Journal of Clinical Outcomes Management

Annual opioid prescriptions for American aged 65 years and older are more than double the amount received by adults under age 65, according to the Agency for Healthcare Quality and Research.

Elderly adults with chronic and acute pain obtained an average of 774 morphine milligram equivalents (MMEs) of prescription opioids annually during 2015-2016 from outpatient clinicians, compared with 376 MMEs a year for nonelderly adults, said Asako S. Moriya, PhD, and G. Edward Miller, PhD, of the AHRQ.

Narrowing the age groups shows that opioid MMEs increased with age, starting at 49 MMEs for 18- to 26-year-olds and rising to a high of 856 MMEs in the 65- to 74-year-old group, before dropping off in the oldest adults, the investigators said in a Medical Expenditure Panel Survey (MEPS) research findings report.

The analysis included “all opioid medications that are commonly used to treat pain” and excluded respiratory agents, antitussives, and drugs used for medication-assisted treatment, they noted. The MEPS data cover prescriptions purchased or obtained in outpatient settings but not those administered in inpatient settings or in clinics or physician offices.

[email protected]

Annual opioid prescriptions for American aged 65 years and older are more than double the amount received by adults under age 65, according to the Agency for Healthcare Quality and Research.

Elderly adults with chronic and acute pain obtained an average of 774 morphine milligram equivalents (MMEs) of prescription opioids annually during 2015-2016 from outpatient clinicians, compared with 376 MMEs a year for nonelderly adults, said Asako S. Moriya, PhD, and G. Edward Miller, PhD, of the AHRQ.

Narrowing the age groups shows that opioid MMEs increased with age, starting at 49 MMEs for 18- to 26-year-olds and rising to a high of 856 MMEs in the 65- to 74-year-old group, before dropping off in the oldest adults, the investigators said in a Medical Expenditure Panel Survey (MEPS) research findings report.

The analysis included “all opioid medications that are commonly used to treat pain” and excluded respiratory agents, antitussives, and drugs used for medication-assisted treatment, they noted. The MEPS data cover prescriptions purchased or obtained in outpatient settings but not those administered in inpatient settings or in clinics or physician offices.

[email protected]

Annual opioid prescriptions for American aged 65 years and older are more than double the amount received by adults under age 65, according to the Agency for Healthcare Quality and Research.

Elderly adults with chronic and acute pain obtained an average of 774 morphine milligram equivalents (MMEs) of prescription opioids annually during 2015-2016 from outpatient clinicians, compared with 376 MMEs a year for nonelderly adults, said Asako S. Moriya, PhD, and G. Edward Miller, PhD, of the AHRQ.

Narrowing the age groups shows that opioid MMEs increased with age, starting at 49 MMEs for 18- to 26-year-olds and rising to a high of 856 MMEs in the 65- to 74-year-old group, before dropping off in the oldest adults, the investigators said in a Medical Expenditure Panel Survey (MEPS) research findings report.

The analysis included “all opioid medications that are commonly used to treat pain” and excluded respiratory agents, antitussives, and drugs used for medication-assisted treatment, they noted. The MEPS data cover prescriptions purchased or obtained in outpatient settings but not those administered in inpatient settings or in clinics or physician offices.

[email protected]

Cancer surgeries may need to be delayed as hospitals are forced to allocate resources to a surge of COVID-19 patients, says the American College of Surgeons, as it issues a new set of recommendations in reaction to the crisis.

Most surgeons have already curtailed or have ceased to perform elective operations, the ACS notes, and recommends that surgeons continue to do so in order to preserve the necessary resources for care of critically ill patients during the COVID-19 pandemic. The new clinical guidance for elective surgical case triage during the pandemic includes recommendations for cancer surgery as well as for procedures that are specific to certain cancer types.

“These triage guidelines and joint recommendations are being issued as we appear to be entering a new phase of the COVID-19 pandemic with more hospitals facing a potential push beyond their resources to care for critically ill patients,” commented ACS Executive Director David B. Hoyt, MD, in a statement.

“ACS will continue to monitor the landscape for surgical care but we feel this guidance document provides a good foundation for surgeons to begin enacting these triage recommendations today to help them make the best decisions possible for their patients during COVID-19,” he said.

For cancer surgery, which is often not elective but essential to treatment, ACS has issued general guidance for triaging patients, taking into account the acuity of the local COVID-19 situation.

First, decisions about whether to proceed with elective surgeries must consider the available resources of local facilities. The parties responsible for preparing the facility to manage coronavirus patients should be sharing information at regular intervals about constraints on local resources, especially personal protective equipment (PPE), which is running low in many jurisdictions. For example, if an elective case has a high likelihood of needing postoperative ICU care, it is imperative to balance the risk of delay against the need of availability for patients with COVID-19.

Second, cancer care coordination should use virtual technologies as much as possible, and facilities with tumor boards may find it helpful to locate multidisciplinary experts by virtual means, to assist with decision making and establishing triage criteria.

Three Phases of Pandemic

The ACS has also organized decision making into three phases that reflect the acuity of the local COVID-19 situation:

• Phase I. Semi-Urgent Setting (Preparation Phase) – few COVID-19 patients, hospital resources not exhausted, institution still has ICU ventilator capacity and COVID-19 trajectory not in rapid escalation phase
• Phase II. Urgent Setting – many COVID-19 patients, ICU and ventilator capacity limited, operating room supplies limited
• Phase III. Hospital resources are all routed to COVID-19 patients, no ventilator or ICU capacity, operating room supplies exhausted; patients in whom death is likely within hours if surgery is deferred

Breast Cancer Surgery

The ACS also issued specific guidance for several tumor types, including guidance for breast cancer surgery.

For phase I, surgery should be restricted to patients who are likely to experience compromised survival if it is not performed within next 3 months. This includes patients completing neoadjuvant treatment, those with clinical stage T2 or N1 ERpos/PRpos/HER2-negative tumors, patients with triple negative or HER2-positive tumors, discordant biopsies that are likely to be malignant, and removal of a recurrent lesion.

Phase II would be restricted to patients whose survival is threatened if surgery is not performed within the next few days. These would include incision and drainage of breast abscess, evacuating a hematoma, revision of an ischemic mastectomy flap, and revascularization/revision of an autologous tissue flap (autologous reconstruction should be deferred).

In Phase III, surgical procedures would be restricted to patients who may not survive if surgery is not performed within a few hours. This includes incision and drainage of breast abscess, evacuation of a hematoma, revision of an ischemic mastectomy flap, and revascularization/revision of an autologous tissue flap (autologous reconstruction should be deferred).

Colorectal Cancer Surgery

Guidance for colorectal cancer surgery is also split into the three phases of the pandemic.

Phase I would include cases needing surgical intervention as soon as feasible, while recognizing that the status of each hospital is likely to evolve over the next week or two. These patients would include those with nearly obstructing colon cancer or rectal cancer; cancers that require frequent transfusions; asymptomatic colon cancers; rectal cancers that do not respond to neoadjuvant chemoradiation; malignancies with a risk of local perforation and sepsis; and those with early stage rectal cancers that are not candidates for adjuvant therapy.

Phase II comprises patients needing surgery as soon as feasible, but recognizing that hospital status is likely to progress over the next few days. These cases include patients with a nearly obstructing colon cancer where stenting is not an option; those with nearly obstructing rectal cancer (should be diverted); cancers with high (inpatient) transfusion requirements; and cancers with pending evidence of local perforation and sepsis.

All colorectal procedures typically scheduled as routine should be delayed.

In Phase III, if the status of the facility is likely to progress within hours, the only surgery that should be performed would be for perforated, obstructed, or actively bleeding (inpatient transfusion dependent) cancers or those with sepsis. All other surgeries should be deferred.

Thoracic Cancer Surgery

Thoracic cancer surgery guidelines follow those for breast cancer. Phase I should be restricted to patients whose survival may be impacted if surgery is not performed within next 3 months. These include:

• Cases with solid or predominantly solid (>50%) lung cancer or presumed lung cancer (>2 cm), clinical node negative
• Node positive lung cancer
• Post-induction therapy cancer
• Esophageal cancer T1b or greater
• Chest wall tumors that are potentially aggressive and not manageable by alternative means
• Stenting for obstructing esophageal tumor
• Staging to start treatment (mediastinoscopy, diagnostic VATS for pleural dissemination)
• Symptomatic mediastinal tumors
• Patients who are enrolled in therapeutic clinical trials.

Phase II would permit surgery if survival will be impacted by a delay of a few days. These cases would include nonseptic perforated cancer of esophagus, a tumor-associated infection, and management of surgical complications in a hemodynamically stable patient.

All thoracic procedures considered to be routine/elective would be deferred.

Phase III restricts surgery to patients whose survival will be compromised if they do not undergo surgery within the next few hours. This group would include perforated cancer of esophagus in a septic patient, a patient with a threatened airway, sepsis associated with the cancer, and management of surgical complications in an unstable patient  (active bleeding that requires surgery, dehiscence of airway, anastomotic leak with sepsis).

All other cases would be deferred.

Other Cancer Types

Although the ACS doesn’t have specific guidelines for all cancer types, a few are included in their general recommendations for the specialty.

For gynecologic surgeries, ACS lists cancer or suspected cancer as indications where significantly delayed surgery could cause “significant harm.”

Delays, in general, are not recommended for neurosurgery, which would include brain cancers. In pediatrics, most cancer surgery is considered “urgent,” where a delay of days to weeks could prove detrimental to the patient. This would comprise all solid tumors, including the initial biopsy and resection following neoadjuvant therapy.
 

This article first appeared on Medscape.com.

Cancer surgeries may need to be delayed as hospitals are forced to allocate resources to a surge of COVID-19 patients, says the American College of Surgeons, as it issues a new set of recommendations in reaction to the crisis.

Most surgeons have already curtailed or have ceased to perform elective operations, the ACS notes, and recommends that surgeons continue to do so in order to preserve the necessary resources for care of critically ill patients during the COVID-19 pandemic. The new clinical guidance for elective surgical case triage during the pandemic includes recommendations for cancer surgery as well as for procedures that are specific to certain cancer types.

“These triage guidelines and joint recommendations are being issued as we appear to be entering a new phase of the COVID-19 pandemic with more hospitals facing a potential push beyond their resources to care for critically ill patients,” commented ACS Executive Director David B. Hoyt, MD, in a statement.

“ACS will continue to monitor the landscape for surgical care but we feel this guidance document provides a good foundation for surgeons to begin enacting these triage recommendations today to help them make the best decisions possible for their patients during COVID-19,” he said.

For cancer surgery, which is often not elective but essential to treatment, ACS has issued general guidance for triaging patients, taking into account the acuity of the local COVID-19 situation.

First, decisions about whether to proceed with elective surgeries must consider the available resources of local facilities. The parties responsible for preparing the facility to manage coronavirus patients should be sharing information at regular intervals about constraints on local resources, especially personal protective equipment (PPE), which is running low in many jurisdictions. For example, if an elective case has a high likelihood of needing postoperative ICU care, it is imperative to balance the risk of delay against the need of availability for patients with COVID-19.

Second, cancer care coordination should use virtual technologies as much as possible, and facilities with tumor boards may find it helpful to locate multidisciplinary experts by virtual means, to assist with decision making and establishing triage criteria.

Three Phases of Pandemic

The ACS has also organized decision making into three phases that reflect the acuity of the local COVID-19 situation:

• Phase I. Semi-Urgent Setting (Preparation Phase) – few COVID-19 patients, hospital resources not exhausted, institution still has ICU ventilator capacity and COVID-19 trajectory not in rapid escalation phase
• Phase II. Urgent Setting – many COVID-19 patients, ICU and ventilator capacity limited, operating room supplies limited
• Phase III. Hospital resources are all routed to COVID-19 patients, no ventilator or ICU capacity, operating room supplies exhausted; patients in whom death is likely within hours if surgery is deferred

Breast Cancer Surgery

The ACS also issued specific guidance for several tumor types, including guidance for breast cancer surgery.

For phase I, surgery should be restricted to patients who are likely to experience compromised survival if it is not performed within next 3 months. This includes patients completing neoadjuvant treatment, those with clinical stage T2 or N1 ERpos/PRpos/HER2-negative tumors, patients with triple negative or HER2-positive tumors, discordant biopsies that are likely to be malignant, and removal of a recurrent lesion.

Phase II would be restricted to patients whose survival is threatened if surgery is not performed within the next few days. These would include incision and drainage of breast abscess, evacuating a hematoma, revision of an ischemic mastectomy flap, and revascularization/revision of an autologous tissue flap (autologous reconstruction should be deferred).

In Phase III, surgical procedures would be restricted to patients who may not survive if surgery is not performed within a few hours. This includes incision and drainage of breast abscess, evacuation of a hematoma, revision of an ischemic mastectomy flap, and revascularization/revision of an autologous tissue flap (autologous reconstruction should be deferred).

Colorectal Cancer Surgery

Guidance for colorectal cancer surgery is also split into the three phases of the pandemic.

Phase I would include cases needing surgical intervention as soon as feasible, while recognizing that the status of each hospital is likely to evolve over the next week or two. These patients would include those with nearly obstructing colon cancer or rectal cancer; cancers that require frequent transfusions; asymptomatic colon cancers; rectal cancers that do not respond to neoadjuvant chemoradiation; malignancies with a risk of local perforation and sepsis; and those with early stage rectal cancers that are not candidates for adjuvant therapy.

Phase II comprises patients needing surgery as soon as feasible, but recognizing that hospital status is likely to progress over the next few days. These cases include patients with a nearly obstructing colon cancer where stenting is not an option; those with nearly obstructing rectal cancer (should be diverted); cancers with high (inpatient) transfusion requirements; and cancers with pending evidence of local perforation and sepsis.

All colorectal procedures typically scheduled as routine should be delayed.

In Phase III, if the status of the facility is likely to progress within hours, the only surgery that should be performed would be for perforated, obstructed, or actively bleeding (inpatient transfusion dependent) cancers or those with sepsis. All other surgeries should be deferred.

Thoracic Cancer Surgery

Thoracic cancer surgery guidelines follow those for breast cancer. Phase I should be restricted to patients whose survival may be impacted if surgery is not performed within next 3 months. These include:

• Cases with solid or predominantly solid (>50%) lung cancer or presumed lung cancer (>2 cm), clinical node negative
• Node positive lung cancer
• Post-induction therapy cancer
• Esophageal cancer T1b or greater
• Chest wall tumors that are potentially aggressive and not manageable by alternative means
• Stenting for obstructing esophageal tumor
• Staging to start treatment (mediastinoscopy, diagnostic VATS for pleural dissemination)
• Symptomatic mediastinal tumors
• Patients who are enrolled in therapeutic clinical trials.

Phase II would permit surgery if survival will be impacted by a delay of a few days. These cases would include nonseptic perforated cancer of esophagus, a tumor-associated infection, and management of surgical complications in a hemodynamically stable patient.

All thoracic procedures considered to be routine/elective would be deferred.

Phase III restricts surgery to patients whose survival will be compromised if they do not undergo surgery within the next few hours. This group would include perforated cancer of esophagus in a septic patient, a patient with a threatened airway, sepsis associated with the cancer, and management of surgical complications in an unstable patient  (active bleeding that requires surgery, dehiscence of airway, anastomotic leak with sepsis).

All other cases would be deferred.

Other Cancer Types

Although the ACS doesn’t have specific guidelines for all cancer types, a few are included in their general recommendations for the specialty.

For gynecologic surgeries, ACS lists cancer or suspected cancer as indications where significantly delayed surgery could cause “significant harm.”

Delays, in general, are not recommended for neurosurgery, which would include brain cancers. In pediatrics, most cancer surgery is considered “urgent,” where a delay of days to weeks could prove detrimental to the patient. This would comprise all solid tumors, including the initial biopsy and resection following neoadjuvant therapy.
 

This article first appeared on Medscape.com.

Cancer surgeries may need to be delayed as hospitals are forced to allocate resources to a surge of COVID-19 patients, says the American College of Surgeons, as it issues a new set of recommendations in reaction to the crisis.

Most surgeons have already curtailed or have ceased to perform elective operations, the ACS notes, and recommends that surgeons continue to do so in order to preserve the necessary resources for care of critically ill patients during the COVID-19 pandemic. The new clinical guidance for elective surgical case triage during the pandemic includes recommendations for cancer surgery as well as for procedures that are specific to certain cancer types.

“These triage guidelines and joint recommendations are being issued as we appear to be entering a new phase of the COVID-19 pandemic with more hospitals facing a potential push beyond their resources to care for critically ill patients,” commented ACS Executive Director David B. Hoyt, MD, in a statement.

“ACS will continue to monitor the landscape for surgical care but we feel this guidance document provides a good foundation for surgeons to begin enacting these triage recommendations today to help them make the best decisions possible for their patients during COVID-19,” he said.

For cancer surgery, which is often not elective but essential to treatment, ACS has issued general guidance for triaging patients, taking into account the acuity of the local COVID-19 situation.

First, decisions about whether to proceed with elective surgeries must consider the available resources of local facilities. The parties responsible for preparing the facility to manage coronavirus patients should be sharing information at regular intervals about constraints on local resources, especially personal protective equipment (PPE), which is running low in many jurisdictions. For example, if an elective case has a high likelihood of needing postoperative ICU care, it is imperative to balance the risk of delay against the need of availability for patients with COVID-19.

Second, cancer care coordination should use virtual technologies as much as possible, and facilities with tumor boards may find it helpful to locate multidisciplinary experts by virtual means, to assist with decision making and establishing triage criteria.

Three Phases of Pandemic

The ACS has also organized decision making into three phases that reflect the acuity of the local COVID-19 situation:

• Phase I. Semi-Urgent Setting (Preparation Phase) – few COVID-19 patients, hospital resources not exhausted, institution still has ICU ventilator capacity and COVID-19 trajectory not in rapid escalation phase
• Phase II. Urgent Setting – many COVID-19 patients, ICU and ventilator capacity limited, operating room supplies limited
• Phase III. Hospital resources are all routed to COVID-19 patients, no ventilator or ICU capacity, operating room supplies exhausted; patients in whom death is likely within hours if surgery is deferred

Breast Cancer Surgery

The ACS also issued specific guidance for several tumor types, including guidance for breast cancer surgery.

For phase I, surgery should be restricted to patients who are likely to experience compromised survival if it is not performed within next 3 months. This includes patients completing neoadjuvant treatment, those with clinical stage T2 or N1 ERpos/PRpos/HER2-negative tumors, patients with triple negative or HER2-positive tumors, discordant biopsies that are likely to be malignant, and removal of a recurrent lesion.

Phase II would be restricted to patients whose survival is threatened if surgery is not performed within the next few days. These would include incision and drainage of breast abscess, evacuating a hematoma, revision of an ischemic mastectomy flap, and revascularization/revision of an autologous tissue flap (autologous reconstruction should be deferred).

In Phase III, surgical procedures would be restricted to patients who may not survive if surgery is not performed within a few hours. This includes incision and drainage of breast abscess, evacuation of a hematoma, revision of an ischemic mastectomy flap, and revascularization/revision of an autologous tissue flap (autologous reconstruction should be deferred).

Colorectal Cancer Surgery

Guidance for colorectal cancer surgery is also split into the three phases of the pandemic.

Phase I would include cases needing surgical intervention as soon as feasible, while recognizing that the status of each hospital is likely to evolve over the next week or two. These patients would include those with nearly obstructing colon cancer or rectal cancer; cancers that require frequent transfusions; asymptomatic colon cancers; rectal cancers that do not respond to neoadjuvant chemoradiation; malignancies with a risk of local perforation and sepsis; and those with early stage rectal cancers that are not candidates for adjuvant therapy.

Phase II comprises patients needing surgery as soon as feasible, but recognizing that hospital status is likely to progress over the next few days. These cases include patients with a nearly obstructing colon cancer where stenting is not an option; those with nearly obstructing rectal cancer (should be diverted); cancers with high (inpatient) transfusion requirements; and cancers with pending evidence of local perforation and sepsis.

All colorectal procedures typically scheduled as routine should be delayed.

In Phase III, if the status of the facility is likely to progress within hours, the only surgery that should be performed would be for perforated, obstructed, or actively bleeding (inpatient transfusion dependent) cancers or those with sepsis. All other surgeries should be deferred.

Thoracic Cancer Surgery

Thoracic cancer surgery guidelines follow those for breast cancer. Phase I should be restricted to patients whose survival may be impacted if surgery is not performed within next 3 months. These include:

• Cases with solid or predominantly solid (>50%) lung cancer or presumed lung cancer (>2 cm), clinical node negative
• Node positive lung cancer
• Post-induction therapy cancer
• Esophageal cancer T1b or greater
• Chest wall tumors that are potentially aggressive and not manageable by alternative means
• Stenting for obstructing esophageal tumor
• Staging to start treatment (mediastinoscopy, diagnostic VATS for pleural dissemination)
• Symptomatic mediastinal tumors
• Patients who are enrolled in therapeutic clinical trials.

Phase II would permit surgery if survival will be impacted by a delay of a few days. These cases would include nonseptic perforated cancer of esophagus, a tumor-associated infection, and management of surgical complications in a hemodynamically stable patient.

All thoracic procedures considered to be routine/elective would be deferred.

Phase III restricts surgery to patients whose survival will be compromised if they do not undergo surgery within the next few hours. This group would include perforated cancer of esophagus in a septic patient, a patient with a threatened airway, sepsis associated with the cancer, and management of surgical complications in an unstable patient  (active bleeding that requires surgery, dehiscence of airway, anastomotic leak with sepsis).

All other cases would be deferred.

Other Cancer Types

Although the ACS doesn’t have specific guidelines for all cancer types, a few are included in their general recommendations for the specialty.

For gynecologic surgeries, ACS lists cancer or suspected cancer as indications where significantly delayed surgery could cause “significant harm.”

Delays, in general, are not recommended for neurosurgery, which would include brain cancers. In pediatrics, most cancer surgery is considered “urgent,” where a delay of days to weeks could prove detrimental to the patient. This would comprise all solid tumors, including the initial biopsy and resection following neoadjuvant therapy.
 

This article first appeared on Medscape.com.

In about 7% of people with confirmed novel coronavirus disease 2019 (COVID-19), and 22% of the critically ill, the virus injures the heart, probably by either attacking it directly or causing a cytokine storm that leads to myocyte apoptosis, according to a report from the Columbia University Division of Cardiology in New York.

Reports from China document patients presenting with palpitations and chest pain without the typical fever and cough. Among those affected, acute myocardial injury is either apparent at presentation or develops after hospitalization.

The exact mechanism of injury is uncertain, but for now, “it appears that the incidence of fulminant myocarditis and profound cardiogenic shock is low; however, the rate of recovery and mode of treatment are yet to be determined,” wrote authors led by Kevin Clerkin, MD, a cardiologist and assistant professor of medicine at Columbia.

High-sensitivity cardiac troponin I (hs-cTnI) might be prognostic. In one Chinese study of hospitalized patients, median hs-cTnI levels were 2.5 pg/mL in survivors on day 4 of symptoms and did not change significantly during follow-up. Among people who died, day 4 hs-cTnI was 8.8 pg/mL and climbed to 290.6 pg/mL by day 22.

“The rise in hs-cTnI tracks with other inflammatory biomarkers ... raising the possibility that this reflects cytokine storm or secondary hemophagocytic lymphohistiocytosis more than isolated myocardial injury,” Dr. Clerkin and colleagues wrote.

But there are also acute heart injury reports out of China, including one man who presented with chest pain and ST-segment elevation, but no coronary obstruction, and another who presented with fulminant myocarditis in addition to severe respiratory manifestations, but with no cardiac history.

Both had depressed left ventricular ejection fractions, enlarged left ventricles, and elevated cardiac biomarkers, and both responded to intravenous immunoglobulin and steroids, among other treatments.

Amid a surge of COVID-19 cases at Columbia, “we have seen both forms of cardiac presentations: those presenting with cardiac predominant symptoms (none have had true [ST-segment elevation myocardial infarctions] yet, but most fall in the myopericarditis group), some of which have required mechanical circulatory support, and those who seem to have secondary myocardial injury with globally elevated inflammatory biomarkers (e.g., ferritin, interleukin-6, lactate dehydrogenase, hs-cTnI, and D-dimer),” Dr. Clerkin said in an interview.

“We are discussing each of these cases in a multidisciplinary fashion with our infectious disease, pulmonary, interventional cardiology, and cardiac surgery colleagues to try to make the best decision based on what we know and as our knowledge evolves,” he said.

The exact cardiac effect of COVID-19 is unknown for now, but it is known already that it rides along with cardiovascular issues. There’s a high prevalence of hypertension, diabetes, and diagnosed cardiovascular disease among patients, but it’s unclear at this point if it’s because the virus favors older people who happen to be more likely to have those problems or if it attacks people with those conditions preferentially.

It might be the latter. The virus that causes COVID-19, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), invades cells through angiotensin converting enzyme (ACE) 2 receptors, which are highly expressed in the heart.

That raises the question of whether ACE inhibitors or angiotensin receptor blockers might help. However, “at this time, nearly all major societies have recommended against adding or stopping ... antagonists in this setting, unless done on clinical grounds independently of COVID-19, given the lack of evidence,” Dr. Clerkin and his colleagues wrote.

As for heart transplants, the current thinking is to continue them without changes in immunosuppression so long as recipients test negative and haven’t been around anyone who has tested positive for a month. If a donor had COVID-19, they should have been free of the virus by polymerase chain reaction for at least 14 days. The concern is that it might be in the donor heart.

If transplant patients come down with COVID-19, the “data to date [indicate that management] is supportive care and continuation of immunosuppression for mild COVID-19 with reduction of the antimetabolite (mycophenolate or azathioprine), and further treatment based on disease severity and drug availability. Notably, one potential treatment option for COVID-19 is protease inhibitors,” the authors said, but it’s important to remember that they will increase the levels of cyclosporine, tacrolimus, and other calcineurin inhibitor transplant drugs.

At Columbia, “our processes have been adjusted” for heart transplants. “For instance, non-urgent testing (pre- and post-transplant) has been tabled, we have predominantly shifted to noninvasive screening for rejection, and each potential transplant requires more scrutiny for urgency, donor screening/risk for COVID-19, and perioperative management,” Dr. Clerkin said in the interview.

A study out of Wuhan, China, the outbreak epicenter, was reassuring. It found that routine prevention efforts were enough to protect heart transplant patients.

There was no funding, and the authors had no disclosures.

[email protected]

SOURCE: Clerkin KJ et al. Circulation. 2020 Mar 21. doi: 10.1161/CIRCULATIONAHA.120.046941

In about 7% of people with confirmed novel coronavirus disease 2019 (COVID-19), and 22% of the critically ill, the virus injures the heart, probably by either attacking it directly or causing a cytokine storm that leads to myocyte apoptosis, according to a report from the Columbia University Division of Cardiology in New York.

Reports from China document patients presenting with palpitations and chest pain without the typical fever and cough. Among those affected, acute myocardial injury is either apparent at presentation or develops after hospitalization.

The exact mechanism of injury is uncertain, but for now, “it appears that the incidence of fulminant myocarditis and profound cardiogenic shock is low; however, the rate of recovery and mode of treatment are yet to be determined,” wrote authors led by Kevin Clerkin, MD, a cardiologist and assistant professor of medicine at Columbia.

High-sensitivity cardiac troponin I (hs-cTnI) might be prognostic. In one Chinese study of hospitalized patients, median hs-cTnI levels were 2.5 pg/mL in survivors on day 4 of symptoms and did not change significantly during follow-up. Among people who died, day 4 hs-cTnI was 8.8 pg/mL and climbed to 290.6 pg/mL by day 22.

“The rise in hs-cTnI tracks with other inflammatory biomarkers ... raising the possibility that this reflects cytokine storm or secondary hemophagocytic lymphohistiocytosis more than isolated myocardial injury,” Dr. Clerkin and colleagues wrote.

But there are also acute heart injury reports out of China, including one man who presented with chest pain and ST-segment elevation, but no coronary obstruction, and another who presented with fulminant myocarditis in addition to severe respiratory manifestations, but with no cardiac history.

Both had depressed left ventricular ejection fractions, enlarged left ventricles, and elevated cardiac biomarkers, and both responded to intravenous immunoglobulin and steroids, among other treatments.

Amid a surge of COVID-19 cases at Columbia, “we have seen both forms of cardiac presentations: those presenting with cardiac predominant symptoms (none have had true [ST-segment elevation myocardial infarctions] yet, but most fall in the myopericarditis group), some of which have required mechanical circulatory support, and those who seem to have secondary myocardial injury with globally elevated inflammatory biomarkers (e.g., ferritin, interleukin-6, lactate dehydrogenase, hs-cTnI, and D-dimer),” Dr. Clerkin said in an interview.

“We are discussing each of these cases in a multidisciplinary fashion with our infectious disease, pulmonary, interventional cardiology, and cardiac surgery colleagues to try to make the best decision based on what we know and as our knowledge evolves,” he said.

The exact cardiac effect of COVID-19 is unknown for now, but it is known already that it rides along with cardiovascular issues. There’s a high prevalence of hypertension, diabetes, and diagnosed cardiovascular disease among patients, but it’s unclear at this point if it’s because the virus favors older people who happen to be more likely to have those problems or if it attacks people with those conditions preferentially.

It might be the latter. The virus that causes COVID-19, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), invades cells through angiotensin converting enzyme (ACE) 2 receptors, which are highly expressed in the heart.

That raises the question of whether ACE inhibitors or angiotensin receptor blockers might help. However, “at this time, nearly all major societies have recommended against adding or stopping ... antagonists in this setting, unless done on clinical grounds independently of COVID-19, given the lack of evidence,” Dr. Clerkin and his colleagues wrote.

As for heart transplants, the current thinking is to continue them without changes in immunosuppression so long as recipients test negative and haven’t been around anyone who has tested positive for a month. If a donor had COVID-19, they should have been free of the virus by polymerase chain reaction for at least 14 days. The concern is that it might be in the donor heart.

If transplant patients come down with COVID-19, the “data to date [indicate that management] is supportive care and continuation of immunosuppression for mild COVID-19 with reduction of the antimetabolite (mycophenolate or azathioprine), and further treatment based on disease severity and drug availability. Notably, one potential treatment option for COVID-19 is protease inhibitors,” the authors said, but it’s important to remember that they will increase the levels of cyclosporine, tacrolimus, and other calcineurin inhibitor transplant drugs.

At Columbia, “our processes have been adjusted” for heart transplants. “For instance, non-urgent testing (pre- and post-transplant) has been tabled, we have predominantly shifted to noninvasive screening for rejection, and each potential transplant requires more scrutiny for urgency, donor screening/risk for COVID-19, and perioperative management,” Dr. Clerkin said in the interview.

A study out of Wuhan, China, the outbreak epicenter, was reassuring. It found that routine prevention efforts were enough to protect heart transplant patients.

There was no funding, and the authors had no disclosures.

[email protected]

SOURCE: Clerkin KJ et al. Circulation. 2020 Mar 21. doi: 10.1161/CIRCULATIONAHA.120.046941

In about 7% of people with confirmed novel coronavirus disease 2019 (COVID-19), and 22% of the critically ill, the virus injures the heart, probably by either attacking it directly or causing a cytokine storm that leads to myocyte apoptosis, according to a report from the Columbia University Division of Cardiology in New York.

Reports from China document patients presenting with palpitations and chest pain without the typical fever and cough. Among those affected, acute myocardial injury is either apparent at presentation or develops after hospitalization.

The exact mechanism of injury is uncertain, but for now, “it appears that the incidence of fulminant myocarditis and profound cardiogenic shock is low; however, the rate of recovery and mode of treatment are yet to be determined,” wrote authors led by Kevin Clerkin, MD, a cardiologist and assistant professor of medicine at Columbia.

High-sensitivity cardiac troponin I (hs-cTnI) might be prognostic. In one Chinese study of hospitalized patients, median hs-cTnI levels were 2.5 pg/mL in survivors on day 4 of symptoms and did not change significantly during follow-up. Among people who died, day 4 hs-cTnI was 8.8 pg/mL and climbed to 290.6 pg/mL by day 22.

“The rise in hs-cTnI tracks with other inflammatory biomarkers ... raising the possibility that this reflects cytokine storm or secondary hemophagocytic lymphohistiocytosis more than isolated myocardial injury,” Dr. Clerkin and colleagues wrote.

But there are also acute heart injury reports out of China, including one man who presented with chest pain and ST-segment elevation, but no coronary obstruction, and another who presented with fulminant myocarditis in addition to severe respiratory manifestations, but with no cardiac history.

Both had depressed left ventricular ejection fractions, enlarged left ventricles, and elevated cardiac biomarkers, and both responded to intravenous immunoglobulin and steroids, among other treatments.

Amid a surge of COVID-19 cases at Columbia, “we have seen both forms of cardiac presentations: those presenting with cardiac predominant symptoms (none have had true [ST-segment elevation myocardial infarctions] yet, but most fall in the myopericarditis group), some of which have required mechanical circulatory support, and those who seem to have secondary myocardial injury with globally elevated inflammatory biomarkers (e.g., ferritin, interleukin-6, lactate dehydrogenase, hs-cTnI, and D-dimer),” Dr. Clerkin said in an interview.

“We are discussing each of these cases in a multidisciplinary fashion with our infectious disease, pulmonary, interventional cardiology, and cardiac surgery colleagues to try to make the best decision based on what we know and as our knowledge evolves,” he said.

The exact cardiac effect of COVID-19 is unknown for now, but it is known already that it rides along with cardiovascular issues. There’s a high prevalence of hypertension, diabetes, and diagnosed cardiovascular disease among patients, but it’s unclear at this point if it’s because the virus favors older people who happen to be more likely to have those problems or if it attacks people with those conditions preferentially.

It might be the latter. The virus that causes COVID-19, severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), invades cells through angiotensin converting enzyme (ACE) 2 receptors, which are highly expressed in the heart.

That raises the question of whether ACE inhibitors or angiotensin receptor blockers might help. However, “at this time, nearly all major societies have recommended against adding or stopping ... antagonists in this setting, unless done on clinical grounds independently of COVID-19, given the lack of evidence,” Dr. Clerkin and his colleagues wrote.

As for heart transplants, the current thinking is to continue them without changes in immunosuppression so long as recipients test negative and haven’t been around anyone who has tested positive for a month. If a donor had COVID-19, they should have been free of the virus by polymerase chain reaction for at least 14 days. The concern is that it might be in the donor heart.

If transplant patients come down with COVID-19, the “data to date [indicate that management] is supportive care and continuation of immunosuppression for mild COVID-19 with reduction of the antimetabolite (mycophenolate or azathioprine), and further treatment based on disease severity and drug availability. Notably, one potential treatment option for COVID-19 is protease inhibitors,” the authors said, but it’s important to remember that they will increase the levels of cyclosporine, tacrolimus, and other calcineurin inhibitor transplant drugs.

At Columbia, “our processes have been adjusted” for heart transplants. “For instance, non-urgent testing (pre- and post-transplant) has been tabled, we have predominantly shifted to noninvasive screening for rejection, and each potential transplant requires more scrutiny for urgency, donor screening/risk for COVID-19, and perioperative management,” Dr. Clerkin said in the interview.

A study out of Wuhan, China, the outbreak epicenter, was reassuring. It found that routine prevention efforts were enough to protect heart transplant patients.

There was no funding, and the authors had no disclosures.

[email protected]

SOURCE: Clerkin KJ et al. Circulation. 2020 Mar 21. doi: 10.1161/CIRCULATIONAHA.120.046941

The Food and Drug Administration has approved the oral medication ozanimod (Zeposia) for relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, according to a release from Bristol-Myers Squibb.

Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. It blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. Although its therapeutic mechanism of action in MS is unknown, it may involve the reduction of lymphocyte migration into the central nervous system. A genetic test is not required to start the drug, and no patient observation is required for the first dose, although up-titration of initial doses are required to reach the maintenance dose because a transient decrease in heart rate and atrioventricular conduction delays may occur, according to the company.

The approval is based on a pair of head-to-head studies that compared it with interferon beta-1a (Avonex) and together included more than 2,600 patients. It delivered better efficacy in terms of relative reduction in annualized relapse rate (48% at 1 year and 38% at 2 years). It also demonstrated better relative reduction of the number of T1-weighted gadolinium-enhanced brain lesions (63% fewer at 1 year and 53% fewer at 2 years) and number of new or enlarging T2 lesions (48% fewer at 1 year and 42% at 2 years).

Ozanimod is contraindicated in patients who, in the past 6 months, experienced a myocardial infarction, unstable angina, stroke, or other conditions. It is associated with other health risks, including infections, liver injury, additive immunosuppressive effects from prior immune-modulating therapies, and increased blood pressure. Certain assessments, such as recent complete blood count, ECG, liver function test, and current and prior medications and vaccinations, are required before initiation of treatment.

In its announcement, Bristol-Myers Squibb said that it has decided to delay the commercial launch of ozanimod during the COVID-19 pandemic until a later date.

The drug is also in development for additional immune-inflammatory indications, including ulcerative colitis and Crohn’s disease.

The full prescribing information can be found on the company’s website.

[email protected]

The Food and Drug Administration has approved the oral medication ozanimod (Zeposia) for relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, according to a release from Bristol-Myers Squibb.

Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. It blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. Although its therapeutic mechanism of action in MS is unknown, it may involve the reduction of lymphocyte migration into the central nervous system. A genetic test is not required to start the drug, and no patient observation is required for the first dose, although up-titration of initial doses are required to reach the maintenance dose because a transient decrease in heart rate and atrioventricular conduction delays may occur, according to the company.

The approval is based on a pair of head-to-head studies that compared it with interferon beta-1a (Avonex) and together included more than 2,600 patients. It delivered better efficacy in terms of relative reduction in annualized relapse rate (48% at 1 year and 38% at 2 years). It also demonstrated better relative reduction of the number of T1-weighted gadolinium-enhanced brain lesions (63% fewer at 1 year and 53% fewer at 2 years) and number of new or enlarging T2 lesions (48% fewer at 1 year and 42% at 2 years).

Ozanimod is contraindicated in patients who, in the past 6 months, experienced a myocardial infarction, unstable angina, stroke, or other conditions. It is associated with other health risks, including infections, liver injury, additive immunosuppressive effects from prior immune-modulating therapies, and increased blood pressure. Certain assessments, such as recent complete blood count, ECG, liver function test, and current and prior medications and vaccinations, are required before initiation of treatment.

In its announcement, Bristol-Myers Squibb said that it has decided to delay the commercial launch of ozanimod during the COVID-19 pandemic until a later date.

The drug is also in development for additional immune-inflammatory indications, including ulcerative colitis and Crohn’s disease.

The full prescribing information can be found on the company’s website.

[email protected]

The Food and Drug Administration has approved the oral medication ozanimod (Zeposia) for relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, according to a release from Bristol-Myers Squibb.

Ozanimod is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. It blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. Although its therapeutic mechanism of action in MS is unknown, it may involve the reduction of lymphocyte migration into the central nervous system. A genetic test is not required to start the drug, and no patient observation is required for the first dose, although up-titration of initial doses are required to reach the maintenance dose because a transient decrease in heart rate and atrioventricular conduction delays may occur, according to the company.

The approval is based on a pair of head-to-head studies that compared it with interferon beta-1a (Avonex) and together included more than 2,600 patients. It delivered better efficacy in terms of relative reduction in annualized relapse rate (48% at 1 year and 38% at 2 years). It also demonstrated better relative reduction of the number of T1-weighted gadolinium-enhanced brain lesions (63% fewer at 1 year and 53% fewer at 2 years) and number of new or enlarging T2 lesions (48% fewer at 1 year and 42% at 2 years).

Ozanimod is contraindicated in patients who, in the past 6 months, experienced a myocardial infarction, unstable angina, stroke, or other conditions. It is associated with other health risks, including infections, liver injury, additive immunosuppressive effects from prior immune-modulating therapies, and increased blood pressure. Certain assessments, such as recent complete blood count, ECG, liver function test, and current and prior medications and vaccinations, are required before initiation of treatment.

In its announcement, Bristol-Myers Squibb said that it has decided to delay the commercial launch of ozanimod during the COVID-19 pandemic until a later date.

The drug is also in development for additional immune-inflammatory indications, including ulcerative colitis and Crohn’s disease.

The full prescribing information can be found on the company’s website.

[email protected]

David Baker, MD, a hospitalist at EvergreenHealth in Kirkland, Wash., had just come off a 7-day stretch of work and was early into his usual 7 days off. He’d helped care for some patients from a nearby assisted living facility who had been admitted with puzzlingly severe viral pneumonia that wasn’t influenza.

Though COVID-19, the novel coronavirus that was sickening tens of thousands in the Chinese province of Hubei, was in the back of everyone’s mind in late February, he said he wasn’t really expecting the call notifying him that two of the patients with pneumonia had tested positive for COVID-19.

Michael Chu, MD, was coming onto EvergreenHealth’s hospitalist service at about the time Dr. Baker was rotating off. He recalled learning of the first two positive COVID-19 tests on the evening of Feb. 28 – a Friday. He and his colleagues took in this information, coming to the realization that they were seeing other patients from the same facility who had viral pneumonia and negative influenza tests. “The first cohort of coronavirus patients all came from Life Care,” the Kirkland assisted living facility that was the epicenter of the first identified U.S. outbreak of community-transmitted coronavirus, said Dr. Chu. “They all fit a clinical syndrome” and many of them were critically ill or failing fast, since they were aged and with multiple risk factors, he said during the interviews he and his colleagues participated in.

The hospital adapts to a new normal

The usual protocol in EvergreenHealth’s ICU is for the nocturnist hospitalists, such as Dr. Baker, to staff that unit, with intensivists readily available for phone consultation. However, as the numbers of critically ill, ventilated COVID-19 patients climbed, the facility switched to 24/7 staffing with intensivists to augment the hospitalist team, said Nancy Marshall, MD, the director of EvergreenHealth’s hospitalist service.

Dr. Marshall related how the entire hospital rallied to create appropriate – but flexible – staffing and environmental adaptations to the influx of coronavirus patients. “Early on, we established a separate portion of the emergency department to evaluate and test persons under investigation,” for COVID-19, she said. When they realized that they were seeing the nation’s first cluster of community coronavirus transmission, they used “appropriate isolation precautions” when indicated. Triggers for clinical suspicion included not just fever or cough, but also a new requirement for supplemental oxygen and new abnormal findings on chest radiographs.

Patients with confirmed or suspected coronavirus, once admitted, were placed in negative-pressure rooms, and droplet precautions were used with these patients. In the absence of aerosol-generating procedures, those caring for these patients used a standard surgical mask, goggles or face shield, an isolation gown, and gloves. For intubations, bronchoscopies, and other aerosol-generating procedures, N95 masks were used; the facility also has some powered and controlled air-purifying respirators.

In short order, once the size of the outbreak was appreciated, said Dr. Marshall, the entire ICU and half of another general medical floor in the hospital were converted to negative-pressure rooms.

Dr. Marshall said that having daily team debriefings has been essential. The hospitalist team room has a big whiteboard where essential information can be put up and shared. Frequent video conferencing has allowed physicians and advanced practice clinicians on the hospitalist team to ask questions, share concerns, and develop a shared knowledge base and vocabulary as they confronted this novel illness.

The rapid adaptations that EvergreenHealth successfully made depended on a responsive administration, good communication among physician services and with nursing staff, and the active participation of engineering and environmental services teams in adjusting to shifting patient needs, said Dr. Marshall.

“Preparedness is key,” Dr. Chu noted. “Managing this has required a unified effort” that addresses everything from the supply chain for personal protective equipment, to cleaning procedures, to engineering fixes that quickly added negative-pressure rooms.

“I can’t emphasize enough that this is a team sport,” said Dr. Marshall.
 

The unpredictable clinical course of COVID-19

The chimeric clinical course of COVID-19 means clinicians need to keep an open mind and be ready to act nimbly, said the EvergreenHealth hospitalists. Pattern recognition is a key to competent clinical management of hospitalized patients, but the course of coronavirus thus far defies any convenient application of heuristics.

Those first two patients had some characteristics in common, aside from their arrival from the same long-term care facility They each had unexplained acute respiratory distress syndrome and ground-glass opacities seen on chest CT, said Dr. Marshall. But all agreed it is still not clear who will fare well, and who will do poorly once they are admitted with coronavirus.

“We have noticed that these patients tend to have a rough course,” said Dr. Marshall. The “brisk inflammatory response” seen in some patients manifests in persistent fevers, big C-reactive protein (CRP) elevations, and likely is part of the picture of yet-unknown host factors that contribute to a worse disease course for some, she said. “These patients look toxic for a long time.”

Dr. Chu said that he’s seen even younger, healthier-looking patients admitted from the emergency department who are already quite dyspneic and may be headed for ventilation. These patients may have a low procalcitonin, and will often turn out to have an “impressive-looking” chest x-ray or CT that will show prominent bilateral infiltrates.

On the other hand, said Dr. Marshall, she and her colleagues have admitted frail-appearing nonagenarians who “just kind of sleep it off,” with little more than a cough and intermittent fevers.

Dr. Chu concurred: “So many of these patients had risk factors for severe disease and only had mild illness. Many were really quite stable.”

In terms of managing respiratory status, Dr. Baker said that the time to start planning for intubation is when the supplemental oxygen demands of COVID-19 patients start to go up. Unlike with patients who may be in some respiratory distress from other causes, once these patients have increased Fi0₂ needs, bridging “doesn’t work. ... They need to be intubated. Early intubation is important.” Clinicians’ level of concern should spike when they see increased work of breathing in a coronavirus patient, regardless of what the numbers are saying, he added.

For coronavirus patients with acute respiratory distress syndrome (ARDS), early proning also seems to provide some benefit, he said. At EvergreenHealth, standard ARDS ventilation protocols are being followed, including low tidal volume ventilation and positive end-expiratory pressure (PEEP) ladders. Coronavirus ventilation management has thus far been “pretty similar to standard practice with ARDS patients,” he said.

The hospitalist team was able to tap into the building knowledge base in China: Two of the EvergreenHealth hospitalists spoke fluent Mandarin, and one had contacts in China that allowed her to connect with Chinese physicians who had been treating COVID-19 patients since that outbreak had started. They established regular communication on WeChat, checking in frequently for updates on therapies and diagnostics being used in China as well.

One benefit of being in communication with colleagues in China, said Dr. Baker, was that they were able to get anecdotal evidence that elevated D-dimer levels and highly elevated CRP levels can portend a worse illness course. These findings seem to have held generally true for EvergreenHealth patients, he said. Dr. Marshall also spoke to the value of early communication with Chinese teams, who confirmed that the picture of a febrile illness with elevated CRP and leukopenia should raise the index of suspicion for coronavirus.

“Patients might improve over a few days, and then in the final 24 hours of their lives, we see changes in hemodynamics,” including reduced ejection fraction consistent with cardiogenic shock, as well as arrhythmias, said Dr. Baker. Some of the early patient deaths at EvergreenHealth followed this pattern, he said, noting that others have called for investigation into whether viral myocarditis is at play in some coronavirus deaths.

Moderately and severely ill coronavirus patients at EvergreenHealth currently receive a course of hydroxychloroquine of approximately 4-5 days’ duration. The hospital obtained remdesivir from Gilead through its compassionate-use program early on, and now is participating in a clinical trial for COVID-19 patients in the ICU.

By March 23, the facility had seen 162 confirmed COVID-19 cases, and 30 patients had died. Twenty-two inpatients had been discharged, and an additional 58 who were seen in the emergency department had been discharged home without admission.
 

Be suspicious – and prepared

When asked what he’d like his colleagues around the country to know as they diagnose and admit their first patients who are ill with coronavirus, Dr. Baker advised maintaining a high index of suspicion and a low threshold for testing. “I’ve given some thought to this,” he said. “From our reading and what information is out there, we are geared to pick up on the classic symptoms of coronavirus – cough, fever, some gastrointestinal symptoms.” However, many elderly patients “are not good historians. Some may have advanced dementia. ... When patients arrive with no history, we do our best to gather information,” but sometimes a case can still take clinicians by surprise, he said.

Dr. Baker told a cautionary tale of one of his patients, a woman who was admitted for a hip fracture after a fall at an assisted living facility. The patient was mildly hypoxic, but had an unremarkable physical exam, no fever, and a clear chest x-ray. She went to surgery and then to a postoperative floor with no isolation measures. When her respiratory status unexpectedly deteriorated, she was tested for COVID-19 – and was positive.

“When in doubt, isolate,” said Dr. Baker.

Dr. Chu concurred: “As soon as you suspect, move them, rather than testing first.”

Dr. Baker acknowledged, though, that when testing criteria and availability of personal protective equipment and test materials may vary by region, “it’s a challenge, especially with limited resources.”

Dr. Chu said that stringent isolation, though necessary, creates great hardship for patients and families. “It’s really important for us to check in with family members,” he said; patients are alone and afraid, and family members feel cut off – and also afraid on behalf of their ill loved ones. Workflow planning should acknowledge this and allocate extra time for patient connection and a little more time on the phone with families.

Dr. Chu offered a sobering final word. Make sure family members know their ill loved one’s wishes for care, he said: “There’s never been a better time to clarify code status on admission.”

Physicians at EvergreenHealth have created a document that contains consolidated information on what to anticipate and how to prepare for the arrival of COVID-19+ patients, recommendations on maximizing safety in the hospital environment, and key clinical management considerations. The document will be updated as new information arises.

[email protected]

Correction, 3/27/20: An earlier version of this article referenced white blood counts, presence of lymphopenia, and elevated hepatic enzymes for patients at EvergreenHealth when in fact that information pertained to patients in China. That paragraph has been deleted. 

David Baker, MD, a hospitalist at EvergreenHealth in Kirkland, Wash., had just come off a 7-day stretch of work and was early into his usual 7 days off. He’d helped care for some patients from a nearby assisted living facility who had been admitted with puzzlingly severe viral pneumonia that wasn’t influenza.

Though COVID-19, the novel coronavirus that was sickening tens of thousands in the Chinese province of Hubei, was in the back of everyone’s mind in late February, he said he wasn’t really expecting the call notifying him that two of the patients with pneumonia had tested positive for COVID-19.

Michael Chu, MD, was coming onto EvergreenHealth’s hospitalist service at about the time Dr. Baker was rotating off. He recalled learning of the first two positive COVID-19 tests on the evening of Feb. 28 – a Friday. He and his colleagues took in this information, coming to the realization that they were seeing other patients from the same facility who had viral pneumonia and negative influenza tests. “The first cohort of coronavirus patients all came from Life Care,” the Kirkland assisted living facility that was the epicenter of the first identified U.S. outbreak of community-transmitted coronavirus, said Dr. Chu. “They all fit a clinical syndrome” and many of them were critically ill or failing fast, since they were aged and with multiple risk factors, he said during the interviews he and his colleagues participated in.

The hospital adapts to a new normal

The usual protocol in EvergreenHealth’s ICU is for the nocturnist hospitalists, such as Dr. Baker, to staff that unit, with intensivists readily available for phone consultation. However, as the numbers of critically ill, ventilated COVID-19 patients climbed, the facility switched to 24/7 staffing with intensivists to augment the hospitalist team, said Nancy Marshall, MD, the director of EvergreenHealth’s hospitalist service.

Dr. Marshall related how the entire hospital rallied to create appropriate – but flexible – staffing and environmental adaptations to the influx of coronavirus patients. “Early on, we established a separate portion of the emergency department to evaluate and test persons under investigation,” for COVID-19, she said. When they realized that they were seeing the nation’s first cluster of community coronavirus transmission, they used “appropriate isolation precautions” when indicated. Triggers for clinical suspicion included not just fever or cough, but also a new requirement for supplemental oxygen and new abnormal findings on chest radiographs.

Patients with confirmed or suspected coronavirus, once admitted, were placed in negative-pressure rooms, and droplet precautions were used with these patients. In the absence of aerosol-generating procedures, those caring for these patients used a standard surgical mask, goggles or face shield, an isolation gown, and gloves. For intubations, bronchoscopies, and other aerosol-generating procedures, N95 masks were used; the facility also has some powered and controlled air-purifying respirators.

In short order, once the size of the outbreak was appreciated, said Dr. Marshall, the entire ICU and half of another general medical floor in the hospital were converted to negative-pressure rooms.

Dr. Marshall said that having daily team debriefings has been essential. The hospitalist team room has a big whiteboard where essential information can be put up and shared. Frequent video conferencing has allowed physicians and advanced practice clinicians on the hospitalist team to ask questions, share concerns, and develop a shared knowledge base and vocabulary as they confronted this novel illness.

The rapid adaptations that EvergreenHealth successfully made depended on a responsive administration, good communication among physician services and with nursing staff, and the active participation of engineering and environmental services teams in adjusting to shifting patient needs, said Dr. Marshall.

“Preparedness is key,” Dr. Chu noted. “Managing this has required a unified effort” that addresses everything from the supply chain for personal protective equipment, to cleaning procedures, to engineering fixes that quickly added negative-pressure rooms.

“I can’t emphasize enough that this is a team sport,” said Dr. Marshall.
 

The unpredictable clinical course of COVID-19

The chimeric clinical course of COVID-19 means clinicians need to keep an open mind and be ready to act nimbly, said the EvergreenHealth hospitalists. Pattern recognition is a key to competent clinical management of hospitalized patients, but the course of coronavirus thus far defies any convenient application of heuristics.

Those first two patients had some characteristics in common, aside from their arrival from the same long-term care facility They each had unexplained acute respiratory distress syndrome and ground-glass opacities seen on chest CT, said Dr. Marshall. But all agreed it is still not clear who will fare well, and who will do poorly once they are admitted with coronavirus.

“We have noticed that these patients tend to have a rough course,” said Dr. Marshall. The “brisk inflammatory response” seen in some patients manifests in persistent fevers, big C-reactive protein (CRP) elevations, and likely is part of the picture of yet-unknown host factors that contribute to a worse disease course for some, she said. “These patients look toxic for a long time.”

Dr. Chu said that he’s seen even younger, healthier-looking patients admitted from the emergency department who are already quite dyspneic and may be headed for ventilation. These patients may have a low procalcitonin, and will often turn out to have an “impressive-looking” chest x-ray or CT that will show prominent bilateral infiltrates.

On the other hand, said Dr. Marshall, she and her colleagues have admitted frail-appearing nonagenarians who “just kind of sleep it off,” with little more than a cough and intermittent fevers.

Dr. Chu concurred: “So many of these patients had risk factors for severe disease and only had mild illness. Many were really quite stable.”

In terms of managing respiratory status, Dr. Baker said that the time to start planning for intubation is when the supplemental oxygen demands of COVID-19 patients start to go up. Unlike with patients who may be in some respiratory distress from other causes, once these patients have increased Fi0₂ needs, bridging “doesn’t work. ... They need to be intubated. Early intubation is important.” Clinicians’ level of concern should spike when they see increased work of breathing in a coronavirus patient, regardless of what the numbers are saying, he added.

For coronavirus patients with acute respiratory distress syndrome (ARDS), early proning also seems to provide some benefit, he said. At EvergreenHealth, standard ARDS ventilation protocols are being followed, including low tidal volume ventilation and positive end-expiratory pressure (PEEP) ladders. Coronavirus ventilation management has thus far been “pretty similar to standard practice with ARDS patients,” he said.

The hospitalist team was able to tap into the building knowledge base in China: Two of the EvergreenHealth hospitalists spoke fluent Mandarin, and one had contacts in China that allowed her to connect with Chinese physicians who had been treating COVID-19 patients since that outbreak had started. They established regular communication on WeChat, checking in frequently for updates on therapies and diagnostics being used in China as well.

One benefit of being in communication with colleagues in China, said Dr. Baker, was that they were able to get anecdotal evidence that elevated D-dimer levels and highly elevated CRP levels can portend a worse illness course. These findings seem to have held generally true for EvergreenHealth patients, he said. Dr. Marshall also spoke to the value of early communication with Chinese teams, who confirmed that the picture of a febrile illness with elevated CRP and leukopenia should raise the index of suspicion for coronavirus.

“Patients might improve over a few days, and then in the final 24 hours of their lives, we see changes in hemodynamics,” including reduced ejection fraction consistent with cardiogenic shock, as well as arrhythmias, said Dr. Baker. Some of the early patient deaths at EvergreenHealth followed this pattern, he said, noting that others have called for investigation into whether viral myocarditis is at play in some coronavirus deaths.

Moderately and severely ill coronavirus patients at EvergreenHealth currently receive a course of hydroxychloroquine of approximately 4-5 days’ duration. The hospital obtained remdesivir from Gilead through its compassionate-use program early on, and now is participating in a clinical trial for COVID-19 patients in the ICU.

By March 23, the facility had seen 162 confirmed COVID-19 cases, and 30 patients had died. Twenty-two inpatients had been discharged, and an additional 58 who were seen in the emergency department had been discharged home without admission.
 

Be suspicious – and prepared

When asked what he’d like his colleagues around the country to know as they diagnose and admit their first patients who are ill with coronavirus, Dr. Baker advised maintaining a high index of suspicion and a low threshold for testing. “I’ve given some thought to this,” he said. “From our reading and what information is out there, we are geared to pick up on the classic symptoms of coronavirus – cough, fever, some gastrointestinal symptoms.” However, many elderly patients “are not good historians. Some may have advanced dementia. ... When patients arrive with no history, we do our best to gather information,” but sometimes a case can still take clinicians by surprise, he said.

Dr. Baker told a cautionary tale of one of his patients, a woman who was admitted for a hip fracture after a fall at an assisted living facility. The patient was mildly hypoxic, but had an unremarkable physical exam, no fever, and a clear chest x-ray. She went to surgery and then to a postoperative floor with no isolation measures. When her respiratory status unexpectedly deteriorated, she was tested for COVID-19 – and was positive.

“When in doubt, isolate,” said Dr. Baker.

Dr. Chu concurred: “As soon as you suspect, move them, rather than testing first.”

Dr. Baker acknowledged, though, that when testing criteria and availability of personal protective equipment and test materials may vary by region, “it’s a challenge, especially with limited resources.”

Dr. Chu said that stringent isolation, though necessary, creates great hardship for patients and families. “It’s really important for us to check in with family members,” he said; patients are alone and afraid, and family members feel cut off – and also afraid on behalf of their ill loved ones. Workflow planning should acknowledge this and allocate extra time for patient connection and a little more time on the phone with families.

Dr. Chu offered a sobering final word. Make sure family members know their ill loved one’s wishes for care, he said: “There’s never been a better time to clarify code status on admission.”

Physicians at EvergreenHealth have created a document that contains consolidated information on what to anticipate and how to prepare for the arrival of COVID-19+ patients, recommendations on maximizing safety in the hospital environment, and key clinical management considerations. The document will be updated as new information arises.

[email protected]

Correction, 3/27/20: An earlier version of this article referenced white blood counts, presence of lymphopenia, and elevated hepatic enzymes for patients at EvergreenHealth when in fact that information pertained to patients in China. That paragraph has been deleted. 

David Baker, MD, a hospitalist at EvergreenHealth in Kirkland, Wash., had just come off a 7-day stretch of work and was early into his usual 7 days off. He’d helped care for some patients from a nearby assisted living facility who had been admitted with puzzlingly severe viral pneumonia that wasn’t influenza.

Though COVID-19, the novel coronavirus that was sickening tens of thousands in the Chinese province of Hubei, was in the back of everyone’s mind in late February, he said he wasn’t really expecting the call notifying him that two of the patients with pneumonia had tested positive for COVID-19.

Michael Chu, MD, was coming onto EvergreenHealth’s hospitalist service at about the time Dr. Baker was rotating off. He recalled learning of the first two positive COVID-19 tests on the evening of Feb. 28 – a Friday. He and his colleagues took in this information, coming to the realization that they were seeing other patients from the same facility who had viral pneumonia and negative influenza tests. “The first cohort of coronavirus patients all came from Life Care,” the Kirkland assisted living facility that was the epicenter of the first identified U.S. outbreak of community-transmitted coronavirus, said Dr. Chu. “They all fit a clinical syndrome” and many of them were critically ill or failing fast, since they were aged and with multiple risk factors, he said during the interviews he and his colleagues participated in.

The hospital adapts to a new normal

The usual protocol in EvergreenHealth’s ICU is for the nocturnist hospitalists, such as Dr. Baker, to staff that unit, with intensivists readily available for phone consultation. However, as the numbers of critically ill, ventilated COVID-19 patients climbed, the facility switched to 24/7 staffing with intensivists to augment the hospitalist team, said Nancy Marshall, MD, the director of EvergreenHealth’s hospitalist service.

Dr. Marshall related how the entire hospital rallied to create appropriate – but flexible – staffing and environmental adaptations to the influx of coronavirus patients. “Early on, we established a separate portion of the emergency department to evaluate and test persons under investigation,” for COVID-19, she said. When they realized that they were seeing the nation’s first cluster of community coronavirus transmission, they used “appropriate isolation precautions” when indicated. Triggers for clinical suspicion included not just fever or cough, but also a new requirement for supplemental oxygen and new abnormal findings on chest radiographs.

Patients with confirmed or suspected coronavirus, once admitted, were placed in negative-pressure rooms, and droplet precautions were used with these patients. In the absence of aerosol-generating procedures, those caring for these patients used a standard surgical mask, goggles or face shield, an isolation gown, and gloves. For intubations, bronchoscopies, and other aerosol-generating procedures, N95 masks were used; the facility also has some powered and controlled air-purifying respirators.

In short order, once the size of the outbreak was appreciated, said Dr. Marshall, the entire ICU and half of another general medical floor in the hospital were converted to negative-pressure rooms.

Dr. Marshall said that having daily team debriefings has been essential. The hospitalist team room has a big whiteboard where essential information can be put up and shared. Frequent video conferencing has allowed physicians and advanced practice clinicians on the hospitalist team to ask questions, share concerns, and develop a shared knowledge base and vocabulary as they confronted this novel illness.

The rapid adaptations that EvergreenHealth successfully made depended on a responsive administration, good communication among physician services and with nursing staff, and the active participation of engineering and environmental services teams in adjusting to shifting patient needs, said Dr. Marshall.

“Preparedness is key,” Dr. Chu noted. “Managing this has required a unified effort” that addresses everything from the supply chain for personal protective equipment, to cleaning procedures, to engineering fixes that quickly added negative-pressure rooms.

“I can’t emphasize enough that this is a team sport,” said Dr. Marshall.
 

The unpredictable clinical course of COVID-19

The chimeric clinical course of COVID-19 means clinicians need to keep an open mind and be ready to act nimbly, said the EvergreenHealth hospitalists. Pattern recognition is a key to competent clinical management of hospitalized patients, but the course of coronavirus thus far defies any convenient application of heuristics.

Those first two patients had some characteristics in common, aside from their arrival from the same long-term care facility They each had unexplained acute respiratory distress syndrome and ground-glass opacities seen on chest CT, said Dr. Marshall. But all agreed it is still not clear who will fare well, and who will do poorly once they are admitted with coronavirus.

“We have noticed that these patients tend to have a rough course,” said Dr. Marshall. The “brisk inflammatory response” seen in some patients manifests in persistent fevers, big C-reactive protein (CRP) elevations, and likely is part of the picture of yet-unknown host factors that contribute to a worse disease course for some, she said. “These patients look toxic for a long time.”

Dr. Chu said that he’s seen even younger, healthier-looking patients admitted from the emergency department who are already quite dyspneic and may be headed for ventilation. These patients may have a low procalcitonin, and will often turn out to have an “impressive-looking” chest x-ray or CT that will show prominent bilateral infiltrates.

On the other hand, said Dr. Marshall, she and her colleagues have admitted frail-appearing nonagenarians who “just kind of sleep it off,” with little more than a cough and intermittent fevers.

Dr. Chu concurred: “So many of these patients had risk factors for severe disease and only had mild illness. Many were really quite stable.”

In terms of managing respiratory status, Dr. Baker said that the time to start planning for intubation is when the supplemental oxygen demands of COVID-19 patients start to go up. Unlike with patients who may be in some respiratory distress from other causes, once these patients have increased Fi0₂ needs, bridging “doesn’t work. ... They need to be intubated. Early intubation is important.” Clinicians’ level of concern should spike when they see increased work of breathing in a coronavirus patient, regardless of what the numbers are saying, he added.

For coronavirus patients with acute respiratory distress syndrome (ARDS), early proning also seems to provide some benefit, he said. At EvergreenHealth, standard ARDS ventilation protocols are being followed, including low tidal volume ventilation and positive end-expiratory pressure (PEEP) ladders. Coronavirus ventilation management has thus far been “pretty similar to standard practice with ARDS patients,” he said.

The hospitalist team was able to tap into the building knowledge base in China: Two of the EvergreenHealth hospitalists spoke fluent Mandarin, and one had contacts in China that allowed her to connect with Chinese physicians who had been treating COVID-19 patients since that outbreak had started. They established regular communication on WeChat, checking in frequently for updates on therapies and diagnostics being used in China as well.

One benefit of being in communication with colleagues in China, said Dr. Baker, was that they were able to get anecdotal evidence that elevated D-dimer levels and highly elevated CRP levels can portend a worse illness course. These findings seem to have held generally true for EvergreenHealth patients, he said. Dr. Marshall also spoke to the value of early communication with Chinese teams, who confirmed that the picture of a febrile illness with elevated CRP and leukopenia should raise the index of suspicion for coronavirus.

“Patients might improve over a few days, and then in the final 24 hours of their lives, we see changes in hemodynamics,” including reduced ejection fraction consistent with cardiogenic shock, as well as arrhythmias, said Dr. Baker. Some of the early patient deaths at EvergreenHealth followed this pattern, he said, noting that others have called for investigation into whether viral myocarditis is at play in some coronavirus deaths.

Moderately and severely ill coronavirus patients at EvergreenHealth currently receive a course of hydroxychloroquine of approximately 4-5 days’ duration. The hospital obtained remdesivir from Gilead through its compassionate-use program early on, and now is participating in a clinical trial for COVID-19 patients in the ICU.

By March 23, the facility had seen 162 confirmed COVID-19 cases, and 30 patients had died. Twenty-two inpatients had been discharged, and an additional 58 who were seen in the emergency department had been discharged home without admission.
 

Be suspicious – and prepared

When asked what he’d like his colleagues around the country to know as they diagnose and admit their first patients who are ill with coronavirus, Dr. Baker advised maintaining a high index of suspicion and a low threshold for testing. “I’ve given some thought to this,” he said. “From our reading and what information is out there, we are geared to pick up on the classic symptoms of coronavirus – cough, fever, some gastrointestinal symptoms.” However, many elderly patients “are not good historians. Some may have advanced dementia. ... When patients arrive with no history, we do our best to gather information,” but sometimes a case can still take clinicians by surprise, he said.

Dr. Baker told a cautionary tale of one of his patients, a woman who was admitted for a hip fracture after a fall at an assisted living facility. The patient was mildly hypoxic, but had an unremarkable physical exam, no fever, and a clear chest x-ray. She went to surgery and then to a postoperative floor with no isolation measures. When her respiratory status unexpectedly deteriorated, she was tested for COVID-19 – and was positive.

“When in doubt, isolate,” said Dr. Baker.

Dr. Chu concurred: “As soon as you suspect, move them, rather than testing first.”

Dr. Baker acknowledged, though, that when testing criteria and availability of personal protective equipment and test materials may vary by region, “it’s a challenge, especially with limited resources.”

Dr. Chu said that stringent isolation, though necessary, creates great hardship for patients and families. “It’s really important for us to check in with family members,” he said; patients are alone and afraid, and family members feel cut off – and also afraid on behalf of their ill loved ones. Workflow planning should acknowledge this and allocate extra time for patient connection and a little more time on the phone with families.

Dr. Chu offered a sobering final word. Make sure family members know their ill loved one’s wishes for care, he said: “There’s never been a better time to clarify code status on admission.”

Physicians at EvergreenHealth have created a document that contains consolidated information on what to anticipate and how to prepare for the arrival of COVID-19+ patients, recommendations on maximizing safety in the hospital environment, and key clinical management considerations. The document will be updated as new information arises.

[email protected]

Correction, 3/27/20: An earlier version of this article referenced white blood counts, presence of lymphopenia, and elevated hepatic enzymes for patients at EvergreenHealth when in fact that information pertained to patients in China. That paragraph has been deleted. 

LAHAINA, HAWAII – Novel topical medications are in the works that will address the longstanding unmet need for a Food and Drug Administration–approved noncorticosteroid topical for use in pediatric atopic dermatitis, Lawrence F. Eichenfield, MD, reported at the SDEF Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/MDedge News

These new agents will be embraced by clinicians for use in delicate skin areas, as well as in the common clinical scenario involving steroid-averse parents, predicted Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital.

First up is crisaborole (Eucrisa), which is approved for atopic dermatitis (AD) in children aged two years and older and has been under review at the Food and Drug Administration for use in infantile AD. (On March 24, several weeks after the meeting, the FDA approved crisaborole down to aged three months for treatment of mild to moderate AD). Agents earlier in the developmental pipeline include two topical Janus kinase (JAK) inhibitors, ruxolitinib and delgocitinib, as well as tapinarof.

Crisaborole: This phosphodiesterase 4 inhibitor is FDA approved down to 2 years of age. In the phase 4, open-label CrisADe CARE 1 study, crisaborole was studied in 137 children ages 3 months to under 24 months. CrisADe CARE 1, presented at the 2019 annual conference of the Pediatric Dermatology Research Alliance (PeDRA), showed close to a 60% reduction from baseline in Eczema Area and Severity Index (EASI) scores after 28 days of twice-daily therapy in the youngsters, 61% of who had moderate AD, the rest mild disease.

Tolerability and safety were reassuring in the phase 4 study. Although about 3% of subjects each experienced application site pain, discomfort, or erythema, the rate of study discontinuation was impressively low at 2.9%, Dr. Eichenfield observed.

Delgocitinib: Japanese investigators have reported positive results in a phase 2 study of delgocitinib ointment in 98 children and adolescents aged 2-15 years, with AD. After 4 weeks of twice-daily treatment, modified EASI scores improved by a mean of 54% with delgocitinib 0.25% and by 62% with 0.5%, compared with less than a 5% improvement with the vehicle control (J Allergy Clin Immunol. 2019 Dec;144[6]:1575-83). The ointment formulation is being developed specifically for the Japanese market.

Studies of an alternative formulation of the JAK inhibitor as a cream rather than ointment, intended for the U.S. and European markets, are in the early stages, conducted by Leo Pharma. Delgocitinib cream, under study in adults and children down to age 2 years with AD, is also under study for chronic hand dermatitis, a program Dr. Eichenfield is enthusiastic about.

“Hand eczema is something you’re going to hear a lot about in the next 2 years. In the U.S., we have no drug approved specifically for hand eczema. And we actually see a lot of hand eczema in pediatric and adolescent patients. I’d say 75%-80% of the ones I see also have atopic dermatitis,” he said.

Ruxolitinib: Incyte, which is developing the topical JAK inhibitor, recently announced positive results in the first of four phase 3 randomized trials, this one conducted in AD patients aged 12 years and older. The efficacy appears to be comparable to that of topical steroids. Studies in younger children are also planned. Ruxolitinib cream is in advanced clinical trials for treatment of vitiligo.

Tapinarof: This topical aryl hydrocarbon receptor agonist downregulates Th17 cytokines, an attribute desirable for treatment of psoriasis. But it also downregulates Th2 cytokines and improves the damaged skin barrier characteristic of AD via upregulation of the filaggrin and involucrin genes in keratinocytes. In a phase 2b, double-blind clinical trial conducted in 247 adults and adolescents with moderate to severe AD, 12 weeks of once-daily tapinarof 1% enabled 51% of patients to achieve a 75% or greater improvement in EASI scores, compared with 18% in controls on vehicle (J Am Acad Dermatol. 2019 Jan;80[1]:89-98.e3).

Dermavant, which is developing the drug, plans to seek an initial indication for treatment of psoriasis, where a phase 3 study is underway, before pursuing regulatory approval in AD.

Dr. Eichenfield disclosed serving as a consultant or investigator for various pharmaceutical companies, including Pfizer, and Dermavant.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

[email protected]

This article was updated 3/27/20.

LAHAINA, HAWAII – Novel topical medications are in the works that will address the longstanding unmet need for a Food and Drug Administration–approved noncorticosteroid topical for use in pediatric atopic dermatitis, Lawrence F. Eichenfield, MD, reported at the SDEF Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/MDedge News

These new agents will be embraced by clinicians for use in delicate skin areas, as well as in the common clinical scenario involving steroid-averse parents, predicted Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital.

First up is crisaborole (Eucrisa), which is approved for atopic dermatitis (AD) in children aged two years and older and has been under review at the Food and Drug Administration for use in infantile AD. (On March 24, several weeks after the meeting, the FDA approved crisaborole down to aged three months for treatment of mild to moderate AD). Agents earlier in the developmental pipeline include two topical Janus kinase (JAK) inhibitors, ruxolitinib and delgocitinib, as well as tapinarof.

Crisaborole: This phosphodiesterase 4 inhibitor is FDA approved down to 2 years of age. In the phase 4, open-label CrisADe CARE 1 study, crisaborole was studied in 137 children ages 3 months to under 24 months. CrisADe CARE 1, presented at the 2019 annual conference of the Pediatric Dermatology Research Alliance (PeDRA), showed close to a 60% reduction from baseline in Eczema Area and Severity Index (EASI) scores after 28 days of twice-daily therapy in the youngsters, 61% of who had moderate AD, the rest mild disease.

Tolerability and safety were reassuring in the phase 4 study. Although about 3% of subjects each experienced application site pain, discomfort, or erythema, the rate of study discontinuation was impressively low at 2.9%, Dr. Eichenfield observed.

Delgocitinib: Japanese investigators have reported positive results in a phase 2 study of delgocitinib ointment in 98 children and adolescents aged 2-15 years, with AD. After 4 weeks of twice-daily treatment, modified EASI scores improved by a mean of 54% with delgocitinib 0.25% and by 62% with 0.5%, compared with less than a 5% improvement with the vehicle control (J Allergy Clin Immunol. 2019 Dec;144[6]:1575-83). The ointment formulation is being developed specifically for the Japanese market.

Studies of an alternative formulation of the JAK inhibitor as a cream rather than ointment, intended for the U.S. and European markets, are in the early stages, conducted by Leo Pharma. Delgocitinib cream, under study in adults and children down to age 2 years with AD, is also under study for chronic hand dermatitis, a program Dr. Eichenfield is enthusiastic about.

“Hand eczema is something you’re going to hear a lot about in the next 2 years. In the U.S., we have no drug approved specifically for hand eczema. And we actually see a lot of hand eczema in pediatric and adolescent patients. I’d say 75%-80% of the ones I see also have atopic dermatitis,” he said.

Ruxolitinib: Incyte, which is developing the topical JAK inhibitor, recently announced positive results in the first of four phase 3 randomized trials, this one conducted in AD patients aged 12 years and older. The efficacy appears to be comparable to that of topical steroids. Studies in younger children are also planned. Ruxolitinib cream is in advanced clinical trials for treatment of vitiligo.

Tapinarof: This topical aryl hydrocarbon receptor agonist downregulates Th17 cytokines, an attribute desirable for treatment of psoriasis. But it also downregulates Th2 cytokines and improves the damaged skin barrier characteristic of AD via upregulation of the filaggrin and involucrin genes in keratinocytes. In a phase 2b, double-blind clinical trial conducted in 247 adults and adolescents with moderate to severe AD, 12 weeks of once-daily tapinarof 1% enabled 51% of patients to achieve a 75% or greater improvement in EASI scores, compared with 18% in controls on vehicle (J Am Acad Dermatol. 2019 Jan;80[1]:89-98.e3).

Dermavant, which is developing the drug, plans to seek an initial indication for treatment of psoriasis, where a phase 3 study is underway, before pursuing regulatory approval in AD.

Dr. Eichenfield disclosed serving as a consultant or investigator for various pharmaceutical companies, including Pfizer, and Dermavant.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

[email protected]

This article was updated 3/27/20.

LAHAINA, HAWAII – Novel topical medications are in the works that will address the longstanding unmet need for a Food and Drug Administration–approved noncorticosteroid topical for use in pediatric atopic dermatitis, Lawrence F. Eichenfield, MD, reported at the SDEF Hawaii Dermatology Seminar provided by the Global Academy for Medical Education/Skin Disease Education Foundation.

Bruce Jancin/MDedge News

These new agents will be embraced by clinicians for use in delicate skin areas, as well as in the common clinical scenario involving steroid-averse parents, predicted Dr. Eichenfield, professor of dermatology and pediatrics at the University of California, San Diego, and chief of pediatric and adolescent dermatology at Rady Children’s Hospital.

First up is crisaborole (Eucrisa), which is approved for atopic dermatitis (AD) in children aged two years and older and has been under review at the Food and Drug Administration for use in infantile AD. (On March 24, several weeks after the meeting, the FDA approved crisaborole down to aged three months for treatment of mild to moderate AD). Agents earlier in the developmental pipeline include two topical Janus kinase (JAK) inhibitors, ruxolitinib and delgocitinib, as well as tapinarof.

Crisaborole: This phosphodiesterase 4 inhibitor is FDA approved down to 2 years of age. In the phase 4, open-label CrisADe CARE 1 study, crisaborole was studied in 137 children ages 3 months to under 24 months. CrisADe CARE 1, presented at the 2019 annual conference of the Pediatric Dermatology Research Alliance (PeDRA), showed close to a 60% reduction from baseline in Eczema Area and Severity Index (EASI) scores after 28 days of twice-daily therapy in the youngsters, 61% of who had moderate AD, the rest mild disease.

Tolerability and safety were reassuring in the phase 4 study. Although about 3% of subjects each experienced application site pain, discomfort, or erythema, the rate of study discontinuation was impressively low at 2.9%, Dr. Eichenfield observed.

Delgocitinib: Japanese investigators have reported positive results in a phase 2 study of delgocitinib ointment in 98 children and adolescents aged 2-15 years, with AD. After 4 weeks of twice-daily treatment, modified EASI scores improved by a mean of 54% with delgocitinib 0.25% and by 62% with 0.5%, compared with less than a 5% improvement with the vehicle control (J Allergy Clin Immunol. 2019 Dec;144[6]:1575-83). The ointment formulation is being developed specifically for the Japanese market.

Studies of an alternative formulation of the JAK inhibitor as a cream rather than ointment, intended for the U.S. and European markets, are in the early stages, conducted by Leo Pharma. Delgocitinib cream, under study in adults and children down to age 2 years with AD, is also under study for chronic hand dermatitis, a program Dr. Eichenfield is enthusiastic about.

“Hand eczema is something you’re going to hear a lot about in the next 2 years. In the U.S., we have no drug approved specifically for hand eczema. And we actually see a lot of hand eczema in pediatric and adolescent patients. I’d say 75%-80% of the ones I see also have atopic dermatitis,” he said.

Ruxolitinib: Incyte, which is developing the topical JAK inhibitor, recently announced positive results in the first of four phase 3 randomized trials, this one conducted in AD patients aged 12 years and older. The efficacy appears to be comparable to that of topical steroids. Studies in younger children are also planned. Ruxolitinib cream is in advanced clinical trials for treatment of vitiligo.

Tapinarof: This topical aryl hydrocarbon receptor agonist downregulates Th17 cytokines, an attribute desirable for treatment of psoriasis. But it also downregulates Th2 cytokines and improves the damaged skin barrier characteristic of AD via upregulation of the filaggrin and involucrin genes in keratinocytes. In a phase 2b, double-blind clinical trial conducted in 247 adults and adolescents with moderate to severe AD, 12 weeks of once-daily tapinarof 1% enabled 51% of patients to achieve a 75% or greater improvement in EASI scores, compared with 18% in controls on vehicle (J Am Acad Dermatol. 2019 Jan;80[1]:89-98.e3).

Dermavant, which is developing the drug, plans to seek an initial indication for treatment of psoriasis, where a phase 3 study is underway, before pursuing regulatory approval in AD.

Dr. Eichenfield disclosed serving as a consultant or investigator for various pharmaceutical companies, including Pfizer, and Dermavant.

SDEF/Global Academy for Medical Education and this news organization are owned by the same parent company.

[email protected]

This article was updated 3/27/20.

I have no knowledge of, or experience with, managing a cancer patient during a pandemic. However, from the published and otherwise shared experience of others, we should not allow ourselves to underestimate the voracity of the coronavirus pandemic on our patients, communities, and health care systems.

Data from China suggest cancer patients infected with SARS-CoV-2 face a 3.5 times higher risk of mechanical ventilation, intensive care unit admission, or death, compared with infected patients without cancer (Lancet Oncol 2020;21:335-7).

Health care workers in Seattle have also shared their experiences battling coronavirus infections in cancer patients (J Natl Compr Canc Netw. 2020 Mar 20. doi: 10.6004/jnccn.2020.7560). Masumi Ueda, MD, of Seattle Cancer Care Alliance, and colleagues reviewed their decisions in multiple domains over a 7-week period, during which the state of Washington went from a single case of SARS-CoV-2 infection to nearly 650 cases and 40 deaths.
 

Making tough treatment decisions

Dr. Ueda and colleagues contrasted their customary resource-rich, innovation-oriented, cancer-combatting environment with their current circumstance, in which they must prioritize treatment for patients for whom the risk-reward balance has tilted substantially toward “risk.”

The authors noted that their most difficult decisions were those regarding delay of cancer treatment. They suggested that plans for potentially curative adjuvant therapy should likely proceed, but, for patients with metastatic disease, the equation is more nuanced.

In some cases, treatment should be delayed or interrupted with recognition of how that could result in worsening performance status and admission for symptom palliation, further stressing inpatient resources.

The authors suggested scenarios for prioritizing cancer surgery. For example, several months of systemic therapy (ideally, low-risk systemic therapy such as hormone therapy for breast or prostate cancer) and surgical delay may be worthwhile, without compromising patient care.

Patients with aggressive hematologic malignancy requiring urgent systemic treatment (potentially stem cell transplantation and cellular immunotherapies) should be treated promptly. However, even in those cases, opportunities should be sought to lessen immunosuppression and transition care as quickly as possible to the outpatient clinic, according to guidelines from the American Society of Transplantation and Cellular Therapy.
 

See one, do one, teach one

Rendering patient care during a pandemic would be unique for me. However, I, like all physicians, am familiar with feelings of inadequacy at times of professional challenge. On countless occasions, I have started my day or walked into a patient’s room wondering whether I will have the fortitude, knowledge, creativity, or help I need to get through that day or make that patient “better” by any definition of that word.

We all know the formula: “Work hard. Make evidence-based, personalized decisions for those who have entrusted their care to us. Learn from those encounters. Teach from our knowledge and experience – that is, ‘See one, do one, teach one.’ ”

The Seattle oncologists are living the lives of first responders and deserve our admiration for putting pen to paper so we can learn from their considerable, relevant experience.

Similar admiration is due to Giuseppe Curigliano, MD, of the European Institute of Oncology in Milan. In the ASCO Daily News, Dr. Curigliano described an epidemic that, within 3 weeks, overloaded the health care system across northern Italy.

Hospitalization was needed for over 60% of infected patients, and nearly 15% of those patients needed intensive care unit services for respiratory distress. The Italians centralized oncology care in specialized hubs, with spokes of institutions working in parallel to provide cancer-specific care in a COVID-free environment.

To build upon cancer-specific information from Italy and other areas hard-hit by COVID-19, more than 30 cancer centers have joined together to form the COVID-19 and Cancer Consortium. The consortium’s website hosts a survey designed to “capture details related to cancer patients presumed to have COVID-19.”
 

Calculating deaths and long-term consequences for cancer care delivery

It is proper that the authors from China, Italy, and Seattle did not focus attention on the case fatality rate from the COVID-19 pandemic among cancer patients. To say the least, it would be complicated to tally the direct mortality – either overall or in clinically important subsets of patients, including country-specific cohorts.

What we know from published reports is that, in Italy, cancer patients account for about 20% of deaths from coronavirus. In China, the case-fatality rate for patients with cancer was 5.6% (JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648).

However, we know nothing about the indirect death toll from malignancy (without coronavirus infection) that was untreated or managed less than optimally because of personnel and physical resources that were diverted to COVID-19–associated cases.

Similarly, we cannot begin to estimate indirect consequences of the pandemic to oncology practices, such as accelerated burnout and posttraumatic stress disorder, as well as the long-range effects of economic turmoil on patients, health care workers, and provider organizations.
 

What happens to cancer trials?

From China, Italy, and Seattle, thus far, there is little information about how the pandemic will affect the vital clinical research endeavor. The Seattle physicians did say they plan to enroll patients on clinical trials only when the trial offers a high chance of benefiting the patient over standard therapy alone.

Fortunately, the National Institutes of Health and Food and Drug Administration have released guidance documents related to clinical trials.

The National Cancer Institute (NCI) has also released guidance documents (March 13 guidance; March 23 guidance) for patients on clinical trials supported by the NCI Cancer Therapy Evaluation Program (CTEP) and the NCI Community Oncology Research Program (NCORP).

CTEP and NCORP are making reasonable accommodations to suspend monitoring visits and audits, allow tele–follow-up visits for patients, and permit local physicians to provide care for patients on study. In addition, with appropriate procedural adherence and documentation, CTEP and NCORP will allow oral investigational medicines to be mailed directly to patients’ homes.

Planned NCI National Clinical Trials Network meetings will be conducted via remote access webinars, conference calls, and similar technology. These adjustments – and probably many more to come – are geared toward facilitating ongoing care to proceed safely and with minimal risk for patients currently receiving investigational therapies and for the sites and investigators engaged in those studies.

Each of us has probably faced a personal “defining professional moment,” when we had to utilize every skill in our arsenal and examine the motivations that led us to a career in oncology. However, it is clear from the forgoing clinical and research processes and guidelines that the COVID-19 pandemic is such a defining professional moment for each of us, in every community we serve.

Critical junctures like this cause more rapid behavior change and innovation than the slow-moving pace that characterizes our idealized preferences. As oncologists who embrace new data and behavioral change, we stand to learn processes that will facilitate more perfected systems of care than the one that preceded this unprecedented crisis, promote more efficient sharing of high-quality information, and improve the outcome for our future patients.


Dr. Lyss was an oncologist and researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

I have no knowledge of, or experience with, managing a cancer patient during a pandemic. However, from the published and otherwise shared experience of others, we should not allow ourselves to underestimate the voracity of the coronavirus pandemic on our patients, communities, and health care systems.

Data from China suggest cancer patients infected with SARS-CoV-2 face a 3.5 times higher risk of mechanical ventilation, intensive care unit admission, or death, compared with infected patients without cancer (Lancet Oncol 2020;21:335-7).

Health care workers in Seattle have also shared their experiences battling coronavirus infections in cancer patients (J Natl Compr Canc Netw. 2020 Mar 20. doi: 10.6004/jnccn.2020.7560). Masumi Ueda, MD, of Seattle Cancer Care Alliance, and colleagues reviewed their decisions in multiple domains over a 7-week period, during which the state of Washington went from a single case of SARS-CoV-2 infection to nearly 650 cases and 40 deaths.
 

Making tough treatment decisions

Dr. Ueda and colleagues contrasted their customary resource-rich, innovation-oriented, cancer-combatting environment with their current circumstance, in which they must prioritize treatment for patients for whom the risk-reward balance has tilted substantially toward “risk.”

The authors noted that their most difficult decisions were those regarding delay of cancer treatment. They suggested that plans for potentially curative adjuvant therapy should likely proceed, but, for patients with metastatic disease, the equation is more nuanced.

In some cases, treatment should be delayed or interrupted with recognition of how that could result in worsening performance status and admission for symptom palliation, further stressing inpatient resources.

The authors suggested scenarios for prioritizing cancer surgery. For example, several months of systemic therapy (ideally, low-risk systemic therapy such as hormone therapy for breast or prostate cancer) and surgical delay may be worthwhile, without compromising patient care.

Patients with aggressive hematologic malignancy requiring urgent systemic treatment (potentially stem cell transplantation and cellular immunotherapies) should be treated promptly. However, even in those cases, opportunities should be sought to lessen immunosuppression and transition care as quickly as possible to the outpatient clinic, according to guidelines from the American Society of Transplantation and Cellular Therapy.
 

See one, do one, teach one

Rendering patient care during a pandemic would be unique for me. However, I, like all physicians, am familiar with feelings of inadequacy at times of professional challenge. On countless occasions, I have started my day or walked into a patient’s room wondering whether I will have the fortitude, knowledge, creativity, or help I need to get through that day or make that patient “better” by any definition of that word.

We all know the formula: “Work hard. Make evidence-based, personalized decisions for those who have entrusted their care to us. Learn from those encounters. Teach from our knowledge and experience – that is, ‘See one, do one, teach one.’ ”

The Seattle oncologists are living the lives of first responders and deserve our admiration for putting pen to paper so we can learn from their considerable, relevant experience.

Similar admiration is due to Giuseppe Curigliano, MD, of the European Institute of Oncology in Milan. In the ASCO Daily News, Dr. Curigliano described an epidemic that, within 3 weeks, overloaded the health care system across northern Italy.

Hospitalization was needed for over 60% of infected patients, and nearly 15% of those patients needed intensive care unit services for respiratory distress. The Italians centralized oncology care in specialized hubs, with spokes of institutions working in parallel to provide cancer-specific care in a COVID-free environment.

To build upon cancer-specific information from Italy and other areas hard-hit by COVID-19, more than 30 cancer centers have joined together to form the COVID-19 and Cancer Consortium. The consortium’s website hosts a survey designed to “capture details related to cancer patients presumed to have COVID-19.”
 

Calculating deaths and long-term consequences for cancer care delivery

It is proper that the authors from China, Italy, and Seattle did not focus attention on the case fatality rate from the COVID-19 pandemic among cancer patients. To say the least, it would be complicated to tally the direct mortality – either overall or in clinically important subsets of patients, including country-specific cohorts.

What we know from published reports is that, in Italy, cancer patients account for about 20% of deaths from coronavirus. In China, the case-fatality rate for patients with cancer was 5.6% (JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648).

However, we know nothing about the indirect death toll from malignancy (without coronavirus infection) that was untreated or managed less than optimally because of personnel and physical resources that were diverted to COVID-19–associated cases.

Similarly, we cannot begin to estimate indirect consequences of the pandemic to oncology practices, such as accelerated burnout and posttraumatic stress disorder, as well as the long-range effects of economic turmoil on patients, health care workers, and provider organizations.
 

What happens to cancer trials?

From China, Italy, and Seattle, thus far, there is little information about how the pandemic will affect the vital clinical research endeavor. The Seattle physicians did say they plan to enroll patients on clinical trials only when the trial offers a high chance of benefiting the patient over standard therapy alone.

Fortunately, the National Institutes of Health and Food and Drug Administration have released guidance documents related to clinical trials.

The National Cancer Institute (NCI) has also released guidance documents (March 13 guidance; March 23 guidance) for patients on clinical trials supported by the NCI Cancer Therapy Evaluation Program (CTEP) and the NCI Community Oncology Research Program (NCORP).

CTEP and NCORP are making reasonable accommodations to suspend monitoring visits and audits, allow tele–follow-up visits for patients, and permit local physicians to provide care for patients on study. In addition, with appropriate procedural adherence and documentation, CTEP and NCORP will allow oral investigational medicines to be mailed directly to patients’ homes.

Planned NCI National Clinical Trials Network meetings will be conducted via remote access webinars, conference calls, and similar technology. These adjustments – and probably many more to come – are geared toward facilitating ongoing care to proceed safely and with minimal risk for patients currently receiving investigational therapies and for the sites and investigators engaged in those studies.

Each of us has probably faced a personal “defining professional moment,” when we had to utilize every skill in our arsenal and examine the motivations that led us to a career in oncology. However, it is clear from the forgoing clinical and research processes and guidelines that the COVID-19 pandemic is such a defining professional moment for each of us, in every community we serve.

Critical junctures like this cause more rapid behavior change and innovation than the slow-moving pace that characterizes our idealized preferences. As oncologists who embrace new data and behavioral change, we stand to learn processes that will facilitate more perfected systems of care than the one that preceded this unprecedented crisis, promote more efficient sharing of high-quality information, and improve the outcome for our future patients.


Dr. Lyss was an oncologist and researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

I have no knowledge of, or experience with, managing a cancer patient during a pandemic. However, from the published and otherwise shared experience of others, we should not allow ourselves to underestimate the voracity of the coronavirus pandemic on our patients, communities, and health care systems.

Data from China suggest cancer patients infected with SARS-CoV-2 face a 3.5 times higher risk of mechanical ventilation, intensive care unit admission, or death, compared with infected patients without cancer (Lancet Oncol 2020;21:335-7).

Health care workers in Seattle have also shared their experiences battling coronavirus infections in cancer patients (J Natl Compr Canc Netw. 2020 Mar 20. doi: 10.6004/jnccn.2020.7560). Masumi Ueda, MD, of Seattle Cancer Care Alliance, and colleagues reviewed their decisions in multiple domains over a 7-week period, during which the state of Washington went from a single case of SARS-CoV-2 infection to nearly 650 cases and 40 deaths.
 

Making tough treatment decisions

Dr. Ueda and colleagues contrasted their customary resource-rich, innovation-oriented, cancer-combatting environment with their current circumstance, in which they must prioritize treatment for patients for whom the risk-reward balance has tilted substantially toward “risk.”

The authors noted that their most difficult decisions were those regarding delay of cancer treatment. They suggested that plans for potentially curative adjuvant therapy should likely proceed, but, for patients with metastatic disease, the equation is more nuanced.

In some cases, treatment should be delayed or interrupted with recognition of how that could result in worsening performance status and admission for symptom palliation, further stressing inpatient resources.

The authors suggested scenarios for prioritizing cancer surgery. For example, several months of systemic therapy (ideally, low-risk systemic therapy such as hormone therapy for breast or prostate cancer) and surgical delay may be worthwhile, without compromising patient care.

Patients with aggressive hematologic malignancy requiring urgent systemic treatment (potentially stem cell transplantation and cellular immunotherapies) should be treated promptly. However, even in those cases, opportunities should be sought to lessen immunosuppression and transition care as quickly as possible to the outpatient clinic, according to guidelines from the American Society of Transplantation and Cellular Therapy.
 

See one, do one, teach one

Rendering patient care during a pandemic would be unique for me. However, I, like all physicians, am familiar with feelings of inadequacy at times of professional challenge. On countless occasions, I have started my day or walked into a patient’s room wondering whether I will have the fortitude, knowledge, creativity, or help I need to get through that day or make that patient “better” by any definition of that word.

We all know the formula: “Work hard. Make evidence-based, personalized decisions for those who have entrusted their care to us. Learn from those encounters. Teach from our knowledge and experience – that is, ‘See one, do one, teach one.’ ”

The Seattle oncologists are living the lives of first responders and deserve our admiration for putting pen to paper so we can learn from their considerable, relevant experience.

Similar admiration is due to Giuseppe Curigliano, MD, of the European Institute of Oncology in Milan. In the ASCO Daily News, Dr. Curigliano described an epidemic that, within 3 weeks, overloaded the health care system across northern Italy.

Hospitalization was needed for over 60% of infected patients, and nearly 15% of those patients needed intensive care unit services for respiratory distress. The Italians centralized oncology care in specialized hubs, with spokes of institutions working in parallel to provide cancer-specific care in a COVID-free environment.

To build upon cancer-specific information from Italy and other areas hard-hit by COVID-19, more than 30 cancer centers have joined together to form the COVID-19 and Cancer Consortium. The consortium’s website hosts a survey designed to “capture details related to cancer patients presumed to have COVID-19.”
 

Calculating deaths and long-term consequences for cancer care delivery

It is proper that the authors from China, Italy, and Seattle did not focus attention on the case fatality rate from the COVID-19 pandemic among cancer patients. To say the least, it would be complicated to tally the direct mortality – either overall or in clinically important subsets of patients, including country-specific cohorts.

What we know from published reports is that, in Italy, cancer patients account for about 20% of deaths from coronavirus. In China, the case-fatality rate for patients with cancer was 5.6% (JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648).

However, we know nothing about the indirect death toll from malignancy (without coronavirus infection) that was untreated or managed less than optimally because of personnel and physical resources that were diverted to COVID-19–associated cases.

Similarly, we cannot begin to estimate indirect consequences of the pandemic to oncology practices, such as accelerated burnout and posttraumatic stress disorder, as well as the long-range effects of economic turmoil on patients, health care workers, and provider organizations.
 

What happens to cancer trials?

From China, Italy, and Seattle, thus far, there is little information about how the pandemic will affect the vital clinical research endeavor. The Seattle physicians did say they plan to enroll patients on clinical trials only when the trial offers a high chance of benefiting the patient over standard therapy alone.

Fortunately, the National Institutes of Health and Food and Drug Administration have released guidance documents related to clinical trials.

The National Cancer Institute (NCI) has also released guidance documents (March 13 guidance; March 23 guidance) for patients on clinical trials supported by the NCI Cancer Therapy Evaluation Program (CTEP) and the NCI Community Oncology Research Program (NCORP).

CTEP and NCORP are making reasonable accommodations to suspend monitoring visits and audits, allow tele–follow-up visits for patients, and permit local physicians to provide care for patients on study. In addition, with appropriate procedural adherence and documentation, CTEP and NCORP will allow oral investigational medicines to be mailed directly to patients’ homes.

Planned NCI National Clinical Trials Network meetings will be conducted via remote access webinars, conference calls, and similar technology. These adjustments – and probably many more to come – are geared toward facilitating ongoing care to proceed safely and with minimal risk for patients currently receiving investigational therapies and for the sites and investigators engaged in those studies.

Each of us has probably faced a personal “defining professional moment,” when we had to utilize every skill in our arsenal and examine the motivations that led us to a career in oncology. However, it is clear from the forgoing clinical and research processes and guidelines that the COVID-19 pandemic is such a defining professional moment for each of us, in every community we serve.

Critical junctures like this cause more rapid behavior change and innovation than the slow-moving pace that characterizes our idealized preferences. As oncologists who embrace new data and behavioral change, we stand to learn processes that will facilitate more perfected systems of care than the one that preceded this unprecedented crisis, promote more efficient sharing of high-quality information, and improve the outcome for our future patients.


Dr. Lyss was an oncologist and researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers, as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.

More than a third of patients diagnosed with multiple myeloma (MM) are over the age of 80, and yet most treatment successes have been reported in younger patients. However, patients over the age of 80 years received similar benefits as younger patients from MM treatment, according to a study reported online in the Journal of Geriatric Oncology.

Researchers identified 2,155 patients diagnosed with MM at age 80 years or older in the Surveillance, Epidemiology, and End Results Program (SEER)–Medicare database from 2007 to 2013. A cohort of 2,933 similar patients diagnosed with myeloma at age 70-79 was used for comparison.

The researcher found that the number of patients receiving treatment for myeloma within 6 months of diagnosis was significantly lower in the 80 years and older group, compared with the 70-79 years group. Only 51% of patients in the 80 years and older cohort received systemic treatment within 6 months following diagnosis, compared with 71% of patients in the 70-79 years cohort received systemic treatment in the same timeframe (P < .001)

The analysis showed that treatment was associated with an overall 26% decrease in hazard for death, independent of age, race, gender, poverty, comorbidities, and proxy measures of performance status. There was no statistically significant difference in treatment benefit based on age cohort (P = .610).

The median overall survival for patients diagnosed at age 80 years or older was 13.4 months, with those patients receiving systemic treatment having a median overall survival of 21.4 months, compared with 6.4 months for those not receiving treatment. In comparison, patients between ages 70 and 79 years had a median overall survival of 30.1 months with treatment.

The population over 80, when myeloma incidence peaks, is projected to triple over the next few decades, according to the researchers. “Antimyeloma treatment in the era of novel therapies seems to have a similar improvement on survival for the oldest-old, those beyond 80 years, as other patients. With growing knowledge of and experience with novel agents in older patients with myeloma, treatment rates have increased, which have in turn improved survival,” they concluded.

The study was funded by the National Cancer Institute. One author reported research funding from Janssen. The other authors had no relevant conflicts of interest.

[email protected]

SOURCE: Fiala MA et al. J Geriatric Oncol. 2020 Mar 10. doi.org/10.1016/j.jgo.2020.03.005.

More than a third of patients diagnosed with multiple myeloma (MM) are over the age of 80, and yet most treatment successes have been reported in younger patients. However, patients over the age of 80 years received similar benefits as younger patients from MM treatment, according to a study reported online in the Journal of Geriatric Oncology.

Researchers identified 2,155 patients diagnosed with MM at age 80 years or older in the Surveillance, Epidemiology, and End Results Program (SEER)–Medicare database from 2007 to 2013. A cohort of 2,933 similar patients diagnosed with myeloma at age 70-79 was used for comparison.

The researcher found that the number of patients receiving treatment for myeloma within 6 months of diagnosis was significantly lower in the 80 years and older group, compared with the 70-79 years group. Only 51% of patients in the 80 years and older cohort received systemic treatment within 6 months following diagnosis, compared with 71% of patients in the 70-79 years cohort received systemic treatment in the same timeframe (P < .001)

The analysis showed that treatment was associated with an overall 26% decrease in hazard for death, independent of age, race, gender, poverty, comorbidities, and proxy measures of performance status. There was no statistically significant difference in treatment benefit based on age cohort (P = .610).

The median overall survival for patients diagnosed at age 80 years or older was 13.4 months, with those patients receiving systemic treatment having a median overall survival of 21.4 months, compared with 6.4 months for those not receiving treatment. In comparison, patients between ages 70 and 79 years had a median overall survival of 30.1 months with treatment.

The population over 80, when myeloma incidence peaks, is projected to triple over the next few decades, according to the researchers. “Antimyeloma treatment in the era of novel therapies seems to have a similar improvement on survival for the oldest-old, those beyond 80 years, as other patients. With growing knowledge of and experience with novel agents in older patients with myeloma, treatment rates have increased, which have in turn improved survival,” they concluded.

The study was funded by the National Cancer Institute. One author reported research funding from Janssen. The other authors had no relevant conflicts of interest.

[email protected]

SOURCE: Fiala MA et al. J Geriatric Oncol. 2020 Mar 10. doi.org/10.1016/j.jgo.2020.03.005.

More than a third of patients diagnosed with multiple myeloma (MM) are over the age of 80, and yet most treatment successes have been reported in younger patients. However, patients over the age of 80 years received similar benefits as younger patients from MM treatment, according to a study reported online in the Journal of Geriatric Oncology.

Researchers identified 2,155 patients diagnosed with MM at age 80 years or older in the Surveillance, Epidemiology, and End Results Program (SEER)–Medicare database from 2007 to 2013. A cohort of 2,933 similar patients diagnosed with myeloma at age 70-79 was used for comparison.

The researcher found that the number of patients receiving treatment for myeloma within 6 months of diagnosis was significantly lower in the 80 years and older group, compared with the 70-79 years group. Only 51% of patients in the 80 years and older cohort received systemic treatment within 6 months following diagnosis, compared with 71% of patients in the 70-79 years cohort received systemic treatment in the same timeframe (P < .001)

The analysis showed that treatment was associated with an overall 26% decrease in hazard for death, independent of age, race, gender, poverty, comorbidities, and proxy measures of performance status. There was no statistically significant difference in treatment benefit based on age cohort (P = .610).

The median overall survival for patients diagnosed at age 80 years or older was 13.4 months, with those patients receiving systemic treatment having a median overall survival of 21.4 months, compared with 6.4 months for those not receiving treatment. In comparison, patients between ages 70 and 79 years had a median overall survival of 30.1 months with treatment.

The population over 80, when myeloma incidence peaks, is projected to triple over the next few decades, according to the researchers. “Antimyeloma treatment in the era of novel therapies seems to have a similar improvement on survival for the oldest-old, those beyond 80 years, as other patients. With growing knowledge of and experience with novel agents in older patients with myeloma, treatment rates have increased, which have in turn improved survival,” they concluded.

The study was funded by the National Cancer Institute. One author reported research funding from Janssen. The other authors had no relevant conflicts of interest.

[email protected]

SOURCE: Fiala MA et al. J Geriatric Oncol. 2020 Mar 10. doi.org/10.1016/j.jgo.2020.03.005.

The coronavirus pandemic weighs heavily on psychiatric patients with conditions such as anxiety, depression and PTSD. Meanwhile, a national poll released March 25 by the American Psychiatric Association shows that almost half of all Americans are anxious about contracting COVID-19 and 40% are anxious about becoming seriously ill or dying from the virus. In light of stressors on patients and nonpatients alike, mental health professionals have a key role in helping to alleviate suffering tied to the public health crisis, according to psychiatrists from across the country.

Courtesy Dr. Shaili Jain

“There’s so much we can do to help people put order on this chaos,” said Shaili Jain, MD, section chief of outpatient mental health with the Veterans Affairs Palo Alto (Calif.) Health Care System, in an interview. “We are essential workers in this time.”

Dr. Jain, who specializes in treating PTSD, said those patients are especially vulnerable to the stress and disruptions spawned by the pandemic. “When you go to the grocery store and there’s no food, that can be triggering for people who survived situations with a feeling of calamity or panic,” she said. “People are reporting worsening of nightmares and spontaneous panic attacks after having been stable with symptoms for many months. These are the kinds of stories that are starting to filter through.”

To make things even more difficult, she said, shelter-in-place orders are preventing patients from taking advantage of healthy coping strategies, such as working out at the gym or going to support groups. “We have an invaluable role to play in trying to prevent long-term consequences by going into problem-solving modes with patients.” Dr. Jain offered several tips that might help patients who are suffering:

• Use technology to stay in touch with support communities and boost self-care. “How can you be flexible with FaceTime, Skype, or phone even if you might not be able to have that face-to-face time? What are you doing to double down on your efforts at self-care – listening to music, reading, daily meditation, or walks? Double down on what you can do to prevent anxiety and stress levels from building up.”
• Take breaks from the news, which can contribute to hypervigilance and disrupted sleep. “I’m seeing that people are going down these rabbit holes of having the news or social media on 24/7,” Dr. Jain said. “You have to stay informed. But you need to pick trusted news sources and have chunks of time that are free of coronavirus coverage.” Understand that life is going to be difficult for a while. “We’re doing a lot of reassurance and education,” she said, “helping people to know and accept that the next few days, weeks, and months are going to be stressful.”

Dr. Jain cautioned colleagues, however, that “there will be a tsunami” of mental illness when the coronavirus crisis lifts. She is especially concerned about patient populations that are socioeconomically disadvantaged already and how their lives with be affected by lost wages, unemployment, and business failures. “Medical professionals will see the consequences of this in the days and weeks and months after the pandemic has settled,” she predicted.

The APA poll shows that, early in the crisis, more than 60% of people are anxious about family and loved ones contracting COVID-19.

Maintaining ‘reflective space’ essential

At the Austen Riggs Center, a psychiatric residential treatment facility in Stockbridge, Mass., staff and patients are adjusting to new rules that aim to prevent transmission of the novel coronavirus. “Social distancing requirements are having a huge impact,” said Eric M. Plakun, MD, medical director and CEO of Austen Riggs, in an interview. “You can’t have groups in the same way; you can’t have families come in for a family meeting; you can’t have quite the same the freedom to come and go. A lot of management issues are being addressed, but it is crucial also to maintain the ‘reflective space’ essential to do the kind of clinical work we do.” One approach, he said, is virtual meetings with colleagues that address on-the-job management issues, but also leave a space for how staff members are feeling.

“It’s easy to get into crisis-response mode,” he said, “where you’re always managing but never leave a space to talk about vulnerability, helplessness, and fear.”

As the facility’s staff adjusts by embracing teleconference technology and adapting group meetings to the 6-feet-apart rule,

Dr. Plakun said it is wise to bring patients into discussions about how to adapt to the era of coronavirus precautions. “They really want to be part of the response,” he said, noting that patients have approached staff members to say they want to collaborate about changes. “That’s a credible offer we intend to accept.” 

Still, communicating with patients as a whole about the coronavirus can be difficult. As Dr. Plakun noted, it’s now impossible to bring 75 people together into one room for a meeting. “If you have four to five smaller meetings, how do you maintain some congruence in the information that’s presented?”

Dr. Plakun suggested that colleagues find time to engage in the familiar, such as face-to-face clinical work. “That’s been the most reassuring and rewarding part of my day since it feels almost like normal,” he said.
 

Stocking up on medications

Jessica “Jessi” Gold, MD, MS, an assistant professor at Washington University in St. Louis, often treats college students. Asian students started to worry early in the pandemic, she said in an interview.

“At the beginning, there were a lot of concerns about the public’s view: ‘Did this come from China? Is it China’s fault?’ A lot of our students felt that if they coughed, and they were a white person, they’d be OK. But if they were Asian, everyone would wonder why they were in class and not at home. That got worse over time: the fear about – and anxiety from – stoking racism.”

Later, as classes began to be canceled, Dr. Gold started to see the psychological effects of disruption and uncertainty about the future. “This can lead people to feel like what they knew before is just not there anymore. This can obviously cause anxiety but also has the potential to cause depression.” Patients also might slip into overuse of alcohol and drugs, or they might engage in other kinds of harmful behavior. Eating disorders, for example, “are ways to have control when other things aren’t in control,” she said.

Dr. Gold pointed to research into the mental health after effects of quarantines, such as those imposed during the SARS outbreak. A review of 24 studies published this year found that most “reported negative psychological effects, including post-traumatic stress symptoms, confusion, and anger. Stressors included longer quarantine duration, infection fears, frustration, boredom, inadequate supplies, inadequate information, financial loss, and stigma. Some researchers have suggested long-lasting effects” (Lancet. 2020;395:912-20).

Dr. Gold is urging patients to recall the warning signs that alerted them to psychological downturns in the past: “Try to remember what those warning signs are and pay attention to whether you see them.” And, Dr. Gold said, she asks patients to think about what has helped them get better.

In some cases, she said, patients are already preparing themselves for experiencing mental distress by stocking up on medications. “Some people have a bottle of 10-20 pills that they only use in emergencies and keep as a kind of security blanket,” she said, and she’s seen some of them ask for refills. It seems they’ve either taken the pills recently or want to stash them just in case. This makes sense, since their anxiety is higher, she said.

Dr. Gold cautioned that psychiatrists need to be careful to not overextend themselves when they’re not treating patients. “It is easy to be therapist to friends, family, and colleagues,” she said, “but we need to take care of ourselves, too.”

Dr. Jain is author of “The Unspeakable Mind: Stories of Trauma and Healing From the Frontlines of PTSD Science” (New York: Harper, 2019). She has no other disclosures. Dr. Plakun and Dr. Gold reported no relevant disclosures.

The coronavirus pandemic weighs heavily on psychiatric patients with conditions such as anxiety, depression and PTSD. Meanwhile, a national poll released March 25 by the American Psychiatric Association shows that almost half of all Americans are anxious about contracting COVID-19 and 40% are anxious about becoming seriously ill or dying from the virus. In light of stressors on patients and nonpatients alike, mental health professionals have a key role in helping to alleviate suffering tied to the public health crisis, according to psychiatrists from across the country.

Courtesy Dr. Shaili Jain

“There’s so much we can do to help people put order on this chaos,” said Shaili Jain, MD, section chief of outpatient mental health with the Veterans Affairs Palo Alto (Calif.) Health Care System, in an interview. “We are essential workers in this time.”

Dr. Jain, who specializes in treating PTSD, said those patients are especially vulnerable to the stress and disruptions spawned by the pandemic. “When you go to the grocery store and there’s no food, that can be triggering for people who survived situations with a feeling of calamity or panic,” she said. “People are reporting worsening of nightmares and spontaneous panic attacks after having been stable with symptoms for many months. These are the kinds of stories that are starting to filter through.”

To make things even more difficult, she said, shelter-in-place orders are preventing patients from taking advantage of healthy coping strategies, such as working out at the gym or going to support groups. “We have an invaluable role to play in trying to prevent long-term consequences by going into problem-solving modes with patients.” Dr. Jain offered several tips that might help patients who are suffering:

• Use technology to stay in touch with support communities and boost self-care. “How can you be flexible with FaceTime, Skype, or phone even if you might not be able to have that face-to-face time? What are you doing to double down on your efforts at self-care – listening to music, reading, daily meditation, or walks? Double down on what you can do to prevent anxiety and stress levels from building up.”
• Take breaks from the news, which can contribute to hypervigilance and disrupted sleep. “I’m seeing that people are going down these rabbit holes of having the news or social media on 24/7,” Dr. Jain said. “You have to stay informed. But you need to pick trusted news sources and have chunks of time that are free of coronavirus coverage.” Understand that life is going to be difficult for a while. “We’re doing a lot of reassurance and education,” she said, “helping people to know and accept that the next few days, weeks, and months are going to be stressful.”

Dr. Jain cautioned colleagues, however, that “there will be a tsunami” of mental illness when the coronavirus crisis lifts. She is especially concerned about patient populations that are socioeconomically disadvantaged already and how their lives with be affected by lost wages, unemployment, and business failures. “Medical professionals will see the consequences of this in the days and weeks and months after the pandemic has settled,” she predicted.

The APA poll shows that, early in the crisis, more than 60% of people are anxious about family and loved ones contracting COVID-19.

Maintaining ‘reflective space’ essential

At the Austen Riggs Center, a psychiatric residential treatment facility in Stockbridge, Mass., staff and patients are adjusting to new rules that aim to prevent transmission of the novel coronavirus. “Social distancing requirements are having a huge impact,” said Eric M. Plakun, MD, medical director and CEO of Austen Riggs, in an interview. “You can’t have groups in the same way; you can’t have families come in for a family meeting; you can’t have quite the same the freedom to come and go. A lot of management issues are being addressed, but it is crucial also to maintain the ‘reflective space’ essential to do the kind of clinical work we do.” One approach, he said, is virtual meetings with colleagues that address on-the-job management issues, but also leave a space for how staff members are feeling.

“It’s easy to get into crisis-response mode,” he said, “where you’re always managing but never leave a space to talk about vulnerability, helplessness, and fear.”

As the facility’s staff adjusts by embracing teleconference technology and adapting group meetings to the 6-feet-apart rule,

Dr. Plakun said it is wise to bring patients into discussions about how to adapt to the era of coronavirus precautions. “They really want to be part of the response,” he said, noting that patients have approached staff members to say they want to collaborate about changes. “That’s a credible offer we intend to accept.” 

Still, communicating with patients as a whole about the coronavirus can be difficult. As Dr. Plakun noted, it’s now impossible to bring 75 people together into one room for a meeting. “If you have four to five smaller meetings, how do you maintain some congruence in the information that’s presented?”

Dr. Plakun suggested that colleagues find time to engage in the familiar, such as face-to-face clinical work. “That’s been the most reassuring and rewarding part of my day since it feels almost like normal,” he said.
 

Stocking up on medications

Jessica “Jessi” Gold, MD, MS, an assistant professor at Washington University in St. Louis, often treats college students. Asian students started to worry early in the pandemic, she said in an interview.

“At the beginning, there were a lot of concerns about the public’s view: ‘Did this come from China? Is it China’s fault?’ A lot of our students felt that if they coughed, and they were a white person, they’d be OK. But if they were Asian, everyone would wonder why they were in class and not at home. That got worse over time: the fear about – and anxiety from – stoking racism.”

Later, as classes began to be canceled, Dr. Gold started to see the psychological effects of disruption and uncertainty about the future. “This can lead people to feel like what they knew before is just not there anymore. This can obviously cause anxiety but also has the potential to cause depression.” Patients also might slip into overuse of alcohol and drugs, or they might engage in other kinds of harmful behavior. Eating disorders, for example, “are ways to have control when other things aren’t in control,” she said.

Dr. Gold pointed to research into the mental health after effects of quarantines, such as those imposed during the SARS outbreak. A review of 24 studies published this year found that most “reported negative psychological effects, including post-traumatic stress symptoms, confusion, and anger. Stressors included longer quarantine duration, infection fears, frustration, boredom, inadequate supplies, inadequate information, financial loss, and stigma. Some researchers have suggested long-lasting effects” (Lancet. 2020;395:912-20).

Dr. Gold is urging patients to recall the warning signs that alerted them to psychological downturns in the past: “Try to remember what those warning signs are and pay attention to whether you see them.” And, Dr. Gold said, she asks patients to think about what has helped them get better.

In some cases, she said, patients are already preparing themselves for experiencing mental distress by stocking up on medications. “Some people have a bottle of 10-20 pills that they only use in emergencies and keep as a kind of security blanket,” she said, and she’s seen some of them ask for refills. It seems they’ve either taken the pills recently or want to stash them just in case. This makes sense, since their anxiety is higher, she said.

Dr. Gold cautioned that psychiatrists need to be careful to not overextend themselves when they’re not treating patients. “It is easy to be therapist to friends, family, and colleagues,” she said, “but we need to take care of ourselves, too.”

Dr. Jain is author of “The Unspeakable Mind: Stories of Trauma and Healing From the Frontlines of PTSD Science” (New York: Harper, 2019). She has no other disclosures. Dr. Plakun and Dr. Gold reported no relevant disclosures.

The coronavirus pandemic weighs heavily on psychiatric patients with conditions such as anxiety, depression and PTSD. Meanwhile, a national poll released March 25 by the American Psychiatric Association shows that almost half of all Americans are anxious about contracting COVID-19 and 40% are anxious about becoming seriously ill or dying from the virus. In light of stressors on patients and nonpatients alike, mental health professionals have a key role in helping to alleviate suffering tied to the public health crisis, according to psychiatrists from across the country.

Courtesy Dr. Shaili Jain

“There’s so much we can do to help people put order on this chaos,” said Shaili Jain, MD, section chief of outpatient mental health with the Veterans Affairs Palo Alto (Calif.) Health Care System, in an interview. “We are essential workers in this time.”

Dr. Jain, who specializes in treating PTSD, said those patients are especially vulnerable to the stress and disruptions spawned by the pandemic. “When you go to the grocery store and there’s no food, that can be triggering for people who survived situations with a feeling of calamity or panic,” she said. “People are reporting worsening of nightmares and spontaneous panic attacks after having been stable with symptoms for many months. These are the kinds of stories that are starting to filter through.”

To make things even more difficult, she said, shelter-in-place orders are preventing patients from taking advantage of healthy coping strategies, such as working out at the gym or going to support groups. “We have an invaluable role to play in trying to prevent long-term consequences by going into problem-solving modes with patients.” Dr. Jain offered several tips that might help patients who are suffering:

• Use technology to stay in touch with support communities and boost self-care. “How can you be flexible with FaceTime, Skype, or phone even if you might not be able to have that face-to-face time? What are you doing to double down on your efforts at self-care – listening to music, reading, daily meditation, or walks? Double down on what you can do to prevent anxiety and stress levels from building up.”
• Take breaks from the news, which can contribute to hypervigilance and disrupted sleep. “I’m seeing that people are going down these rabbit holes of having the news or social media on 24/7,” Dr. Jain said. “You have to stay informed. But you need to pick trusted news sources and have chunks of time that are free of coronavirus coverage.” Understand that life is going to be difficult for a while. “We’re doing a lot of reassurance and education,” she said, “helping people to know and accept that the next few days, weeks, and months are going to be stressful.”

Dr. Jain cautioned colleagues, however, that “there will be a tsunami” of mental illness when the coronavirus crisis lifts. She is especially concerned about patient populations that are socioeconomically disadvantaged already and how their lives with be affected by lost wages, unemployment, and business failures. “Medical professionals will see the consequences of this in the days and weeks and months after the pandemic has settled,” she predicted.

The APA poll shows that, early in the crisis, more than 60% of people are anxious about family and loved ones contracting COVID-19.

Maintaining ‘reflective space’ essential

At the Austen Riggs Center, a psychiatric residential treatment facility in Stockbridge, Mass., staff and patients are adjusting to new rules that aim to prevent transmission of the novel coronavirus. “Social distancing requirements are having a huge impact,” said Eric M. Plakun, MD, medical director and CEO of Austen Riggs, in an interview. “You can’t have groups in the same way; you can’t have families come in for a family meeting; you can’t have quite the same the freedom to come and go. A lot of management issues are being addressed, but it is crucial also to maintain the ‘reflective space’ essential to do the kind of clinical work we do.” One approach, he said, is virtual meetings with colleagues that address on-the-job management issues, but also leave a space for how staff members are feeling.

“It’s easy to get into crisis-response mode,” he said, “where you’re always managing but never leave a space to talk about vulnerability, helplessness, and fear.”

As the facility’s staff adjusts by embracing teleconference technology and adapting group meetings to the 6-feet-apart rule,

Dr. Plakun said it is wise to bring patients into discussions about how to adapt to the era of coronavirus precautions. “They really want to be part of the response,” he said, noting that patients have approached staff members to say they want to collaborate about changes. “That’s a credible offer we intend to accept.” 

Still, communicating with patients as a whole about the coronavirus can be difficult. As Dr. Plakun noted, it’s now impossible to bring 75 people together into one room for a meeting. “If you have four to five smaller meetings, how do you maintain some congruence in the information that’s presented?”

Dr. Plakun suggested that colleagues find time to engage in the familiar, such as face-to-face clinical work. “That’s been the most reassuring and rewarding part of my day since it feels almost like normal,” he said.
 

Stocking up on medications

Jessica “Jessi” Gold, MD, MS, an assistant professor at Washington University in St. Louis, often treats college students. Asian students started to worry early in the pandemic, she said in an interview.

“At the beginning, there were a lot of concerns about the public’s view: ‘Did this come from China? Is it China’s fault?’ A lot of our students felt that if they coughed, and they were a white person, they’d be OK. But if they were Asian, everyone would wonder why they were in class and not at home. That got worse over time: the fear about – and anxiety from – stoking racism.”

Later, as classes began to be canceled, Dr. Gold started to see the psychological effects of disruption and uncertainty about the future. “This can lead people to feel like what they knew before is just not there anymore. This can obviously cause anxiety but also has the potential to cause depression.” Patients also might slip into overuse of alcohol and drugs, or they might engage in other kinds of harmful behavior. Eating disorders, for example, “are ways to have control when other things aren’t in control,” she said.

Dr. Gold pointed to research into the mental health after effects of quarantines, such as those imposed during the SARS outbreak. A review of 24 studies published this year found that most “reported negative psychological effects, including post-traumatic stress symptoms, confusion, and anger. Stressors included longer quarantine duration, infection fears, frustration, boredom, inadequate supplies, inadequate information, financial loss, and stigma. Some researchers have suggested long-lasting effects” (Lancet. 2020;395:912-20).

Dr. Gold is urging patients to recall the warning signs that alerted them to psychological downturns in the past: “Try to remember what those warning signs are and pay attention to whether you see them.” And, Dr. Gold said, she asks patients to think about what has helped them get better.

In some cases, she said, patients are already preparing themselves for experiencing mental distress by stocking up on medications. “Some people have a bottle of 10-20 pills that they only use in emergencies and keep as a kind of security blanket,” she said, and she’s seen some of them ask for refills. It seems they’ve either taken the pills recently or want to stash them just in case. This makes sense, since their anxiety is higher, she said.

Dr. Gold cautioned that psychiatrists need to be careful to not overextend themselves when they’re not treating patients. “It is easy to be therapist to friends, family, and colleagues,” she said, “but we need to take care of ourselves, too.”

Dr. Jain is author of “The Unspeakable Mind: Stories of Trauma and Healing From the Frontlines of PTSD Science” (New York: Harper, 2019). She has no other disclosures. Dr. Plakun and Dr. Gold reported no relevant disclosures.

The test-driven world of cardiovascular medicine is rapidly shifting to remote hands-off telemedicine to keep patients and their physicians safe during the COVID-19 pandemic.

During a recent telehealth webinar, Ami Bhatt, MD, director of the adult congenital heart disease program, Massachusetts General Hospital, Boston, said they’ve gone from seeing 400 patients a day in their clinic to fewer than 40 and are trying to push that number even lower and use virtual care as much as possible.

“The reason is we are having to send home physicians who are exposed and it’s cutting into our workforce very quickly. So the more people you could have at home doing work virtually is important because you’re going to need to call them in [during] the next couple of weeks,” she said. “And our PPE [personal protective equipment] is running low. So if we can afford to not have someone come in the office and not wear a mask because they had a cough, that’s a mask that can be used by someone performing CPR in an ICU.”

The hospital also adopted a train-the-trainer method to bring its existing telehealth program to cardiology, said Dr. Bhatt, who coauthored the American College of Cardiology’s recent guidance on establishing telehealth in the cardiology clinic.

“We find that sending people tip sheets and PowerPoints in addition to everything that is happening ... is too much,” Dr. Bhatt observed. “So actually holding your friend’s hand and walking them through it once you’ve learned how to do it has been really great in terms of adoption. Otherwise, everyone would fall back on phone, which is OK for now, but we need to establish a long-term plan.”

During the same March 20 webinar, David Konur, CEO of the Cardiovascular Institute of the South, Houma, La., said they began doing telecardiology more than 5 years ago and now do about 30,000 “patient touches” a month with 24/7 access.

“This is certainly an unprecedented time,” he said. “COVID-19 is shining a very bright light on the barriers that exist in health care, as well as the friction that exists to accessing care for all of our patients.”
 

New mandates

A new Food and Drug Administration policy, temporarily relaxing prior guidance on certain connected remote monitoring devices such as ECGs and cardiac monitors, is part of a shifting landscape to reduce barriers to telehealth during the ongoing pandemic. The increased flexibility may increase access to important patient physiological data, while eliminating unnecessary patient contact and easing the burden on healthcare facilities and providers, the agency said in the new guidance, issued March 20.

As such, the FDA “does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared noninvasive remote monitoring devices that are used to support patient monitoring.”

Modifications could include the addition of monitoring statements for patients with COVID-19 or coexisting conditions such as hypertension and heart failure; a change to the indications or claims related to home use of devices previously cleared for use only in health care settings; and changes to hardware or software to increase remote monitoring capability. The approved devices listed in the guidance are clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximetry, noninvasive blood pressure monitors, respiratory rate/breathing frequency monitors, and electronic stethoscopes.

The FDA policy comes just days after the Centers for Medicare & Medicaid Services expanded telehealth coverage to Medicare beneficiaries and the Office for Civil Rights at the U.S. Department of Health & Human Services said it would not penalize health care providers for using such non–HIPAA compliant third-party apps as Skype or Google Hangouts video. The HHS also signaled that physicians would be allowed to practice across state lines during the COVID-19 crisis.

“All these mandates have come in a time of desperation where we’re doing the best that we can to provide for patients and keep them safe,” Eugenia Gianos, MD, system director of cardiovascular prevention at Northwell Health and director of the Women’s Cardiovascular Center, Lenox Hill Hospital, New York, said in an interview. “Realistically, the whole digital realm has a lot of promise for our patients.” She noted that telehealth programs are still being developed for the department, but that office visits have been purposely scaled back by more than 75% to protect patients as well as health care providers. “In times of need, the most promising technologies we have, have to come to the forefront,” Dr. Gianos said. “So using the data from the home – whether they have a blood pressure cuff or something that tracks their heart rate or their weight – when we don’t otherwise have data, is of great value.”

Andrew M. Freeman, MD, director of clinical cardiology and operations at National Jewish Hospital in Denver, said “in the current situation, telehealth is the most viable option because it keeps patients safe and physicians safe. So it wouldn’t surprise me if every institution in the country, if not worldwide, is very rapidly pursuing this kind of approach.”
Exactly how many programs or cardiologists were already using telehealth is impossible to say, although the ACC is planning to survey its members on their practices during the COVID-19 pandemic, he noted.

The situation is so fluid that ACC is already revising its March 13 telehealth guidance to reflect the recent policy changes. Another document is being prepared to provide physicians with a template for the telehealth space, said Dr. Freeman, who coauthored the telehealth guidance and also serves on the ACC’s Innovation Leadership Council. 
The new FDA policy allowing greater flexibility on remote monitoring devices is somewhat “vaguely worded,” Dr. Freeman noted, but highlights the ability of existing technology to provide essential patient data from home. “I think as we add adjuncts to the things we’re used to in the normal face-to-face visit, it’s going to make the face-to-face visit less required,” he said.

Questions remain, however, on implementing telehealth for new patients and whether payers will follow HHS’s decision not to conduct audits to ensure a prior relationship existed. The potential for telehealth to reach across state lines also is being viewed cautiously until tested legally, Dr. Freeman observed.

“If there’s one blessing in this awful disease that we have received, is that it may really give the power to clinicians, hospital systems, and payers to make telehealth a true viable, sustainable solution for good care that’s readily available to folks,” he said.
 

Fast-tracked research

On March 24, the American Heart Association announced it is committing $2.5 million for fast-tracked research grants for projects than can turn around results within 9-12 months and focus on how this novel coronavirus affects heart and brain health.

Additional funding also will be made available to the AHA’s new Center for Health Technology & Innovation’s Strategically Focused Research Networks to develop rapid technology solutions to aid in dealing with the pandemic.

The rapid response grant is an “unprecedented but logical move for the organization in these extraordinary times,” AHA President Bob Harrington, MD, chair of medicine at Stanford (Calif.) University, said in a statement. “We are committed to quickly bringing together and supporting some of the brightest minds in research science and clinical care who are shovel ready with the laboratories, tools, and data resources to immediately begin work on addressing this emergent issue.”

Dr. Freeman and Dr. Bhatt have disclosed no relevant financial relationships. Dr. Harrington is on the editorial board for Medscape Cardiology.

A version of this article originally appeared on Medscape.com

The test-driven world of cardiovascular medicine is rapidly shifting to remote hands-off telemedicine to keep patients and their physicians safe during the COVID-19 pandemic.

During a recent telehealth webinar, Ami Bhatt, MD, director of the adult congenital heart disease program, Massachusetts General Hospital, Boston, said they’ve gone from seeing 400 patients a day in their clinic to fewer than 40 and are trying to push that number even lower and use virtual care as much as possible.

“The reason is we are having to send home physicians who are exposed and it’s cutting into our workforce very quickly. So the more people you could have at home doing work virtually is important because you’re going to need to call them in [during] the next couple of weeks,” she said. “And our PPE [personal protective equipment] is running low. So if we can afford to not have someone come in the office and not wear a mask because they had a cough, that’s a mask that can be used by someone performing CPR in an ICU.”

The hospital also adopted a train-the-trainer method to bring its existing telehealth program to cardiology, said Dr. Bhatt, who coauthored the American College of Cardiology’s recent guidance on establishing telehealth in the cardiology clinic.

“We find that sending people tip sheets and PowerPoints in addition to everything that is happening ... is too much,” Dr. Bhatt observed. “So actually holding your friend’s hand and walking them through it once you’ve learned how to do it has been really great in terms of adoption. Otherwise, everyone would fall back on phone, which is OK for now, but we need to establish a long-term plan.”

During the same March 20 webinar, David Konur, CEO of the Cardiovascular Institute of the South, Houma, La., said they began doing telecardiology more than 5 years ago and now do about 30,000 “patient touches” a month with 24/7 access.

“This is certainly an unprecedented time,” he said. “COVID-19 is shining a very bright light on the barriers that exist in health care, as well as the friction that exists to accessing care for all of our patients.”
 

New mandates

A new Food and Drug Administration policy, temporarily relaxing prior guidance on certain connected remote monitoring devices such as ECGs and cardiac monitors, is part of a shifting landscape to reduce barriers to telehealth during the ongoing pandemic. The increased flexibility may increase access to important patient physiological data, while eliminating unnecessary patient contact and easing the burden on healthcare facilities and providers, the agency said in the new guidance, issued March 20.

As such, the FDA “does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared noninvasive remote monitoring devices that are used to support patient monitoring.”

Modifications could include the addition of monitoring statements for patients with COVID-19 or coexisting conditions such as hypertension and heart failure; a change to the indications or claims related to home use of devices previously cleared for use only in health care settings; and changes to hardware or software to increase remote monitoring capability. The approved devices listed in the guidance are clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximetry, noninvasive blood pressure monitors, respiratory rate/breathing frequency monitors, and electronic stethoscopes.

The FDA policy comes just days after the Centers for Medicare & Medicaid Services expanded telehealth coverage to Medicare beneficiaries and the Office for Civil Rights at the U.S. Department of Health & Human Services said it would not penalize health care providers for using such non–HIPAA compliant third-party apps as Skype or Google Hangouts video. The HHS also signaled that physicians would be allowed to practice across state lines during the COVID-19 crisis.

“All these mandates have come in a time of desperation where we’re doing the best that we can to provide for patients and keep them safe,” Eugenia Gianos, MD, system director of cardiovascular prevention at Northwell Health and director of the Women’s Cardiovascular Center, Lenox Hill Hospital, New York, said in an interview. “Realistically, the whole digital realm has a lot of promise for our patients.” She noted that telehealth programs are still being developed for the department, but that office visits have been purposely scaled back by more than 75% to protect patients as well as health care providers. “In times of need, the most promising technologies we have, have to come to the forefront,” Dr. Gianos said. “So using the data from the home – whether they have a blood pressure cuff or something that tracks their heart rate or their weight – when we don’t otherwise have data, is of great value.”

Andrew M. Freeman, MD, director of clinical cardiology and operations at National Jewish Hospital in Denver, said “in the current situation, telehealth is the most viable option because it keeps patients safe and physicians safe. So it wouldn’t surprise me if every institution in the country, if not worldwide, is very rapidly pursuing this kind of approach.”
Exactly how many programs or cardiologists were already using telehealth is impossible to say, although the ACC is planning to survey its members on their practices during the COVID-19 pandemic, he noted.

The situation is so fluid that ACC is already revising its March 13 telehealth guidance to reflect the recent policy changes. Another document is being prepared to provide physicians with a template for the telehealth space, said Dr. Freeman, who coauthored the telehealth guidance and also serves on the ACC’s Innovation Leadership Council. 
The new FDA policy allowing greater flexibility on remote monitoring devices is somewhat “vaguely worded,” Dr. Freeman noted, but highlights the ability of existing technology to provide essential patient data from home. “I think as we add adjuncts to the things we’re used to in the normal face-to-face visit, it’s going to make the face-to-face visit less required,” he said.

Questions remain, however, on implementing telehealth for new patients and whether payers will follow HHS’s decision not to conduct audits to ensure a prior relationship existed. The potential for telehealth to reach across state lines also is being viewed cautiously until tested legally, Dr. Freeman observed.

“If there’s one blessing in this awful disease that we have received, is that it may really give the power to clinicians, hospital systems, and payers to make telehealth a true viable, sustainable solution for good care that’s readily available to folks,” he said.
 

Fast-tracked research

On March 24, the American Heart Association announced it is committing $2.5 million for fast-tracked research grants for projects than can turn around results within 9-12 months and focus on how this novel coronavirus affects heart and brain health.

Additional funding also will be made available to the AHA’s new Center for Health Technology & Innovation’s Strategically Focused Research Networks to develop rapid technology solutions to aid in dealing with the pandemic.

The rapid response grant is an “unprecedented but logical move for the organization in these extraordinary times,” AHA President Bob Harrington, MD, chair of medicine at Stanford (Calif.) University, said in a statement. “We are committed to quickly bringing together and supporting some of the brightest minds in research science and clinical care who are shovel ready with the laboratories, tools, and data resources to immediately begin work on addressing this emergent issue.”

Dr. Freeman and Dr. Bhatt have disclosed no relevant financial relationships. Dr. Harrington is on the editorial board for Medscape Cardiology.

A version of this article originally appeared on Medscape.com

The test-driven world of cardiovascular medicine is rapidly shifting to remote hands-off telemedicine to keep patients and their physicians safe during the COVID-19 pandemic.

During a recent telehealth webinar, Ami Bhatt, MD, director of the adult congenital heart disease program, Massachusetts General Hospital, Boston, said they’ve gone from seeing 400 patients a day in their clinic to fewer than 40 and are trying to push that number even lower and use virtual care as much as possible.

“The reason is we are having to send home physicians who are exposed and it’s cutting into our workforce very quickly. So the more people you could have at home doing work virtually is important because you’re going to need to call them in [during] the next couple of weeks,” she said. “And our PPE [personal protective equipment] is running low. So if we can afford to not have someone come in the office and not wear a mask because they had a cough, that’s a mask that can be used by someone performing CPR in an ICU.”

The hospital also adopted a train-the-trainer method to bring its existing telehealth program to cardiology, said Dr. Bhatt, who coauthored the American College of Cardiology’s recent guidance on establishing telehealth in the cardiology clinic.

“We find that sending people tip sheets and PowerPoints in addition to everything that is happening ... is too much,” Dr. Bhatt observed. “So actually holding your friend’s hand and walking them through it once you’ve learned how to do it has been really great in terms of adoption. Otherwise, everyone would fall back on phone, which is OK for now, but we need to establish a long-term plan.”

During the same March 20 webinar, David Konur, CEO of the Cardiovascular Institute of the South, Houma, La., said they began doing telecardiology more than 5 years ago and now do about 30,000 “patient touches” a month with 24/7 access.

“This is certainly an unprecedented time,” he said. “COVID-19 is shining a very bright light on the barriers that exist in health care, as well as the friction that exists to accessing care for all of our patients.”
 

New mandates

A new Food and Drug Administration policy, temporarily relaxing prior guidance on certain connected remote monitoring devices such as ECGs and cardiac monitors, is part of a shifting landscape to reduce barriers to telehealth during the ongoing pandemic. The increased flexibility may increase access to important patient physiological data, while eliminating unnecessary patient contact and easing the burden on healthcare facilities and providers, the agency said in the new guidance, issued March 20.

As such, the FDA “does not intend to object to limited modifications to the indications, claims, functionality, or hardware or software of FDA-cleared noninvasive remote monitoring devices that are used to support patient monitoring.”

Modifications could include the addition of monitoring statements for patients with COVID-19 or coexisting conditions such as hypertension and heart failure; a change to the indications or claims related to home use of devices previously cleared for use only in health care settings; and changes to hardware or software to increase remote monitoring capability. The approved devices listed in the guidance are clinical electronic thermometers, ECGs, cardiac monitors, ECG software for over-the-counter use, pulse oximetry, noninvasive blood pressure monitors, respiratory rate/breathing frequency monitors, and electronic stethoscopes.

The FDA policy comes just days after the Centers for Medicare & Medicaid Services expanded telehealth coverage to Medicare beneficiaries and the Office for Civil Rights at the U.S. Department of Health & Human Services said it would not penalize health care providers for using such non–HIPAA compliant third-party apps as Skype or Google Hangouts video. The HHS also signaled that physicians would be allowed to practice across state lines during the COVID-19 crisis.

“All these mandates have come in a time of desperation where we’re doing the best that we can to provide for patients and keep them safe,” Eugenia Gianos, MD, system director of cardiovascular prevention at Northwell Health and director of the Women’s Cardiovascular Center, Lenox Hill Hospital, New York, said in an interview. “Realistically, the whole digital realm has a lot of promise for our patients.” She noted that telehealth programs are still being developed for the department, but that office visits have been purposely scaled back by more than 75% to protect patients as well as health care providers. “In times of need, the most promising technologies we have, have to come to the forefront,” Dr. Gianos said. “So using the data from the home – whether they have a blood pressure cuff or something that tracks their heart rate or their weight – when we don’t otherwise have data, is of great value.”

Andrew M. Freeman, MD, director of clinical cardiology and operations at National Jewish Hospital in Denver, said “in the current situation, telehealth is the most viable option because it keeps patients safe and physicians safe. So it wouldn’t surprise me if every institution in the country, if not worldwide, is very rapidly pursuing this kind of approach.”
Exactly how many programs or cardiologists were already using telehealth is impossible to say, although the ACC is planning to survey its members on their practices during the COVID-19 pandemic, he noted.

The situation is so fluid that ACC is already revising its March 13 telehealth guidance to reflect the recent policy changes. Another document is being prepared to provide physicians with a template for the telehealth space, said Dr. Freeman, who coauthored the telehealth guidance and also serves on the ACC’s Innovation Leadership Council. 
The new FDA policy allowing greater flexibility on remote monitoring devices is somewhat “vaguely worded,” Dr. Freeman noted, but highlights the ability of existing technology to provide essential patient data from home. “I think as we add adjuncts to the things we’re used to in the normal face-to-face visit, it’s going to make the face-to-face visit less required,” he said.

Questions remain, however, on implementing telehealth for new patients and whether payers will follow HHS’s decision not to conduct audits to ensure a prior relationship existed. The potential for telehealth to reach across state lines also is being viewed cautiously until tested legally, Dr. Freeman observed.

“If there’s one blessing in this awful disease that we have received, is that it may really give the power to clinicians, hospital systems, and payers to make telehealth a true viable, sustainable solution for good care that’s readily available to folks,” he said.
 

Fast-tracked research

On March 24, the American Heart Association announced it is committing $2.5 million for fast-tracked research grants for projects than can turn around results within 9-12 months and focus on how this novel coronavirus affects heart and brain health.

Additional funding also will be made available to the AHA’s new Center for Health Technology & Innovation’s Strategically Focused Research Networks to develop rapid technology solutions to aid in dealing with the pandemic.

The rapid response grant is an “unprecedented but logical move for the organization in these extraordinary times,” AHA President Bob Harrington, MD, chair of medicine at Stanford (Calif.) University, said in a statement. “We are committed to quickly bringing together and supporting some of the brightest minds in research science and clinical care who are shovel ready with the laboratories, tools, and data resources to immediately begin work on addressing this emergent issue.”

Dr. Freeman and Dr. Bhatt have disclosed no relevant financial relationships. Dr. Harrington is on the editorial board for Medscape Cardiology.

A version of this article originally appeared on Medscape.com