr. Cappellini discussed the Italian experience with 11 thalassemia patients followed by a network survey who developed COVID-19 in the northern part of Italy, where the pandemic has been most widespread.

There are no published data focusing specifically on SARS-CoV-2 infection in patients with thalassemic syndromes, but patients with preexisting comorbidities are likely to be more severely affected by SARS-CoV-2, according to Dr. Cappellini.

Of particular concern is the fact that patients with thalassemia, especially older ones, are frequently splenectomized, which renders them more vulnerable to bacterial infections and can trigger life-threatening sepsis. However, splenectomy is not known to increase the risk of viral infection or severe viral illness. Of additional concern is the fact that many thalassemia patients need routine and frequent transfusions.

Overall, the 11 thalassemia patients who developed COVID-19 experienced only mild to moderate symptoms. This is despite the fact that 72% of the patients were splenectomized, which did not appear to affect the clinical course, and all of the patients had thalassemia-related comorbidities.

Around half of the patients were hospitalized, but none of them required transfer to the ICU. One patient who was treated with chemotherapy for diffuse large B-cell lymphoma in 2019 but is now in remission required more intense ventilation support with the use of continuous positive airway pressure.

Only three patients received specific treatment for COVID-19: one with hydroxychloroquine (HCQ) alone, one with HCQ plus anakinra, and one with HCQ plus ritonavir/darunavir.

Overall, “the number of infected thalassemia patients was lower than expected, likely due to earlier and more vigilant self-isolation compared to the general population,” Dr. Cappellini said. She pointed out that the first early response in February by thalassemia physicians was to warn their patients via email and phone calls about the need for self-isolation and precautions against the pandemic.

Physicians “rapidly reorganized activities, postponing nonessential ones” and managed to provide patients “a safe track at the hospital to receive their life-saving treatment in COVID-19–free areas with health care personnel wearing protective equipment” and assessment of all entering patients for COVID-19 infection, Dr. Cappellini said.
 

Results in additional thalassemia patients and SCD patients

Dr. Eleftheriou described 51 cases of thalassemia patients with SARS-CoV-2 infection reported to TIF as of April 16. Patients were from Cyprus, Italy, the United Kingdom, France, Turkey, Iran, Pakistan, and Indonesia.

Of the 51 patients, 46 presented with mild to moderate symptoms. Five patients had severe respiratory symptoms and required hospitalization, two were hospitalized and discharged, and three died between day 5 and day 15 post hospitalization.

Dr. Colombatti followed with a brief presentation of the intersection of COVID-19 with SCD patients. She presented anecdotal data involving 32 SCD patients who exhibited COVID-19 symptoms. Dr. Colombatti obtained the data via personal communication with Pablo Bartolucci, of Hôpitaux Universitaires Henri Mondor in Créteil, France.

All 32 SCD patients were screened and treated for COVID-19, and 17 of them continued treatment for 10 days. In all, 22 patients were hospitalized, 11 were transferred to the ICU, and 1 died.
 

Ensuring adequate blood supply

Dr. Eleftheriou also discussed the TIF response to the COVID-19 pandemic, which focused on the adequacy of blood supplies for these patients who so often need transfusions.

Dr. Eleftheriou stated that a shortage of blood was reported in 75% of the 62 member countries of the TIF, with 58% reporting severe shortages and 35% reporting moderate to severe shortages.

The shortages resulted in many countries returning to older family/friends donation practices, rare use of whole blood transfusions, and the use of older blood transfusions (older than 28 days).

In addition, physicians have modified their transfusion strategy. They have reduced the amount of blood given to thalassemia patients from two units to one unit during any transfusion, while making arrangements for more frequent transfusions; for example, one transfusion per week but with precautions made to “limit the time spent in the clinic and to control blood supplies while safeguarding that all [thalassemia] patients will be able to get their transfusion,” Dr. Eleftheriou said.

The information in the webinar was provided with the caveat that “no general evidence-based guidance can be derived from this discussion.” There were no other disclosures given.

[email protected]

With careful review and some changes, cancer centers can provide effective care during the COVID-19 pandemic without sacrificing the safety of patients, caregivers, and health care workers, according to the authors of a special feature article in the Journal of the National Comprehensive Cancer Network.

Prescreening, telemedicine, and limiting procedures top the authors’ list of 10 recommendations for ensuring patient safety in U.S. oncology practices. Assuring appropriate personal proctective equipment (PPE), encouraging telecommuting, and providing wellness/stress management are a few of the ways to look out for health care worker safety during the crisis.

These recommendations were drafted to provide guidance during the rapidly evolving global pandemic that, in some cases, has deluged health care delivery systems and strained the ability of providers to assure safe and effective care, said lead author Pelin Cinar, MD, of the Hellen Diller Family Comprehensive Cancer Center at the University of California, San Francisco.

“I think we have been so overwhelmed that sometimes it’s difficult to get organized in our thought processes,” Dr. Cinar said in an interview. “So this [article] was really trying to provide some structure to each of the different steps that we should be addressing at minimum.”
 

Screening patients

Prescreening systems are a critical first step to ensure cancer centers are helping control community spread of the virus, according to the article. Whether done by phone or online, prescreening 1-2 days before a patient’s visit can help identify COVID-19 symptoms and exposure history, guiding whether patients need to be evaluated, monitored, or referred to an ED.

Next, screening clinics can help ensure cancer patients with COVID-19 symptoms are evaluated and tested in a unit with dedicated staff, according to the article.

“If symptomatic patients present to the cancer center for treatment after a negative prescreening assessment, they must be provided with a mask and directed to a screening clinic for evaluation and potential testing before moving forward with any cancer-directed therapy,” the article states.
 

Telemedicine and treatment

Telemedicine visits should be done whenever possible to avoid in-person visits, according to the article. Dr. Cinar said that her center, like other cancer centers, has seen a major uptick in these visits, which are typically done over video. In February, there were a total of 232 video visits at her center, which jumped to 1,702 in March, or an approximate 600% increase.

“Even though we had a relatively robust presence [before the pandemic], we still weren’t at a level where we are now,” Dr. Cinar said.

When it comes to cancer treatment, surgeries and procedures should be limited to essential or urgent cases, and, if possible, chemotherapy and systemic therapy regimens can be modified to allow for fewer visits to the cancer center or infusion center, according to the article.

Transitions to outpatient care can help further reduce the need for in-person visits, while intervals between scans can be increased, or biochemical markers can be used instead of scans.
 

Protecting providers

Health care workers providing cancer care should be assured appropriate PPE, and websites or other centralized resources should be in place to make sure workers are aware of current PPE guidelines and changes in workflow, according to the article.

The authors note that daily screening tools or temperature checks of symptomatic workers can help decrease the risk of exposure to others. The authors also recommend establishing clear rules for when health care workers with suspected or confirmed COVID-19 should be staying at home and returning to the job.

Telecommuting should be encouraged, with limited staff participating in onsite rotations to further reduce exposure risks, the article states.

Anxiety, insomnia, and distress have been reported among frontline health care workers managing patients with COVID-19, according to the article, which recommends wellness and stress management resources be available as an “invaluable resource” in cancer centers.

“We have to take care of ourselves to be able to take care of others,” Dr. Cinar said. “With PPE, you’re physically protecting yourself, while self-care, stress management, and wellness are also a big component of protecting ourselves.”

The report by Dr. Cinar and colleagues was an invited article from the NCCN Best Practices Committee. One coauthor reported relationships with Abbvie, Adaptive Biotechnologies, Aduro, and several other companies. Dr. Cinar and the remaining authors said they had no relevant conflicts of interest.

SOURCE: Cinar P et al. J Natl Compr Canc Netw. 2020 Apr 15. doi: 10.6004/jnccn.2020.7572.

With careful review and some changes, cancer centers can provide effective care during the COVID-19 pandemic without sacrificing the safety of patients, caregivers, and health care workers, according to the authors of a special feature article in the Journal of the National Comprehensive Cancer Network.

Prescreening, telemedicine, and limiting procedures top the authors’ list of 10 recommendations for ensuring patient safety in U.S. oncology practices. Assuring appropriate personal proctective equipment (PPE), encouraging telecommuting, and providing wellness/stress management are a few of the ways to look out for health care worker safety during the crisis.

These recommendations were drafted to provide guidance during the rapidly evolving global pandemic that, in some cases, has deluged health care delivery systems and strained the ability of providers to assure safe and effective care, said lead author Pelin Cinar, MD, of the Hellen Diller Family Comprehensive Cancer Center at the University of California, San Francisco.

“I think we have been so overwhelmed that sometimes it’s difficult to get organized in our thought processes,” Dr. Cinar said in an interview. “So this [article] was really trying to provide some structure to each of the different steps that we should be addressing at minimum.”
 

Screening patients

Prescreening systems are a critical first step to ensure cancer centers are helping control community spread of the virus, according to the article. Whether done by phone or online, prescreening 1-2 days before a patient’s visit can help identify COVID-19 symptoms and exposure history, guiding whether patients need to be evaluated, monitored, or referred to an ED.

Next, screening clinics can help ensure cancer patients with COVID-19 symptoms are evaluated and tested in a unit with dedicated staff, according to the article.

“If symptomatic patients present to the cancer center for treatment after a negative prescreening assessment, they must be provided with a mask and directed to a screening clinic for evaluation and potential testing before moving forward with any cancer-directed therapy,” the article states.
 

Telemedicine and treatment

Telemedicine visits should be done whenever possible to avoid in-person visits, according to the article. Dr. Cinar said that her center, like other cancer centers, has seen a major uptick in these visits, which are typically done over video. In February, there were a total of 232 video visits at her center, which jumped to 1,702 in March, or an approximate 600% increase.

“Even though we had a relatively robust presence [before the pandemic], we still weren’t at a level where we are now,” Dr. Cinar said.

When it comes to cancer treatment, surgeries and procedures should be limited to essential or urgent cases, and, if possible, chemotherapy and systemic therapy regimens can be modified to allow for fewer visits to the cancer center or infusion center, according to the article.

Transitions to outpatient care can help further reduce the need for in-person visits, while intervals between scans can be increased, or biochemical markers can be used instead of scans.
 

Protecting providers

Health care workers providing cancer care should be assured appropriate PPE, and websites or other centralized resources should be in place to make sure workers are aware of current PPE guidelines and changes in workflow, according to the article.

The authors note that daily screening tools or temperature checks of symptomatic workers can help decrease the risk of exposure to others. The authors also recommend establishing clear rules for when health care workers with suspected or confirmed COVID-19 should be staying at home and returning to the job.

Telecommuting should be encouraged, with limited staff participating in onsite rotations to further reduce exposure risks, the article states.

Anxiety, insomnia, and distress have been reported among frontline health care workers managing patients with COVID-19, according to the article, which recommends wellness and stress management resources be available as an “invaluable resource” in cancer centers.

“We have to take care of ourselves to be able to take care of others,” Dr. Cinar said. “With PPE, you’re physically protecting yourself, while self-care, stress management, and wellness are also a big component of protecting ourselves.”

The report by Dr. Cinar and colleagues was an invited article from the NCCN Best Practices Committee. One coauthor reported relationships with Abbvie, Adaptive Biotechnologies, Aduro, and several other companies. Dr. Cinar and the remaining authors said they had no relevant conflicts of interest.

SOURCE: Cinar P et al. J Natl Compr Canc Netw. 2020 Apr 15. doi: 10.6004/jnccn.2020.7572.

With careful review and some changes, cancer centers can provide effective care during the COVID-19 pandemic without sacrificing the safety of patients, caregivers, and health care workers, according to the authors of a special feature article in the Journal of the National Comprehensive Cancer Network.

Prescreening, telemedicine, and limiting procedures top the authors’ list of 10 recommendations for ensuring patient safety in U.S. oncology practices. Assuring appropriate personal proctective equipment (PPE), encouraging telecommuting, and providing wellness/stress management are a few of the ways to look out for health care worker safety during the crisis.

These recommendations were drafted to provide guidance during the rapidly evolving global pandemic that, in some cases, has deluged health care delivery systems and strained the ability of providers to assure safe and effective care, said lead author Pelin Cinar, MD, of the Hellen Diller Family Comprehensive Cancer Center at the University of California, San Francisco.

“I think we have been so overwhelmed that sometimes it’s difficult to get organized in our thought processes,” Dr. Cinar said in an interview. “So this [article] was really trying to provide some structure to each of the different steps that we should be addressing at minimum.”
 

Screening patients

Prescreening systems are a critical first step to ensure cancer centers are helping control community spread of the virus, according to the article. Whether done by phone or online, prescreening 1-2 days before a patient’s visit can help identify COVID-19 symptoms and exposure history, guiding whether patients need to be evaluated, monitored, or referred to an ED.

Next, screening clinics can help ensure cancer patients with COVID-19 symptoms are evaluated and tested in a unit with dedicated staff, according to the article.

“If symptomatic patients present to the cancer center for treatment after a negative prescreening assessment, they must be provided with a mask and directed to a screening clinic for evaluation and potential testing before moving forward with any cancer-directed therapy,” the article states.
 

Telemedicine and treatment

Telemedicine visits should be done whenever possible to avoid in-person visits, according to the article. Dr. Cinar said that her center, like other cancer centers, has seen a major uptick in these visits, which are typically done over video. In February, there were a total of 232 video visits at her center, which jumped to 1,702 in March, or an approximate 600% increase.

“Even though we had a relatively robust presence [before the pandemic], we still weren’t at a level where we are now,” Dr. Cinar said.

When it comes to cancer treatment, surgeries and procedures should be limited to essential or urgent cases, and, if possible, chemotherapy and systemic therapy regimens can be modified to allow for fewer visits to the cancer center or infusion center, according to the article.

Transitions to outpatient care can help further reduce the need for in-person visits, while intervals between scans can be increased, or biochemical markers can be used instead of scans.
 

Protecting providers

Health care workers providing cancer care should be assured appropriate PPE, and websites or other centralized resources should be in place to make sure workers are aware of current PPE guidelines and changes in workflow, according to the article.

The authors note that daily screening tools or temperature checks of symptomatic workers can help decrease the risk of exposure to others. The authors also recommend establishing clear rules for when health care workers with suspected or confirmed COVID-19 should be staying at home and returning to the job.

Telecommuting should be encouraged, with limited staff participating in onsite rotations to further reduce exposure risks, the article states.

Anxiety, insomnia, and distress have been reported among frontline health care workers managing patients with COVID-19, according to the article, which recommends wellness and stress management resources be available as an “invaluable resource” in cancer centers.

“We have to take care of ourselves to be able to take care of others,” Dr. Cinar said. “With PPE, you’re physically protecting yourself, while self-care, stress management, and wellness are also a big component of protecting ourselves.”

The report by Dr. Cinar and colleagues was an invited article from the NCCN Best Practices Committee. One coauthor reported relationships with Abbvie, Adaptive Biotechnologies, Aduro, and several other companies. Dr. Cinar and the remaining authors said they had no relevant conflicts of interest.

SOURCE: Cinar P et al. J Natl Compr Canc Netw. 2020 Apr 15. doi: 10.6004/jnccn.2020.7572.

The European Society for Medical Oncology (ESMO) has published guidelines for managing patients with gastrointestinal cancers during the COVID-19 pandemic, helping clinicians identify patients who require immediate care and those for whom treatment can wait.

The guidelines are part of an ESMO-led initiative to address pandemic-related clinical issues. ESMO has released recommendations for solid tumors and hematologic malignancies that were drafted by leading experts representing almost 60 research centers.

According to Florian Lordick, MD, PhD, ESMO director of education and professor of oncology at the University of Leipzig Medical Center, Germany, the effort was a response to clinician requests from around the world.

“Many physicians … in their centers, in their countries, would appreciate some guidance [regarding] how to act and how to react in this crisis,” Dr. Lordick said in an interview.

“This situation is very heterogenous,” he noted. “Even within Europe, even within some countries, some [health care providers] have very limited resources. ... Others can almost do their job as usual, so it’s not easy to give recommendations today that are exactly valid for everyone.”
 

Prioritizing patients and interventions

To account for disparities across countries, the ESMO guidelines are categorized by patient tiers, including low, medium, and high priority, as determined by the Cancer Care Ontario, Huntsman Cancer Institute and Magnitude of Clinical Benefit Scale. The scale incorporates both patient factors and benefits of intervention.

High-priority patients are in life-threatening condition, and delaying care would jeopardize their survival and/or quality of life. Medium-priority patients are noncritical, but delaying intervention beyond 6 weeks could affect outcomes. Low-priority patients are clinically stable, and delaying intervention would not affect their quality of life and/or survival.

ESMO’s guidelines for gastrointestinal cancers include recommendations for colorectal cancer, hepatocellular carcinoma, gastroesophageal tumors, and pancreatic cancer. The recommendations encompass outpatient visits, imaging and radiological/endoscopic interventions, surgical procedures, medical oncology, and radiotherapy.

According to Dr. Lordick, many patients with pancreatic cancer or gastroesophageal tumors have clinical needs that cannot wait, and the guidelines reflect that.

“We are dealing here with two cancer types that are highly aggressive, that have high mortality if not treated adequately,” Dr. Lordick said. “So we have to say that whenever there is a suspicion for one of these cancers, we put the diagnosis and staging – including imaging of these cancers – into high priority. We think, with these cancers, people cannot wait. We know that it may be difficult in some systems, but if there is a suspicion [of a pancreatic tumor], then it’s not a situation where you could wait for 6 or 8 weeks.”

Radiological diagnostic workup of suspected hepatocellular carcinoma is also a high priority, according to the guidelines. However, diagnostic imaging and endoscopy are considered medium-priority interventions for clinically suspected colorectal cancer or for patients at high risk of colorectal cancer.

The lowest-priority patients are those in the survivorship group without symptoms, Dr. Lordick said, noting that these patients are eligible for delayed or remote consultation.
 

Professionalism, preparedness, and patient empowerment

More generally, Dr. Lordick urged oncologists to maintain a high level of professionalism and preparedness during the pandemic.

“I think a good center really tries to create areas that are COVID-free for their cancer patients,” he said. “They try to see as soon as possible if someone is at risk of having an infection, to test these patients early, to isolate them from the other patients.”

Dr. Lordick also emphasized the importance of patient empowerment.

“Really give [patients] all the information – what they can do to protect themselves from infection, including all the things that are usually recommended, like hygiene of the hands, avoiding social contact, reporting quickly if they have symptoms,” he said. “That is something we find really important – the patient empowerment.”

To that end, the ESMO team also created a comprehensive patient guide to help those with cancer navigate the pandemic.

All of these resources are the result of a major collaboration by guideline experts from around the world, Dr. Lordick said. He expressed gratitude for their work, which was performed without pay, under a tight deadline, and often following a full day in the clinic. From concept to publication, the recommendations were completed in 14 days.“To be honest, I’m a bit surprised, even a bit proud of what people did in a short period of time,” Dr. Lordick said.He reported no conflicts of interest.

SOURCE: ESMO. April 2020. Cancer Patient Management During the COVID-19 Pandemic

The European Society for Medical Oncology (ESMO) has published guidelines for managing patients with gastrointestinal cancers during the COVID-19 pandemic, helping clinicians identify patients who require immediate care and those for whom treatment can wait.

The guidelines are part of an ESMO-led initiative to address pandemic-related clinical issues. ESMO has released recommendations for solid tumors and hematologic malignancies that were drafted by leading experts representing almost 60 research centers.

According to Florian Lordick, MD, PhD, ESMO director of education and professor of oncology at the University of Leipzig Medical Center, Germany, the effort was a response to clinician requests from around the world.

“Many physicians … in their centers, in their countries, would appreciate some guidance [regarding] how to act and how to react in this crisis,” Dr. Lordick said in an interview.

“This situation is very heterogenous,” he noted. “Even within Europe, even within some countries, some [health care providers] have very limited resources. ... Others can almost do their job as usual, so it’s not easy to give recommendations today that are exactly valid for everyone.”
 

Prioritizing patients and interventions

To account for disparities across countries, the ESMO guidelines are categorized by patient tiers, including low, medium, and high priority, as determined by the Cancer Care Ontario, Huntsman Cancer Institute and Magnitude of Clinical Benefit Scale. The scale incorporates both patient factors and benefits of intervention.

High-priority patients are in life-threatening condition, and delaying care would jeopardize their survival and/or quality of life. Medium-priority patients are noncritical, but delaying intervention beyond 6 weeks could affect outcomes. Low-priority patients are clinically stable, and delaying intervention would not affect their quality of life and/or survival.

ESMO’s guidelines for gastrointestinal cancers include recommendations for colorectal cancer, hepatocellular carcinoma, gastroesophageal tumors, and pancreatic cancer. The recommendations encompass outpatient visits, imaging and radiological/endoscopic interventions, surgical procedures, medical oncology, and radiotherapy.

According to Dr. Lordick, many patients with pancreatic cancer or gastroesophageal tumors have clinical needs that cannot wait, and the guidelines reflect that.

“We are dealing here with two cancer types that are highly aggressive, that have high mortality if not treated adequately,” Dr. Lordick said. “So we have to say that whenever there is a suspicion for one of these cancers, we put the diagnosis and staging – including imaging of these cancers – into high priority. We think, with these cancers, people cannot wait. We know that it may be difficult in some systems, but if there is a suspicion [of a pancreatic tumor], then it’s not a situation where you could wait for 6 or 8 weeks.”

Radiological diagnostic workup of suspected hepatocellular carcinoma is also a high priority, according to the guidelines. However, diagnostic imaging and endoscopy are considered medium-priority interventions for clinically suspected colorectal cancer or for patients at high risk of colorectal cancer.

The lowest-priority patients are those in the survivorship group without symptoms, Dr. Lordick said, noting that these patients are eligible for delayed or remote consultation.
 

Professionalism, preparedness, and patient empowerment

More generally, Dr. Lordick urged oncologists to maintain a high level of professionalism and preparedness during the pandemic.

“I think a good center really tries to create areas that are COVID-free for their cancer patients,” he said. “They try to see as soon as possible if someone is at risk of having an infection, to test these patients early, to isolate them from the other patients.”

Dr. Lordick also emphasized the importance of patient empowerment.

“Really give [patients] all the information – what they can do to protect themselves from infection, including all the things that are usually recommended, like hygiene of the hands, avoiding social contact, reporting quickly if they have symptoms,” he said. “That is something we find really important – the patient empowerment.”

To that end, the ESMO team also created a comprehensive patient guide to help those with cancer navigate the pandemic.

All of these resources are the result of a major collaboration by guideline experts from around the world, Dr. Lordick said. He expressed gratitude for their work, which was performed without pay, under a tight deadline, and often following a full day in the clinic. From concept to publication, the recommendations were completed in 14 days.“To be honest, I’m a bit surprised, even a bit proud of what people did in a short period of time,” Dr. Lordick said.He reported no conflicts of interest.

SOURCE: ESMO. April 2020. Cancer Patient Management During the COVID-19 Pandemic

The European Society for Medical Oncology (ESMO) has published guidelines for managing patients with gastrointestinal cancers during the COVID-19 pandemic, helping clinicians identify patients who require immediate care and those for whom treatment can wait.

The guidelines are part of an ESMO-led initiative to address pandemic-related clinical issues. ESMO has released recommendations for solid tumors and hematologic malignancies that were drafted by leading experts representing almost 60 research centers.

According to Florian Lordick, MD, PhD, ESMO director of education and professor of oncology at the University of Leipzig Medical Center, Germany, the effort was a response to clinician requests from around the world.

“Many physicians … in their centers, in their countries, would appreciate some guidance [regarding] how to act and how to react in this crisis,” Dr. Lordick said in an interview.

“This situation is very heterogenous,” he noted. “Even within Europe, even within some countries, some [health care providers] have very limited resources. ... Others can almost do their job as usual, so it’s not easy to give recommendations today that are exactly valid for everyone.”
 

Prioritizing patients and interventions

To account for disparities across countries, the ESMO guidelines are categorized by patient tiers, including low, medium, and high priority, as determined by the Cancer Care Ontario, Huntsman Cancer Institute and Magnitude of Clinical Benefit Scale. The scale incorporates both patient factors and benefits of intervention.

High-priority patients are in life-threatening condition, and delaying care would jeopardize their survival and/or quality of life. Medium-priority patients are noncritical, but delaying intervention beyond 6 weeks could affect outcomes. Low-priority patients are clinically stable, and delaying intervention would not affect their quality of life and/or survival.

ESMO’s guidelines for gastrointestinal cancers include recommendations for colorectal cancer, hepatocellular carcinoma, gastroesophageal tumors, and pancreatic cancer. The recommendations encompass outpatient visits, imaging and radiological/endoscopic interventions, surgical procedures, medical oncology, and radiotherapy.

According to Dr. Lordick, many patients with pancreatic cancer or gastroesophageal tumors have clinical needs that cannot wait, and the guidelines reflect that.

“We are dealing here with two cancer types that are highly aggressive, that have high mortality if not treated adequately,” Dr. Lordick said. “So we have to say that whenever there is a suspicion for one of these cancers, we put the diagnosis and staging – including imaging of these cancers – into high priority. We think, with these cancers, people cannot wait. We know that it may be difficult in some systems, but if there is a suspicion [of a pancreatic tumor], then it’s not a situation where you could wait for 6 or 8 weeks.”

Radiological diagnostic workup of suspected hepatocellular carcinoma is also a high priority, according to the guidelines. However, diagnostic imaging and endoscopy are considered medium-priority interventions for clinically suspected colorectal cancer or for patients at high risk of colorectal cancer.

The lowest-priority patients are those in the survivorship group without symptoms, Dr. Lordick said, noting that these patients are eligible for delayed or remote consultation.
 

Professionalism, preparedness, and patient empowerment

More generally, Dr. Lordick urged oncologists to maintain a high level of professionalism and preparedness during the pandemic.

“I think a good center really tries to create areas that are COVID-free for their cancer patients,” he said. “They try to see as soon as possible if someone is at risk of having an infection, to test these patients early, to isolate them from the other patients.”

Dr. Lordick also emphasized the importance of patient empowerment.

“Really give [patients] all the information – what they can do to protect themselves from infection, including all the things that are usually recommended, like hygiene of the hands, avoiding social contact, reporting quickly if they have symptoms,” he said. “That is something we find really important – the patient empowerment.”

To that end, the ESMO team also created a comprehensive patient guide to help those with cancer navigate the pandemic.

All of these resources are the result of a major collaboration by guideline experts from around the world, Dr. Lordick said. He expressed gratitude for their work, which was performed without pay, under a tight deadline, and often following a full day in the clinic. From concept to publication, the recommendations were completed in 14 days.“To be honest, I’m a bit surprised, even a bit proud of what people did in a short period of time,” Dr. Lordick said.He reported no conflicts of interest.

SOURCE: ESMO. April 2020. Cancer Patient Management During the COVID-19 Pandemic

Extraordinary cooperation and accommodations are needed in the race to build a COVID-19 vaccine from scratch while chasing a pandemic, said members of industry and government who convened for an update on the vaccine clinical trial process.

The message came from representatives from the Food and Drug Administration, a think tank, and the nonprofit sector who provided some insight into the vaccine development process for COVID-19 at a press briefing hosted by the Commonwealth Fund.

Even in the best of times, vaccine development is not simple, said Litjen (L.J.) Tan, PhD, chief strategy officer for the Immunization Action Coalition. Ordinarily, the process can take from 10 to 20 years and cost well over a billion dollars. Many vaccines wind up being abandoned before phase 3 development just because the cost is prohibitive, he said.

Vaccines undergo extensive ongoing postmarketing surveillance even after approval, licensing, and distribution, noted Dr. Tan, adding that the development of a safe, effective vaccine is a “very complicated, significant process.”

In these extraordinary times, many adjustments to the usual trial trajectory are needed, agreed all participants. To speed the process, the traditional vaccine trajectory is being accelerated and compressed; changes may include simultaneous rather than sequential clinical trials that are run in parallel. These trials may be optimized for multiple target populations at the same time, and run in different countries, explained Dr. Tan.

“We are likely going to use something called adaptive trial designs” in which results are gathered during the trial and used to modify the trial according to prespecified rules, he said. “These trials shift to accommodate data as it comes up.”

Regulatory agencies are actively engaging in the process much earlier than usual, with input including how to incentivize scaling up production of vaccines and ensuring that vaccines will be fairly and equitably distributed across the globe, he added.

Esther Krofah is the executive director of FasterCures, a center within the nonprofit Milken Institute. Currently 86 different active COVID-19 vaccine projects are underway, she said, with 6 currently in clinical trials and about two dozen more expected to enter the clinical trial phase by the summer of 2020.

Many of these projects will involve a smaller biotech company or an academic research group with deep knowledge of a particular immune strategy partnering with a large pharmaceutical company that has economic capacity and global resources and reach, said Ms. Krofah.

From a policy perspective, she said, it’s important for the FDA to have surge capacity with “enough arms, legs, and staff to actively provide input into clinical design and protocols of studies.” The goal is to be able to review data in real-time and provide rapid feedback as studies are occurring so adaptive clinical trial design can be implemented.

As COVID-19 vaccine trials are rolled out, necessary compromises may include incorporation of real world evidence in later clinical trial stages. “There is a way to do randomized trials in the real world in situations that come up like this,” said Peter Marks, MD, the FDA’s director of the Center for Biologics Evaluation and Research. Long-term data about vaccine efficacy may be accrued over time, once a vaccine is being administered beyond the clinical trial stage, to see if efficacy wanes over time.

However, he said, “a lot will depend on where the vaccine is and what we encounter with whether there’s circulating virus or not” in terms of clinical trial design, including whether surrogate efficacy markers such as antibody production would be used.

Unvaccinated members of a population may be used as controls against a vaccinated group during an active outbreak, he said, a break from traditional trial design. “It’s not perfect. I’ll acknowledge right away there are certain people at the [National Institutes of Health] that would like to tell me that’s a horrible idea, but I think we are going to entertain and discuss all potential designs” for COVID-19 vaccine trials, he said. “We can’t out-of-hand dismiss any design here, whether real world based or evidence based.”

“This may be a little unusual hearing this from the FDA,” he said, “but this is possibly one of the most important things we are going to have to do in the next few years.” He added, “It’s unfortunately not unlikely that we will see a second wave, or maybe even a third wave, if we don’t get it right.”

He pointed out that there was no candidate vaccine in the pipeline when the pandemic blossomed and began its race around the globe. Current coronavirus candidates aren’t useful against COVID-19. “We know that there might be some complexities in development” related to the contributions of immune enhancement to the pathogenicity of the SARS-CoV-2 virus, he said.

The agency is currently working closely with sponsors of various candidate vaccines to take a hard look at preclinical data and trial design.

“Low efficacy could distract from capacity for more robust candidates to come forward,” he said. “We’d like to encourage people to have the absolute best vaccines. ... We hope to be able to facilitate rapid development of these,” he said.

Moving forward, a whole-government approach is necessary for development and delivery of the best vaccine. Ms. Krofah elaborated that the FDA and the Centers for Medicare & Medicaid will need to collaborate closely as studies evolve. In particular, CMS needs to be ready with reimbursement codes, recognizing that both public and private payers will likely be providing reimbursement for COVID-19 vaccinations.

“When these vaccines get approved, we are going to have to decide who is going to pay for them,” said Dr. Tan, who previously served as the director of medicine and public health at the American Medical Association. He noted that CPT coding comes through the AMA.

Dr. Marks stressed that ultimately, although treatments or prophylactic regimes against COVID-19 may be developed, “a vaccine is the most efficient way to protect large numbers of people.” Though there’s going to have to be a balancing act so speed doesn’t come at the expense of vaccine safety and efficacy. “We are very much hoping that we can find vaccines that have relatively high levels of efficacy,” he said, adding a hopeful point: “Right now there have not been mutations that have occurred … that would alter vaccine development programs in terms of the targets they’re going after.”

Dr. Marks offered a wildly optimistic – and then a more realistic – judgment as to when a successful vaccine might emerge from the development, trial, and approval process. After acknowledging that the FDA might consider an Emergency Use Authorization (EUA) if coronavirus activity is high when a candidate vaccine emerges, he said that “if everything goes perfectly,” an EUA for a vaccine might be issued within 9-12 months.

“The most likely timeline – and this is total speculation – is that it could be 12-18 months,” he said.

Ms. Krofah concurred, adding, “We’re seeing the big companies put a big bet on that timeline as well.” She cited Johnson & Johnson, which has committed to a $1 billion COVID-19 vaccine development program by the end of 2021.

Finally, when a vaccine does become available, who is first in line to receive it? Ms. Krofah said that it will be important for the public to know that there will be a tiering scheme for vaccine administration in the early days. Healthcare workers, emergency responders, and the particularly vulnerable may be among the first to receive protection, she said.

[email protected]

Extraordinary cooperation and accommodations are needed in the race to build a COVID-19 vaccine from scratch while chasing a pandemic, said members of industry and government who convened for an update on the vaccine clinical trial process.

The message came from representatives from the Food and Drug Administration, a think tank, and the nonprofit sector who provided some insight into the vaccine development process for COVID-19 at a press briefing hosted by the Commonwealth Fund.

Even in the best of times, vaccine development is not simple, said Litjen (L.J.) Tan, PhD, chief strategy officer for the Immunization Action Coalition. Ordinarily, the process can take from 10 to 20 years and cost well over a billion dollars. Many vaccines wind up being abandoned before phase 3 development just because the cost is prohibitive, he said.

Vaccines undergo extensive ongoing postmarketing surveillance even after approval, licensing, and distribution, noted Dr. Tan, adding that the development of a safe, effective vaccine is a “very complicated, significant process.”

In these extraordinary times, many adjustments to the usual trial trajectory are needed, agreed all participants. To speed the process, the traditional vaccine trajectory is being accelerated and compressed; changes may include simultaneous rather than sequential clinical trials that are run in parallel. These trials may be optimized for multiple target populations at the same time, and run in different countries, explained Dr. Tan.

“We are likely going to use something called adaptive trial designs” in which results are gathered during the trial and used to modify the trial according to prespecified rules, he said. “These trials shift to accommodate data as it comes up.”

Regulatory agencies are actively engaging in the process much earlier than usual, with input including how to incentivize scaling up production of vaccines and ensuring that vaccines will be fairly and equitably distributed across the globe, he added.

Esther Krofah is the executive director of FasterCures, a center within the nonprofit Milken Institute. Currently 86 different active COVID-19 vaccine projects are underway, she said, with 6 currently in clinical trials and about two dozen more expected to enter the clinical trial phase by the summer of 2020.

Many of these projects will involve a smaller biotech company or an academic research group with deep knowledge of a particular immune strategy partnering with a large pharmaceutical company that has economic capacity and global resources and reach, said Ms. Krofah.

From a policy perspective, she said, it’s important for the FDA to have surge capacity with “enough arms, legs, and staff to actively provide input into clinical design and protocols of studies.” The goal is to be able to review data in real-time and provide rapid feedback as studies are occurring so adaptive clinical trial design can be implemented.

As COVID-19 vaccine trials are rolled out, necessary compromises may include incorporation of real world evidence in later clinical trial stages. “There is a way to do randomized trials in the real world in situations that come up like this,” said Peter Marks, MD, the FDA’s director of the Center for Biologics Evaluation and Research. Long-term data about vaccine efficacy may be accrued over time, once a vaccine is being administered beyond the clinical trial stage, to see if efficacy wanes over time.

However, he said, “a lot will depend on where the vaccine is and what we encounter with whether there’s circulating virus or not” in terms of clinical trial design, including whether surrogate efficacy markers such as antibody production would be used.

Unvaccinated members of a population may be used as controls against a vaccinated group during an active outbreak, he said, a break from traditional trial design. “It’s not perfect. I’ll acknowledge right away there are certain people at the [National Institutes of Health] that would like to tell me that’s a horrible idea, but I think we are going to entertain and discuss all potential designs” for COVID-19 vaccine trials, he said. “We can’t out-of-hand dismiss any design here, whether real world based or evidence based.”

“This may be a little unusual hearing this from the FDA,” he said, “but this is possibly one of the most important things we are going to have to do in the next few years.” He added, “It’s unfortunately not unlikely that we will see a second wave, or maybe even a third wave, if we don’t get it right.”

He pointed out that there was no candidate vaccine in the pipeline when the pandemic blossomed and began its race around the globe. Current coronavirus candidates aren’t useful against COVID-19. “We know that there might be some complexities in development” related to the contributions of immune enhancement to the pathogenicity of the SARS-CoV-2 virus, he said.

The agency is currently working closely with sponsors of various candidate vaccines to take a hard look at preclinical data and trial design.

“Low efficacy could distract from capacity for more robust candidates to come forward,” he said. “We’d like to encourage people to have the absolute best vaccines. ... We hope to be able to facilitate rapid development of these,” he said.

Moving forward, a whole-government approach is necessary for development and delivery of the best vaccine. Ms. Krofah elaborated that the FDA and the Centers for Medicare & Medicaid will need to collaborate closely as studies evolve. In particular, CMS needs to be ready with reimbursement codes, recognizing that both public and private payers will likely be providing reimbursement for COVID-19 vaccinations.

“When these vaccines get approved, we are going to have to decide who is going to pay for them,” said Dr. Tan, who previously served as the director of medicine and public health at the American Medical Association. He noted that CPT coding comes through the AMA.

Dr. Marks stressed that ultimately, although treatments or prophylactic regimes against COVID-19 may be developed, “a vaccine is the most efficient way to protect large numbers of people.” Though there’s going to have to be a balancing act so speed doesn’t come at the expense of vaccine safety and efficacy. “We are very much hoping that we can find vaccines that have relatively high levels of efficacy,” he said, adding a hopeful point: “Right now there have not been mutations that have occurred … that would alter vaccine development programs in terms of the targets they’re going after.”

Dr. Marks offered a wildly optimistic – and then a more realistic – judgment as to when a successful vaccine might emerge from the development, trial, and approval process. After acknowledging that the FDA might consider an Emergency Use Authorization (EUA) if coronavirus activity is high when a candidate vaccine emerges, he said that “if everything goes perfectly,” an EUA for a vaccine might be issued within 9-12 months.

“The most likely timeline – and this is total speculation – is that it could be 12-18 months,” he said.

Ms. Krofah concurred, adding, “We’re seeing the big companies put a big bet on that timeline as well.” She cited Johnson & Johnson, which has committed to a $1 billion COVID-19 vaccine development program by the end of 2021.

Finally, when a vaccine does become available, who is first in line to receive it? Ms. Krofah said that it will be important for the public to know that there will be a tiering scheme for vaccine administration in the early days. Healthcare workers, emergency responders, and the particularly vulnerable may be among the first to receive protection, she said.

[email protected]

Extraordinary cooperation and accommodations are needed in the race to build a COVID-19 vaccine from scratch while chasing a pandemic, said members of industry and government who convened for an update on the vaccine clinical trial process.

The message came from representatives from the Food and Drug Administration, a think tank, and the nonprofit sector who provided some insight into the vaccine development process for COVID-19 at a press briefing hosted by the Commonwealth Fund.

Even in the best of times, vaccine development is not simple, said Litjen (L.J.) Tan, PhD, chief strategy officer for the Immunization Action Coalition. Ordinarily, the process can take from 10 to 20 years and cost well over a billion dollars. Many vaccines wind up being abandoned before phase 3 development just because the cost is prohibitive, he said.

Vaccines undergo extensive ongoing postmarketing surveillance even after approval, licensing, and distribution, noted Dr. Tan, adding that the development of a safe, effective vaccine is a “very complicated, significant process.”

In these extraordinary times, many adjustments to the usual trial trajectory are needed, agreed all participants. To speed the process, the traditional vaccine trajectory is being accelerated and compressed; changes may include simultaneous rather than sequential clinical trials that are run in parallel. These trials may be optimized for multiple target populations at the same time, and run in different countries, explained Dr. Tan.

“We are likely going to use something called adaptive trial designs” in which results are gathered during the trial and used to modify the trial according to prespecified rules, he said. “These trials shift to accommodate data as it comes up.”

Regulatory agencies are actively engaging in the process much earlier than usual, with input including how to incentivize scaling up production of vaccines and ensuring that vaccines will be fairly and equitably distributed across the globe, he added.

Esther Krofah is the executive director of FasterCures, a center within the nonprofit Milken Institute. Currently 86 different active COVID-19 vaccine projects are underway, she said, with 6 currently in clinical trials and about two dozen more expected to enter the clinical trial phase by the summer of 2020.

Many of these projects will involve a smaller biotech company or an academic research group with deep knowledge of a particular immune strategy partnering with a large pharmaceutical company that has economic capacity and global resources and reach, said Ms. Krofah.

From a policy perspective, she said, it’s important for the FDA to have surge capacity with “enough arms, legs, and staff to actively provide input into clinical design and protocols of studies.” The goal is to be able to review data in real-time and provide rapid feedback as studies are occurring so adaptive clinical trial design can be implemented.

As COVID-19 vaccine trials are rolled out, necessary compromises may include incorporation of real world evidence in later clinical trial stages. “There is a way to do randomized trials in the real world in situations that come up like this,” said Peter Marks, MD, the FDA’s director of the Center for Biologics Evaluation and Research. Long-term data about vaccine efficacy may be accrued over time, once a vaccine is being administered beyond the clinical trial stage, to see if efficacy wanes over time.

However, he said, “a lot will depend on where the vaccine is and what we encounter with whether there’s circulating virus or not” in terms of clinical trial design, including whether surrogate efficacy markers such as antibody production would be used.

Unvaccinated members of a population may be used as controls against a vaccinated group during an active outbreak, he said, a break from traditional trial design. “It’s not perfect. I’ll acknowledge right away there are certain people at the [National Institutes of Health] that would like to tell me that’s a horrible idea, but I think we are going to entertain and discuss all potential designs” for COVID-19 vaccine trials, he said. “We can’t out-of-hand dismiss any design here, whether real world based or evidence based.”

“This may be a little unusual hearing this from the FDA,” he said, “but this is possibly one of the most important things we are going to have to do in the next few years.” He added, “It’s unfortunately not unlikely that we will see a second wave, or maybe even a third wave, if we don’t get it right.”

He pointed out that there was no candidate vaccine in the pipeline when the pandemic blossomed and began its race around the globe. Current coronavirus candidates aren’t useful against COVID-19. “We know that there might be some complexities in development” related to the contributions of immune enhancement to the pathogenicity of the SARS-CoV-2 virus, he said.

The agency is currently working closely with sponsors of various candidate vaccines to take a hard look at preclinical data and trial design.

“Low efficacy could distract from capacity for more robust candidates to come forward,” he said. “We’d like to encourage people to have the absolute best vaccines. ... We hope to be able to facilitate rapid development of these,” he said.

Moving forward, a whole-government approach is necessary for development and delivery of the best vaccine. Ms. Krofah elaborated that the FDA and the Centers for Medicare & Medicaid will need to collaborate closely as studies evolve. In particular, CMS needs to be ready with reimbursement codes, recognizing that both public and private payers will likely be providing reimbursement for COVID-19 vaccinations.

“When these vaccines get approved, we are going to have to decide who is going to pay for them,” said Dr. Tan, who previously served as the director of medicine and public health at the American Medical Association. He noted that CPT coding comes through the AMA.

Dr. Marks stressed that ultimately, although treatments or prophylactic regimes against COVID-19 may be developed, “a vaccine is the most efficient way to protect large numbers of people.” Though there’s going to have to be a balancing act so speed doesn’t come at the expense of vaccine safety and efficacy. “We are very much hoping that we can find vaccines that have relatively high levels of efficacy,” he said, adding a hopeful point: “Right now there have not been mutations that have occurred … that would alter vaccine development programs in terms of the targets they’re going after.”

Dr. Marks offered a wildly optimistic – and then a more realistic – judgment as to when a successful vaccine might emerge from the development, trial, and approval process. After acknowledging that the FDA might consider an Emergency Use Authorization (EUA) if coronavirus activity is high when a candidate vaccine emerges, he said that “if everything goes perfectly,” an EUA for a vaccine might be issued within 9-12 months.

“The most likely timeline – and this is total speculation – is that it could be 12-18 months,” he said.

Ms. Krofah concurred, adding, “We’re seeing the big companies put a big bet on that timeline as well.” She cited Johnson & Johnson, which has committed to a $1 billion COVID-19 vaccine development program by the end of 2021.

Finally, when a vaccine does become available, who is first in line to receive it? Ms. Krofah said that it will be important for the public to know that there will be a tiering scheme for vaccine administration in the early days. Healthcare workers, emergency responders, and the particularly vulnerable may be among the first to receive protection, she said.

[email protected]

Evidence on the link between smoking and the likelihood of developing COVID-19 remains unclear to date, but quitting smoking is likely to lower the risk of developing more severe or fatal cases of the infection, according to research from several recent papers.

bilderbox/fotolia.com

Interest in how tobacco use affects COVID-19 infection rates stems from research showing that men at the epicenter of the outbreak in China having a higher early mortality rate. Early reports from China showed a case fatality rate of 4.7% for men, compared with 2.8% for women, according to the World Health Organization. The virus that causes COVID-19, severe acute respiratory syndrome coronavirus 2, is suspected to enter a cell using the ACE2 receptor. Since smoking up-regulates this receptor, one popular theory is that smoking can increase the risk of COVID-19 or exacerbate symptoms of an existing infection (Eur Respir J. 2020 Apr 8. doi: 10.1183/13993003.00688-2020). In China, about half of men are active smokers, compared with 2.7% of women (Transl Lung Cancer Res. 2019;8[Suppl 1]:S21-30), so this association would explain the severe cases and increased mortality in this group. In response to potential risk for public health, the World Health Organization, Centers for Disease Control and Prevention, the Attorney General of Massachusetts, and other organizations have warned that smoking may increase one’s risk of transmitting and developing COVID-19 or may worsen the infection.

“While it is easy to jump to the conclusion that more ACE2 means more susceptibility to severe infection, there is no evidence to support this,” Brandon Michael Henry, MD, of the cardiac intensive care unit and the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in an interview. “Moreover, some would argue (including myself) that increased ACE2 may in fact be protective, as ACE2 decreases the levels of angiotensin-2 which likely plays a significant role in the pathophysiology of ARDS.”

Some researchers have examined the limited evidence of smoking on COVID-19 risk and come to preliminary conclusions. In a letter to the editor recently published in the European Journal of Internal Medicine, Dr. Henry and Giuseppe Lippi, MD, of the section of clinical biochemistry in the department of neuroscience, biomedicine, and movement at the University of Verona (Italy), performed a meta-analysis of papers examining smoking and COVID-19 up to March 9, 2020 and identified five articles with 1,399 COVID-19 cases (Eur J Intern Med. 2020 Mar 16. doi: 10.1016/j.ejim.2020.03.014).

“Given the fact that COVID-19 is a primarily respiratory illness, smoking was one of first risk factors we examined,” Dr. Henry said.

They noted that a study by Liu et al. in the Chinese Medical Journal was the only paper that showed a significant association between smoking status and COVID-19 case severity (Chin Med J [Engl]. 2020 Feb 28. doi: 10.1097/CM9.0000000000000775), while the four other studies showed no significant association. The pooled data of all five studies showed an association that was not statistically significant (odds ratio, 1.69; 95% confidence interval, 0.41-6.92; P = .254). When Dr. Lippi and Dr. Henry performed the analysis again after removing a paper by Guan et al. (N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032) comprising 89.5% of patients in the pooled analysis, there was no significant association (OR, 4.35; 95% CI, 0.86-21.86; P = .129).

Constantine I. Vardavas, MD, FCCP, of the department of oral health policy and epidemiology at Harvard School of Dental Medicine, Boston, and Katerina Nikitara, of the University of Crete in Heraklion, Greece, also published a systematic review in Tobacco Induced Diseases of five studies evaluating smoking and COVID-19 (Tob Induc Dis. 2020. doi: 10.18332/tid/119324). Of the studies chosen for the review, four were shared with the paper by Dr. Lippi and Dr. Henry. They found “a higher percentage of smokers” made up severe COVID-19 cases, but acknowledged the majority of these were from the largest study by Guan et al. Overall, they calculated smokers carried a risk ratio of 1.4 (95% CI, 0.98-2.00) for developing severe COVID-19 symptoms, and were over twice as likely to be admitted to an ICU, require a mechanical ventilator, or die from COVID-19, compared with patients who did not smoke (RR, 2.4; 95% CI, 1.43-4.04).

“Although further research is warranted as the weight of the evidence increases, with the limited available data, and although the above results are unadjusted for other factors that may impact disease progression, smoking is most likely associated with the negative progression and adverse outcomes of COVID-19,” Dr. Vardavas and Ms. Nikitara concluded.

However, the association between smoking and severe disease was not significant, and it is not immediately clear how the analysis was performed based on the details in the editorial. “Both of our reports were limited by a lack of data adjusted for age, sex, and comorbidities which may influence any analysis on smoking,” Dr. Henry said.

Some researchers have proposed collecting information on smoking status and conducting further research on whether vaping devices like e-cigarettes also impact COVID-19 cases. An editorial by Samuel Brake and colleagues published in the Journal of Clinical Medicine proposed the ACE2-receptor binding site as an area of interest for COVID-19 and as a potential therapeutic target (J Clin Med. 2020 Mar 20. doi: 10.3390/jcm9030841).

Ultimately, whether smoking itself is associated with COVID-19 is still an open question. Nonetheless, encouraging patients to quit smoking should be a priority because long-term sequelae of smoking have been linked to worsened or fatal COVID-19 cases, said Dr. Henry.

“There is a lack of definitive data on smoking to date. Nonetheless, we do know that many illnesses associated with smoking, such as [chronic obstructive pulmonary disease, hypertension, and heart disease are all strong risk factors for severe and fatal COVID-19,” he said. “Thus, absolutely we should encourage the public to quit smoking, especially for older individuals and those with comorbidities.”

The papers by Lippi et al., Vardavas et al., and Brake et al. had no funding source, and the authors reported no relevant conflicts of interest.

Evidence on the link between smoking and the likelihood of developing COVID-19 remains unclear to date, but quitting smoking is likely to lower the risk of developing more severe or fatal cases of the infection, according to research from several recent papers.

bilderbox/fotolia.com

Interest in how tobacco use affects COVID-19 infection rates stems from research showing that men at the epicenter of the outbreak in China having a higher early mortality rate. Early reports from China showed a case fatality rate of 4.7% for men, compared with 2.8% for women, according to the World Health Organization. The virus that causes COVID-19, severe acute respiratory syndrome coronavirus 2, is suspected to enter a cell using the ACE2 receptor. Since smoking up-regulates this receptor, one popular theory is that smoking can increase the risk of COVID-19 or exacerbate symptoms of an existing infection (Eur Respir J. 2020 Apr 8. doi: 10.1183/13993003.00688-2020). In China, about half of men are active smokers, compared with 2.7% of women (Transl Lung Cancer Res. 2019;8[Suppl 1]:S21-30), so this association would explain the severe cases and increased mortality in this group. In response to potential risk for public health, the World Health Organization, Centers for Disease Control and Prevention, the Attorney General of Massachusetts, and other organizations have warned that smoking may increase one’s risk of transmitting and developing COVID-19 or may worsen the infection.

“While it is easy to jump to the conclusion that more ACE2 means more susceptibility to severe infection, there is no evidence to support this,” Brandon Michael Henry, MD, of the cardiac intensive care unit and the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in an interview. “Moreover, some would argue (including myself) that increased ACE2 may in fact be protective, as ACE2 decreases the levels of angiotensin-2 which likely plays a significant role in the pathophysiology of ARDS.”

Some researchers have examined the limited evidence of smoking on COVID-19 risk and come to preliminary conclusions. In a letter to the editor recently published in the European Journal of Internal Medicine, Dr. Henry and Giuseppe Lippi, MD, of the section of clinical biochemistry in the department of neuroscience, biomedicine, and movement at the University of Verona (Italy), performed a meta-analysis of papers examining smoking and COVID-19 up to March 9, 2020 and identified five articles with 1,399 COVID-19 cases (Eur J Intern Med. 2020 Mar 16. doi: 10.1016/j.ejim.2020.03.014).

“Given the fact that COVID-19 is a primarily respiratory illness, smoking was one of first risk factors we examined,” Dr. Henry said.

They noted that a study by Liu et al. in the Chinese Medical Journal was the only paper that showed a significant association between smoking status and COVID-19 case severity (Chin Med J [Engl]. 2020 Feb 28. doi: 10.1097/CM9.0000000000000775), while the four other studies showed no significant association. The pooled data of all five studies showed an association that was not statistically significant (odds ratio, 1.69; 95% confidence interval, 0.41-6.92; P = .254). When Dr. Lippi and Dr. Henry performed the analysis again after removing a paper by Guan et al. (N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032) comprising 89.5% of patients in the pooled analysis, there was no significant association (OR, 4.35; 95% CI, 0.86-21.86; P = .129).

Constantine I. Vardavas, MD, FCCP, of the department of oral health policy and epidemiology at Harvard School of Dental Medicine, Boston, and Katerina Nikitara, of the University of Crete in Heraklion, Greece, also published a systematic review in Tobacco Induced Diseases of five studies evaluating smoking and COVID-19 (Tob Induc Dis. 2020. doi: 10.18332/tid/119324). Of the studies chosen for the review, four were shared with the paper by Dr. Lippi and Dr. Henry. They found “a higher percentage of smokers” made up severe COVID-19 cases, but acknowledged the majority of these were from the largest study by Guan et al. Overall, they calculated smokers carried a risk ratio of 1.4 (95% CI, 0.98-2.00) for developing severe COVID-19 symptoms, and were over twice as likely to be admitted to an ICU, require a mechanical ventilator, or die from COVID-19, compared with patients who did not smoke (RR, 2.4; 95% CI, 1.43-4.04).

“Although further research is warranted as the weight of the evidence increases, with the limited available data, and although the above results are unadjusted for other factors that may impact disease progression, smoking is most likely associated with the negative progression and adverse outcomes of COVID-19,” Dr. Vardavas and Ms. Nikitara concluded.

However, the association between smoking and severe disease was not significant, and it is not immediately clear how the analysis was performed based on the details in the editorial. “Both of our reports were limited by a lack of data adjusted for age, sex, and comorbidities which may influence any analysis on smoking,” Dr. Henry said.

Some researchers have proposed collecting information on smoking status and conducting further research on whether vaping devices like e-cigarettes also impact COVID-19 cases. An editorial by Samuel Brake and colleagues published in the Journal of Clinical Medicine proposed the ACE2-receptor binding site as an area of interest for COVID-19 and as a potential therapeutic target (J Clin Med. 2020 Mar 20. doi: 10.3390/jcm9030841).

Ultimately, whether smoking itself is associated with COVID-19 is still an open question. Nonetheless, encouraging patients to quit smoking should be a priority because long-term sequelae of smoking have been linked to worsened or fatal COVID-19 cases, said Dr. Henry.

“There is a lack of definitive data on smoking to date. Nonetheless, we do know that many illnesses associated with smoking, such as [chronic obstructive pulmonary disease, hypertension, and heart disease are all strong risk factors for severe and fatal COVID-19,” he said. “Thus, absolutely we should encourage the public to quit smoking, especially for older individuals and those with comorbidities.”

The papers by Lippi et al., Vardavas et al., and Brake et al. had no funding source, and the authors reported no relevant conflicts of interest.

Evidence on the link between smoking and the likelihood of developing COVID-19 remains unclear to date, but quitting smoking is likely to lower the risk of developing more severe or fatal cases of the infection, according to research from several recent papers.

bilderbox/fotolia.com

Interest in how tobacco use affects COVID-19 infection rates stems from research showing that men at the epicenter of the outbreak in China having a higher early mortality rate. Early reports from China showed a case fatality rate of 4.7% for men, compared with 2.8% for women, according to the World Health Organization. The virus that causes COVID-19, severe acute respiratory syndrome coronavirus 2, is suspected to enter a cell using the ACE2 receptor. Since smoking up-regulates this receptor, one popular theory is that smoking can increase the risk of COVID-19 or exacerbate symptoms of an existing infection (Eur Respir J. 2020 Apr 8. doi: 10.1183/13993003.00688-2020). In China, about half of men are active smokers, compared with 2.7% of women (Transl Lung Cancer Res. 2019;8[Suppl 1]:S21-30), so this association would explain the severe cases and increased mortality in this group. In response to potential risk for public health, the World Health Organization, Centers for Disease Control and Prevention, the Attorney General of Massachusetts, and other organizations have warned that smoking may increase one’s risk of transmitting and developing COVID-19 or may worsen the infection.

“While it is easy to jump to the conclusion that more ACE2 means more susceptibility to severe infection, there is no evidence to support this,” Brandon Michael Henry, MD, of the cardiac intensive care unit and the Heart Institute at Cincinnati Children’s Hospital Medical Center, said in an interview. “Moreover, some would argue (including myself) that increased ACE2 may in fact be protective, as ACE2 decreases the levels of angiotensin-2 which likely plays a significant role in the pathophysiology of ARDS.”

Some researchers have examined the limited evidence of smoking on COVID-19 risk and come to preliminary conclusions. In a letter to the editor recently published in the European Journal of Internal Medicine, Dr. Henry and Giuseppe Lippi, MD, of the section of clinical biochemistry in the department of neuroscience, biomedicine, and movement at the University of Verona (Italy), performed a meta-analysis of papers examining smoking and COVID-19 up to March 9, 2020 and identified five articles with 1,399 COVID-19 cases (Eur J Intern Med. 2020 Mar 16. doi: 10.1016/j.ejim.2020.03.014).

“Given the fact that COVID-19 is a primarily respiratory illness, smoking was one of first risk factors we examined,” Dr. Henry said.

They noted that a study by Liu et al. in the Chinese Medical Journal was the only paper that showed a significant association between smoking status and COVID-19 case severity (Chin Med J [Engl]. 2020 Feb 28. doi: 10.1097/CM9.0000000000000775), while the four other studies showed no significant association. The pooled data of all five studies showed an association that was not statistically significant (odds ratio, 1.69; 95% confidence interval, 0.41-6.92; P = .254). When Dr. Lippi and Dr. Henry performed the analysis again after removing a paper by Guan et al. (N Engl J Med. 2020 Feb 28. doi: 10.1056/NEJMoa2002032) comprising 89.5% of patients in the pooled analysis, there was no significant association (OR, 4.35; 95% CI, 0.86-21.86; P = .129).

Constantine I. Vardavas, MD, FCCP, of the department of oral health policy and epidemiology at Harvard School of Dental Medicine, Boston, and Katerina Nikitara, of the University of Crete in Heraklion, Greece, also published a systematic review in Tobacco Induced Diseases of five studies evaluating smoking and COVID-19 (Tob Induc Dis. 2020. doi: 10.18332/tid/119324). Of the studies chosen for the review, four were shared with the paper by Dr. Lippi and Dr. Henry. They found “a higher percentage of smokers” made up severe COVID-19 cases, but acknowledged the majority of these were from the largest study by Guan et al. Overall, they calculated smokers carried a risk ratio of 1.4 (95% CI, 0.98-2.00) for developing severe COVID-19 symptoms, and were over twice as likely to be admitted to an ICU, require a mechanical ventilator, or die from COVID-19, compared with patients who did not smoke (RR, 2.4; 95% CI, 1.43-4.04).

“Although further research is warranted as the weight of the evidence increases, with the limited available data, and although the above results are unadjusted for other factors that may impact disease progression, smoking is most likely associated with the negative progression and adverse outcomes of COVID-19,” Dr. Vardavas and Ms. Nikitara concluded.

However, the association between smoking and severe disease was not significant, and it is not immediately clear how the analysis was performed based on the details in the editorial. “Both of our reports were limited by a lack of data adjusted for age, sex, and comorbidities which may influence any analysis on smoking,” Dr. Henry said.

Some researchers have proposed collecting information on smoking status and conducting further research on whether vaping devices like e-cigarettes also impact COVID-19 cases. An editorial by Samuel Brake and colleagues published in the Journal of Clinical Medicine proposed the ACE2-receptor binding site as an area of interest for COVID-19 and as a potential therapeutic target (J Clin Med. 2020 Mar 20. doi: 10.3390/jcm9030841).

Ultimately, whether smoking itself is associated with COVID-19 is still an open question. Nonetheless, encouraging patients to quit smoking should be a priority because long-term sequelae of smoking have been linked to worsened or fatal COVID-19 cases, said Dr. Henry.

“There is a lack of definitive data on smoking to date. Nonetheless, we do know that many illnesses associated with smoking, such as [chronic obstructive pulmonary disease, hypertension, and heart disease are all strong risk factors for severe and fatal COVID-19,” he said. “Thus, absolutely we should encourage the public to quit smoking, especially for older individuals and those with comorbidities.”

The papers by Lippi et al., Vardavas et al., and Brake et al. had no funding source, and the authors reported no relevant conflicts of interest.

When March began, Valerie Vaughn, MD, split her time between caring for general inpatients at the University of Michigan’s hospitals in Ann Arbor and doing research on how to reduce overuse of antibiotics in hospitals nationwide.

By the time the month was over, she had helped create a new kind of hospital team focused on caring for patients with COVID-19, learned how to provide an intensive level of care for the sickest among them, trained hundreds of physicians in how to do the same, and created free online learning tools for physicians nationwide.

Call it switching gears while driving a race car. Changing horses in the middle of a raging river. Or going to medical boot camp. Whatever the metaphor, Dr. Vaughn and her colleagues did it.

And now they’re hoping that sharing what they learned will help others if their hospitals go through the same thing.
 

Near the epicenter

Michigan Medicine, the University of Michigan’s academic medical center, is a few dozen miles west of the Detroit hospitals that have become a national epicenter for COVID-19 cases. It’s gotten plenty of direct and transferred COVID-19 patients since mid-March.

When Dr. Vaughn’s boss, division of hospital medicine chief Vineet Chopra, MD, was tapped to lead the creation of an all-COVID unit, he asked Dr. Vaughn to work with him and the team of hospitalists, nurse practitioners, physician assistants, nurses, respiratory therapists, and other staff that had volunteered for the team.

They had 3 days to prepare.

The “SWAT team”, as Dr. Vaughn calls it, opened the RICU, or Regional Infectious Containment Unit, on March 16. They doubled the number of beds 2 weeks later.

By the end of March, the team had handed over the reins to a team of experienced intensive care professionals so the unit could focus on the sickest patients. And the RICU team had moved on to transforming other areas of the hospital, and training their staff, in the same way.

By early April, more than 200 beds across the University of Michigan’s hospitals were devoted to COVID-19 care. General medicine physicians who hadn’t practiced inside a hospital since their residency days – thanks to the ability to hand off to hospitalists – were being pulled into inpatient duty. Hospitalists were being pulled into caring for patients who would normally have been in the care of an intensive care team.

“What’s amazed me most is how much people have stepped up to the challenge,” says Dr. Vaughn. “As hard and uncomfortable as it is to do something you’re not typically doing, it can also be therapeutic to say how can I help, let me do something. Yes, they’re anxious, but they want to know how they can be as prepared as they can be, to be as helpful as possible to these patients.”

Dr. Chopra agrees. “The silver lining in all of this is that I have personally seen the best in us come to the surface. Nurses, physicians, pharmacists, and therapists have come together and have shown selflessness, kindness, empathy and resilience in profound ways.”
 

Making the leap

Even though they didn’t choose hospital medicine, or ICU medicine, as their specialty, physicians may greatly underestimate how useful they can be with a little just-in-time training and the help of residents, fellows, advanced practice providers, and experienced nurses and respiratory therapists. 

That training is now available for free through Michigan Medicine’s new online COVID-19 CME portal. The session in “Inpatient Management of COVID-19 patients” provides an important overview for those who have never cared for a case, especially if they haven’t been on inpatient duty in a while. The ICU Bootcamp is for those who will be caring for sicker COVID-19 patients but haven’t practiced in an ICU for a while.

One of the most important roles of a COVID-19 inpatient physician, Dr. Vaughn notes, doesn’t involve new skills. Rather, it draws on the doctoring skills that general medicine and hospital medicine physicians have already honed: the ability to assess and treat the entire patient, to talk with families who can’t be with their loved ones, to humanize the experience for patients and their loved ones as much as possible, and to bring messages of love from the family back to the bedside.

By pairing a general medicine physician newly placed on inpatient duty with a resident, nurse practitioner, or physician assistant who can handle inpatient charting duties, the team can make the most of each kind of provider’s time. Administrators, too, can reduce the burden on the entire team by simplifying processes for what must be charted and recorded in the EMR.

“Hospitals facing a COVID-19 crunch need to make it easier for teams to focus on the medicine and the human connection” and to shorten the learning curve for those shifting into unfamiliar duties, she advises.
 

Other lessons learned

Placing COVID-19 patients on the same unit, and keeping non–COVID-19 patients in another area of the hospital, isn’t just a good idea for protecting uninfected patients, Dr. Vaughn notes. It’s also good for providers who are getting used to treating COVID-19 because they don’t have to shift between the needs of different types of patients as they go from room to room.

“The learning curve is steep, but after a couple of days taking care of these patients, you have a good feeling about how to care for them and a great sense of camaraderie with the rest of the team involved in caring for them,” she says. “Everyone jumps in to help because they know we’re in this as a team and that it’s OK for respiratory therapists to step up to help a physician who doesn’t know as much about ventilator care or for nurses to suggest medications based on what other physicians have used.”

The flattening of professional hierarchies long ingrained in hospitals may be a side effect of the tremendous and urgent sense of mission that has developed around responding to COVID-19, Dr. Vaughn notes.

Those stepping into new roles should invite their colleagues to alert them when they see them about to slip up on protective practices that might be new to them. Similarly, they should help each other resist the urge to rush into a COVID-19 patient’s room unprotected in order to help with an urgent situation. The safety of providers – to preserve their ability to care for the many more patients who will need them – must be paramount.

“To handle this pandemic, we need to all be all-in and working toward a common goal, without competing priorities,” she says. “We need to use everyone’s skill sets to the fullest, without creating burnout. We’re going to be different when all this is done.”

Avoiding provider burnout is harder than ever because team members caring for COVID-19 must stay apart from family at home and avoid in-person visits with loved ones and friends. Those who are switching to inpatient or ICU-level care should make a point of focusing on exercise, sleep, virtual connections with loved ones, and healthy eating in between shifts.

“You’re no good to anyone else if you’re not healthy,” Dr. Vaughn says. “Your mental and physical health have to come first because they enable you to help others.”

Paying attention to the appreciation that the community is showing health care workers can also brighten the day of a stressed COVID-19 inpatient clinician, she notes.

“All the little signs of love from the community – the thank you signs, sidewalk chalk drawings, hearts in people’s windows – really do help.”

This article is published courtesy of the University of Michigan Health Lab, where it appeared originally.

When March began, Valerie Vaughn, MD, split her time between caring for general inpatients at the University of Michigan’s hospitals in Ann Arbor and doing research on how to reduce overuse of antibiotics in hospitals nationwide.

By the time the month was over, she had helped create a new kind of hospital team focused on caring for patients with COVID-19, learned how to provide an intensive level of care for the sickest among them, trained hundreds of physicians in how to do the same, and created free online learning tools for physicians nationwide.

Call it switching gears while driving a race car. Changing horses in the middle of a raging river. Or going to medical boot camp. Whatever the metaphor, Dr. Vaughn and her colleagues did it.

And now they’re hoping that sharing what they learned will help others if their hospitals go through the same thing.
 

Near the epicenter

Michigan Medicine, the University of Michigan’s academic medical center, is a few dozen miles west of the Detroit hospitals that have become a national epicenter for COVID-19 cases. It’s gotten plenty of direct and transferred COVID-19 patients since mid-March.

When Dr. Vaughn’s boss, division of hospital medicine chief Vineet Chopra, MD, was tapped to lead the creation of an all-COVID unit, he asked Dr. Vaughn to work with him and the team of hospitalists, nurse practitioners, physician assistants, nurses, respiratory therapists, and other staff that had volunteered for the team.

They had 3 days to prepare.

The “SWAT team”, as Dr. Vaughn calls it, opened the RICU, or Regional Infectious Containment Unit, on March 16. They doubled the number of beds 2 weeks later.

By the end of March, the team had handed over the reins to a team of experienced intensive care professionals so the unit could focus on the sickest patients. And the RICU team had moved on to transforming other areas of the hospital, and training their staff, in the same way.

By early April, more than 200 beds across the University of Michigan’s hospitals were devoted to COVID-19 care. General medicine physicians who hadn’t practiced inside a hospital since their residency days – thanks to the ability to hand off to hospitalists – were being pulled into inpatient duty. Hospitalists were being pulled into caring for patients who would normally have been in the care of an intensive care team.

“What’s amazed me most is how much people have stepped up to the challenge,” says Dr. Vaughn. “As hard and uncomfortable as it is to do something you’re not typically doing, it can also be therapeutic to say how can I help, let me do something. Yes, they’re anxious, but they want to know how they can be as prepared as they can be, to be as helpful as possible to these patients.”

Dr. Chopra agrees. “The silver lining in all of this is that I have personally seen the best in us come to the surface. Nurses, physicians, pharmacists, and therapists have come together and have shown selflessness, kindness, empathy and resilience in profound ways.”
 

Making the leap

Even though they didn’t choose hospital medicine, or ICU medicine, as their specialty, physicians may greatly underestimate how useful they can be with a little just-in-time training and the help of residents, fellows, advanced practice providers, and experienced nurses and respiratory therapists. 

That training is now available for free through Michigan Medicine’s new online COVID-19 CME portal. The session in “Inpatient Management of COVID-19 patients” provides an important overview for those who have never cared for a case, especially if they haven’t been on inpatient duty in a while. The ICU Bootcamp is for those who will be caring for sicker COVID-19 patients but haven’t practiced in an ICU for a while.

One of the most important roles of a COVID-19 inpatient physician, Dr. Vaughn notes, doesn’t involve new skills. Rather, it draws on the doctoring skills that general medicine and hospital medicine physicians have already honed: the ability to assess and treat the entire patient, to talk with families who can’t be with their loved ones, to humanize the experience for patients and their loved ones as much as possible, and to bring messages of love from the family back to the bedside.

By pairing a general medicine physician newly placed on inpatient duty with a resident, nurse practitioner, or physician assistant who can handle inpatient charting duties, the team can make the most of each kind of provider’s time. Administrators, too, can reduce the burden on the entire team by simplifying processes for what must be charted and recorded in the EMR.

“Hospitals facing a COVID-19 crunch need to make it easier for teams to focus on the medicine and the human connection” and to shorten the learning curve for those shifting into unfamiliar duties, she advises.
 

Other lessons learned

Placing COVID-19 patients on the same unit, and keeping non–COVID-19 patients in another area of the hospital, isn’t just a good idea for protecting uninfected patients, Dr. Vaughn notes. It’s also good for providers who are getting used to treating COVID-19 because they don’t have to shift between the needs of different types of patients as they go from room to room.

“The learning curve is steep, but after a couple of days taking care of these patients, you have a good feeling about how to care for them and a great sense of camaraderie with the rest of the team involved in caring for them,” she says. “Everyone jumps in to help because they know we’re in this as a team and that it’s OK for respiratory therapists to step up to help a physician who doesn’t know as much about ventilator care or for nurses to suggest medications based on what other physicians have used.”

The flattening of professional hierarchies long ingrained in hospitals may be a side effect of the tremendous and urgent sense of mission that has developed around responding to COVID-19, Dr. Vaughn notes.

Those stepping into new roles should invite their colleagues to alert them when they see them about to slip up on protective practices that might be new to them. Similarly, they should help each other resist the urge to rush into a COVID-19 patient’s room unprotected in order to help with an urgent situation. The safety of providers – to preserve their ability to care for the many more patients who will need them – must be paramount.

“To handle this pandemic, we need to all be all-in and working toward a common goal, without competing priorities,” she says. “We need to use everyone’s skill sets to the fullest, without creating burnout. We’re going to be different when all this is done.”

Avoiding provider burnout is harder than ever because team members caring for COVID-19 must stay apart from family at home and avoid in-person visits with loved ones and friends. Those who are switching to inpatient or ICU-level care should make a point of focusing on exercise, sleep, virtual connections with loved ones, and healthy eating in between shifts.

“You’re no good to anyone else if you’re not healthy,” Dr. Vaughn says. “Your mental and physical health have to come first because they enable you to help others.”

Paying attention to the appreciation that the community is showing health care workers can also brighten the day of a stressed COVID-19 inpatient clinician, she notes.

“All the little signs of love from the community – the thank you signs, sidewalk chalk drawings, hearts in people’s windows – really do help.”

This article is published courtesy of the University of Michigan Health Lab, where it appeared originally.

When March began, Valerie Vaughn, MD, split her time between caring for general inpatients at the University of Michigan’s hospitals in Ann Arbor and doing research on how to reduce overuse of antibiotics in hospitals nationwide.

By the time the month was over, she had helped create a new kind of hospital team focused on caring for patients with COVID-19, learned how to provide an intensive level of care for the sickest among them, trained hundreds of physicians in how to do the same, and created free online learning tools for physicians nationwide.

Call it switching gears while driving a race car. Changing horses in the middle of a raging river. Or going to medical boot camp. Whatever the metaphor, Dr. Vaughn and her colleagues did it.

And now they’re hoping that sharing what they learned will help others if their hospitals go through the same thing.
 

Near the epicenter

Michigan Medicine, the University of Michigan’s academic medical center, is a few dozen miles west of the Detroit hospitals that have become a national epicenter for COVID-19 cases. It’s gotten plenty of direct and transferred COVID-19 patients since mid-March.

When Dr. Vaughn’s boss, division of hospital medicine chief Vineet Chopra, MD, was tapped to lead the creation of an all-COVID unit, he asked Dr. Vaughn to work with him and the team of hospitalists, nurse practitioners, physician assistants, nurses, respiratory therapists, and other staff that had volunteered for the team.

They had 3 days to prepare.

The “SWAT team”, as Dr. Vaughn calls it, opened the RICU, or Regional Infectious Containment Unit, on March 16. They doubled the number of beds 2 weeks later.

By the end of March, the team had handed over the reins to a team of experienced intensive care professionals so the unit could focus on the sickest patients. And the RICU team had moved on to transforming other areas of the hospital, and training their staff, in the same way.

By early April, more than 200 beds across the University of Michigan’s hospitals were devoted to COVID-19 care. General medicine physicians who hadn’t practiced inside a hospital since their residency days – thanks to the ability to hand off to hospitalists – were being pulled into inpatient duty. Hospitalists were being pulled into caring for patients who would normally have been in the care of an intensive care team.

“What’s amazed me most is how much people have stepped up to the challenge,” says Dr. Vaughn. “As hard and uncomfortable as it is to do something you’re not typically doing, it can also be therapeutic to say how can I help, let me do something. Yes, they’re anxious, but they want to know how they can be as prepared as they can be, to be as helpful as possible to these patients.”

Dr. Chopra agrees. “The silver lining in all of this is that I have personally seen the best in us come to the surface. Nurses, physicians, pharmacists, and therapists have come together and have shown selflessness, kindness, empathy and resilience in profound ways.”
 

Making the leap

Even though they didn’t choose hospital medicine, or ICU medicine, as their specialty, physicians may greatly underestimate how useful they can be with a little just-in-time training and the help of residents, fellows, advanced practice providers, and experienced nurses and respiratory therapists. 

That training is now available for free through Michigan Medicine’s new online COVID-19 CME portal. The session in “Inpatient Management of COVID-19 patients” provides an important overview for those who have never cared for a case, especially if they haven’t been on inpatient duty in a while. The ICU Bootcamp is for those who will be caring for sicker COVID-19 patients but haven’t practiced in an ICU for a while.

One of the most important roles of a COVID-19 inpatient physician, Dr. Vaughn notes, doesn’t involve new skills. Rather, it draws on the doctoring skills that general medicine and hospital medicine physicians have already honed: the ability to assess and treat the entire patient, to talk with families who can’t be with their loved ones, to humanize the experience for patients and their loved ones as much as possible, and to bring messages of love from the family back to the bedside.

By pairing a general medicine physician newly placed on inpatient duty with a resident, nurse practitioner, or physician assistant who can handle inpatient charting duties, the team can make the most of each kind of provider’s time. Administrators, too, can reduce the burden on the entire team by simplifying processes for what must be charted and recorded in the EMR.

“Hospitals facing a COVID-19 crunch need to make it easier for teams to focus on the medicine and the human connection” and to shorten the learning curve for those shifting into unfamiliar duties, she advises.
 

Other lessons learned

Placing COVID-19 patients on the same unit, and keeping non–COVID-19 patients in another area of the hospital, isn’t just a good idea for protecting uninfected patients, Dr. Vaughn notes. It’s also good for providers who are getting used to treating COVID-19 because they don’t have to shift between the needs of different types of patients as they go from room to room.

“The learning curve is steep, but after a couple of days taking care of these patients, you have a good feeling about how to care for them and a great sense of camaraderie with the rest of the team involved in caring for them,” she says. “Everyone jumps in to help because they know we’re in this as a team and that it’s OK for respiratory therapists to step up to help a physician who doesn’t know as much about ventilator care or for nurses to suggest medications based on what other physicians have used.”

The flattening of professional hierarchies long ingrained in hospitals may be a side effect of the tremendous and urgent sense of mission that has developed around responding to COVID-19, Dr. Vaughn notes.

Those stepping into new roles should invite their colleagues to alert them when they see them about to slip up on protective practices that might be new to them. Similarly, they should help each other resist the urge to rush into a COVID-19 patient’s room unprotected in order to help with an urgent situation. The safety of providers – to preserve their ability to care for the many more patients who will need them – must be paramount.

“To handle this pandemic, we need to all be all-in and working toward a common goal, without competing priorities,” she says. “We need to use everyone’s skill sets to the fullest, without creating burnout. We’re going to be different when all this is done.”

Avoiding provider burnout is harder than ever because team members caring for COVID-19 must stay apart from family at home and avoid in-person visits with loved ones and friends. Those who are switching to inpatient or ICU-level care should make a point of focusing on exercise, sleep, virtual connections with loved ones, and healthy eating in between shifts.

“You’re no good to anyone else if you’re not healthy,” Dr. Vaughn says. “Your mental and physical health have to come first because they enable you to help others.”

Paying attention to the appreciation that the community is showing health care workers can also brighten the day of a stressed COVID-19 inpatient clinician, she notes.

“All the little signs of love from the community – the thank you signs, sidewalk chalk drawings, hearts in people’s windows – really do help.”

This article is published courtesy of the University of Michigan Health Lab, where it appeared originally.

Each night, while my 2-year-old is having her dinner of macaroni and cheese or chicken nuggets, we video chat with my elderly parents. It used to be that this time was mainly my daughter showing off her newfound fork skills, but lately it has become “elderly parent education hour.”

“Well, we’re trying to decide if we should go to the bridge club,” announced my mother early in the week of March 13th.

“No, mom! Under no circumstances should you go to the bridge club! Social distance! Stay home! If I’ve given up restaurants and babysitters and am sitting here every night holding a phone covered in mac and cheese grease, you can give up the bridge club!”

I am all for keeping my elderly parents as isolated as possible during these pandemic times. I wasn’t alone in my fear that they weren’t taking my advice seriously: My social media feed was subsequently filled with posts from other physicians who had also been educating their parents about the need for social distancing.

Then, just as we were all settling into “social distancing,” on March 20, a debate emerged on the opinion pages of The New York Times that took the argument to the next level: A former professor of mine suggested a move from a policy of “horizontal interdiction” (one that restricts the movement of the entire population, without taking risk into consideration) to a “vertical interdiction” strategy that focuses on sequestering those among us most likely to experience poor outcomes from coronavirus infection (eg, the elderly, people with chronic diseases, and the immunologically compromised).¹

This first piece was followed 2 days later on March 22 by an article from a regular New York Times contributor who called social distancing “groupthink” and then seconded the vertical interdiction proposal.² Both pieces referred to the downturn in the economy as the reason the policy would be an improvement on social distancing; they argued that lost jobs and services would cause less suffering and loss than a policy that required extended isolation of the elderly.

On closer inspection, however, vertical interdiction is different and much scarier than “social distancing.” The words used by the author of the original article gave a clue: “If we were to focus on the especially vulnerable, there would be resources to keep them at home, provide them with needed services and coronavirus testing, and direct our medical system to their early care. I would favor proactive rather than reactive testing.” This was not just a plan to keep my parents from the bridge club. This was a plan for forced quarantine, mandatory testing, and months of isolation. Almost immediately, physicians and policy makers identified feasibility problems with the idea.³ To name a few, it is not clear that the death rate in young people is all that low; even with removing elders from the equation, the demand for hospital and critical care services is rapidly overwhelming supply; testing the “herd immunity” hypothesis in real time with a virus that has a death rate of 1%-3% still runs the risk of causing millions of deaths.

I will add a few more reasons why this idea of vertical interdiction was never feasible: There is no existing structure to facilitate mandatory isolation and quarantine of elders. We have no mechanism for caring for elders who are isolated at home. We cannot rapidly design the digital health monitoring needed. We cannot provide the mobile testing proposed. In the case of seniors who require nursing care, the problems would be even greater. Our recent efforts to protect patients in nursing facilities have proven to be extremely difficult. The greatest problem is finding a way to keep the staff from bringing the virus into the facility (and there are many staff: nutrition services, nursing, patient care technicians, physical therapy, social work). The only possible answer to this issue might mean wearing extensive protective equipment, similar to physicians in Wuhan⁴ (full-head hood plus goggles). Imagine being a patient in this scenario: months of being bathed, dressed, fed, and helped to the bathroom by a person in an isolation suit.

Now, just a few weeks later, with the virus spreading and many nonelders on ventilators, the idea of “elderly sequestration” as it was presented in mid-March feels dated and irrelevant. However, the episode can and should teach us a more important lesson: The idea was fatally flawed not only because it was not feasible but primarily because it was so lacking in compassion.

The lack of compassion was not just related to the fact that patients with end-stage dementia will undoubtedly be confused and frightened when confronted with months of care administered by people in hazmat suits. It is also that the proposed policy, by creating pockets of isolation, felt like a setup for missteps and subsequent rampant infection. My first thought was that these policies would not protect vulnerable elders but hide them from view, causing another situation like the one at Lifecare in Kirkland, Washington, which resulted in more than 35 deaths.⁵ This time, our policies (and not just our carelessness) would be responsible for creating it.

While writing this article, sadly, such a thing has happened, just miles from my home. The Soldiers Home in Holyoke, Massachusetts, is a skilled nursing facility that has generally been very highly regarded by veterans and their families. Unfortunately, a lack of responsiveness to the current pandemic, including failure to provide protective equipment, failure to remove symptomatic staff from frontline care, and a lack of transparency about symptomatic staff and patients has resulted in a scandal and a tragedy.⁶ Over 5 days at the end of March, eight veterans died of coronavirus without patients being sent to hospitals and without the cases being reported to either Massachusetts or local officials. Many other patients in the facility also tested positive for coronavirus, as did staff members. While this incident was not driven by a vertical interdiction policy, it was the result of actions taken to isolate and sequester elders from the community. The worst (and most symbolic) injustice was the fact that, because of rules about disposing of bodies with coronavirus (and possibly to cover up the incompetence that led to the deaths), the bodies of deceased veterans were piled into a refrigeration truck sitting in the parking lot of the facility as the tragedy unfolded.

This is a defining moment for physicians, for the healthcare system, and for our society. I am so proud of my colleagues who have stepped up, shown up, worn their (sometimes improvised) personal protective equipment and kept seeing patients because it is our job and it is part of the contract we entered into when we became physicians. Our policy choices in this moment are just as important, and it is not our ability to “get the economy started again” but our sacrifices now (or lack thereof) that will be remembered for a hundred years. Choosing patients over profit, compassion over callousness, are important not just for controlling hospital volumes and reserving intensive care unit beds, but also for preserving our professional integrity and saving our humanity.

Each night, while my 2-year-old is having her dinner of macaroni and cheese or chicken nuggets, we video chat with my elderly parents. It used to be that this time was mainly my daughter showing off her newfound fork skills, but lately it has become “elderly parent education hour.”

“Well, we’re trying to decide if we should go to the bridge club,” announced my mother early in the week of March 13th.

“No, mom! Under no circumstances should you go to the bridge club! Social distance! Stay home! If I’ve given up restaurants and babysitters and am sitting here every night holding a phone covered in mac and cheese grease, you can give up the bridge club!”

I am all for keeping my elderly parents as isolated as possible during these pandemic times. I wasn’t alone in my fear that they weren’t taking my advice seriously: My social media feed was subsequently filled with posts from other physicians who had also been educating their parents about the need for social distancing.

Then, just as we were all settling into “social distancing,” on March 20, a debate emerged on the opinion pages of The New York Times that took the argument to the next level: A former professor of mine suggested a move from a policy of “horizontal interdiction” (one that restricts the movement of the entire population, without taking risk into consideration) to a “vertical interdiction” strategy that focuses on sequestering those among us most likely to experience poor outcomes from coronavirus infection (eg, the elderly, people with chronic diseases, and the immunologically compromised).¹

This first piece was followed 2 days later on March 22 by an article from a regular New York Times contributor who called social distancing “groupthink” and then seconded the vertical interdiction proposal.² Both pieces referred to the downturn in the economy as the reason the policy would be an improvement on social distancing; they argued that lost jobs and services would cause less suffering and loss than a policy that required extended isolation of the elderly.

On closer inspection, however, vertical interdiction is different and much scarier than “social distancing.” The words used by the author of the original article gave a clue: “If we were to focus on the especially vulnerable, there would be resources to keep them at home, provide them with needed services and coronavirus testing, and direct our medical system to their early care. I would favor proactive rather than reactive testing.” This was not just a plan to keep my parents from the bridge club. This was a plan for forced quarantine, mandatory testing, and months of isolation. Almost immediately, physicians and policy makers identified feasibility problems with the idea.³ To name a few, it is not clear that the death rate in young people is all that low; even with removing elders from the equation, the demand for hospital and critical care services is rapidly overwhelming supply; testing the “herd immunity” hypothesis in real time with a virus that has a death rate of 1%-3% still runs the risk of causing millions of deaths.

I will add a few more reasons why this idea of vertical interdiction was never feasible: There is no existing structure to facilitate mandatory isolation and quarantine of elders. We have no mechanism for caring for elders who are isolated at home. We cannot rapidly design the digital health monitoring needed. We cannot provide the mobile testing proposed. In the case of seniors who require nursing care, the problems would be even greater. Our recent efforts to protect patients in nursing facilities have proven to be extremely difficult. The greatest problem is finding a way to keep the staff from bringing the virus into the facility (and there are many staff: nutrition services, nursing, patient care technicians, physical therapy, social work). The only possible answer to this issue might mean wearing extensive protective equipment, similar to physicians in Wuhan⁴ (full-head hood plus goggles). Imagine being a patient in this scenario: months of being bathed, dressed, fed, and helped to the bathroom by a person in an isolation suit.

Now, just a few weeks later, with the virus spreading and many nonelders on ventilators, the idea of “elderly sequestration” as it was presented in mid-March feels dated and irrelevant. However, the episode can and should teach us a more important lesson: The idea was fatally flawed not only because it was not feasible but primarily because it was so lacking in compassion.

The lack of compassion was not just related to the fact that patients with end-stage dementia will undoubtedly be confused and frightened when confronted with months of care administered by people in hazmat suits. It is also that the proposed policy, by creating pockets of isolation, felt like a setup for missteps and subsequent rampant infection. My first thought was that these policies would not protect vulnerable elders but hide them from view, causing another situation like the one at Lifecare in Kirkland, Washington, which resulted in more than 35 deaths.⁵ This time, our policies (and not just our carelessness) would be responsible for creating it.

While writing this article, sadly, such a thing has happened, just miles from my home. The Soldiers Home in Holyoke, Massachusetts, is a skilled nursing facility that has generally been very highly regarded by veterans and their families. Unfortunately, a lack of responsiveness to the current pandemic, including failure to provide protective equipment, failure to remove symptomatic staff from frontline care, and a lack of transparency about symptomatic staff and patients has resulted in a scandal and a tragedy.⁶ Over 5 days at the end of March, eight veterans died of coronavirus without patients being sent to hospitals and without the cases being reported to either Massachusetts or local officials. Many other patients in the facility also tested positive for coronavirus, as did staff members. While this incident was not driven by a vertical interdiction policy, it was the result of actions taken to isolate and sequester elders from the community. The worst (and most symbolic) injustice was the fact that, because of rules about disposing of bodies with coronavirus (and possibly to cover up the incompetence that led to the deaths), the bodies of deceased veterans were piled into a refrigeration truck sitting in the parking lot of the facility as the tragedy unfolded.

This is a defining moment for physicians, for the healthcare system, and for our society. I am so proud of my colleagues who have stepped up, shown up, worn their (sometimes improvised) personal protective equipment and kept seeing patients because it is our job and it is part of the contract we entered into when we became physicians. Our policy choices in this moment are just as important, and it is not our ability to “get the economy started again” but our sacrifices now (or lack thereof) that will be remembered for a hundred years. Choosing patients over profit, compassion over callousness, are important not just for controlling hospital volumes and reserving intensive care unit beds, but also for preserving our professional integrity and saving our humanity.

Each night, while my 2-year-old is having her dinner of macaroni and cheese or chicken nuggets, we video chat with my elderly parents. It used to be that this time was mainly my daughter showing off her newfound fork skills, but lately it has become “elderly parent education hour.”

“Well, we’re trying to decide if we should go to the bridge club,” announced my mother early in the week of March 13th.

“No, mom! Under no circumstances should you go to the bridge club! Social distance! Stay home! If I’ve given up restaurants and babysitters and am sitting here every night holding a phone covered in mac and cheese grease, you can give up the bridge club!”

I am all for keeping my elderly parents as isolated as possible during these pandemic times. I wasn’t alone in my fear that they weren’t taking my advice seriously: My social media feed was subsequently filled with posts from other physicians who had also been educating their parents about the need for social distancing.

Then, just as we were all settling into “social distancing,” on March 20, a debate emerged on the opinion pages of The New York Times that took the argument to the next level: A former professor of mine suggested a move from a policy of “horizontal interdiction” (one that restricts the movement of the entire population, without taking risk into consideration) to a “vertical interdiction” strategy that focuses on sequestering those among us most likely to experience poor outcomes from coronavirus infection (eg, the elderly, people with chronic diseases, and the immunologically compromised).¹

This first piece was followed 2 days later on March 22 by an article from a regular New York Times contributor who called social distancing “groupthink” and then seconded the vertical interdiction proposal.² Both pieces referred to the downturn in the economy as the reason the policy would be an improvement on social distancing; they argued that lost jobs and services would cause less suffering and loss than a policy that required extended isolation of the elderly.

On closer inspection, however, vertical interdiction is different and much scarier than “social distancing.” The words used by the author of the original article gave a clue: “If we were to focus on the especially vulnerable, there would be resources to keep them at home, provide them with needed services and coronavirus testing, and direct our medical system to their early care. I would favor proactive rather than reactive testing.” This was not just a plan to keep my parents from the bridge club. This was a plan for forced quarantine, mandatory testing, and months of isolation. Almost immediately, physicians and policy makers identified feasibility problems with the idea.³ To name a few, it is not clear that the death rate in young people is all that low; even with removing elders from the equation, the demand for hospital and critical care services is rapidly overwhelming supply; testing the “herd immunity” hypothesis in real time with a virus that has a death rate of 1%-3% still runs the risk of causing millions of deaths.

I will add a few more reasons why this idea of vertical interdiction was never feasible: There is no existing structure to facilitate mandatory isolation and quarantine of elders. We have no mechanism for caring for elders who are isolated at home. We cannot rapidly design the digital health monitoring needed. We cannot provide the mobile testing proposed. In the case of seniors who require nursing care, the problems would be even greater. Our recent efforts to protect patients in nursing facilities have proven to be extremely difficult. The greatest problem is finding a way to keep the staff from bringing the virus into the facility (and there are many staff: nutrition services, nursing, patient care technicians, physical therapy, social work). The only possible answer to this issue might mean wearing extensive protective equipment, similar to physicians in Wuhan⁴ (full-head hood plus goggles). Imagine being a patient in this scenario: months of being bathed, dressed, fed, and helped to the bathroom by a person in an isolation suit.

Now, just a few weeks later, with the virus spreading and many nonelders on ventilators, the idea of “elderly sequestration” as it was presented in mid-March feels dated and irrelevant. However, the episode can and should teach us a more important lesson: The idea was fatally flawed not only because it was not feasible but primarily because it was so lacking in compassion.

The lack of compassion was not just related to the fact that patients with end-stage dementia will undoubtedly be confused and frightened when confronted with months of care administered by people in hazmat suits. It is also that the proposed policy, by creating pockets of isolation, felt like a setup for missteps and subsequent rampant infection. My first thought was that these policies would not protect vulnerable elders but hide them from view, causing another situation like the one at Lifecare in Kirkland, Washington, which resulted in more than 35 deaths.⁵ This time, our policies (and not just our carelessness) would be responsible for creating it.

While writing this article, sadly, such a thing has happened, just miles from my home. The Soldiers Home in Holyoke, Massachusetts, is a skilled nursing facility that has generally been very highly regarded by veterans and their families. Unfortunately, a lack of responsiveness to the current pandemic, including failure to provide protective equipment, failure to remove symptomatic staff from frontline care, and a lack of transparency about symptomatic staff and patients has resulted in a scandal and a tragedy.⁶ Over 5 days at the end of March, eight veterans died of coronavirus without patients being sent to hospitals and without the cases being reported to either Massachusetts or local officials. Many other patients in the facility also tested positive for coronavirus, as did staff members. While this incident was not driven by a vertical interdiction policy, it was the result of actions taken to isolate and sequester elders from the community. The worst (and most symbolic) injustice was the fact that, because of rules about disposing of bodies with coronavirus (and possibly to cover up the incompetence that led to the deaths), the bodies of deceased veterans were piled into a refrigeration truck sitting in the parking lot of the facility as the tragedy unfolded.

This is a defining moment for physicians, for the healthcare system, and for our society. I am so proud of my colleagues who have stepped up, shown up, worn their (sometimes improvised) personal protective equipment and kept seeing patients because it is our job and it is part of the contract we entered into when we became physicians. Our policy choices in this moment are just as important, and it is not our ability to “get the economy started again” but our sacrifices now (or lack thereof) that will be remembered for a hundred years. Choosing patients over profit, compassion over callousness, are important not just for controlling hospital volumes and reserving intensive care unit beds, but also for preserving our professional integrity and saving our humanity.

People with hypothyroidism who choose desiccated thyroid extract (DTE) over levothyroxine alone perceive that it works better, but patients may not be aware of the risks, new research suggests.

Those were among the findings from qualitative analyses of nearly 700 online posts from three popular online hypothyroidism forums that found that 75% of patients felt they fared better on DTE than the standard therapy of levothyroxine (LT4).

A select group of patients do better on combined T4/T3

Asked to comment, endocrinologist Rachel Pessah-Pollack, MD, of New York University Langone Health, said in an interview, “Animal-derived desiccated thyroid hormone contains both T4 and T3. We typically do not recommend using this because it can vary in concentration, meaning that the actual preparation is not physiologic.”

Dr. Pessah-Pollack, a coauthor of the 2012 joint clinical practice guidelines on hypothyroidism by the American Thyroid Association and American Association of Clinical Endocrinologists, added that one of the major concerns about using DTE is the risk for iatrogenic hyperthyroidism, which could potentially lead to atrial fibrillation and fractures.

“That is one of the main factors that drive many professional societies to really use caution regarding DTE. That’s also why major societies recommend against using DTE ... based on the evidence to date,” she said.

The whole issue of “combination therapy” in hypothyroidism is contentious, however. Physicians can also prescribe a “combination” of synthetic levothyroxine (LT4) and triiodothyronine (LT3) treatment; this, along with use of DTE products, has been a subject of debate for many years.

The current (2014) American Thyroid Association guidelines do not specifically rule out use of synthetic LT4/LT3 therapy, rather they “recommend only against the routine use of combination therapy.” And although they don’t expressly endorse use of DTE, they removed a statement saying it “should not be used.”

“There is definitely a select group of patients who do better on combined T4/T3 treatment, and we’re still trying to delineate who that population is,”Dr. Pessah-Pollack said.

“As long as these patients are closely monitored and aware of the risk of hyperthyroidism and have their levels followed to ensure that they’re not hyperthyroid, in select cases this is appropriate.”

“But, first-line is ensuring that a good evaluation occurs. ... Clearly this helps us understand that we do need more studies in this area – well-designed, blinded studies to really help us get to the bottom of this controversy.”
 

Those taking DTE cite improved symptoms, well-being

Dr. Toloza and colleagues analyzed 673 posts from three online forums, WebMD (Medscape’s parent company), PatientsLikeMe, and Drugs.com, selected from an initial 1,235 posts because they included more complete information.

About half (51%, n = 257) of patients had primary hypothyroidism/Hashimoto’s thyroiditis, 25% (n = 126) had postsurgical hypothyroidism, and 16% (n = 81) had postablation hypothyroidism. Among the 172 posts in which DTE dose information was available, the mean dose was 84.1 mg/day. Treatment duration ranged widely, from 2 weeks to 45 years.

Among the posts describing the source of the DTE prescription, the initial interest was driven mainly by the patient in 54% (n = 88), while 46% (n = 74) said that a clinician drove their interest in trying DTE. (The type of clinician was not reported.)

Among posts mentioning the source of DTE, local pharmacies were the most common (63%, n = 75), followed by pharmacies outside the United States (31%, n = 37), and online (6%, n = 7).

Previous thyroid treatments were mentioned in 300 posts, of which 93% mentioned LT4 monotherapy.

Among the reasons for changing to DTE were no improvement in clinical symptoms (47%, n = 75), development of side effects (24%, n = 38), no change in overall well-being (22%, n = 36), and no changes in laboratory work-up (7%, n = 12).

Perceived benefits of DTE included improvement in clinical symptoms (56%, n = 155), change in overall well-being (34%, n = 94), possibility of reaching previous health status (7%, n = 19), and low cost, compared with previous treatment (3%, n = 8).

Specific symptoms reported to have improved included fatigue (28%, n = 43), weight gain (17%, n = 26), and neurocognitive symptoms (5%, n = 8). The average time to notice benefits with DTE was about 30 days but ranged widely from 2 days to 4 months.

The majority of posts (77%, n = 99) stated that DTE was more effective than their previous therapy, while 13% (n = 17) described it as equally effective, and 10% (n = 13) said it was less effective.

Side effects of DTE were described by 20% (n = 136), including weight loss (15%), fatigue (11%), palpitations (11%), heat intolerance (11%), sleep disturbances (10%), high blood pressure (7%), and hair loss (5%).
 

“Doctors think they know how u feel”

A qualitative analysis of the posts yielded five major themes: experience with previous therapies before starting DTE, perceived effectiveness and benefits of DTE, DTE side effects, need for individualized therapy for hypothyroidism, and barriers to obtaining DTE.

One patient posted: “Synthroid [levothyroxine] did not help ... and gives me bad side effects. ... My endocrinologist blamed all side effects on everything except the Synthroid.”

Another wrote, “It [Armour] changed my life. ...I’m glad I found a medication that makes me feel normal again. ... All have improved; moods, skin (no itching), no headaches, goiter is down.”

Others cited the lower cost of Armour compared with Synthroid.

However, some expressed negative experiences with DTE, such as, “My doctor expected that this medication would help me with brain fog, energy, and tiredness. I experienced the opposite.”

And some couldn’t obtain it. One wrote, “Doctors think they know how u feel and do not even tell you about Armour. I asked my doctor and was told there was not enough studies on it to show its effectiveness.”
 

Better evaluation, more data needed

Dr. Pessah-Pollack pointed out that the study data don’t address whether patients’ initially prescribed levothyroxine doses were optimal, and noted that sometimes changes are needed, such as during pregnancy, following weight gain, or if the patient is taking other certain medications.

“It’s unclear from patient-reported symptoms whether or not they actually had an evaluation of their thyroid levels to ensure that their dose of thyroid hormone was correct before switching over to T4/T3 replacement. ... There are many factors that need to be taken into account before we decide that the medication itself isn’t working.”

What’s sorely needed, she said, are “well-designed, blinded studies that look at this controversy.”

“Here, we don’t know why patients are feeling better. ... We need to do additional work including validated symptom questionnaires and comparing thyroid levels of patients who are on Armour thyroid with those on levothyroxine monotherapy.”

Dr. Toloza agrees: “It is not possible to say that DTE is working better for the user due to the limitations and the nature of the data used in our study.”

“However, our findings are in-line with previously published research, which has shown that a subset of patients may prefer DTE to levothyroxine and have higher satisfaction with this treatment. Nevertheless, the reason behind this is still not well understood,” and it should be further investigated.

Dr. Toloza and colleagues reported that they had no conflicts of interests. Dr. Pessah-Pollack has reported being an adviser for Boehringer Ingelheim-Eli Lilly and Radius Health, and a moderator for Sanofi.

This article first appeared on Medscape.com.

People with hypothyroidism who choose desiccated thyroid extract (DTE) over levothyroxine alone perceive that it works better, but patients may not be aware of the risks, new research suggests.

Those were among the findings from qualitative analyses of nearly 700 online posts from three popular online hypothyroidism forums that found that 75% of patients felt they fared better on DTE than the standard therapy of levothyroxine (LT4).

A select group of patients do better on combined T4/T3

Asked to comment, endocrinologist Rachel Pessah-Pollack, MD, of New York University Langone Health, said in an interview, “Animal-derived desiccated thyroid hormone contains both T4 and T3. We typically do not recommend using this because it can vary in concentration, meaning that the actual preparation is not physiologic.”

Dr. Pessah-Pollack, a coauthor of the 2012 joint clinical practice guidelines on hypothyroidism by the American Thyroid Association and American Association of Clinical Endocrinologists, added that one of the major concerns about using DTE is the risk for iatrogenic hyperthyroidism, which could potentially lead to atrial fibrillation and fractures.

“That is one of the main factors that drive many professional societies to really use caution regarding DTE. That’s also why major societies recommend against using DTE ... based on the evidence to date,” she said.

The whole issue of “combination therapy” in hypothyroidism is contentious, however. Physicians can also prescribe a “combination” of synthetic levothyroxine (LT4) and triiodothyronine (LT3) treatment; this, along with use of DTE products, has been a subject of debate for many years.

The current (2014) American Thyroid Association guidelines do not specifically rule out use of synthetic LT4/LT3 therapy, rather they “recommend only against the routine use of combination therapy.” And although they don’t expressly endorse use of DTE, they removed a statement saying it “should not be used.”

“There is definitely a select group of patients who do better on combined T4/T3 treatment, and we’re still trying to delineate who that population is,”Dr. Pessah-Pollack said.

“As long as these patients are closely monitored and aware of the risk of hyperthyroidism and have their levels followed to ensure that they’re not hyperthyroid, in select cases this is appropriate.”

“But, first-line is ensuring that a good evaluation occurs. ... Clearly this helps us understand that we do need more studies in this area – well-designed, blinded studies to really help us get to the bottom of this controversy.”
 

Those taking DTE cite improved symptoms, well-being

Dr. Toloza and colleagues analyzed 673 posts from three online forums, WebMD (Medscape’s parent company), PatientsLikeMe, and Drugs.com, selected from an initial 1,235 posts because they included more complete information.

About half (51%, n = 257) of patients had primary hypothyroidism/Hashimoto’s thyroiditis, 25% (n = 126) had postsurgical hypothyroidism, and 16% (n = 81) had postablation hypothyroidism. Among the 172 posts in which DTE dose information was available, the mean dose was 84.1 mg/day. Treatment duration ranged widely, from 2 weeks to 45 years.

Among the posts describing the source of the DTE prescription, the initial interest was driven mainly by the patient in 54% (n = 88), while 46% (n = 74) said that a clinician drove their interest in trying DTE. (The type of clinician was not reported.)

Among posts mentioning the source of DTE, local pharmacies were the most common (63%, n = 75), followed by pharmacies outside the United States (31%, n = 37), and online (6%, n = 7).

Previous thyroid treatments were mentioned in 300 posts, of which 93% mentioned LT4 monotherapy.

Among the reasons for changing to DTE were no improvement in clinical symptoms (47%, n = 75), development of side effects (24%, n = 38), no change in overall well-being (22%, n = 36), and no changes in laboratory work-up (7%, n = 12).

Perceived benefits of DTE included improvement in clinical symptoms (56%, n = 155), change in overall well-being (34%, n = 94), possibility of reaching previous health status (7%, n = 19), and low cost, compared with previous treatment (3%, n = 8).

Specific symptoms reported to have improved included fatigue (28%, n = 43), weight gain (17%, n = 26), and neurocognitive symptoms (5%, n = 8). The average time to notice benefits with DTE was about 30 days but ranged widely from 2 days to 4 months.

The majority of posts (77%, n = 99) stated that DTE was more effective than their previous therapy, while 13% (n = 17) described it as equally effective, and 10% (n = 13) said it was less effective.

Side effects of DTE were described by 20% (n = 136), including weight loss (15%), fatigue (11%), palpitations (11%), heat intolerance (11%), sleep disturbances (10%), high blood pressure (7%), and hair loss (5%).
 

“Doctors think they know how u feel”

A qualitative analysis of the posts yielded five major themes: experience with previous therapies before starting DTE, perceived effectiveness and benefits of DTE, DTE side effects, need for individualized therapy for hypothyroidism, and barriers to obtaining DTE.

One patient posted: “Synthroid [levothyroxine] did not help ... and gives me bad side effects. ... My endocrinologist blamed all side effects on everything except the Synthroid.”

Another wrote, “It [Armour] changed my life. ...I’m glad I found a medication that makes me feel normal again. ... All have improved; moods, skin (no itching), no headaches, goiter is down.”

Others cited the lower cost of Armour compared with Synthroid.

However, some expressed negative experiences with DTE, such as, “My doctor expected that this medication would help me with brain fog, energy, and tiredness. I experienced the opposite.”

And some couldn’t obtain it. One wrote, “Doctors think they know how u feel and do not even tell you about Armour. I asked my doctor and was told there was not enough studies on it to show its effectiveness.”
 

Better evaluation, more data needed

Dr. Pessah-Pollack pointed out that the study data don’t address whether patients’ initially prescribed levothyroxine doses were optimal, and noted that sometimes changes are needed, such as during pregnancy, following weight gain, or if the patient is taking other certain medications.

“It’s unclear from patient-reported symptoms whether or not they actually had an evaluation of their thyroid levels to ensure that their dose of thyroid hormone was correct before switching over to T4/T3 replacement. ... There are many factors that need to be taken into account before we decide that the medication itself isn’t working.”

What’s sorely needed, she said, are “well-designed, blinded studies that look at this controversy.”

“Here, we don’t know why patients are feeling better. ... We need to do additional work including validated symptom questionnaires and comparing thyroid levels of patients who are on Armour thyroid with those on levothyroxine monotherapy.”

Dr. Toloza agrees: “It is not possible to say that DTE is working better for the user due to the limitations and the nature of the data used in our study.”

“However, our findings are in-line with previously published research, which has shown that a subset of patients may prefer DTE to levothyroxine and have higher satisfaction with this treatment. Nevertheless, the reason behind this is still not well understood,” and it should be further investigated.

Dr. Toloza and colleagues reported that they had no conflicts of interests. Dr. Pessah-Pollack has reported being an adviser for Boehringer Ingelheim-Eli Lilly and Radius Health, and a moderator for Sanofi.

This article first appeared on Medscape.com.

People with hypothyroidism who choose desiccated thyroid extract (DTE) over levothyroxine alone perceive that it works better, but patients may not be aware of the risks, new research suggests.

Those were among the findings from qualitative analyses of nearly 700 online posts from three popular online hypothyroidism forums that found that 75% of patients felt they fared better on DTE than the standard therapy of levothyroxine (LT4).

A select group of patients do better on combined T4/T3

Asked to comment, endocrinologist Rachel Pessah-Pollack, MD, of New York University Langone Health, said in an interview, “Animal-derived desiccated thyroid hormone contains both T4 and T3. We typically do not recommend using this because it can vary in concentration, meaning that the actual preparation is not physiologic.”

Dr. Pessah-Pollack, a coauthor of the 2012 joint clinical practice guidelines on hypothyroidism by the American Thyroid Association and American Association of Clinical Endocrinologists, added that one of the major concerns about using DTE is the risk for iatrogenic hyperthyroidism, which could potentially lead to atrial fibrillation and fractures.

“That is one of the main factors that drive many professional societies to really use caution regarding DTE. That’s also why major societies recommend against using DTE ... based on the evidence to date,” she said.

The whole issue of “combination therapy” in hypothyroidism is contentious, however. Physicians can also prescribe a “combination” of synthetic levothyroxine (LT4) and triiodothyronine (LT3) treatment; this, along with use of DTE products, has been a subject of debate for many years.

The current (2014) American Thyroid Association guidelines do not specifically rule out use of synthetic LT4/LT3 therapy, rather they “recommend only against the routine use of combination therapy.” And although they don’t expressly endorse use of DTE, they removed a statement saying it “should not be used.”

“There is definitely a select group of patients who do better on combined T4/T3 treatment, and we’re still trying to delineate who that population is,”Dr. Pessah-Pollack said.

“As long as these patients are closely monitored and aware of the risk of hyperthyroidism and have their levels followed to ensure that they’re not hyperthyroid, in select cases this is appropriate.”

“But, first-line is ensuring that a good evaluation occurs. ... Clearly this helps us understand that we do need more studies in this area – well-designed, blinded studies to really help us get to the bottom of this controversy.”
 

Those taking DTE cite improved symptoms, well-being

Dr. Toloza and colleagues analyzed 673 posts from three online forums, WebMD (Medscape’s parent company), PatientsLikeMe, and Drugs.com, selected from an initial 1,235 posts because they included more complete information.

About half (51%, n = 257) of patients had primary hypothyroidism/Hashimoto’s thyroiditis, 25% (n = 126) had postsurgical hypothyroidism, and 16% (n = 81) had postablation hypothyroidism. Among the 172 posts in which DTE dose information was available, the mean dose was 84.1 mg/day. Treatment duration ranged widely, from 2 weeks to 45 years.

Among the posts describing the source of the DTE prescription, the initial interest was driven mainly by the patient in 54% (n = 88), while 46% (n = 74) said that a clinician drove their interest in trying DTE. (The type of clinician was not reported.)

Among posts mentioning the source of DTE, local pharmacies were the most common (63%, n = 75), followed by pharmacies outside the United States (31%, n = 37), and online (6%, n = 7).

Previous thyroid treatments were mentioned in 300 posts, of which 93% mentioned LT4 monotherapy.

Among the reasons for changing to DTE were no improvement in clinical symptoms (47%, n = 75), development of side effects (24%, n = 38), no change in overall well-being (22%, n = 36), and no changes in laboratory work-up (7%, n = 12).

Perceived benefits of DTE included improvement in clinical symptoms (56%, n = 155), change in overall well-being (34%, n = 94), possibility of reaching previous health status (7%, n = 19), and low cost, compared with previous treatment (3%, n = 8).

Specific symptoms reported to have improved included fatigue (28%, n = 43), weight gain (17%, n = 26), and neurocognitive symptoms (5%, n = 8). The average time to notice benefits with DTE was about 30 days but ranged widely from 2 days to 4 months.

The majority of posts (77%, n = 99) stated that DTE was more effective than their previous therapy, while 13% (n = 17) described it as equally effective, and 10% (n = 13) said it was less effective.

Side effects of DTE were described by 20% (n = 136), including weight loss (15%), fatigue (11%), palpitations (11%), heat intolerance (11%), sleep disturbances (10%), high blood pressure (7%), and hair loss (5%).
 

“Doctors think they know how u feel”

A qualitative analysis of the posts yielded five major themes: experience with previous therapies before starting DTE, perceived effectiveness and benefits of DTE, DTE side effects, need for individualized therapy for hypothyroidism, and barriers to obtaining DTE.

One patient posted: “Synthroid [levothyroxine] did not help ... and gives me bad side effects. ... My endocrinologist blamed all side effects on everything except the Synthroid.”

Another wrote, “It [Armour] changed my life. ...I’m glad I found a medication that makes me feel normal again. ... All have improved; moods, skin (no itching), no headaches, goiter is down.”

Others cited the lower cost of Armour compared with Synthroid.

However, some expressed negative experiences with DTE, such as, “My doctor expected that this medication would help me with brain fog, energy, and tiredness. I experienced the opposite.”

And some couldn’t obtain it. One wrote, “Doctors think they know how u feel and do not even tell you about Armour. I asked my doctor and was told there was not enough studies on it to show its effectiveness.”
 

Better evaluation, more data needed

Dr. Pessah-Pollack pointed out that the study data don’t address whether patients’ initially prescribed levothyroxine doses were optimal, and noted that sometimes changes are needed, such as during pregnancy, following weight gain, or if the patient is taking other certain medications.

“It’s unclear from patient-reported symptoms whether or not they actually had an evaluation of their thyroid levels to ensure that their dose of thyroid hormone was correct before switching over to T4/T3 replacement. ... There are many factors that need to be taken into account before we decide that the medication itself isn’t working.”

What’s sorely needed, she said, are “well-designed, blinded studies that look at this controversy.”

“Here, we don’t know why patients are feeling better. ... We need to do additional work including validated symptom questionnaires and comparing thyroid levels of patients who are on Armour thyroid with those on levothyroxine monotherapy.”

Dr. Toloza agrees: “It is not possible to say that DTE is working better for the user due to the limitations and the nature of the data used in our study.”

“However, our findings are in-line with previously published research, which has shown that a subset of patients may prefer DTE to levothyroxine and have higher satisfaction with this treatment. Nevertheless, the reason behind this is still not well understood,” and it should be further investigated.

Dr. Toloza and colleagues reported that they had no conflicts of interests. Dr. Pessah-Pollack has reported being an adviser for Boehringer Ingelheim-Eli Lilly and Radius Health, and a moderator for Sanofi.

This article first appeared on Medscape.com.

“All VA facilities are equipped with essential items and supplies, and we are continually monitoring the status of those items to ensure a robust supply chain,” US Department of Veterans Affairs (VA) Press Secretary Christina Noel insisted on April 14th. The problem? The Wall Street Journal had just reported that internal VA memos detailing concerns about shortages in personal protective equipment (PPE), including memos saying PPE rationing had begun, were circulating at the highest levels. Top VA officials, including Secretary Robert Wilkie, had been briefed several times on systemwide shortages, the memos indicated.

The department had about 2 weeks’ worth of masks on hand, the Journal said, according to a briefing made to Congress several days earlier.

One April 7, 2020 memo noted that the “United States is experiencing challenges procuring adequate supplies of [facemasks and N95 respirators] to protect Veterans Health Administration (VHA) staff” and suggested limiting access to PPE. “Mask supply levels in VHA do not support providing masks to all other employees not working directly with COVID-19 infected veterans,” the memo noted. The memo also recommended that one mask per day for health care workers involved in “screening program activities” and taking care of “COVID-19 positive patients not undergoing high risk procedures.” Even employees “performing high risk procedures or activities on suspect or confirmed COVID19 patients,” were recommended to “wear an N95 respirator for extended use with multiple COVID-19 patients.”

Secretary Wilkie conceded to the Wall Street Journal that,  “[W]e don’t have the supplies that we would have in an optimal situation, we have the supplies that we need as the [CDC] prescribes.”

The VA COVID-19 National Summary reported 5,468 positive cases of COVID-19 and 339 inpatient deaths on April 20. Although the rate of infection for veterans remains low—just .06% of veterans in the VHA system have tested positive—the 6.2% rate of death is higher than the US rate (4.6%) and nearly as high as the global rate. More than 1,600 employees at the VHA have tested positive for COVID-19, according to the VA, and 14 medical center employees had died of complications due to the virus.

The VA now appears to be increasing the number of health workers allotted protective masks. In an April 15 email, Executive in Charge Richard A. Stone, MD, sought to reassure VHA employees. “VA always had a contingency supply of PPE,” Stone explained. “However, when this crisis started to face every healthcare organization in the nation, it became more difficult to project our incoming supply chain. For this reason, and out of an abundance of caution, we implemented austerity measures to ensure that every person working with COVID-19 patients had the equipment they needed.”

According to Stone, the VA is now more confident in its supply chain. Under his direction “all employees in a community living center, spinal cord injury unit or inpatient mental health unit will receive one mask a day to support their duties. We will continue providing N95 masks to those directly in contact with COVID-19-positive patients.”

“Your safety is the most important thing to us – we need to protect you,” Stone insisted. “I give you my word that we are doing everything to help you continue to take care of our Veterans.

“All VA facilities are equipped with essential items and supplies, and we are continually monitoring the status of those items to ensure a robust supply chain,” US Department of Veterans Affairs (VA) Press Secretary Christina Noel insisted on April 14th. The problem? The Wall Street Journal had just reported that internal VA memos detailing concerns about shortages in personal protective equipment (PPE), including memos saying PPE rationing had begun, were circulating at the highest levels. Top VA officials, including Secretary Robert Wilkie, had been briefed several times on systemwide shortages, the memos indicated.

The department had about 2 weeks’ worth of masks on hand, the Journal said, according to a briefing made to Congress several days earlier.

One April 7, 2020 memo noted that the “United States is experiencing challenges procuring adequate supplies of [facemasks and N95 respirators] to protect Veterans Health Administration (VHA) staff” and suggested limiting access to PPE. “Mask supply levels in VHA do not support providing masks to all other employees not working directly with COVID-19 infected veterans,” the memo noted. The memo also recommended that one mask per day for health care workers involved in “screening program activities” and taking care of “COVID-19 positive patients not undergoing high risk procedures.” Even employees “performing high risk procedures or activities on suspect or confirmed COVID19 patients,” were recommended to “wear an N95 respirator for extended use with multiple COVID-19 patients.”

Secretary Wilkie conceded to the Wall Street Journal that,  “[W]e don’t have the supplies that we would have in an optimal situation, we have the supplies that we need as the [CDC] prescribes.”

The VA COVID-19 National Summary reported 5,468 positive cases of COVID-19 and 339 inpatient deaths on April 20. Although the rate of infection for veterans remains low—just .06% of veterans in the VHA system have tested positive—the 6.2% rate of death is higher than the US rate (4.6%) and nearly as high as the global rate. More than 1,600 employees at the VHA have tested positive for COVID-19, according to the VA, and 14 medical center employees had died of complications due to the virus.

The VA now appears to be increasing the number of health workers allotted protective masks. In an April 15 email, Executive in Charge Richard A. Stone, MD, sought to reassure VHA employees. “VA always had a contingency supply of PPE,” Stone explained. “However, when this crisis started to face every healthcare organization in the nation, it became more difficult to project our incoming supply chain. For this reason, and out of an abundance of caution, we implemented austerity measures to ensure that every person working with COVID-19 patients had the equipment they needed.”

According to Stone, the VA is now more confident in its supply chain. Under his direction “all employees in a community living center, spinal cord injury unit or inpatient mental health unit will receive one mask a day to support their duties. We will continue providing N95 masks to those directly in contact with COVID-19-positive patients.”

“Your safety is the most important thing to us – we need to protect you,” Stone insisted. “I give you my word that we are doing everything to help you continue to take care of our Veterans.

“All VA facilities are equipped with essential items and supplies, and we are continually monitoring the status of those items to ensure a robust supply chain,” US Department of Veterans Affairs (VA) Press Secretary Christina Noel insisted on April 14th. The problem? The Wall Street Journal had just reported that internal VA memos detailing concerns about shortages in personal protective equipment (PPE), including memos saying PPE rationing had begun, were circulating at the highest levels. Top VA officials, including Secretary Robert Wilkie, had been briefed several times on systemwide shortages, the memos indicated.

The department had about 2 weeks’ worth of masks on hand, the Journal said, according to a briefing made to Congress several days earlier.

One April 7, 2020 memo noted that the “United States is experiencing challenges procuring adequate supplies of [facemasks and N95 respirators] to protect Veterans Health Administration (VHA) staff” and suggested limiting access to PPE. “Mask supply levels in VHA do not support providing masks to all other employees not working directly with COVID-19 infected veterans,” the memo noted. The memo also recommended that one mask per day for health care workers involved in “screening program activities” and taking care of “COVID-19 positive patients not undergoing high risk procedures.” Even employees “performing high risk procedures or activities on suspect or confirmed COVID19 patients,” were recommended to “wear an N95 respirator for extended use with multiple COVID-19 patients.”

Secretary Wilkie conceded to the Wall Street Journal that,  “[W]e don’t have the supplies that we would have in an optimal situation, we have the supplies that we need as the [CDC] prescribes.”

The VA COVID-19 National Summary reported 5,468 positive cases of COVID-19 and 339 inpatient deaths on April 20. Although the rate of infection for veterans remains low—just .06% of veterans in the VHA system have tested positive—the 6.2% rate of death is higher than the US rate (4.6%) and nearly as high as the global rate. More than 1,600 employees at the VHA have tested positive for COVID-19, according to the VA, and 14 medical center employees had died of complications due to the virus.

The VA now appears to be increasing the number of health workers allotted protective masks. In an April 15 email, Executive in Charge Richard A. Stone, MD, sought to reassure VHA employees. “VA always had a contingency supply of PPE,” Stone explained. “However, when this crisis started to face every healthcare organization in the nation, it became more difficult to project our incoming supply chain. For this reason, and out of an abundance of caution, we implemented austerity measures to ensure that every person working with COVID-19 patients had the equipment they needed.”

According to Stone, the VA is now more confident in its supply chain. Under his direction “all employees in a community living center, spinal cord injury unit or inpatient mental health unit will receive one mask a day to support their duties. We will continue providing N95 masks to those directly in contact with COVID-19-positive patients.”

“Your safety is the most important thing to us – we need to protect you,” Stone insisted. “I give you my word that we are doing everything to help you continue to take care of our Veterans.

As I write, I must admit this message is different than the one I’d envisioned sharing with you weeks ago. I anticipated updating you on meetings and collaborations with sister societies, new educational offerings, and how the Bologna World Congress and Annual Meeting plans were progressing, but activities at CHEST – and our sense of priority – have evolved along with those of our global community.

Pulmonary and critical care providers are now at the forefront of health care. Our patients, and now the greater public, are relying on our efforts and those of our teams. Amid this crisis, there is a renewed appreciation for the work all of you do; and with it, an opportunity for CHEST to lead and help ensure that the profession and our systems emerge stronger.

Back in February, we held the program committee meeting for the Annual Meeting with over 1000 submissions. It is astounding how the program came together over just a few days thanks to the preemptive work done by Chair, Dr. Victor Test, and, Co-Chair, Dr. Christopher Carroll, and all of the curricular groups, program committee members, and staff putting in so much work prior to the face-to-face meeting. Also during February, CHEST leadership held the Forum of International Respiratory Societies’ (FIRS) strategic planning meeting. The main outcome is a plan to engage a lobbyist to represent the worldwide respiratory societies in the WHO in Geneva on universal topics such as air pollution and now, unfortunately, COVID-19. CHEST was represented at the Society of Critical Care Medicine (SCCM) Congress where we heard late-breaking information as the pandemic was beginning to unfold. We met with the Critical Care Societies Collaborative (CCSC), which is composed of representatives from CHEST, SCCM, the American Thoracic Society (ATS), and the American Association of Critical-Care Nurses (AACN). We had an opportunity to meet with the European Society of Intensive Care Medicine (ESICM) and initiate discussions toward future collaboration.

In early March, as COVID-19 began to interfere with in-person meetings, we participated virtually in the NAMDRC meeting, and finalized our commitment to formally joining forces under the umbrella of CHEST to better serve our members in the area of advocacy. To this end, a new standing CHEST committee was founded, consisting of members from the former NAMRDC Board and members from the CHEST Board of Regents and Board of Trustees and chaired by Dr. Neil Freedman and Dr. Jim Lamberti. We look forward to hosting advocacy sessions during our October meeting, and going forward, our Spring Leadership Meeting will be combined with the former NAMDRC meeting to allow our leaders to participate in advocacy efforts. We will continue to publish the Washington Watchline, bringing important news on efforts to enhance access to care and our ability to deliver it effectively. Our spring leadership meetings, board meetings, and committee meetings in early April were held virtually in light of the pandemic.

Since March, CHEST has been heavily immersed in COVID-19 preparation with new plans for alternate methods of educational delivery, new business models, and curtailment of travel on both our home fronts and on the CHEST front. Zoom and like platforms are now my best friend! Our daily vocabulary now includes an abundance of caution, surge, sheltering in place, quarantine, social distancing, flattening the curve, tele-medicine, and don and doff, and we close e-mails, texts, and phone calls with Stay Safe! I established a COVID task force led by Dr. Steve Simpson (CHEST President-Elect) and with representation from the Critical Care, Chest Infections, and Disaster Response and Global Health NetWorks. They have been meeting weekly with the goals of disseminating and distilling COVID-related materials for the busy practitioner with links to the specific article or statement along with the BLUF (Bottom Line Up Front). I’m sure you were able to see and hear some of the reports by Dr. Mangala Narasimhan and others on the front lines in New York, on the CHEST website, 60 Minutes, and CNN. CHEST held a two-part webinar with our Chinese colleagues who shared their COVID experiences with us. These relationships were in part built from the PCCM Fellowship Training program we conducted with Chinese physicians, led by Dr. Darcy Marciniuk and Dr. Chen Wang under the guidance of Dr. Renli Qiao, and with the help of the late Dr. Mark Rosen, Dr. Jack Buckley, and myself. CHEST has posted a webinar on point of care ultrasound testing in the setting of COVID since many units are now using more POCUS instead of standard imaging for the critically ill. We have also posted some of our board review lectures on demand for those who want to brush up on their critical care skills and knowledge.

CHEST, unfortunately, had to reschedule the Bologna meeting due to the tragic situation in Italy and plans to reconvene the meeting June 24-26 of 2021. As of now, CHEST 2020 in Chicago is a go, but, of course, we will monitor that situation carefully. We have extended the deadline for abstracts and case reports to June 1, 2020, given the ongoing crisis. The team is busy planning for standalone and complementary online offerings to ensure seamless delivery of critical education in formats that cater easily to our newly formed habits.

CHEST staff have been working from home due to the Illinois shelter in place order but continue to work tremendously hard. They are implementing new areas to the website in an effort to improve the user experience by making information easier to find and more timely. In the publishing space, Dr. Peter Mazzone and the journal team have been receiving hundreds of COVID-related publications, which they have been reviewing and expediting for publication where appropriate. There will also be additional podcasts coming from our journal. The guidelines group has been working on shorter expert panel statements in the setting of rapidly changing evidence. And, to keep us all well, there are opportunities to share our personal feelings and experiences with treating those with COVID in video format on the website and across CHEST social media channels. The CHEST and the CHEST Foundation have initiated a new microgrants program and have reached out to over 150 ILD and COPD support groups across the country to offer them the opportunity to apply for a max $2,500 grant. So far, 7seven groups have requested support. These grants go directly to patients and caregivers and provide needed relief through provision of:

1. Groceries

2. Gift cards

3. Medical supplies (including PPE for patients)

4. Technology needed to communicate with their community and HCPs

5. Household supplies, cleaning supplies

In an attempt to assist our colleagues in New York City, a call went out for volunteers at the end of March and has resulted in over 200 volunteers and more than 400 inquiries from our members. Bravo!!! We want to thank our sister societies for joining our efforts during this time to help all of our respective members and, ultimately, those patients stricken with this terrible illness. As I don and doff my COVID gear, I hope you are all safe and well in this time of unprecedented change in our lives. I look forward to my next report in a few months, hopefully on a happier note.

Stay safe!

Stephanie

As I write, I must admit this message is different than the one I’d envisioned sharing with you weeks ago. I anticipated updating you on meetings and collaborations with sister societies, new educational offerings, and how the Bologna World Congress and Annual Meeting plans were progressing, but activities at CHEST – and our sense of priority – have evolved along with those of our global community.

Pulmonary and critical care providers are now at the forefront of health care. Our patients, and now the greater public, are relying on our efforts and those of our teams. Amid this crisis, there is a renewed appreciation for the work all of you do; and with it, an opportunity for CHEST to lead and help ensure that the profession and our systems emerge stronger.

Back in February, we held the program committee meeting for the Annual Meeting with over 1000 submissions. It is astounding how the program came together over just a few days thanks to the preemptive work done by Chair, Dr. Victor Test, and, Co-Chair, Dr. Christopher Carroll, and all of the curricular groups, program committee members, and staff putting in so much work prior to the face-to-face meeting. Also during February, CHEST leadership held the Forum of International Respiratory Societies’ (FIRS) strategic planning meeting. The main outcome is a plan to engage a lobbyist to represent the worldwide respiratory societies in the WHO in Geneva on universal topics such as air pollution and now, unfortunately, COVID-19. CHEST was represented at the Society of Critical Care Medicine (SCCM) Congress where we heard late-breaking information as the pandemic was beginning to unfold. We met with the Critical Care Societies Collaborative (CCSC), which is composed of representatives from CHEST, SCCM, the American Thoracic Society (ATS), and the American Association of Critical-Care Nurses (AACN). We had an opportunity to meet with the European Society of Intensive Care Medicine (ESICM) and initiate discussions toward future collaboration.

In early March, as COVID-19 began to interfere with in-person meetings, we participated virtually in the NAMDRC meeting, and finalized our commitment to formally joining forces under the umbrella of CHEST to better serve our members in the area of advocacy. To this end, a new standing CHEST committee was founded, consisting of members from the former NAMRDC Board and members from the CHEST Board of Regents and Board of Trustees and chaired by Dr. Neil Freedman and Dr. Jim Lamberti. We look forward to hosting advocacy sessions during our October meeting, and going forward, our Spring Leadership Meeting will be combined with the former NAMDRC meeting to allow our leaders to participate in advocacy efforts. We will continue to publish the Washington Watchline, bringing important news on efforts to enhance access to care and our ability to deliver it effectively. Our spring leadership meetings, board meetings, and committee meetings in early April were held virtually in light of the pandemic.

Since March, CHEST has been heavily immersed in COVID-19 preparation with new plans for alternate methods of educational delivery, new business models, and curtailment of travel on both our home fronts and on the CHEST front. Zoom and like platforms are now my best friend! Our daily vocabulary now includes an abundance of caution, surge, sheltering in place, quarantine, social distancing, flattening the curve, tele-medicine, and don and doff, and we close e-mails, texts, and phone calls with Stay Safe! I established a COVID task force led by Dr. Steve Simpson (CHEST President-Elect) and with representation from the Critical Care, Chest Infections, and Disaster Response and Global Health NetWorks. They have been meeting weekly with the goals of disseminating and distilling COVID-related materials for the busy practitioner with links to the specific article or statement along with the BLUF (Bottom Line Up Front). I’m sure you were able to see and hear some of the reports by Dr. Mangala Narasimhan and others on the front lines in New York, on the CHEST website, 60 Minutes, and CNN. CHEST held a two-part webinar with our Chinese colleagues who shared their COVID experiences with us. These relationships were in part built from the PCCM Fellowship Training program we conducted with Chinese physicians, led by Dr. Darcy Marciniuk and Dr. Chen Wang under the guidance of Dr. Renli Qiao, and with the help of the late Dr. Mark Rosen, Dr. Jack Buckley, and myself. CHEST has posted a webinar on point of care ultrasound testing in the setting of COVID since many units are now using more POCUS instead of standard imaging for the critically ill. We have also posted some of our board review lectures on demand for those who want to brush up on their critical care skills and knowledge.

CHEST, unfortunately, had to reschedule the Bologna meeting due to the tragic situation in Italy and plans to reconvene the meeting June 24-26 of 2021. As of now, CHEST 2020 in Chicago is a go, but, of course, we will monitor that situation carefully. We have extended the deadline for abstracts and case reports to June 1, 2020, given the ongoing crisis. The team is busy planning for standalone and complementary online offerings to ensure seamless delivery of critical education in formats that cater easily to our newly formed habits.

CHEST staff have been working from home due to the Illinois shelter in place order but continue to work tremendously hard. They are implementing new areas to the website in an effort to improve the user experience by making information easier to find and more timely. In the publishing space, Dr. Peter Mazzone and the journal team have been receiving hundreds of COVID-related publications, which they have been reviewing and expediting for publication where appropriate. There will also be additional podcasts coming from our journal. The guidelines group has been working on shorter expert panel statements in the setting of rapidly changing evidence. And, to keep us all well, there are opportunities to share our personal feelings and experiences with treating those with COVID in video format on the website and across CHEST social media channels. The CHEST and the CHEST Foundation have initiated a new microgrants program and have reached out to over 150 ILD and COPD support groups across the country to offer them the opportunity to apply for a max $2,500 grant. So far, 7seven groups have requested support. These grants go directly to patients and caregivers and provide needed relief through provision of:

1. Groceries

2. Gift cards

3. Medical supplies (including PPE for patients)

4. Technology needed to communicate with their community and HCPs

5. Household supplies, cleaning supplies

In an attempt to assist our colleagues in New York City, a call went out for volunteers at the end of March and has resulted in over 200 volunteers and more than 400 inquiries from our members. Bravo!!! We want to thank our sister societies for joining our efforts during this time to help all of our respective members and, ultimately, those patients stricken with this terrible illness. As I don and doff my COVID gear, I hope you are all safe and well in this time of unprecedented change in our lives. I look forward to my next report in a few months, hopefully on a happier note.

Stay safe!

Stephanie

As I write, I must admit this message is different than the one I’d envisioned sharing with you weeks ago. I anticipated updating you on meetings and collaborations with sister societies, new educational offerings, and how the Bologna World Congress and Annual Meeting plans were progressing, but activities at CHEST – and our sense of priority – have evolved along with those of our global community.

Pulmonary and critical care providers are now at the forefront of health care. Our patients, and now the greater public, are relying on our efforts and those of our teams. Amid this crisis, there is a renewed appreciation for the work all of you do; and with it, an opportunity for CHEST to lead and help ensure that the profession and our systems emerge stronger.

Back in February, we held the program committee meeting for the Annual Meeting with over 1000 submissions. It is astounding how the program came together over just a few days thanks to the preemptive work done by Chair, Dr. Victor Test, and, Co-Chair, Dr. Christopher Carroll, and all of the curricular groups, program committee members, and staff putting in so much work prior to the face-to-face meeting. Also during February, CHEST leadership held the Forum of International Respiratory Societies’ (FIRS) strategic planning meeting. The main outcome is a plan to engage a lobbyist to represent the worldwide respiratory societies in the WHO in Geneva on universal topics such as air pollution and now, unfortunately, COVID-19. CHEST was represented at the Society of Critical Care Medicine (SCCM) Congress where we heard late-breaking information as the pandemic was beginning to unfold. We met with the Critical Care Societies Collaborative (CCSC), which is composed of representatives from CHEST, SCCM, the American Thoracic Society (ATS), and the American Association of Critical-Care Nurses (AACN). We had an opportunity to meet with the European Society of Intensive Care Medicine (ESICM) and initiate discussions toward future collaboration.

In early March, as COVID-19 began to interfere with in-person meetings, we participated virtually in the NAMDRC meeting, and finalized our commitment to formally joining forces under the umbrella of CHEST to better serve our members in the area of advocacy. To this end, a new standing CHEST committee was founded, consisting of members from the former NAMRDC Board and members from the CHEST Board of Regents and Board of Trustees and chaired by Dr. Neil Freedman and Dr. Jim Lamberti. We look forward to hosting advocacy sessions during our October meeting, and going forward, our Spring Leadership Meeting will be combined with the former NAMDRC meeting to allow our leaders to participate in advocacy efforts. We will continue to publish the Washington Watchline, bringing important news on efforts to enhance access to care and our ability to deliver it effectively. Our spring leadership meetings, board meetings, and committee meetings in early April were held virtually in light of the pandemic.

Since March, CHEST has been heavily immersed in COVID-19 preparation with new plans for alternate methods of educational delivery, new business models, and curtailment of travel on both our home fronts and on the CHEST front. Zoom and like platforms are now my best friend! Our daily vocabulary now includes an abundance of caution, surge, sheltering in place, quarantine, social distancing, flattening the curve, tele-medicine, and don and doff, and we close e-mails, texts, and phone calls with Stay Safe! I established a COVID task force led by Dr. Steve Simpson (CHEST President-Elect) and with representation from the Critical Care, Chest Infections, and Disaster Response and Global Health NetWorks. They have been meeting weekly with the goals of disseminating and distilling COVID-related materials for the busy practitioner with links to the specific article or statement along with the BLUF (Bottom Line Up Front). I’m sure you were able to see and hear some of the reports by Dr. Mangala Narasimhan and others on the front lines in New York, on the CHEST website, 60 Minutes, and CNN. CHEST held a two-part webinar with our Chinese colleagues who shared their COVID experiences with us. These relationships were in part built from the PCCM Fellowship Training program we conducted with Chinese physicians, led by Dr. Darcy Marciniuk and Dr. Chen Wang under the guidance of Dr. Renli Qiao, and with the help of the late Dr. Mark Rosen, Dr. Jack Buckley, and myself. CHEST has posted a webinar on point of care ultrasound testing in the setting of COVID since many units are now using more POCUS instead of standard imaging for the critically ill. We have also posted some of our board review lectures on demand for those who want to brush up on their critical care skills and knowledge.

CHEST, unfortunately, had to reschedule the Bologna meeting due to the tragic situation in Italy and plans to reconvene the meeting June 24-26 of 2021. As of now, CHEST 2020 in Chicago is a go, but, of course, we will monitor that situation carefully. We have extended the deadline for abstracts and case reports to June 1, 2020, given the ongoing crisis. The team is busy planning for standalone and complementary online offerings to ensure seamless delivery of critical education in formats that cater easily to our newly formed habits.

CHEST staff have been working from home due to the Illinois shelter in place order but continue to work tremendously hard. They are implementing new areas to the website in an effort to improve the user experience by making information easier to find and more timely. In the publishing space, Dr. Peter Mazzone and the journal team have been receiving hundreds of COVID-related publications, which they have been reviewing and expediting for publication where appropriate. There will also be additional podcasts coming from our journal. The guidelines group has been working on shorter expert panel statements in the setting of rapidly changing evidence. And, to keep us all well, there are opportunities to share our personal feelings and experiences with treating those with COVID in video format on the website and across CHEST social media channels. The CHEST and the CHEST Foundation have initiated a new microgrants program and have reached out to over 150 ILD and COPD support groups across the country to offer them the opportunity to apply for a max $2,500 grant. So far, 7seven groups have requested support. These grants go directly to patients and caregivers and provide needed relief through provision of:

1. Groceries

2. Gift cards

3. Medical supplies (including PPE for patients)

4. Technology needed to communicate with their community and HCPs

5. Household supplies, cleaning supplies

In an attempt to assist our colleagues in New York City, a call went out for volunteers at the end of March and has resulted in over 200 volunteers and more than 400 inquiries from our members. Bravo!!! We want to thank our sister societies for joining our efforts during this time to help all of our respective members and, ultimately, those patients stricken with this terrible illness. As I don and doff my COVID gear, I hope you are all safe and well in this time of unprecedented change in our lives. I look forward to my next report in a few months, hopefully on a happier note.

Stay safe!

Stephanie