Journal of Clinical Outcomes Management

Dapagliflozin treatment of patients with heart failure but without diabetes in the DAPA-HF trial led to a one-third cut in the relative incidence of new-onset diabetes over a median follow-up of 18 months in a prespecified analysis from the multicenter trial that included 2,605 heart failure patients without diabetes at baseline.

The findings represented the first evidence that a drug from dapagliflozin’s class, the sodium-glucose cotransporter 2 (SGLT2) inhibitors, could prevent or slow the onset of type 2 diabetes. It represents “an additional benefit” that dapagliflozin (Farxiga) offers to patients with heart failure with reduced ejection fraction (HFrEF) like those enrolled in the DAPA-HF trial, Silvio E. Inzucchi, MD, said at the virtual annual scientific sessions of the American Diabetes Association. DAPA-HF had previously proved that treatment with this drug significantly reduced the study’s primary endpoint of cardiovascular death or heart failure worsening.

During 18 months of follow-up, 7.1% of patients in the placebo arm developed type 2 diabetes, compared with 4.9% in those who received dapagliflozin, a 2.2% absolute difference and a 32% relative risk reduction that was statistically significant for this prespecified but “exploratory” endpoint, reported Dr. Inzucchi, an endocrinologist and professor of medicine at Yale University, New Haven, Conn.

For this analysis, a hemoglobin A1c level of at least 6.5% measured in two consecutive assessments was the criterion for diagnosing incident diabetes. The 2,605 enrolled patients without diabetes in the DAPA-HF trial represented 55% of the entire trial cohort of 4,744 patients with HFrEF.

The 32% relative risk reduction for incident diabetes was primarily relevant to enrolled patients with prediabetes at entry, who constituted 67% of the enrolled cohort based on the usual definition of prediabetes, an A1c of 5.7%-6.4%.

Among all 157 (6%) of the DAPA-HF patients who developed diabetes during the trial, 150 (96%) occurred in patients with prediabetes by the usual definition; 136 of the incident cases (87%) had prediabetes by a more stringent criterion of an A1c of 6.0%-6.4%.

To put the preventive efficacy of dapagliflozin into more context, Dr. Inzucchi cited the 31% relative protection rate exerted by metformin in the Diabetes Prevention Program study (N Engl J Med. 2002 Feb 7;346[6]:393-403).

The findings showed that “dapagliflozin is the first medication demonstrated to reduce both incident type 2 diabetes and mortality in a single trial,” as well as the first agent from the SGLT2 inhibitor class to show a diabetes prevention effect, Dr. Inzucchi noted. Patients with both heart failure and diabetes are known to have a substantially increased mortality risk, compared with patients with just one of these diseases, and the potent risk posed by the confluence of both was confirmed in the results Dr. Inzucchi reported.

The 157 HFrEF patients in the trial who developed diabetes had a statistically significant 70% increased incidence of all-cause mortality during the trial’s follow-up, compared with similar HFrEF patients who remained free from a diabetes diagnosis, and they also had a significant 77% relative increase in their incidence of cardiovascular death. This analysis failed to show that incident diabetes had a significant impact on hospitalizations for heart failure coupled with cardiovascular death, another endpoint of the trial.

Mitchel L. Zoler/Frontline Medical News

“This is a tremendously important analysis. We recognize that diabetes is an important factor that can forecast heart failure risk, even over relatively short follow-up. A drug that targets both diseases can be quite beneficial,” commented Muthiah Vaduganathan, MD, a cardiologist at Brigham and Women’s Hospital in Boston.

The impact of dapagliflozin on average A1c levels during the DAPA-HF trial was minimal, reducing levels by an average of 0.04% among those who entered with prediabetes and by 0.05% among the other patients. This suggests that the mechanisms by which dapagliflozin reduced incident diabetes was by routes that did not involve simply reducing hyperglycemia, and the observed decrease in incident diabetes was not apparently caused by “masking” of hyperglycemia by dapagliflozin, said Dr. Inzucchi.

One possibility is that dapagliflozin, which also improved quality of life and reduced hospitalizations in the DAPA-HF trial, led to improved function and mobility among patients that had beneficial effects on their insulin sensitivity, Dr. Vaduganathan speculated in an interview.

The new finding of dapagliflozin’s benefit “is great news,” commented Yehuda Handelsman, MD, an endocrinologist and diabetes specialist who is medical director of the Metabolic Institute of America in Tarzana, Calif. “It’s an impressive and important result, and another reason to use dapagliflozin in patients with HFrEF, a group of patients whom you want to prevent from having worse outcomes” by developing diabetes.

The DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) trial enrolled HFrEF patients at 410 centers in 20 countries during February 2017–August 2018. The study’s primary endpoint was the composite incidence of cardiovascular death or worsening heart failure, which occurred in 16.3% of patients randomized to receive dapagliflozin and in 21.2% of control patients on standard care but on placebo instead of the study drug, a statistically significant relative risk reduction of 26% (N Engl J Med. 2019 Nov 21;381[21]:1995-2008). In the 2,605-patient subgroup without type 2 diabetes at baseline the primary endpoint fell by a statistically significant 27% with dapagliflozin treatment, the first time an SGLT2 inhibitor drug was shown effective for reducing this endpoint in patients with HFrEF but without diabetes. DAPA-HF did not enroll any patients with type 1 diabetes.

DAPA-HF was sponsored by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Inzucchi has been a consultant to AstraZeneca and to Abbott, Boehringer Ingelheim, Merck, Novo Nordisk, Sanofi/Lexicon, and vTv Therapeutics. Dr. Vaduganathan has been an adviser to AstraZeneca and to Amgen, Baxter, Bayer, Boehringer Ingelheim, Cytokinetics, and Relypsa. Dr. Handelsman has been a consultant to several drug companies including AstraZeneca.

[email protected]

SOURCE: Inzucchi SE et al. ADA 2020, abstract 271-OR.

Dapagliflozin treatment of patients with heart failure but without diabetes in the DAPA-HF trial led to a one-third cut in the relative incidence of new-onset diabetes over a median follow-up of 18 months in a prespecified analysis from the multicenter trial that included 2,605 heart failure patients without diabetes at baseline.

The findings represented the first evidence that a drug from dapagliflozin’s class, the sodium-glucose cotransporter 2 (SGLT2) inhibitors, could prevent or slow the onset of type 2 diabetes. It represents “an additional benefit” that dapagliflozin (Farxiga) offers to patients with heart failure with reduced ejection fraction (HFrEF) like those enrolled in the DAPA-HF trial, Silvio E. Inzucchi, MD, said at the virtual annual scientific sessions of the American Diabetes Association. DAPA-HF had previously proved that treatment with this drug significantly reduced the study’s primary endpoint of cardiovascular death or heart failure worsening.

During 18 months of follow-up, 7.1% of patients in the placebo arm developed type 2 diabetes, compared with 4.9% in those who received dapagliflozin, a 2.2% absolute difference and a 32% relative risk reduction that was statistically significant for this prespecified but “exploratory” endpoint, reported Dr. Inzucchi, an endocrinologist and professor of medicine at Yale University, New Haven, Conn.

For this analysis, a hemoglobin A1c level of at least 6.5% measured in two consecutive assessments was the criterion for diagnosing incident diabetes. The 2,605 enrolled patients without diabetes in the DAPA-HF trial represented 55% of the entire trial cohort of 4,744 patients with HFrEF.

The 32% relative risk reduction for incident diabetes was primarily relevant to enrolled patients with prediabetes at entry, who constituted 67% of the enrolled cohort based on the usual definition of prediabetes, an A1c of 5.7%-6.4%.

Among all 157 (6%) of the DAPA-HF patients who developed diabetes during the trial, 150 (96%) occurred in patients with prediabetes by the usual definition; 136 of the incident cases (87%) had prediabetes by a more stringent criterion of an A1c of 6.0%-6.4%.

To put the preventive efficacy of dapagliflozin into more context, Dr. Inzucchi cited the 31% relative protection rate exerted by metformin in the Diabetes Prevention Program study (N Engl J Med. 2002 Feb 7;346[6]:393-403).

The findings showed that “dapagliflozin is the first medication demonstrated to reduce both incident type 2 diabetes and mortality in a single trial,” as well as the first agent from the SGLT2 inhibitor class to show a diabetes prevention effect, Dr. Inzucchi noted. Patients with both heart failure and diabetes are known to have a substantially increased mortality risk, compared with patients with just one of these diseases, and the potent risk posed by the confluence of both was confirmed in the results Dr. Inzucchi reported.

The 157 HFrEF patients in the trial who developed diabetes had a statistically significant 70% increased incidence of all-cause mortality during the trial’s follow-up, compared with similar HFrEF patients who remained free from a diabetes diagnosis, and they also had a significant 77% relative increase in their incidence of cardiovascular death. This analysis failed to show that incident diabetes had a significant impact on hospitalizations for heart failure coupled with cardiovascular death, another endpoint of the trial.

Mitchel L. Zoler/Frontline Medical News

“This is a tremendously important analysis. We recognize that diabetes is an important factor that can forecast heart failure risk, even over relatively short follow-up. A drug that targets both diseases can be quite beneficial,” commented Muthiah Vaduganathan, MD, a cardiologist at Brigham and Women’s Hospital in Boston.

The impact of dapagliflozin on average A1c levels during the DAPA-HF trial was minimal, reducing levels by an average of 0.04% among those who entered with prediabetes and by 0.05% among the other patients. This suggests that the mechanisms by which dapagliflozin reduced incident diabetes was by routes that did not involve simply reducing hyperglycemia, and the observed decrease in incident diabetes was not apparently caused by “masking” of hyperglycemia by dapagliflozin, said Dr. Inzucchi.

One possibility is that dapagliflozin, which also improved quality of life and reduced hospitalizations in the DAPA-HF trial, led to improved function and mobility among patients that had beneficial effects on their insulin sensitivity, Dr. Vaduganathan speculated in an interview.

The new finding of dapagliflozin’s benefit “is great news,” commented Yehuda Handelsman, MD, an endocrinologist and diabetes specialist who is medical director of the Metabolic Institute of America in Tarzana, Calif. “It’s an impressive and important result, and another reason to use dapagliflozin in patients with HFrEF, a group of patients whom you want to prevent from having worse outcomes” by developing diabetes.

The DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) trial enrolled HFrEF patients at 410 centers in 20 countries during February 2017–August 2018. The study’s primary endpoint was the composite incidence of cardiovascular death or worsening heart failure, which occurred in 16.3% of patients randomized to receive dapagliflozin and in 21.2% of control patients on standard care but on placebo instead of the study drug, a statistically significant relative risk reduction of 26% (N Engl J Med. 2019 Nov 21;381[21]:1995-2008). In the 2,605-patient subgroup without type 2 diabetes at baseline the primary endpoint fell by a statistically significant 27% with dapagliflozin treatment, the first time an SGLT2 inhibitor drug was shown effective for reducing this endpoint in patients with HFrEF but without diabetes. DAPA-HF did not enroll any patients with type 1 diabetes.

DAPA-HF was sponsored by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Inzucchi has been a consultant to AstraZeneca and to Abbott, Boehringer Ingelheim, Merck, Novo Nordisk, Sanofi/Lexicon, and vTv Therapeutics. Dr. Vaduganathan has been an adviser to AstraZeneca and to Amgen, Baxter, Bayer, Boehringer Ingelheim, Cytokinetics, and Relypsa. Dr. Handelsman has been a consultant to several drug companies including AstraZeneca.

[email protected]

SOURCE: Inzucchi SE et al. ADA 2020, abstract 271-OR.

Dapagliflozin treatment of patients with heart failure but without diabetes in the DAPA-HF trial led to a one-third cut in the relative incidence of new-onset diabetes over a median follow-up of 18 months in a prespecified analysis from the multicenter trial that included 2,605 heart failure patients without diabetes at baseline.

The findings represented the first evidence that a drug from dapagliflozin’s class, the sodium-glucose cotransporter 2 (SGLT2) inhibitors, could prevent or slow the onset of type 2 diabetes. It represents “an additional benefit” that dapagliflozin (Farxiga) offers to patients with heart failure with reduced ejection fraction (HFrEF) like those enrolled in the DAPA-HF trial, Silvio E. Inzucchi, MD, said at the virtual annual scientific sessions of the American Diabetes Association. DAPA-HF had previously proved that treatment with this drug significantly reduced the study’s primary endpoint of cardiovascular death or heart failure worsening.

During 18 months of follow-up, 7.1% of patients in the placebo arm developed type 2 diabetes, compared with 4.9% in those who received dapagliflozin, a 2.2% absolute difference and a 32% relative risk reduction that was statistically significant for this prespecified but “exploratory” endpoint, reported Dr. Inzucchi, an endocrinologist and professor of medicine at Yale University, New Haven, Conn.

For this analysis, a hemoglobin A1c level of at least 6.5% measured in two consecutive assessments was the criterion for diagnosing incident diabetes. The 2,605 enrolled patients without diabetes in the DAPA-HF trial represented 55% of the entire trial cohort of 4,744 patients with HFrEF.

The 32% relative risk reduction for incident diabetes was primarily relevant to enrolled patients with prediabetes at entry, who constituted 67% of the enrolled cohort based on the usual definition of prediabetes, an A1c of 5.7%-6.4%.

Among all 157 (6%) of the DAPA-HF patients who developed diabetes during the trial, 150 (96%) occurred in patients with prediabetes by the usual definition; 136 of the incident cases (87%) had prediabetes by a more stringent criterion of an A1c of 6.0%-6.4%.

To put the preventive efficacy of dapagliflozin into more context, Dr. Inzucchi cited the 31% relative protection rate exerted by metformin in the Diabetes Prevention Program study (N Engl J Med. 2002 Feb 7;346[6]:393-403).

The findings showed that “dapagliflozin is the first medication demonstrated to reduce both incident type 2 diabetes and mortality in a single trial,” as well as the first agent from the SGLT2 inhibitor class to show a diabetes prevention effect, Dr. Inzucchi noted. Patients with both heart failure and diabetes are known to have a substantially increased mortality risk, compared with patients with just one of these diseases, and the potent risk posed by the confluence of both was confirmed in the results Dr. Inzucchi reported.

The 157 HFrEF patients in the trial who developed diabetes had a statistically significant 70% increased incidence of all-cause mortality during the trial’s follow-up, compared with similar HFrEF patients who remained free from a diabetes diagnosis, and they also had a significant 77% relative increase in their incidence of cardiovascular death. This analysis failed to show that incident diabetes had a significant impact on hospitalizations for heart failure coupled with cardiovascular death, another endpoint of the trial.

Mitchel L. Zoler/Frontline Medical News

“This is a tremendously important analysis. We recognize that diabetes is an important factor that can forecast heart failure risk, even over relatively short follow-up. A drug that targets both diseases can be quite beneficial,” commented Muthiah Vaduganathan, MD, a cardiologist at Brigham and Women’s Hospital in Boston.

The impact of dapagliflozin on average A1c levels during the DAPA-HF trial was minimal, reducing levels by an average of 0.04% among those who entered with prediabetes and by 0.05% among the other patients. This suggests that the mechanisms by which dapagliflozin reduced incident diabetes was by routes that did not involve simply reducing hyperglycemia, and the observed decrease in incident diabetes was not apparently caused by “masking” of hyperglycemia by dapagliflozin, said Dr. Inzucchi.

One possibility is that dapagliflozin, which also improved quality of life and reduced hospitalizations in the DAPA-HF trial, led to improved function and mobility among patients that had beneficial effects on their insulin sensitivity, Dr. Vaduganathan speculated in an interview.

The new finding of dapagliflozin’s benefit “is great news,” commented Yehuda Handelsman, MD, an endocrinologist and diabetes specialist who is medical director of the Metabolic Institute of America in Tarzana, Calif. “It’s an impressive and important result, and another reason to use dapagliflozin in patients with HFrEF, a group of patients whom you want to prevent from having worse outcomes” by developing diabetes.

The DAPA-HF (Dapagliflozin and Prevention of Adverse Outcomes in Heart Failure) trial enrolled HFrEF patients at 410 centers in 20 countries during February 2017–August 2018. The study’s primary endpoint was the composite incidence of cardiovascular death or worsening heart failure, which occurred in 16.3% of patients randomized to receive dapagliflozin and in 21.2% of control patients on standard care but on placebo instead of the study drug, a statistically significant relative risk reduction of 26% (N Engl J Med. 2019 Nov 21;381[21]:1995-2008). In the 2,605-patient subgroup without type 2 diabetes at baseline the primary endpoint fell by a statistically significant 27% with dapagliflozin treatment, the first time an SGLT2 inhibitor drug was shown effective for reducing this endpoint in patients with HFrEF but without diabetes. DAPA-HF did not enroll any patients with type 1 diabetes.

DAPA-HF was sponsored by AstraZeneca, the company that markets dapagliflozin (Farxiga). Dr. Inzucchi has been a consultant to AstraZeneca and to Abbott, Boehringer Ingelheim, Merck, Novo Nordisk, Sanofi/Lexicon, and vTv Therapeutics. Dr. Vaduganathan has been an adviser to AstraZeneca and to Amgen, Baxter, Bayer, Boehringer Ingelheim, Cytokinetics, and Relypsa. Dr. Handelsman has been a consultant to several drug companies including AstraZeneca.

[email protected]

SOURCE: Inzucchi SE et al. ADA 2020, abstract 271-OR.

The U.S. Food and Drug Administration revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” the agency announced in a June 15 statement.

The FDA also warned today that the use of hydroxychloroquine or chloroquine may have a potential drug interaction with the investigational antiviral drug remdesivir that limits its effectiveness against COVID-19.

Remdesivir was granted emergency use authorization by the FDA on May 1.

“Based on a recently completed nonclinical laboratory study, the FDA is revising the fact sheet for healthcare providers that accompanies the drug to state that coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” the FDA said in a news release.
 

Controversy over hydroxychloroquine

Even with such federal permission, since late March the use of these two agents has been mired in controversy.

President Donald J. Trump promoted the use of hydroxychloroquine and chloroquine to treat Americans with COVID-19, while scientific studies raised questions about their safety and effectiveness. Recent research, for example, pointed to elevated cardiovascular risks, as reported by Medscape Medical News.

The FDA acknowledged this recent evidence. “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The full suspension of the EUA follows a warning the agency issued on April 24. The FDA’s Safety Communication cautioned against use of the two agents outside of a hospital setting, citing an increase in outpatient prescriptions and “reports of serious heart rhythm problems.”

“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate,” based on a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” Patrizia Cavazzoni, MD, acting director of CDER, noted in the FDA statement.

This article first appeared on Medscape.com.

The U.S. Food and Drug Administration revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” the agency announced in a June 15 statement.

The FDA also warned today that the use of hydroxychloroquine or chloroquine may have a potential drug interaction with the investigational antiviral drug remdesivir that limits its effectiveness against COVID-19.

Remdesivir was granted emergency use authorization by the FDA on May 1.

“Based on a recently completed nonclinical laboratory study, the FDA is revising the fact sheet for healthcare providers that accompanies the drug to state that coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” the FDA said in a news release.
 

Controversy over hydroxychloroquine

Even with such federal permission, since late March the use of these two agents has been mired in controversy.

President Donald J. Trump promoted the use of hydroxychloroquine and chloroquine to treat Americans with COVID-19, while scientific studies raised questions about their safety and effectiveness. Recent research, for example, pointed to elevated cardiovascular risks, as reported by Medscape Medical News.

The FDA acknowledged this recent evidence. “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The full suspension of the EUA follows a warning the agency issued on April 24. The FDA’s Safety Communication cautioned against use of the two agents outside of a hospital setting, citing an increase in outpatient prescriptions and “reports of serious heart rhythm problems.”

“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate,” based on a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” Patrizia Cavazzoni, MD, acting director of CDER, noted in the FDA statement.

This article first appeared on Medscape.com.

The U.S. Food and Drug Administration revoked its decision from March 28 allowing use of hydroxychloroquine and chloroquine to treat people hospitalized with COVID-19 under an emergency use authorization (EUA).

“Based on its ongoing analysis of the EUA and emerging scientific data, the FDA determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA,” the agency announced in a June 15 statement.

The FDA also warned today that the use of hydroxychloroquine or chloroquine may have a potential drug interaction with the investigational antiviral drug remdesivir that limits its effectiveness against COVID-19.

Remdesivir was granted emergency use authorization by the FDA on May 1.

“Based on a recently completed nonclinical laboratory study, the FDA is revising the fact sheet for healthcare providers that accompanies the drug to state that coadministration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. The agency is not aware of instances of this reduced activity occurring in the clinical setting but is continuing to evaluate all data related to remdesivir,” the FDA said in a news release.
 

Controversy over hydroxychloroquine

Even with such federal permission, since late March the use of these two agents has been mired in controversy.

President Donald J. Trump promoted the use of hydroxychloroquine and chloroquine to treat Americans with COVID-19, while scientific studies raised questions about their safety and effectiveness. Recent research, for example, pointed to elevated cardiovascular risks, as reported by Medscape Medical News.

The FDA acknowledged this recent evidence. “Additionally, in light of ongoing serious cardiac adverse events and other potential serious side effects, the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the authorized use.”

The full suspension of the EUA follows a warning the agency issued on April 24. The FDA’s Safety Communication cautioned against use of the two agents outside of a hospital setting, citing an increase in outpatient prescriptions and “reports of serious heart rhythm problems.”

“While additional clinical trials continue to evaluate the potential benefit of these drugs in treating or preventing COVID-19, we determined the emergency use authorization was no longer appropriate,” based on a rigorous assessment by scientists in our Center for Drug Evaluation and Research,” Patrizia Cavazzoni, MD, acting director of CDER, noted in the FDA statement.

This article first appeared on Medscape.com.

COVID-19 now. The urban phase of the U.S. pandemic is leveling somewhat, while the rural phase is accelerating – in part because of food processing and handling industries. The pediatric burden has been surprisingly small, with the multisystem inflammatory disease (MIS-c) in children noted in several hundred cases now being seen across the country.

CDC

Next wave? Given ongoing COVID-19 disease, controversy rages about when and how to re-open the country. Regardless how more reopening occurs over the next months, we should expect a next or ongoing COVID-19 wave, particularly given loss of social distancing during social justice protests. A sawtooth disease prevalence pattern is predicted by many experts: a drop in prevalence leading to reopening, leading to scattered prevalence increases and regional if not local restriction tightening, followed by another drop in prevalence. Then “rinse and repeat” until 70% of the population is immune either by disease experience or vaccine-induced immunity, likely sometime in 2021.

Influenza too. A COVID-19 up-cycle is likely during influenza season, although influenza season’s onset could be altered because of whatever social distancing rules are in place in November and December. That said, we need to consider the worst. We have seen what happens if we fail to prepare and then react only after a prevalent respiratory infection has surged into the overall population. Best estimates are that at most 20% of the U.S. population is currently immune to SARS-CoV-2. Given that at least some of that 20% of individuals currently immune to SARS-CoV-2 will lose their neutralizing antibody over the next 4-6 months, we can still expect 70%-80% of the U.S. population to be susceptible to SARS-CoV-2 infection in the fall of 2020.

Pediatric preparedness. As pediatric providers, we have struggled with lower patient loads and dramatic income losses/declines. Many clinics/offices’ attendance remain less than 50% of pre–COVID-19 levels, with necessary furloughs of personnel and spotty office hours. But influenza is coming, and SARS-CoV-2 will not be gone yet. How do we prepare for concurrent influenza and COVID-19?

The annual purchase/administration of influenza vaccine in summer/fall is expensive, time consuming, and logistically difficult even in the best times. Given the loss of income, likely reluctance of patients to come to clinics/offices if COVID-19 is still circulating, and likely need for some form of social distancing during late summer and early fall, how will providers, health departments, and hospitals implement influenza vaccine administration this year?

Minimize double whammy infections. Maximizing influenza vaccine uptake during the COVID-19 pandemic is super important. It is easy to understand why we should maximize influenza protection in SARS-CoV-2 vulnerables (elderly or persons with existing comorbidities). But is it as critical for otherwise healthy children? My answer is yes.

Children are not currently known as SARS-CoV-2 vectors, but children are excellent influenza vectors, shedding higher titers for longer than other age groups. As with SARS-CoV-2, influenza exposure is cumulative, i.e., the more intense and more frequently a person is exposed, the more likely that infection/disease will result. So, the fewer who get and can transmit influenza during the COVID-19 pandemic, the fewer people are likely to get a double whammy of SARS-CoV-2 concurrent or in tandem with influenza. Double whammy infections likely would further increase the medical care burden and return us to March-April crisis mode.

One alarming new question is whether recent influenza could make children vulnerable to SARS-CoV-2 and trigger hospitalizations. A surge in pediatric plus adult COVID-19 disease plus a surge in all-ages influenza disease would likely break the medical care system, at least in some areas.

CDC

Staggering COVID-19 burden. As of June 8, we have had approximately 2 million SARS-CoV-2 cases with 500,000 hospitalizations and 120,000 deaths. Over the past 10 years, total annual U.S. influenza hospitalizations ranged from 180,000 (2011-2012) to 825,000 (2017-2018). The interquartile range for hospitalization length of stay for influenza is 4-6 days¹ vs. 15-23 days² for SARS-CoV-2. One COVID-19 hospitalization uses hospital resources roughly equal to four influenza hospitalizations. To date COVID-19 hospitalizations have used resources equal to an estimated 1.9 million influenza hospitalizations – over twice the worst influenza season in this century – and we are still on the rise. We are likely not even halfway to truly controlling the U.S. pandemic, so expect another 500,000 hospitalizations – equal to another 1.9 million influenza hospitalizations. Further, pneumonia deaths have skyrocketed this year when COVID-19 was superimposed on the last third of influenza season. One hope is that widespread use of antivirals (for example, new antivirals, convalescent plasma, or other interventions) can reduce length of stay by 30% for COVID-19 hospitalizations, yet even with that the numbers remain grim.

Less influenza disease can free up medical resources. Planning ahead could prevent a bad influenza season (for example, up to 850,000 hospitalizations just for influenza). Can we preemptively use vaccine to reduce influenza hospitalizations below 2011-2012 levels – less than 150,000 hospitalizations? Perhaps, if we start by reducing pediatric influenza.

1. Aim to exceed 75% influenza vaccine uptake in your patients.

a. It is ambitious, but if there was ever a year that needed influenza herd immunity, it is 2020-2021.

2. Review practice/group/institution plans for vaccine purchase and ensure adequate personnel to administer vaccine.

3. Plan safe and efficient processes to vaccinate large numbers in August through November.

a. Consider that routine and influenza vaccines can be given concurrently with the annual uptick in school and sports physical examinations.

b. What social distancing and masking rules will be needed?

i. Will patients need to bring their own masks, or will you supply them?

c. What extra supplies and efforts are needed, e.g. hand sanitizer, new signage, 6-foot interval markings on floors or sidewalks, families calling from parking lot to announce their arrivals, etc.?

d. Remember younger patients need two doses before Dec 1, 2020.

e. Be creative, for example, are parking-lot tents for influenza vaccination feasible?

f. Can we partner with other providers to implement influenza vaccine–specific mass clinics?

Ramping up to give seasonal influenza vaccine in 2020 is daunting. But if we do not prepare, it will be even more difficult. Let’s make this the mildest influenza season in memory by vaccinating more than any time in memory – and by doing so, we can hope to blunt medical care burdens despite ongoing COVID-19 disease.
 

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Kansas City (Mo.). Children’s Mercy receives funding from GlaxoSmithKline, Merck, and Pfizer for vaccine research studies on which Dr. Harrison is an investigator. Email him at [email protected].
 

References

1.. HCUP Statistical Brief #253. 2019 Oct.

2. medrxiv. 2020 Apr 10. doi: 10.1101/2020.04.07.20057299.
 

COVID-19 now. The urban phase of the U.S. pandemic is leveling somewhat, while the rural phase is accelerating – in part because of food processing and handling industries. The pediatric burden has been surprisingly small, with the multisystem inflammatory disease (MIS-c) in children noted in several hundred cases now being seen across the country.

CDC

Next wave? Given ongoing COVID-19 disease, controversy rages about when and how to re-open the country. Regardless how more reopening occurs over the next months, we should expect a next or ongoing COVID-19 wave, particularly given loss of social distancing during social justice protests. A sawtooth disease prevalence pattern is predicted by many experts: a drop in prevalence leading to reopening, leading to scattered prevalence increases and regional if not local restriction tightening, followed by another drop in prevalence. Then “rinse and repeat” until 70% of the population is immune either by disease experience or vaccine-induced immunity, likely sometime in 2021.

Influenza too. A COVID-19 up-cycle is likely during influenza season, although influenza season’s onset could be altered because of whatever social distancing rules are in place in November and December. That said, we need to consider the worst. We have seen what happens if we fail to prepare and then react only after a prevalent respiratory infection has surged into the overall population. Best estimates are that at most 20% of the U.S. population is currently immune to SARS-CoV-2. Given that at least some of that 20% of individuals currently immune to SARS-CoV-2 will lose their neutralizing antibody over the next 4-6 months, we can still expect 70%-80% of the U.S. population to be susceptible to SARS-CoV-2 infection in the fall of 2020.

Pediatric preparedness. As pediatric providers, we have struggled with lower patient loads and dramatic income losses/declines. Many clinics/offices’ attendance remain less than 50% of pre–COVID-19 levels, with necessary furloughs of personnel and spotty office hours. But influenza is coming, and SARS-CoV-2 will not be gone yet. How do we prepare for concurrent influenza and COVID-19?

The annual purchase/administration of influenza vaccine in summer/fall is expensive, time consuming, and logistically difficult even in the best times. Given the loss of income, likely reluctance of patients to come to clinics/offices if COVID-19 is still circulating, and likely need for some form of social distancing during late summer and early fall, how will providers, health departments, and hospitals implement influenza vaccine administration this year?

Minimize double whammy infections. Maximizing influenza vaccine uptake during the COVID-19 pandemic is super important. It is easy to understand why we should maximize influenza protection in SARS-CoV-2 vulnerables (elderly or persons with existing comorbidities). But is it as critical for otherwise healthy children? My answer is yes.

Children are not currently known as SARS-CoV-2 vectors, but children are excellent influenza vectors, shedding higher titers for longer than other age groups. As with SARS-CoV-2, influenza exposure is cumulative, i.e., the more intense and more frequently a person is exposed, the more likely that infection/disease will result. So, the fewer who get and can transmit influenza during the COVID-19 pandemic, the fewer people are likely to get a double whammy of SARS-CoV-2 concurrent or in tandem with influenza. Double whammy infections likely would further increase the medical care burden and return us to March-April crisis mode.

One alarming new question is whether recent influenza could make children vulnerable to SARS-CoV-2 and trigger hospitalizations. A surge in pediatric plus adult COVID-19 disease plus a surge in all-ages influenza disease would likely break the medical care system, at least in some areas.

CDC

Staggering COVID-19 burden. As of June 8, we have had approximately 2 million SARS-CoV-2 cases with 500,000 hospitalizations and 120,000 deaths. Over the past 10 years, total annual U.S. influenza hospitalizations ranged from 180,000 (2011-2012) to 825,000 (2017-2018). The interquartile range for hospitalization length of stay for influenza is 4-6 days¹ vs. 15-23 days² for SARS-CoV-2. One COVID-19 hospitalization uses hospital resources roughly equal to four influenza hospitalizations. To date COVID-19 hospitalizations have used resources equal to an estimated 1.9 million influenza hospitalizations – over twice the worst influenza season in this century – and we are still on the rise. We are likely not even halfway to truly controlling the U.S. pandemic, so expect another 500,000 hospitalizations – equal to another 1.9 million influenza hospitalizations. Further, pneumonia deaths have skyrocketed this year when COVID-19 was superimposed on the last third of influenza season. One hope is that widespread use of antivirals (for example, new antivirals, convalescent plasma, or other interventions) can reduce length of stay by 30% for COVID-19 hospitalizations, yet even with that the numbers remain grim.

Less influenza disease can free up medical resources. Planning ahead could prevent a bad influenza season (for example, up to 850,000 hospitalizations just for influenza). Can we preemptively use vaccine to reduce influenza hospitalizations below 2011-2012 levels – less than 150,000 hospitalizations? Perhaps, if we start by reducing pediatric influenza.

1. Aim to exceed 75% influenza vaccine uptake in your patients.

a. It is ambitious, but if there was ever a year that needed influenza herd immunity, it is 2020-2021.

2. Review practice/group/institution plans for vaccine purchase and ensure adequate personnel to administer vaccine.

3. Plan safe and efficient processes to vaccinate large numbers in August through November.

a. Consider that routine and influenza vaccines can be given concurrently with the annual uptick in school and sports physical examinations.

b. What social distancing and masking rules will be needed?

i. Will patients need to bring their own masks, or will you supply them?

c. What extra supplies and efforts are needed, e.g. hand sanitizer, new signage, 6-foot interval markings on floors or sidewalks, families calling from parking lot to announce their arrivals, etc.?

d. Remember younger patients need two doses before Dec 1, 2020.

e. Be creative, for example, are parking-lot tents for influenza vaccination feasible?

f. Can we partner with other providers to implement influenza vaccine–specific mass clinics?

Ramping up to give seasonal influenza vaccine in 2020 is daunting. But if we do not prepare, it will be even more difficult. Let’s make this the mildest influenza season in memory by vaccinating more than any time in memory – and by doing so, we can hope to blunt medical care burdens despite ongoing COVID-19 disease.
 

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Kansas City (Mo.). Children’s Mercy receives funding from GlaxoSmithKline, Merck, and Pfizer for vaccine research studies on which Dr. Harrison is an investigator. Email him at [email protected].
 

References

1.. HCUP Statistical Brief #253. 2019 Oct.

2. medrxiv. 2020 Apr 10. doi: 10.1101/2020.04.07.20057299.
 

COVID-19 now. The urban phase of the U.S. pandemic is leveling somewhat, while the rural phase is accelerating – in part because of food processing and handling industries. The pediatric burden has been surprisingly small, with the multisystem inflammatory disease (MIS-c) in children noted in several hundred cases now being seen across the country.

CDC

Next wave? Given ongoing COVID-19 disease, controversy rages about when and how to re-open the country. Regardless how more reopening occurs over the next months, we should expect a next or ongoing COVID-19 wave, particularly given loss of social distancing during social justice protests. A sawtooth disease prevalence pattern is predicted by many experts: a drop in prevalence leading to reopening, leading to scattered prevalence increases and regional if not local restriction tightening, followed by another drop in prevalence. Then “rinse and repeat” until 70% of the population is immune either by disease experience or vaccine-induced immunity, likely sometime in 2021.

Influenza too. A COVID-19 up-cycle is likely during influenza season, although influenza season’s onset could be altered because of whatever social distancing rules are in place in November and December. That said, we need to consider the worst. We have seen what happens if we fail to prepare and then react only after a prevalent respiratory infection has surged into the overall population. Best estimates are that at most 20% of the U.S. population is currently immune to SARS-CoV-2. Given that at least some of that 20% of individuals currently immune to SARS-CoV-2 will lose their neutralizing antibody over the next 4-6 months, we can still expect 70%-80% of the U.S. population to be susceptible to SARS-CoV-2 infection in the fall of 2020.

Pediatric preparedness. As pediatric providers, we have struggled with lower patient loads and dramatic income losses/declines. Many clinics/offices’ attendance remain less than 50% of pre–COVID-19 levels, with necessary furloughs of personnel and spotty office hours. But influenza is coming, and SARS-CoV-2 will not be gone yet. How do we prepare for concurrent influenza and COVID-19?

The annual purchase/administration of influenza vaccine in summer/fall is expensive, time consuming, and logistically difficult even in the best times. Given the loss of income, likely reluctance of patients to come to clinics/offices if COVID-19 is still circulating, and likely need for some form of social distancing during late summer and early fall, how will providers, health departments, and hospitals implement influenza vaccine administration this year?

Minimize double whammy infections. Maximizing influenza vaccine uptake during the COVID-19 pandemic is super important. It is easy to understand why we should maximize influenza protection in SARS-CoV-2 vulnerables (elderly or persons with existing comorbidities). But is it as critical for otherwise healthy children? My answer is yes.

Children are not currently known as SARS-CoV-2 vectors, but children are excellent influenza vectors, shedding higher titers for longer than other age groups. As with SARS-CoV-2, influenza exposure is cumulative, i.e., the more intense and more frequently a person is exposed, the more likely that infection/disease will result. So, the fewer who get and can transmit influenza during the COVID-19 pandemic, the fewer people are likely to get a double whammy of SARS-CoV-2 concurrent or in tandem with influenza. Double whammy infections likely would further increase the medical care burden and return us to March-April crisis mode.

One alarming new question is whether recent influenza could make children vulnerable to SARS-CoV-2 and trigger hospitalizations. A surge in pediatric plus adult COVID-19 disease plus a surge in all-ages influenza disease would likely break the medical care system, at least in some areas.

CDC

Staggering COVID-19 burden. As of June 8, we have had approximately 2 million SARS-CoV-2 cases with 500,000 hospitalizations and 120,000 deaths. Over the past 10 years, total annual U.S. influenza hospitalizations ranged from 180,000 (2011-2012) to 825,000 (2017-2018). The interquartile range for hospitalization length of stay for influenza is 4-6 days¹ vs. 15-23 days² for SARS-CoV-2. One COVID-19 hospitalization uses hospital resources roughly equal to four influenza hospitalizations. To date COVID-19 hospitalizations have used resources equal to an estimated 1.9 million influenza hospitalizations – over twice the worst influenza season in this century – and we are still on the rise. We are likely not even halfway to truly controlling the U.S. pandemic, so expect another 500,000 hospitalizations – equal to another 1.9 million influenza hospitalizations. Further, pneumonia deaths have skyrocketed this year when COVID-19 was superimposed on the last third of influenza season. One hope is that widespread use of antivirals (for example, new antivirals, convalescent plasma, or other interventions) can reduce length of stay by 30% for COVID-19 hospitalizations, yet even with that the numbers remain grim.

Less influenza disease can free up medical resources. Planning ahead could prevent a bad influenza season (for example, up to 850,000 hospitalizations just for influenza). Can we preemptively use vaccine to reduce influenza hospitalizations below 2011-2012 levels – less than 150,000 hospitalizations? Perhaps, if we start by reducing pediatric influenza.

1. Aim to exceed 75% influenza vaccine uptake in your patients.

a. It is ambitious, but if there was ever a year that needed influenza herd immunity, it is 2020-2021.

2. Review practice/group/institution plans for vaccine purchase and ensure adequate personnel to administer vaccine.

3. Plan safe and efficient processes to vaccinate large numbers in August through November.

a. Consider that routine and influenza vaccines can be given concurrently with the annual uptick in school and sports physical examinations.

b. What social distancing and masking rules will be needed?

i. Will patients need to bring their own masks, or will you supply them?

c. What extra supplies and efforts are needed, e.g. hand sanitizer, new signage, 6-foot interval markings on floors or sidewalks, families calling from parking lot to announce their arrivals, etc.?

d. Remember younger patients need two doses before Dec 1, 2020.

e. Be creative, for example, are parking-lot tents for influenza vaccination feasible?

f. Can we partner with other providers to implement influenza vaccine–specific mass clinics?

Ramping up to give seasonal influenza vaccine in 2020 is daunting. But if we do not prepare, it will be even more difficult. Let’s make this the mildest influenza season in memory by vaccinating more than any time in memory – and by doing so, we can hope to blunt medical care burdens despite ongoing COVID-19 disease.
 

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Kansas City (Mo.). Children’s Mercy receives funding from GlaxoSmithKline, Merck, and Pfizer for vaccine research studies on which Dr. Harrison is an investigator. Email him at [email protected].
 

References

1.. HCUP Statistical Brief #253. 2019 Oct.

2. medrxiv. 2020 Apr 10. doi: 10.1101/2020.04.07.20057299.
 

Although deployment of hospitalists into ICUs during the COVID-19 crisis varies widely, in that sense it reflects the pre-COVID hospital landscape of variable involvement, in which many hospitalists pressed into this role expressed discomfort practicing critical care beyond their scope of training, according to a survey published in the Journal of Hospital Medicine in 2018.¹ “Hospitalists frequently deliver critical care services without adequate training or support, most prevalently in rural hospitals,” the authors concluded.

A Critical Care for the Hospitalist Series of resources and lectures developed by Eric Siegal, MD, a pulmonologist in Milwaukee, Wisc., and David Aymond, MD, a hospitalist in Alexandria, La., is available on the SHM website. They recommend that hospitalists trying to get oriented to working in the ICU start with the online courses on fluid resuscitation, mechanical ventilation, and noninvasive ventilation.

“Ninety-five percent of management of COVID-19 patients is nothing other than practicing sound critical care medicine,” Dr. Siegal said. “If you want to take effective care of sick COVID patients, you need to develop good foundational critical care skills and knowledge. Without them, you’re doing stuff without understand it.”

Dr. Aymond also encourages hospitalists to develop a stronger understanding of key physiological concepts by reviewing the critical care clinical topics compiled at SHM’s website.

References

1. Sweigart JR et al. Characterizing hospitalist practice and perceptions of critical care delivery. J Hosp Med. 2018 Jan;13(1):6-12.

Although deployment of hospitalists into ICUs during the COVID-19 crisis varies widely, in that sense it reflects the pre-COVID hospital landscape of variable involvement, in which many hospitalists pressed into this role expressed discomfort practicing critical care beyond their scope of training, according to a survey published in the Journal of Hospital Medicine in 2018.¹ “Hospitalists frequently deliver critical care services without adequate training or support, most prevalently in rural hospitals,” the authors concluded.

A Critical Care for the Hospitalist Series of resources and lectures developed by Eric Siegal, MD, a pulmonologist in Milwaukee, Wisc., and David Aymond, MD, a hospitalist in Alexandria, La., is available on the SHM website. They recommend that hospitalists trying to get oriented to working in the ICU start with the online courses on fluid resuscitation, mechanical ventilation, and noninvasive ventilation.

“Ninety-five percent of management of COVID-19 patients is nothing other than practicing sound critical care medicine,” Dr. Siegal said. “If you want to take effective care of sick COVID patients, you need to develop good foundational critical care skills and knowledge. Without them, you’re doing stuff without understand it.”

Dr. Aymond also encourages hospitalists to develop a stronger understanding of key physiological concepts by reviewing the critical care clinical topics compiled at SHM’s website.

References

1. Sweigart JR et al. Characterizing hospitalist practice and perceptions of critical care delivery. J Hosp Med. 2018 Jan;13(1):6-12.

Although deployment of hospitalists into ICUs during the COVID-19 crisis varies widely, in that sense it reflects the pre-COVID hospital landscape of variable involvement, in which many hospitalists pressed into this role expressed discomfort practicing critical care beyond their scope of training, according to a survey published in the Journal of Hospital Medicine in 2018.¹ “Hospitalists frequently deliver critical care services without adequate training or support, most prevalently in rural hospitals,” the authors concluded.

A Critical Care for the Hospitalist Series of resources and lectures developed by Eric Siegal, MD, a pulmonologist in Milwaukee, Wisc., and David Aymond, MD, a hospitalist in Alexandria, La., is available on the SHM website. They recommend that hospitalists trying to get oriented to working in the ICU start with the online courses on fluid resuscitation, mechanical ventilation, and noninvasive ventilation.

“Ninety-five percent of management of COVID-19 patients is nothing other than practicing sound critical care medicine,” Dr. Siegal said. “If you want to take effective care of sick COVID patients, you need to develop good foundational critical care skills and knowledge. Without them, you’re doing stuff without understand it.”

Dr. Aymond also encourages hospitalists to develop a stronger understanding of key physiological concepts by reviewing the critical care clinical topics compiled at SHM’s website.

References

1. Sweigart JR et al. Characterizing hospitalist practice and perceptions of critical care delivery. J Hosp Med. 2018 Jan;13(1):6-12.

Optimizing glycemic control “is the key to overall treatment in people with diabetes and COVID-19,” said Antonio Ceriello, MD, during a June 5 webinar sponsored by Harvard Medical School, Boston.

©Tashatuvango/Thinkstockphotos.com

Dr. Ceriello, a research consultant with the Italian Ministry of Health, IRCCS Multi-Medica, Milan, highlighted a recent study that examined the association of blood glucose control and outcomes in COVID-19 patients with preexisting type 2 diabetes.

Among 7,000 cases of COVID-19, type 2 diabetes correlated with a higher death rate. However, those with well-controlled blood glucose (upper limit ≤10 mmol/L) had a survival rate of 98.9%, compared with just 11% among those with poorly controlled blood glucose (upper limit >10 mmol/L), a reduction in risk of 86% (adjusted hazard ratio, 0.14; Cell Metab. 2020 May 1. doi: 10.1016/j.cmet.2020.04.021).

Clinicians should also consider the possible side effects of hypoglycemic agents in the evolution of this disease. This is true of all patients, not just diabetes patients, Dr. Ceriello said. “We have data showing that ... hyperglycemia contributes directly to worsening the prognosis of COVID-19 independent of the presence of diabetes.”

One study found that the glycosylation of ACE-2 played an important role in allowing cellular entry of the virus (Am J Physiol Endocrinol Metab. 2020 Mar 31;318:E736-41). “This is something that could be related to hyperglycemia,” he added.

Another risk factor is thrombosis, a clear contributor to death rates in COVID-19. Research on thrombosis incidence in COVID-19 patients with diabetes reported higher levels of D-dimer levels in people with diabetes, especially among those who couldn’t manage their disease.

Tying all of these factors together, Dr. Ceriello discussed how ACE-2 glycosylation, in combination with other factors in SARS-CoV-2 infection, could lead to hyperglycemia, thrombosis, and subsequently multiorgan damage in diabetes patients.

Other research has associated higher HbA1c levels (mean HbA1c, 7.5%) with higher mortality risk in COVID-19 patients, said another speaker, Linong Ji, MD, director for endocrinology and metabolism at Peking University People’s Hospital, Beijing, and director of Peking University’s Diabetes Center. Proper guidance is key to ensuring early detection of hyperglycemic crisis in people with diabetes, advised Dr. Ji.

Global management of diabetes in SARS-CoV-2 patients is “quite challenging,” given that most patients don’t have their diabetes under control, said host and moderator A. Enrique Caballero, MD, an endocrinologist/investigator in the division of endocrinology, diabetes, and hypertension and division of global health equity at Brigham and Women’s Hospital, Boston. “They are not meeting treatment targets for cholesterol or glucose control. So we’re not managing optimal care. And now on top of this, we have COVID-19.”

Optimizing glycemic control “is the key to overall treatment in people with diabetes and COVID-19,” said Antonio Ceriello, MD, during a June 5 webinar sponsored by Harvard Medical School, Boston.

©Tashatuvango/Thinkstockphotos.com

Dr. Ceriello, a research consultant with the Italian Ministry of Health, IRCCS Multi-Medica, Milan, highlighted a recent study that examined the association of blood glucose control and outcomes in COVID-19 patients with preexisting type 2 diabetes.

Among 7,000 cases of COVID-19, type 2 diabetes correlated with a higher death rate. However, those with well-controlled blood glucose (upper limit ≤10 mmol/L) had a survival rate of 98.9%, compared with just 11% among those with poorly controlled blood glucose (upper limit >10 mmol/L), a reduction in risk of 86% (adjusted hazard ratio, 0.14; Cell Metab. 2020 May 1. doi: 10.1016/j.cmet.2020.04.021).

Clinicians should also consider the possible side effects of hypoglycemic agents in the evolution of this disease. This is true of all patients, not just diabetes patients, Dr. Ceriello said. “We have data showing that ... hyperglycemia contributes directly to worsening the prognosis of COVID-19 independent of the presence of diabetes.”

One study found that the glycosylation of ACE-2 played an important role in allowing cellular entry of the virus (Am J Physiol Endocrinol Metab. 2020 Mar 31;318:E736-41). “This is something that could be related to hyperglycemia,” he added.

Another risk factor is thrombosis, a clear contributor to death rates in COVID-19. Research on thrombosis incidence in COVID-19 patients with diabetes reported higher levels of D-dimer levels in people with diabetes, especially among those who couldn’t manage their disease.

Tying all of these factors together, Dr. Ceriello discussed how ACE-2 glycosylation, in combination with other factors in SARS-CoV-2 infection, could lead to hyperglycemia, thrombosis, and subsequently multiorgan damage in diabetes patients.

Other research has associated higher HbA1c levels (mean HbA1c, 7.5%) with higher mortality risk in COVID-19 patients, said another speaker, Linong Ji, MD, director for endocrinology and metabolism at Peking University People’s Hospital, Beijing, and director of Peking University’s Diabetes Center. Proper guidance is key to ensuring early detection of hyperglycemic crisis in people with diabetes, advised Dr. Ji.

Global management of diabetes in SARS-CoV-2 patients is “quite challenging,” given that most patients don’t have their diabetes under control, said host and moderator A. Enrique Caballero, MD, an endocrinologist/investigator in the division of endocrinology, diabetes, and hypertension and division of global health equity at Brigham and Women’s Hospital, Boston. “They are not meeting treatment targets for cholesterol or glucose control. So we’re not managing optimal care. And now on top of this, we have COVID-19.”

Optimizing glycemic control “is the key to overall treatment in people with diabetes and COVID-19,” said Antonio Ceriello, MD, during a June 5 webinar sponsored by Harvard Medical School, Boston.

©Tashatuvango/Thinkstockphotos.com

Dr. Ceriello, a research consultant with the Italian Ministry of Health, IRCCS Multi-Medica, Milan, highlighted a recent study that examined the association of blood glucose control and outcomes in COVID-19 patients with preexisting type 2 diabetes.

Among 7,000 cases of COVID-19, type 2 diabetes correlated with a higher death rate. However, those with well-controlled blood glucose (upper limit ≤10 mmol/L) had a survival rate of 98.9%, compared with just 11% among those with poorly controlled blood glucose (upper limit >10 mmol/L), a reduction in risk of 86% (adjusted hazard ratio, 0.14; Cell Metab. 2020 May 1. doi: 10.1016/j.cmet.2020.04.021).

Clinicians should also consider the possible side effects of hypoglycemic agents in the evolution of this disease. This is true of all patients, not just diabetes patients, Dr. Ceriello said. “We have data showing that ... hyperglycemia contributes directly to worsening the prognosis of COVID-19 independent of the presence of diabetes.”

One study found that the glycosylation of ACE-2 played an important role in allowing cellular entry of the virus (Am J Physiol Endocrinol Metab. 2020 Mar 31;318:E736-41). “This is something that could be related to hyperglycemia,” he added.

Another risk factor is thrombosis, a clear contributor to death rates in COVID-19. Research on thrombosis incidence in COVID-19 patients with diabetes reported higher levels of D-dimer levels in people with diabetes, especially among those who couldn’t manage their disease.

Tying all of these factors together, Dr. Ceriello discussed how ACE-2 glycosylation, in combination with other factors in SARS-CoV-2 infection, could lead to hyperglycemia, thrombosis, and subsequently multiorgan damage in diabetes patients.

Other research has associated higher HbA1c levels (mean HbA1c, 7.5%) with higher mortality risk in COVID-19 patients, said another speaker, Linong Ji, MD, director for endocrinology and metabolism at Peking University People’s Hospital, Beijing, and director of Peking University’s Diabetes Center. Proper guidance is key to ensuring early detection of hyperglycemic crisis in people with diabetes, advised Dr. Ji.

Global management of diabetes in SARS-CoV-2 patients is “quite challenging,” given that most patients don’t have their diabetes under control, said host and moderator A. Enrique Caballero, MD, an endocrinologist/investigator in the division of endocrinology, diabetes, and hypertension and division of global health equity at Brigham and Women’s Hospital, Boston. “They are not meeting treatment targets for cholesterol or glucose control. So we’re not managing optimal care. And now on top of this, we have COVID-19.”

Secondary respiratory infections appear to be highly prevalent among patients with severe COVID-19, but at this point, most pulmonologists aren’t sure what to make of this understudied phenomenon.

“We really do not understand the implications of secondary infections on outcomes in COVID-19 patients,” David L. Bowton, MD, FCCP, said in an interview. “In most early reports the incidence of secondary infections was much higher in patients dying from COVID-19, compared to survivors, but it isn’t clear whether this indicates that the secondary infection itself led to excess mortality or was more a marker of the severity of the COVID-19 infection.

“Further, details of the diagnostic criteria used, the microbiology, and the appropriateness of treatment of these secondary infections has not generally been included in these reports,” added Dr. Bowton, a pulmonologist and professor emeritus of critical care anesthesiology at Wake Forest University, Winston-Salem, N.C.

One such early retrospective cohort study included 191 COVID-19 patients in Wuhan, China. Of the 54 who died in hospital, half had secondary bacterial lung infections (Lancet. 2020 Mar 28;395[10229]:1054-62). That comes as no surprise to U.S. pulmonologists, who learned back in their training that many deaths during the so-called Spanish influenza epidemic of 1918-1920 were actually caused by secondary pneumonia involving Staphylococcus aureus, commented Daniel L. Ouellette, MD, FCCP, associate director of medical critical care at Henry Ford Hospital, Detroit.

“Critically ill patients are highly susceptible to secondary infections regardless of the cause of the patient’s critical illness,” he noted in an interview. “Recent reports of secondary infections in patients critically ill from COVID-19 are interesting but should be considered in this context. To confirm that COVID-19 patients have a different, or increased, risk of infection at specific sites or from specific agents will require careful study.”

That will be no easy matter given the challenges of obtaining bronchoalveolar lavage samples in mechanically ventilated patients with COVID-19, according to Eric J. Gartman, MD, FCCP, a pulmonologist at Brown University, Providence, R.I., and director of the pulmonary function laboratory at the Providence Veterans Affairs Medical Center.

“Unfortunately, many of the invasive modalities that are typically employed to help diagnose secondary infections in critically ill patients are being severely limited or even prohibited in COVID-19 patients due to infection control measures,” he said. As a result, Dr. Gartman noted, intensivists are often resorting to empiric broad-spectrum antimicrobial therapy in patients with severe COVID-19 and are without ready access to the bacterial cultures which might otherwise permit later treatment de-escalation or retargeting.

Among the myriad areas of uncertainty regarding COVID-19 is the proportion of bacterial coinfections that are hospital acquired. Given the lengthy duration of invasive mechanical ventilation in patients with severe COVID-19 – a mean of 9.1 days in the United Kingdom – the chances of hospital-acquired infection are likely substantial. Moreover, a recent single-center U.K. study involving microbiologic testing in 195 consecutive patients newly hospitalized for COVID-19 reported that community-acquired bacterial infection was uncommon: Just 4% of patients had pneumococcal coinfection at hospital admission, and S. aureus wasn’t detected in anyone (Lancet. 2020;1:362. doi:10.1016/S2666-5247[20]30036-7). French investigators have reported detecting putative invasive pulmonary aspergillosis in nearly one-third of a small series of 27 consecutive mechanically ventilated COVID-19 patients (Lancet Resp Med. 2020; 8[6]:e48-9). Dr. Gartman said the diagnostic testing methods utilized in this and similar reports haven’t been prospectively validated in COVID-19. The testing methods may not indicate invasive Aspergillus infection in this population with a high degree of certainty, since they have previously been performed mainly in patients with hematologic malignancies.

“Although there is nothing definitive regarding this research, as a practicing critical care doctor one should respect these findings and consider this secondary diagnosis if the supporting clinical data is positive, especially given that the mortality risk in this population is high,” he advised.

Dr. Bowton said that he and his fellow intensivists at Wake Forest Baptist Health don’t routinely screen COVID-19 patients for secondary bacterial or fungal infections. And in talking with colleagues around the country, it’s his impression that most have similarly elected not to do so.

“However, our clinical index of suspicion for secondary infections is heightened and, if triggered, will initiate a search for and treatment of these secondary infections,” Dr. Bowton said.
 

[email protected]

Secondary respiratory infections appear to be highly prevalent among patients with severe COVID-19, but at this point, most pulmonologists aren’t sure what to make of this understudied phenomenon.

“We really do not understand the implications of secondary infections on outcomes in COVID-19 patients,” David L. Bowton, MD, FCCP, said in an interview. “In most early reports the incidence of secondary infections was much higher in patients dying from COVID-19, compared to survivors, but it isn’t clear whether this indicates that the secondary infection itself led to excess mortality or was more a marker of the severity of the COVID-19 infection.

“Further, details of the diagnostic criteria used, the microbiology, and the appropriateness of treatment of these secondary infections has not generally been included in these reports,” added Dr. Bowton, a pulmonologist and professor emeritus of critical care anesthesiology at Wake Forest University, Winston-Salem, N.C.

One such early retrospective cohort study included 191 COVID-19 patients in Wuhan, China. Of the 54 who died in hospital, half had secondary bacterial lung infections (Lancet. 2020 Mar 28;395[10229]:1054-62). That comes as no surprise to U.S. pulmonologists, who learned back in their training that many deaths during the so-called Spanish influenza epidemic of 1918-1920 were actually caused by secondary pneumonia involving Staphylococcus aureus, commented Daniel L. Ouellette, MD, FCCP, associate director of medical critical care at Henry Ford Hospital, Detroit.

“Critically ill patients are highly susceptible to secondary infections regardless of the cause of the patient’s critical illness,” he noted in an interview. “Recent reports of secondary infections in patients critically ill from COVID-19 are interesting but should be considered in this context. To confirm that COVID-19 patients have a different, or increased, risk of infection at specific sites or from specific agents will require careful study.”

That will be no easy matter given the challenges of obtaining bronchoalveolar lavage samples in mechanically ventilated patients with COVID-19, according to Eric J. Gartman, MD, FCCP, a pulmonologist at Brown University, Providence, R.I., and director of the pulmonary function laboratory at the Providence Veterans Affairs Medical Center.

“Unfortunately, many of the invasive modalities that are typically employed to help diagnose secondary infections in critically ill patients are being severely limited or even prohibited in COVID-19 patients due to infection control measures,” he said. As a result, Dr. Gartman noted, intensivists are often resorting to empiric broad-spectrum antimicrobial therapy in patients with severe COVID-19 and are without ready access to the bacterial cultures which might otherwise permit later treatment de-escalation or retargeting.

Among the myriad areas of uncertainty regarding COVID-19 is the proportion of bacterial coinfections that are hospital acquired. Given the lengthy duration of invasive mechanical ventilation in patients with severe COVID-19 – a mean of 9.1 days in the United Kingdom – the chances of hospital-acquired infection are likely substantial. Moreover, a recent single-center U.K. study involving microbiologic testing in 195 consecutive patients newly hospitalized for COVID-19 reported that community-acquired bacterial infection was uncommon: Just 4% of patients had pneumococcal coinfection at hospital admission, and S. aureus wasn’t detected in anyone (Lancet. 2020;1:362. doi:10.1016/S2666-5247[20]30036-7). French investigators have reported detecting putative invasive pulmonary aspergillosis in nearly one-third of a small series of 27 consecutive mechanically ventilated COVID-19 patients (Lancet Resp Med. 2020; 8[6]:e48-9). Dr. Gartman said the diagnostic testing methods utilized in this and similar reports haven’t been prospectively validated in COVID-19. The testing methods may not indicate invasive Aspergillus infection in this population with a high degree of certainty, since they have previously been performed mainly in patients with hematologic malignancies.

“Although there is nothing definitive regarding this research, as a practicing critical care doctor one should respect these findings and consider this secondary diagnosis if the supporting clinical data is positive, especially given that the mortality risk in this population is high,” he advised.

Dr. Bowton said that he and his fellow intensivists at Wake Forest Baptist Health don’t routinely screen COVID-19 patients for secondary bacterial or fungal infections. And in talking with colleagues around the country, it’s his impression that most have similarly elected not to do so.

“However, our clinical index of suspicion for secondary infections is heightened and, if triggered, will initiate a search for and treatment of these secondary infections,” Dr. Bowton said.
 

[email protected]

Secondary respiratory infections appear to be highly prevalent among patients with severe COVID-19, but at this point, most pulmonologists aren’t sure what to make of this understudied phenomenon.

“We really do not understand the implications of secondary infections on outcomes in COVID-19 patients,” David L. Bowton, MD, FCCP, said in an interview. “In most early reports the incidence of secondary infections was much higher in patients dying from COVID-19, compared to survivors, but it isn’t clear whether this indicates that the secondary infection itself led to excess mortality or was more a marker of the severity of the COVID-19 infection.

“Further, details of the diagnostic criteria used, the microbiology, and the appropriateness of treatment of these secondary infections has not generally been included in these reports,” added Dr. Bowton, a pulmonologist and professor emeritus of critical care anesthesiology at Wake Forest University, Winston-Salem, N.C.

One such early retrospective cohort study included 191 COVID-19 patients in Wuhan, China. Of the 54 who died in hospital, half had secondary bacterial lung infections (Lancet. 2020 Mar 28;395[10229]:1054-62). That comes as no surprise to U.S. pulmonologists, who learned back in their training that many deaths during the so-called Spanish influenza epidemic of 1918-1920 were actually caused by secondary pneumonia involving Staphylococcus aureus, commented Daniel L. Ouellette, MD, FCCP, associate director of medical critical care at Henry Ford Hospital, Detroit.

“Critically ill patients are highly susceptible to secondary infections regardless of the cause of the patient’s critical illness,” he noted in an interview. “Recent reports of secondary infections in patients critically ill from COVID-19 are interesting but should be considered in this context. To confirm that COVID-19 patients have a different, or increased, risk of infection at specific sites or from specific agents will require careful study.”

That will be no easy matter given the challenges of obtaining bronchoalveolar lavage samples in mechanically ventilated patients with COVID-19, according to Eric J. Gartman, MD, FCCP, a pulmonologist at Brown University, Providence, R.I., and director of the pulmonary function laboratory at the Providence Veterans Affairs Medical Center.

“Unfortunately, many of the invasive modalities that are typically employed to help diagnose secondary infections in critically ill patients are being severely limited or even prohibited in COVID-19 patients due to infection control measures,” he said. As a result, Dr. Gartman noted, intensivists are often resorting to empiric broad-spectrum antimicrobial therapy in patients with severe COVID-19 and are without ready access to the bacterial cultures which might otherwise permit later treatment de-escalation or retargeting.

Among the myriad areas of uncertainty regarding COVID-19 is the proportion of bacterial coinfections that are hospital acquired. Given the lengthy duration of invasive mechanical ventilation in patients with severe COVID-19 – a mean of 9.1 days in the United Kingdom – the chances of hospital-acquired infection are likely substantial. Moreover, a recent single-center U.K. study involving microbiologic testing in 195 consecutive patients newly hospitalized for COVID-19 reported that community-acquired bacterial infection was uncommon: Just 4% of patients had pneumococcal coinfection at hospital admission, and S. aureus wasn’t detected in anyone (Lancet. 2020;1:362. doi:10.1016/S2666-5247[20]30036-7). French investigators have reported detecting putative invasive pulmonary aspergillosis in nearly one-third of a small series of 27 consecutive mechanically ventilated COVID-19 patients (Lancet Resp Med. 2020; 8[6]:e48-9). Dr. Gartman said the diagnostic testing methods utilized in this and similar reports haven’t been prospectively validated in COVID-19. The testing methods may not indicate invasive Aspergillus infection in this population with a high degree of certainty, since they have previously been performed mainly in patients with hematologic malignancies.

“Although there is nothing definitive regarding this research, as a practicing critical care doctor one should respect these findings and consider this secondary diagnosis if the supporting clinical data is positive, especially given that the mortality risk in this population is high,” he advised.

Dr. Bowton said that he and his fellow intensivists at Wake Forest Baptist Health don’t routinely screen COVID-19 patients for secondary bacterial or fungal infections. And in talking with colleagues around the country, it’s his impression that most have similarly elected not to do so.

“However, our clinical index of suspicion for secondary infections is heightened and, if triggered, will initiate a search for and treatment of these secondary infections,” Dr. Bowton said.
 

[email protected]

Even without GI symptoms, many patients with COVID-19 shed viral RNA in feces, suggesting that stool testing and prevention of fecal-oral transmission may be needed to combat the ongoing pandemic, according to investigators.

A meta-analysis of 29 studies showed that 12% of patients with COVID-19 developed nausea, diarrhea, or vomiting, while 41% shed viral RNA in feces, reported lead author Sravanthi Parasa, MD, of Swedish Medical Center, Seattle.Writing in JAMA Network Open, Dr. Parasa and colleagues emphasized that respiratory symptoms remain the predominant form of disease; however, GI symptoms can occur.

“In fact, the first reported patient with COVID-19 in the U.S. reported GI symptoms of loose bowel movements and abdominal discomfort,” the investigators wrote, noting that the patient went on to test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in both respiratory and stool specimens.

“This raises the question of inadvertent human-to-human transmission via the fecal route despite public health emphasis on droplet transmission and precautions for contact with respiratory secretions,” the investigators wrote.

To address this question, the investigators conducted a systematic review and meta-analysis involving 23 published and 6 preprint studies involving a total of 4,805 patients, all of whom tested positive for SARS-CoV-2 based on PCR results from nasopharyngeal swabs. Dr. Parasa and colleagues noted that most of the studies “scored between 8 and 10 on the MINORS quality assessment,” suggesting moderate quality.

Pooled data from these studies showed that 4.6% of patients reported nausea or vomiting, while 7.4% reported diarrhea. Such symptoms may serve as an early warning flag for clinicians, the investigators noted.

“[T]he presence of GI symptoms may portend a worse outcome for patients infected with SARS-CoV-2,” they wrote, citing a study by Pan and colleagues, which found that GI symptoms were associated with lower rates of recovery and hospital discharge.

Regardless of GI symptoms, 40.5% of patients in the meta-analysis tested positive for viral RNA in feces (95% confidence interval, 27.4%-55.1%). Duration of viral shedding in feces lasted up to 11 days after symptom onset, or in a single-patient case study, 18 days after hospitalization.

The investigators called these duration figures “particularly concerning,” especially in light of a study published by Xiao and colleagues, which showed that 23.3% of patients with negative respiratory tests were still shedding live virus in feces.

“[T]he fecal-oral route of transmission could be an additional potential source of infection spread,” wrote Dr. Parasa and colleagues. “Our results also suggest that testing of the virus in feces ... could be helpful in disease monitoring and surveillance.”

David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, said that the findings confirm what has been suspected for some time: GI disease is relatively common with COVID-19.

“The evidence is clear now that a sizable percentage of patients have GI symptoms,” Dr. Johnson said in an interview.

GI issues may precede respiratory signs, he added, so clinicians should be aware that nausea, vomiting, or diarrhea could be early indicators of COVID-19, and possibly, a worse outcome.

“The other highlight of this study is that stool shedding may be extended beyond respiratory shedding,” Dr. Johnson said.

He suggested that this finding could influence current CDC criteria, which define absence of infectious risk by two consecutive, negative nasopharyngeal swabs. Instead, fecal testing may be needed, he said, along with measures to prevent fecal-oral transmission.

Dr. Johnson expressed particular concern for risk of infection via toilet plume, in which toilet flushing aerosolizes viral particles.

“As much as people try to social distance by 6 feet – you can do that when you walk into a store, or a building, but you can’t necessarily do that when you walk into a public toilet, where the plume may have been expansive for a period of time,” he said. “That toilet may never really get cleaned to a high level of disinfection, and those droplets set up potential for fecal-oral spread.”

Dr. Sharma disclosed relationships with Medtronic, Fujifilm, Boston Scientific, and others. Dr. Johnson disclosed no relevant conflicts of interest.

SOURCE: Parasa S et al. JAMA Network Open. 2020 Jun 11. doi: 10.1001/jamanetworkopen.2020.11335.

Even without GI symptoms, many patients with COVID-19 shed viral RNA in feces, suggesting that stool testing and prevention of fecal-oral transmission may be needed to combat the ongoing pandemic, according to investigators.

A meta-analysis of 29 studies showed that 12% of patients with COVID-19 developed nausea, diarrhea, or vomiting, while 41% shed viral RNA in feces, reported lead author Sravanthi Parasa, MD, of Swedish Medical Center, Seattle.Writing in JAMA Network Open, Dr. Parasa and colleagues emphasized that respiratory symptoms remain the predominant form of disease; however, GI symptoms can occur.

“In fact, the first reported patient with COVID-19 in the U.S. reported GI symptoms of loose bowel movements and abdominal discomfort,” the investigators wrote, noting that the patient went on to test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in both respiratory and stool specimens.

“This raises the question of inadvertent human-to-human transmission via the fecal route despite public health emphasis on droplet transmission and precautions for contact with respiratory secretions,” the investigators wrote.

To address this question, the investigators conducted a systematic review and meta-analysis involving 23 published and 6 preprint studies involving a total of 4,805 patients, all of whom tested positive for SARS-CoV-2 based on PCR results from nasopharyngeal swabs. Dr. Parasa and colleagues noted that most of the studies “scored between 8 and 10 on the MINORS quality assessment,” suggesting moderate quality.

Pooled data from these studies showed that 4.6% of patients reported nausea or vomiting, while 7.4% reported diarrhea. Such symptoms may serve as an early warning flag for clinicians, the investigators noted.

“[T]he presence of GI symptoms may portend a worse outcome for patients infected with SARS-CoV-2,” they wrote, citing a study by Pan and colleagues, which found that GI symptoms were associated with lower rates of recovery and hospital discharge.

Regardless of GI symptoms, 40.5% of patients in the meta-analysis tested positive for viral RNA in feces (95% confidence interval, 27.4%-55.1%). Duration of viral shedding in feces lasted up to 11 days after symptom onset, or in a single-patient case study, 18 days after hospitalization.

The investigators called these duration figures “particularly concerning,” especially in light of a study published by Xiao and colleagues, which showed that 23.3% of patients with negative respiratory tests were still shedding live virus in feces.

“[T]he fecal-oral route of transmission could be an additional potential source of infection spread,” wrote Dr. Parasa and colleagues. “Our results also suggest that testing of the virus in feces ... could be helpful in disease monitoring and surveillance.”

David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, said that the findings confirm what has been suspected for some time: GI disease is relatively common with COVID-19.

“The evidence is clear now that a sizable percentage of patients have GI symptoms,” Dr. Johnson said in an interview.

GI issues may precede respiratory signs, he added, so clinicians should be aware that nausea, vomiting, or diarrhea could be early indicators of COVID-19, and possibly, a worse outcome.

“The other highlight of this study is that stool shedding may be extended beyond respiratory shedding,” Dr. Johnson said.

He suggested that this finding could influence current CDC criteria, which define absence of infectious risk by two consecutive, negative nasopharyngeal swabs. Instead, fecal testing may be needed, he said, along with measures to prevent fecal-oral transmission.

Dr. Johnson expressed particular concern for risk of infection via toilet plume, in which toilet flushing aerosolizes viral particles.

“As much as people try to social distance by 6 feet – you can do that when you walk into a store, or a building, but you can’t necessarily do that when you walk into a public toilet, where the plume may have been expansive for a period of time,” he said. “That toilet may never really get cleaned to a high level of disinfection, and those droplets set up potential for fecal-oral spread.”

Dr. Sharma disclosed relationships with Medtronic, Fujifilm, Boston Scientific, and others. Dr. Johnson disclosed no relevant conflicts of interest.

SOURCE: Parasa S et al. JAMA Network Open. 2020 Jun 11. doi: 10.1001/jamanetworkopen.2020.11335.

Even without GI symptoms, many patients with COVID-19 shed viral RNA in feces, suggesting that stool testing and prevention of fecal-oral transmission may be needed to combat the ongoing pandemic, according to investigators.

A meta-analysis of 29 studies showed that 12% of patients with COVID-19 developed nausea, diarrhea, or vomiting, while 41% shed viral RNA in feces, reported lead author Sravanthi Parasa, MD, of Swedish Medical Center, Seattle.Writing in JAMA Network Open, Dr. Parasa and colleagues emphasized that respiratory symptoms remain the predominant form of disease; however, GI symptoms can occur.

“In fact, the first reported patient with COVID-19 in the U.S. reported GI symptoms of loose bowel movements and abdominal discomfort,” the investigators wrote, noting that the patient went on to test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in both respiratory and stool specimens.

“This raises the question of inadvertent human-to-human transmission via the fecal route despite public health emphasis on droplet transmission and precautions for contact with respiratory secretions,” the investigators wrote.

To address this question, the investigators conducted a systematic review and meta-analysis involving 23 published and 6 preprint studies involving a total of 4,805 patients, all of whom tested positive for SARS-CoV-2 based on PCR results from nasopharyngeal swabs. Dr. Parasa and colleagues noted that most of the studies “scored between 8 and 10 on the MINORS quality assessment,” suggesting moderate quality.

Pooled data from these studies showed that 4.6% of patients reported nausea or vomiting, while 7.4% reported diarrhea. Such symptoms may serve as an early warning flag for clinicians, the investigators noted.

“[T]he presence of GI symptoms may portend a worse outcome for patients infected with SARS-CoV-2,” they wrote, citing a study by Pan and colleagues, which found that GI symptoms were associated with lower rates of recovery and hospital discharge.

Regardless of GI symptoms, 40.5% of patients in the meta-analysis tested positive for viral RNA in feces (95% confidence interval, 27.4%-55.1%). Duration of viral shedding in feces lasted up to 11 days after symptom onset, or in a single-patient case study, 18 days after hospitalization.

The investigators called these duration figures “particularly concerning,” especially in light of a study published by Xiao and colleagues, which showed that 23.3% of patients with negative respiratory tests were still shedding live virus in feces.

“[T]he fecal-oral route of transmission could be an additional potential source of infection spread,” wrote Dr. Parasa and colleagues. “Our results also suggest that testing of the virus in feces ... could be helpful in disease monitoring and surveillance.”

David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, said that the findings confirm what has been suspected for some time: GI disease is relatively common with COVID-19.

“The evidence is clear now that a sizable percentage of patients have GI symptoms,” Dr. Johnson said in an interview.

GI issues may precede respiratory signs, he added, so clinicians should be aware that nausea, vomiting, or diarrhea could be early indicators of COVID-19, and possibly, a worse outcome.

“The other highlight of this study is that stool shedding may be extended beyond respiratory shedding,” Dr. Johnson said.

He suggested that this finding could influence current CDC criteria, which define absence of infectious risk by two consecutive, negative nasopharyngeal swabs. Instead, fecal testing may be needed, he said, along with measures to prevent fecal-oral transmission.

Dr. Johnson expressed particular concern for risk of infection via toilet plume, in which toilet flushing aerosolizes viral particles.

“As much as people try to social distance by 6 feet – you can do that when you walk into a store, or a building, but you can’t necessarily do that when you walk into a public toilet, where the plume may have been expansive for a period of time,” he said. “That toilet may never really get cleaned to a high level of disinfection, and those droplets set up potential for fecal-oral spread.”

Dr. Sharma disclosed relationships with Medtronic, Fujifilm, Boston Scientific, and others. Dr. Johnson disclosed no relevant conflicts of interest.

SOURCE: Parasa S et al. JAMA Network Open. 2020 Jun 11. doi: 10.1001/jamanetworkopen.2020.11335.

New preliminary data from the T1D Exchange suggest that, although hyperglycemia and diabetic ketoacidosis (DKA) are common in people with type 1 diabetes who develop COVID-19, many are still able to manage the illness at home and overall mortality is relatively low.

The new findings – the first US data on individuals with type 1 diabetes and COVID-19 – were published online June 5 in Diabetes Care by Osagie A. Ebekozien, MD, vice president, quality improvement and population health at the T1D Exchange, and colleagues.

Two UK studies are the only prior ones to previously examine the topic.

The newly published study includes data as of May 5 on 64 individuals from a total of 64 US sites, including 15 T1D Exchange member clinics and an additional 49 endocrinology clinics from around the country. Since the paper was submitted, there are now 220 patients from 68 sites. Another publication with a more detailed analysis of risk factors and adjustment for confounders is planned for later this year.

Some of the findings from the preliminary data have shifted, but many aspects remain consistent, Ebekozien told Medscape Medical News.

“One thing still very true, even with the unpublished findings, is the influence of A1c and glycemic management. ...With higher A1c levels, we’re seeing more COVID-19 hospitalizations and worse outcomes,” he said.

And as has been generally reported for COVID-19, high body mass index was a major risk factor in the preliminary dataset – and remains so.

There were two deaths in the preliminary report, both individuals with comorbidities in addition to type 1 diabetes, Ebekozien said. There have been a few more deaths in the larger dataset, but the mortality rate remains relatively low.

Interestingly, females predominate in both cohorts. That may be a reporting phenomenon, another factor that is being analyzed.

Hyperglycemia Remains a Major Risk Factor

The study is specifically being conducted by the T1D Exchange’s Quality Improvement Collaborative, which Ebekozien heads.

Data were obtained for 33 patients with type 1 diabetes who tested positive for COVID-19, and another 31 who were classified as “COVID-19–like” because they had symptoms consistent with COVID-19, as identified by the Centers for Disease Control and Prevention, but hadn’t been tested for the virus.

For all 64 patients, the mean age was 20.9 years and two thirds (65.6%) were aged 18 or younger. A higher proportion of the COVID-19–like patients were pediatric than the confirmed cases. The larger dataset includes more adult patients, Ebekozien told Medscape Medical News.

Overall, 60.9% of patients were female. Nearly half were white, a quarter Hispanic, and 18.8% black. More confirmed COVID-19 cases were black compared with suspected cases (30.3% vs 6.5%).

Median A1c for the overall group (including suspected COVID-19 cases) was 8.0%, but it was 8.5% among confirmed cases. Overall, six patients (9.8%) presented with new-onset type 1 diabetes after they developed COVID-19.

Hyperglycemia was present in half (32) of patients overall. DKA occurred in 19 people (30.2%): 15 of the confirmed COVID-19 cases (45.5%) versus just 4 (13.3%) of the COVID-19–like cases. Nausea was reported in 30.2% of patients overall.

Other symptoms were typical of COVID-19, including fever (41.3%), dry cough (38.1%), and shortness of breath (27.0%). Loss of taste and smell was less common, at just 9.5% overall.

Obesity was present in 39.7% of patients overall, with similar proportions in the confirmed and suspected COVID-19 groups. Hypertension and/or cardiovascular disease were present in 14.3% of patients overall, and the rate was similar between the two subgroups.

One of the two patients who died was a 79-year-old man who had hypertension and a prior stroke in addition to type 1 diabetes. The other was a 19-year-old woman with a history of asthma who developed a pulmonary embolism during the onset of COVID-19. Neither had DKA.

Even in Type 1 Diabetes, COVID-19 Can Be Managed at Home

Overall, 34.9% of patients were able to manage COVID-19 entirely at home, with 27.3% of the confirmed and 43.3% of the suspected cases able to do so.

At the other extreme, 22.2% of patients overall were admitted to the intensive care unit; 30.3% of the confirmed versus 13.3% of suspected cases.

Including the small proportion of patients sent home after being seen in emergency or urgent care, overall roughly half were not admitted to hospital.

“Interestingly, even in this preliminary study, half were managed at home via telemedicine with an endocrinologist and infectious disease specialist. ... I think it continues to be a case-by-case clinical decision between the patient and their provider,” Ebekozien said.

“But, we’re seeing a good number of patients who are managed at home and the symptoms resolve in a week or two, and the illness runs its course, and they don’t have to even be seen,” he added.

The research team is also collecting data on barriers to remote care, including challenges with telemedicine and how frontline providers are navigating them.

“Those are all things that our future paper will be able to shed more light on,” he explained.

Endocrinologists around the country are invited to report cases of COVID-19 in patients with type 1 diabetes to the T1D Exchange by emailing [email protected].

And in fact, Ebekozien also requested that clinicians with a large type 1 diabetes population also report if they’ve had no COVID-19 cases.

“Even if they haven’t had a case, that’s very useful information for us to know. One of the things we want to calculate down the line is the incidence ratio. Not all participating sites have had a case.”

Endocrinologists from all the participating sites have formed a dedicated community that meets regularly via webinars to share information, he noted. “It’s been a very selfless effort to work collaboratively as a community to quickly answer critical questions.”

The Helmsley Charitable Trust funds the T1D Exchange Quality Improvement Collaborative. The T1D Exchange received financial support for this study from Abbott Diabetes, Dexcom, JDRF, Insulet Corporation, Lilly, Medtronic, and Tandem Diabetes Care. No other relevant financial relationships were reported.
 

This article first appeared on Medscape.com.

New preliminary data from the T1D Exchange suggest that, although hyperglycemia and diabetic ketoacidosis (DKA) are common in people with type 1 diabetes who develop COVID-19, many are still able to manage the illness at home and overall mortality is relatively low.

The new findings – the first US data on individuals with type 1 diabetes and COVID-19 – were published online June 5 in Diabetes Care by Osagie A. Ebekozien, MD, vice president, quality improvement and population health at the T1D Exchange, and colleagues.

Two UK studies are the only prior ones to previously examine the topic.

The newly published study includes data as of May 5 on 64 individuals from a total of 64 US sites, including 15 T1D Exchange member clinics and an additional 49 endocrinology clinics from around the country. Since the paper was submitted, there are now 220 patients from 68 sites. Another publication with a more detailed analysis of risk factors and adjustment for confounders is planned for later this year.

Some of the findings from the preliminary data have shifted, but many aspects remain consistent, Ebekozien told Medscape Medical News.

“One thing still very true, even with the unpublished findings, is the influence of A1c and glycemic management. ...With higher A1c levels, we’re seeing more COVID-19 hospitalizations and worse outcomes,” he said.

And as has been generally reported for COVID-19, high body mass index was a major risk factor in the preliminary dataset – and remains so.

There were two deaths in the preliminary report, both individuals with comorbidities in addition to type 1 diabetes, Ebekozien said. There have been a few more deaths in the larger dataset, but the mortality rate remains relatively low.

Interestingly, females predominate in both cohorts. That may be a reporting phenomenon, another factor that is being analyzed.

Hyperglycemia Remains a Major Risk Factor

The study is specifically being conducted by the T1D Exchange’s Quality Improvement Collaborative, which Ebekozien heads.

Data were obtained for 33 patients with type 1 diabetes who tested positive for COVID-19, and another 31 who were classified as “COVID-19–like” because they had symptoms consistent with COVID-19, as identified by the Centers for Disease Control and Prevention, but hadn’t been tested for the virus.

For all 64 patients, the mean age was 20.9 years and two thirds (65.6%) were aged 18 or younger. A higher proportion of the COVID-19–like patients were pediatric than the confirmed cases. The larger dataset includes more adult patients, Ebekozien told Medscape Medical News.

Overall, 60.9% of patients were female. Nearly half were white, a quarter Hispanic, and 18.8% black. More confirmed COVID-19 cases were black compared with suspected cases (30.3% vs 6.5%).

Median A1c for the overall group (including suspected COVID-19 cases) was 8.0%, but it was 8.5% among confirmed cases. Overall, six patients (9.8%) presented with new-onset type 1 diabetes after they developed COVID-19.

Hyperglycemia was present in half (32) of patients overall. DKA occurred in 19 people (30.2%): 15 of the confirmed COVID-19 cases (45.5%) versus just 4 (13.3%) of the COVID-19–like cases. Nausea was reported in 30.2% of patients overall.

Other symptoms were typical of COVID-19, including fever (41.3%), dry cough (38.1%), and shortness of breath (27.0%). Loss of taste and smell was less common, at just 9.5% overall.

Obesity was present in 39.7% of patients overall, with similar proportions in the confirmed and suspected COVID-19 groups. Hypertension and/or cardiovascular disease were present in 14.3% of patients overall, and the rate was similar between the two subgroups.

One of the two patients who died was a 79-year-old man who had hypertension and a prior stroke in addition to type 1 diabetes. The other was a 19-year-old woman with a history of asthma who developed a pulmonary embolism during the onset of COVID-19. Neither had DKA.

Even in Type 1 Diabetes, COVID-19 Can Be Managed at Home

Overall, 34.9% of patients were able to manage COVID-19 entirely at home, with 27.3% of the confirmed and 43.3% of the suspected cases able to do so.

At the other extreme, 22.2% of patients overall were admitted to the intensive care unit; 30.3% of the confirmed versus 13.3% of suspected cases.

Including the small proportion of patients sent home after being seen in emergency or urgent care, overall roughly half were not admitted to hospital.

“Interestingly, even in this preliminary study, half were managed at home via telemedicine with an endocrinologist and infectious disease specialist. ... I think it continues to be a case-by-case clinical decision between the patient and their provider,” Ebekozien said.

“But, we’re seeing a good number of patients who are managed at home and the symptoms resolve in a week or two, and the illness runs its course, and they don’t have to even be seen,” he added.

The research team is also collecting data on barriers to remote care, including challenges with telemedicine and how frontline providers are navigating them.

“Those are all things that our future paper will be able to shed more light on,” he explained.

Endocrinologists around the country are invited to report cases of COVID-19 in patients with type 1 diabetes to the T1D Exchange by emailing [email protected].

And in fact, Ebekozien also requested that clinicians with a large type 1 diabetes population also report if they’ve had no COVID-19 cases.

“Even if they haven’t had a case, that’s very useful information for us to know. One of the things we want to calculate down the line is the incidence ratio. Not all participating sites have had a case.”

Endocrinologists from all the participating sites have formed a dedicated community that meets regularly via webinars to share information, he noted. “It’s been a very selfless effort to work collaboratively as a community to quickly answer critical questions.”

The Helmsley Charitable Trust funds the T1D Exchange Quality Improvement Collaborative. The T1D Exchange received financial support for this study from Abbott Diabetes, Dexcom, JDRF, Insulet Corporation, Lilly, Medtronic, and Tandem Diabetes Care. No other relevant financial relationships were reported.
 

This article first appeared on Medscape.com.

New preliminary data from the T1D Exchange suggest that, although hyperglycemia and diabetic ketoacidosis (DKA) are common in people with type 1 diabetes who develop COVID-19, many are still able to manage the illness at home and overall mortality is relatively low.

The new findings – the first US data on individuals with type 1 diabetes and COVID-19 – were published online June 5 in Diabetes Care by Osagie A. Ebekozien, MD, vice president, quality improvement and population health at the T1D Exchange, and colleagues.

Two UK studies are the only prior ones to previously examine the topic.

The newly published study includes data as of May 5 on 64 individuals from a total of 64 US sites, including 15 T1D Exchange member clinics and an additional 49 endocrinology clinics from around the country. Since the paper was submitted, there are now 220 patients from 68 sites. Another publication with a more detailed analysis of risk factors and adjustment for confounders is planned for later this year.

Some of the findings from the preliminary data have shifted, but many aspects remain consistent, Ebekozien told Medscape Medical News.

“One thing still very true, even with the unpublished findings, is the influence of A1c and glycemic management. ...With higher A1c levels, we’re seeing more COVID-19 hospitalizations and worse outcomes,” he said.

And as has been generally reported for COVID-19, high body mass index was a major risk factor in the preliminary dataset – and remains so.

There were two deaths in the preliminary report, both individuals with comorbidities in addition to type 1 diabetes, Ebekozien said. There have been a few more deaths in the larger dataset, but the mortality rate remains relatively low.

Interestingly, females predominate in both cohorts. That may be a reporting phenomenon, another factor that is being analyzed.

Hyperglycemia Remains a Major Risk Factor

The study is specifically being conducted by the T1D Exchange’s Quality Improvement Collaborative, which Ebekozien heads.

Data were obtained for 33 patients with type 1 diabetes who tested positive for COVID-19, and another 31 who were classified as “COVID-19–like” because they had symptoms consistent with COVID-19, as identified by the Centers for Disease Control and Prevention, but hadn’t been tested for the virus.

For all 64 patients, the mean age was 20.9 years and two thirds (65.6%) were aged 18 or younger. A higher proportion of the COVID-19–like patients were pediatric than the confirmed cases. The larger dataset includes more adult patients, Ebekozien told Medscape Medical News.

Overall, 60.9% of patients were female. Nearly half were white, a quarter Hispanic, and 18.8% black. More confirmed COVID-19 cases were black compared with suspected cases (30.3% vs 6.5%).

Median A1c for the overall group (including suspected COVID-19 cases) was 8.0%, but it was 8.5% among confirmed cases. Overall, six patients (9.8%) presented with new-onset type 1 diabetes after they developed COVID-19.

Hyperglycemia was present in half (32) of patients overall. DKA occurred in 19 people (30.2%): 15 of the confirmed COVID-19 cases (45.5%) versus just 4 (13.3%) of the COVID-19–like cases. Nausea was reported in 30.2% of patients overall.

Other symptoms were typical of COVID-19, including fever (41.3%), dry cough (38.1%), and shortness of breath (27.0%). Loss of taste and smell was less common, at just 9.5% overall.

Obesity was present in 39.7% of patients overall, with similar proportions in the confirmed and suspected COVID-19 groups. Hypertension and/or cardiovascular disease were present in 14.3% of patients overall, and the rate was similar between the two subgroups.

One of the two patients who died was a 79-year-old man who had hypertension and a prior stroke in addition to type 1 diabetes. The other was a 19-year-old woman with a history of asthma who developed a pulmonary embolism during the onset of COVID-19. Neither had DKA.

Even in Type 1 Diabetes, COVID-19 Can Be Managed at Home

Overall, 34.9% of patients were able to manage COVID-19 entirely at home, with 27.3% of the confirmed and 43.3% of the suspected cases able to do so.

At the other extreme, 22.2% of patients overall were admitted to the intensive care unit; 30.3% of the confirmed versus 13.3% of suspected cases.

Including the small proportion of patients sent home after being seen in emergency or urgent care, overall roughly half were not admitted to hospital.

“Interestingly, even in this preliminary study, half were managed at home via telemedicine with an endocrinologist and infectious disease specialist. ... I think it continues to be a case-by-case clinical decision between the patient and their provider,” Ebekozien said.

“But, we’re seeing a good number of patients who are managed at home and the symptoms resolve in a week or two, and the illness runs its course, and they don’t have to even be seen,” he added.

The research team is also collecting data on barriers to remote care, including challenges with telemedicine and how frontline providers are navigating them.

“Those are all things that our future paper will be able to shed more light on,” he explained.

Endocrinologists around the country are invited to report cases of COVID-19 in patients with type 1 diabetes to the T1D Exchange by emailing [email protected].

And in fact, Ebekozien also requested that clinicians with a large type 1 diabetes population also report if they’ve had no COVID-19 cases.

“Even if they haven’t had a case, that’s very useful information for us to know. One of the things we want to calculate down the line is the incidence ratio. Not all participating sites have had a case.”

Endocrinologists from all the participating sites have formed a dedicated community that meets regularly via webinars to share information, he noted. “It’s been a very selfless effort to work collaboratively as a community to quickly answer critical questions.”

The Helmsley Charitable Trust funds the T1D Exchange Quality Improvement Collaborative. The T1D Exchange received financial support for this study from Abbott Diabetes, Dexcom, JDRF, Insulet Corporation, Lilly, Medtronic, and Tandem Diabetes Care. No other relevant financial relationships were reported.
 

This article first appeared on Medscape.com.

On April 16, the White House released federal guidelines for reopening American businesses – followed 3 days later by specific recommendations from the Centers for Medicare and Medicaid Services for health care practices in areas with a low incidence of COVID-19. Since then, a slew of resources and guidelines have emerged to help you safely reopen your medical practice.

Depending on where you live, you may have already reopened (or even never closed), or you may be awaiting the relaxation of restrictions in your state. (As I write this on June 10, the stay-at-home order in my state, New Jersey, is being rescinded.)

The big question, of course, is whether patients can be convinced that it is safe to leave their homes and come to your office. The answer may depend on how well you time your reopening and adhere to the appropriate federal, state, and independent guidelines.

The federal guidelines have three sections: criteria, which outline conditions each region or state should satisfy before reopening; preparedness, which lists how states should prepare for reopening; and phase guidelines, which detail responsibilities of individuals and employers during distinct reopening phases.

You should pay the most attention to the “criteria” section. The key question to ask: “Has my state or region satisfied the basic criteria for reopening?”

Those criteria are as follows:

• Symptoms reported within a 14-day period should be on a downward trajectory.
• Cases documented (or positive tests as a percentage of total tests) within a 14-day period should also be on a downward trajectory.
• Hospitals should be treating all patients without crisis care. They should also have a robust testing program in place for at-risk health care workers.

If your area meets these criteria, you can proceed to the CMS recommendations. They cover general advice related to personal protective equipment (PPE), workforce availability, facility considerations, sanitation protocols, supplies, and testing capacity.

The key takeaway: As long as your area has the resources to quickly respond to a surge of COVID-19 cases, you can start offering care to non-COVID patients. Keep seeing patients via telehealth as often as possible, and prioritize surgical/procedural care and high-complexity chronic disease management before moving on to preventive and cosmetic services.

The American Medical Association has issued its own checklist of criteria for reopening your practice to supplement the federal guidelines. Highlights include the following:

• Sit down with a calendar and pick an expected reopening day. Ideally, this should include a “soft reopening.” Make a plan to stock necessary PPE and write down plans for cleaning and staffing if an employee or patient is diagnosed with COVID-19 after visiting your office.
• Take a stepwise approach so you can identify challenges early and address them. It’s important to figure out which visits can continue via telehealth, and begin with just a few in-person visits each day. Plan out a schedule and clearly communicate it to patients, clinicians, and staff.
• Patient safety is your top concern. Encourage patients to visit without companions whenever possible, and of course, all individuals who visit the office should wear a cloth face covering.
• Screen employees for fevers and other symptoms of COVID-19; remember that those records are subject to HIPAA rules and must be kept confidential. Minimize contact between employees as much as possible.
• Do your best to screen patients before in-person visits, to verify they don’t have symptoms of COVID-19. Consider creating a script that office staff can use to contact patients 24 hours before they come in. Use this as a chance to ask about symptoms, and explain any reopening logistics they should know about.
• Contact your malpractice insurance carrier to discuss whether you need to make any changes to your coverage.

This would also be a great time to review your confidentiality, privacy, and data security protocols. COVID-19 presents new challenges for data privacy – for example, if you must inform coworkers or patients that they have come into contact with someone who tested positive. Make a plan that follows HIPAA guidelines during COVID-19. Also, make sure you have a plan for handling issues like paid sick leave or reporting COVID-19 cases to your local health department.

Another useful resource is the Medical Group Management Association’s COVID-19 Medical Practice Reopening Checklist. You can use it to confirm that you are addressing all the important items, and that you haven’t missed anything.

As for me, I am advising patients who are reluctant to seek treatment that many medical problems pose more risk than COVID-19, faster treatment means better outcomes, and because we maintain strict disinfection protocols, they are far less likely to be infected with COVID-19 in my office than, say, at a grocery store.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

On April 16, the White House released federal guidelines for reopening American businesses – followed 3 days later by specific recommendations from the Centers for Medicare and Medicaid Services for health care practices in areas with a low incidence of COVID-19. Since then, a slew of resources and guidelines have emerged to help you safely reopen your medical practice.

Depending on where you live, you may have already reopened (or even never closed), or you may be awaiting the relaxation of restrictions in your state. (As I write this on June 10, the stay-at-home order in my state, New Jersey, is being rescinded.)

The big question, of course, is whether patients can be convinced that it is safe to leave their homes and come to your office. The answer may depend on how well you time your reopening and adhere to the appropriate federal, state, and independent guidelines.

The federal guidelines have three sections: criteria, which outline conditions each region or state should satisfy before reopening; preparedness, which lists how states should prepare for reopening; and phase guidelines, which detail responsibilities of individuals and employers during distinct reopening phases.

You should pay the most attention to the “criteria” section. The key question to ask: “Has my state or region satisfied the basic criteria for reopening?”

Those criteria are as follows:

• Symptoms reported within a 14-day period should be on a downward trajectory.
• Cases documented (or positive tests as a percentage of total tests) within a 14-day period should also be on a downward trajectory.
• Hospitals should be treating all patients without crisis care. They should also have a robust testing program in place for at-risk health care workers.

If your area meets these criteria, you can proceed to the CMS recommendations. They cover general advice related to personal protective equipment (PPE), workforce availability, facility considerations, sanitation protocols, supplies, and testing capacity.

The key takeaway: As long as your area has the resources to quickly respond to a surge of COVID-19 cases, you can start offering care to non-COVID patients. Keep seeing patients via telehealth as often as possible, and prioritize surgical/procedural care and high-complexity chronic disease management before moving on to preventive and cosmetic services.

The American Medical Association has issued its own checklist of criteria for reopening your practice to supplement the federal guidelines. Highlights include the following:

• Sit down with a calendar and pick an expected reopening day. Ideally, this should include a “soft reopening.” Make a plan to stock necessary PPE and write down plans for cleaning and staffing if an employee or patient is diagnosed with COVID-19 after visiting your office.
• Take a stepwise approach so you can identify challenges early and address them. It’s important to figure out which visits can continue via telehealth, and begin with just a few in-person visits each day. Plan out a schedule and clearly communicate it to patients, clinicians, and staff.
• Patient safety is your top concern. Encourage patients to visit without companions whenever possible, and of course, all individuals who visit the office should wear a cloth face covering.
• Screen employees for fevers and other symptoms of COVID-19; remember that those records are subject to HIPAA rules and must be kept confidential. Minimize contact between employees as much as possible.
• Do your best to screen patients before in-person visits, to verify they don’t have symptoms of COVID-19. Consider creating a script that office staff can use to contact patients 24 hours before they come in. Use this as a chance to ask about symptoms, and explain any reopening logistics they should know about.
• Contact your malpractice insurance carrier to discuss whether you need to make any changes to your coverage.

This would also be a great time to review your confidentiality, privacy, and data security protocols. COVID-19 presents new challenges for data privacy – for example, if you must inform coworkers or patients that they have come into contact with someone who tested positive. Make a plan that follows HIPAA guidelines during COVID-19. Also, make sure you have a plan for handling issues like paid sick leave or reporting COVID-19 cases to your local health department.

Another useful resource is the Medical Group Management Association’s COVID-19 Medical Practice Reopening Checklist. You can use it to confirm that you are addressing all the important items, and that you haven’t missed anything.

As for me, I am advising patients who are reluctant to seek treatment that many medical problems pose more risk than COVID-19, faster treatment means better outcomes, and because we maintain strict disinfection protocols, they are far less likely to be infected with COVID-19 in my office than, say, at a grocery store.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

On April 16, the White House released federal guidelines for reopening American businesses – followed 3 days later by specific recommendations from the Centers for Medicare and Medicaid Services for health care practices in areas with a low incidence of COVID-19. Since then, a slew of resources and guidelines have emerged to help you safely reopen your medical practice.

Depending on where you live, you may have already reopened (or even never closed), or you may be awaiting the relaxation of restrictions in your state. (As I write this on June 10, the stay-at-home order in my state, New Jersey, is being rescinded.)

The big question, of course, is whether patients can be convinced that it is safe to leave their homes and come to your office. The answer may depend on how well you time your reopening and adhere to the appropriate federal, state, and independent guidelines.

The federal guidelines have three sections: criteria, which outline conditions each region or state should satisfy before reopening; preparedness, which lists how states should prepare for reopening; and phase guidelines, which detail responsibilities of individuals and employers during distinct reopening phases.

You should pay the most attention to the “criteria” section. The key question to ask: “Has my state or region satisfied the basic criteria for reopening?”

Those criteria are as follows:

• Symptoms reported within a 14-day period should be on a downward trajectory.
• Cases documented (or positive tests as a percentage of total tests) within a 14-day period should also be on a downward trajectory.
• Hospitals should be treating all patients without crisis care. They should also have a robust testing program in place for at-risk health care workers.

If your area meets these criteria, you can proceed to the CMS recommendations. They cover general advice related to personal protective equipment (PPE), workforce availability, facility considerations, sanitation protocols, supplies, and testing capacity.

The key takeaway: As long as your area has the resources to quickly respond to a surge of COVID-19 cases, you can start offering care to non-COVID patients. Keep seeing patients via telehealth as often as possible, and prioritize surgical/procedural care and high-complexity chronic disease management before moving on to preventive and cosmetic services.

The American Medical Association has issued its own checklist of criteria for reopening your practice to supplement the federal guidelines. Highlights include the following:

• Sit down with a calendar and pick an expected reopening day. Ideally, this should include a “soft reopening.” Make a plan to stock necessary PPE and write down plans for cleaning and staffing if an employee or patient is diagnosed with COVID-19 after visiting your office.
• Take a stepwise approach so you can identify challenges early and address them. It’s important to figure out which visits can continue via telehealth, and begin with just a few in-person visits each day. Plan out a schedule and clearly communicate it to patients, clinicians, and staff.
• Patient safety is your top concern. Encourage patients to visit without companions whenever possible, and of course, all individuals who visit the office should wear a cloth face covering.
• Screen employees for fevers and other symptoms of COVID-19; remember that those records are subject to HIPAA rules and must be kept confidential. Minimize contact between employees as much as possible.
• Do your best to screen patients before in-person visits, to verify they don’t have symptoms of COVID-19. Consider creating a script that office staff can use to contact patients 24 hours before they come in. Use this as a chance to ask about symptoms, and explain any reopening logistics they should know about.
• Contact your malpractice insurance carrier to discuss whether you need to make any changes to your coverage.

This would also be a great time to review your confidentiality, privacy, and data security protocols. COVID-19 presents new challenges for data privacy – for example, if you must inform coworkers or patients that they have come into contact with someone who tested positive. Make a plan that follows HIPAA guidelines during COVID-19. Also, make sure you have a plan for handling issues like paid sick leave or reporting COVID-19 cases to your local health department.

Another useful resource is the Medical Group Management Association’s COVID-19 Medical Practice Reopening Checklist. You can use it to confirm that you are addressing all the important items, and that you haven’t missed anything.

As for me, I am advising patients who are reluctant to seek treatment that many medical problems pose more risk than COVID-19, faster treatment means better outcomes, and because we maintain strict disinfection protocols, they are far less likely to be infected with COVID-19 in my office than, say, at a grocery store.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

In the midst of the COVID-19 pandemic, health systems, hospitals, and hospitalists – especially in hot spots like New York, Detroit, or Boston – have been challenged to stretch limits, redefine roles, and redeploy critical staff in response to rapidly changing needs on the ground.

Many hospitalists are working above and beyond their normal duties, sometimes beyond their training, specialty, or comfort zone and are rising to the occasion in ways they never imagined. These include doing shifts in ICUs, working with ventilator patients, and reporting to other atypical sites of care like postanesthesia care units and post-acute or step-down units.

Valerie Vaughn, MD, MSc, a hospitalist with Michigan Medicine and assistant professor of medicine at the University of Michigan in Ann Arbor, was doing research on how to reduce overuse of antibiotics in hospitals when the COVID-19 crisis hit and dramatically redefined her job. “We were afraid that we might have 3,000 to 5,000 hospitalized COVID patients by now, based on predictive modeling done while the pandemic was still growing exponentially,” she explained. Although Michigan continues to have high COVID-19 infection rates, centered on nearby Detroit, “things are a lot better today than they were 4 weeks ago.”

Dr. Vaughn helped to mobilize a team of 25 hospitalists, along with other health care providers, who volunteered to manage COVID-19 patients in the ICU and other hospital units. She was asked to help develop an all-COVID unit called the Regional Infectious Containment Unit or RICU, which opened March 16. Then, when the RICU became full, it was supplemented by two COVID-19 Moderate Care Units staffed by hospitalists who had “learned the ropes” in the RICU.

Both of these new models were defined in relation to the ICUs at Michigan Medicine – which were doubling in capacity, up to 200 beds at last count – and to the provision of intensive-level and long-term ventilator care for the sickest patients. The moderate care units are for patients who are not on ventilators but still very sick, for example, those receiving massive high-flow oxygen, often with a medical do-not-resuscitate/do-not-intubate order. “We established these units to do everything (medically) short of vents,” Dr. Vaughn said.

“We are having in-depth conversations about goals of care with patients soon after they arrive at the hospital. We know outcomes from ventilators are worse for COVID-positive patients who have comorbidities, and we’re using that information to inform these conversations. We’ve given scripts to clinicians to help guide them in leading these conversations. We can do other things than `use ventilators to manage their symptoms. But these are still difficult conversations,” Dr. Vaughn said.

“We also engaged palliative care early on and asked them to round with us on every [COVID] patient – until demand got too high.” The bottleneck has been the number of ICU beds available, she explained. “If you want your patient to come in and take that bed, make sure you’ve talked to the family about it.”

The COVID-19 team developed guidelines printed on pocket cards addressing critical care issues such as a refresher on how to treat acute respiratory distress syndrome and how to use vasopressors. (See the COVID-19 Continuing Medical Education Portal for web-accessible educational resources developed by Michigan Health).

It’s amazing how quickly patients can become very sick with COVID-19, Dr. Vaughn said. “One of the good things to happen from the beginning with our RICU is that a group of doctors became COVID care experts very quickly. We joined four to five hospitalists and their teams with each intensivist, so one critical care expert is there to do teaching and answer clinicians’ questions. The hospitalists coordinate the COVID care and talk to the families.”

Working on the front lines of this crisis, Dr. Vaughn said, has generated a powerful sense of purpose and camaraderie, creating bonds like in war time. “All of us on our days off feel a twinge of guilt for not being there in the hospital. The sense of gratitude we get from patients and families has been enormous, even when we were telling them bad news. That just brings us to tears.”

One of the hardest things for the doctors practicing above their typical scope of practice is that, when something bad happens, they can’t know whether it was a mistake on their part or not, she noted. “But I’ve never been so proud of our group or to be a hospitalist. No one has complained or pushed back. Everyone has responded by saying: ‘What can I do to help?’ ”
 

Enough work in hospital medicine

Hospitalists had not been deployed to care for ICU patients at Beth Israel Deaconess Medical Center (BIDMC) in Boston, a major hot spot for COVID-19, said Joseph Ming Wah Li, MD, SFHM, director of the hospital medicine program at BIDMC, when he spoke to The Hospitalist in mid-May. That’s because there were plenty of hospital medicine assignments to keep them busy. Dr. Li leads a service of 120 hospitalists practicing at four hospitals.

“As we speak today, we have 300 patients with COVID, with 70 or 80 of them in our ICU. I’m taking care of 17 patients today, 15 of them COVID-positive, and the other two placed in a former radiology holding suite adapted for COVID-negative patients. Our postanesthesia care unit is now an ICU filled with COVID patients,” he said.

“Half of my day is seeing patients and the other half I’m on Zoom calls. I’m also one of the resource allocation officers for BIDMC,” Dr. Li said. He helped to create a standard of care for the hospital, addressing what to do if there weren’t enough ICU beds or ventilators. “We’ve never actualized it and probably won’t, but it was important to go through this exercise, with a lot of discussion up front.”

Haki Laho, MD, an orthopedic hospitalist at New England Baptist Hospital (NEBH), also in Boston, has been redeployed to care for a different population of patients as his system tries to bunch patients. “All of a sudden – within hours and days – at the beginning of the pandemic and based on the recommendations, our whole system decided to stop all elective procedures and devote the resources to COVID,” he said.

NEBH is Beth Israel Lahey Health’s 141-bed orthopedic and surgical hospital, and the system has tried to keep the specialty facility COVID-19–free as much as possible, with the COVID-19 patients grouped together at BIDMC. Dr. Laho’s orthopedic hospitalist group, just five doctors, has been managing the influx of medical patients with multiple comorbidities – not COVID-19–infected but still a different kind of patient than they are used to.

“So far, so good. We’re dealing with it,” he said. “But if one of us got sick, the others would have to step up and do more shifts. We are physicians, internal medicine trained, but since my residency I hadn’t had to deal with these kinds of issues on a daily basis, such as setting up IV lines. I feel like I am back in residency mode.”
 

Convention Center medicine

Another Boston hospitalist, Amy Baughman, MD, who practices at Massachusetts General Hospital, is using her skills in a new setting, serving as a co-medical director at Boston Hope Medical Center, a 1,000-bed field hospital for patients with COVID-19. Open since April 10 and housed in the Boston Convention and Exhibition Center, it is a four-way collaboration between the Commonwealth of Massachusetts, the City of Boston, Partners HealthCare, and the Boston Health Care for the Homeless Program.

Boston Hope is divided into a post-acute care section for recovering COVID-19 patients and a respite section for undomiciled patients with COVID-19 who need a place to safely quarantine. Built for a maximum of 1,000 beds, it is currently using fewer, with 83 patients on the post-acute side and 73 on the respite side as of May 12. A total of 370 and 315, respectively, had been admitted through May 12.

The team had 5 days to put the field hospital together with the help of the Army National Guard. “During that first week I was installing hand sanitizer dispensers and making [personal protective equipment] signs. Everyone here has had to do things like that,” Dr. Baughman said. “We’ve had to be incredibly creative in our staffing, using doctors from primary care and subspecialties including dermatology, radiology, and orthopedics. We had to fast-track trainings on how to use EPIC and to provide post-acute COVID care. How do you simultaneously build a medical facility and lead teams to provide high quality care?”

Dr. Baughman still works hospitalist shifts half-time at Massachusetts General. Her prior experience providing post-acute care in the VA system was helpful in creating the post-acute level of care at Boston Hope.

“My medical director role involves supervising, staffing, and scheduling. My co-medical director, Dr. Kerri Palamara, and I also supervise the clinical care,” she said. “There are a lot of systems issues, like ordering labs or prescriptions, with couriers going back and forth. And we developed clinical pathways, such as for [deep vein thrombosis] prophylaxis or for COVID retesting to determine when it is safe to end a quarantine. We’re just now rolling out virtual specialist consultations,” she noted.

“It has gone incredibly well. So much of it has been about our ability and willingness to work hard, and take feedback and go forward. We don’t have time to harp on things. We have to be very solution oriented. At the same time, honestly, it’s been fun. Every single day is different,” Dr. Baughman said.

“It’s been an opportunity to use my skills in a totally new setting, and at a level of responsibility I haven’t had before, although that’s probably a common theme with COVID-19. I was put on this team because I am a hospitalist,” she said. “I think hospitalists have been the backbone of the response to COVID in this country. It’s been an opportunity for our specialty to shine. We need to embrace the opportunity.”
 

Balancing expertise and supervision

Mount Sinai Hospital (MSH) in Manhattan is in the New York epicenter of the COVID-19 crisis and has mobilized large numbers of pulmonary critical care and anesthesia physicians to staff up multiple ICUs for COVID-19 patients, said Andrew Dunn, MD, chief of the division of hospital medicine at Mount Sinai School of Medicine.

“My hospitalist group is covering many step-down units, medical wards, and atypical locations, providing advanced oxygen therapies, [bilevel positive airway pressure], high-flow nasal cannulas, and managing some patients on ventilators,” he said.

MSH has teaching services with house staff and nonteaching services. “We combined them into a unified service with house staff dispersed across all of the teams. We drafted a lot of nonhospitalists from different specialties to be attendings, and that has given us a tiered model, with a hospitalist supervising three or four nonhospitalist-led teams. Although the supervising hospitalists carry no patient caseloads of their own, this is primarily a clinical rather than an administrative role.”

At the peak, there were 40 rounding teams at MSH, each with a typical census of 15 patients or more, which meant that 10 supervisory hospitalists were responsible for 300 to 400 patients. “What we learned first was the need to balance the level of expertise. For example, a team may include a postgraduate year 3 resident and a radiology intern,” Dr. Dunn said. As COVID-19 census has started coming down, supervisory hospitalists are returning to direct care attending roles, and some hospitalists have been shared across the Mount Sinai system’s hospitals.

Dr. Dunn’s advice for hospitalists filling a supervisory role like this in a tiered model: Make sure you talk to your team the night before the first day of a scheduling block and try to address as many of their questions as possible. “If you wait until the morning of the shift to connect with them, anxiety will be high. But after going through a couple of scheduling cycles, we find that things are getting better. I think we’ve paid a lot of attention to the risks of burnout by our physicians. We’re using a model of 4 days on/4 off.”

Another variation on these themes is Joshua Shatzkes, MD, assistant professor of medicine and cardiology at Mount Sinai, who practices outpatient cardiology at MSH and in several off-site offices in Brooklyn. He saw early on that COVID-19 would have a huge effect on his practice, so he volunteered to help out with inpatient care. “I made it known to my chief that I was available, and I was deployed in the first week, after a weekend of cramming webinars and lectures on critical care and pulling out critical concepts that I already knew.”

Dr. Shatzkes said his career path led him into outpatient cardiology 11 years ago, where he was quickly too busy to see his patients when they went into the hospital, even though he missed hospital medicine. Working as a temporary hospitalist with the arrival of COVID-19, he has been invigorated and mobilized by the experience and reminded of why he went to medical school in the first place. “Each day’s shift went quickly but felt long. At the end of the day, I was tired but not exhausted. When I walked out of a patient’s room, they could tell, ‘This is a doctor who cared for me,’ ” he said.

After Dr. Shatzkes volunteered, he got the call from his division chief. “I was officially deployed for a 4-day shift at Mount Sinai and then as a backup.” On his first morning as an inpatient doctor, he was still getting oriented when calls started coming from the nurses. “I had five patients struggling to breathe. Their degree of hypoxia was remarkable. I kept them out of the ICU, at least for that day.”

Since then, he has continued to follow some of those patients in the hospital, along with some from his outpatient practice who were hospitalized, and others referred by colleagues, while remaining available to his outpatients through telemedicine. When this is all over, Dr. Shatzkes said, he would love to find a way to incorporate a hospital practice in his job – depending on the realities of New York traffic.

“Joshua is not a hospitalist, but he went on service and felt so fulfilled and rewarded, he asked me if he could stay on service,” Dr. Dunn said. “I also got an email from the nurse manager on the unit. They want him back.”

In the midst of the COVID-19 pandemic, health systems, hospitals, and hospitalists – especially in hot spots like New York, Detroit, or Boston – have been challenged to stretch limits, redefine roles, and redeploy critical staff in response to rapidly changing needs on the ground.

Many hospitalists are working above and beyond their normal duties, sometimes beyond their training, specialty, or comfort zone and are rising to the occasion in ways they never imagined. These include doing shifts in ICUs, working with ventilator patients, and reporting to other atypical sites of care like postanesthesia care units and post-acute or step-down units.

Valerie Vaughn, MD, MSc, a hospitalist with Michigan Medicine and assistant professor of medicine at the University of Michigan in Ann Arbor, was doing research on how to reduce overuse of antibiotics in hospitals when the COVID-19 crisis hit and dramatically redefined her job. “We were afraid that we might have 3,000 to 5,000 hospitalized COVID patients by now, based on predictive modeling done while the pandemic was still growing exponentially,” she explained. Although Michigan continues to have high COVID-19 infection rates, centered on nearby Detroit, “things are a lot better today than they were 4 weeks ago.”

Dr. Vaughn helped to mobilize a team of 25 hospitalists, along with other health care providers, who volunteered to manage COVID-19 patients in the ICU and other hospital units. She was asked to help develop an all-COVID unit called the Regional Infectious Containment Unit or RICU, which opened March 16. Then, when the RICU became full, it was supplemented by two COVID-19 Moderate Care Units staffed by hospitalists who had “learned the ropes” in the RICU.

Both of these new models were defined in relation to the ICUs at Michigan Medicine – which were doubling in capacity, up to 200 beds at last count – and to the provision of intensive-level and long-term ventilator care for the sickest patients. The moderate care units are for patients who are not on ventilators but still very sick, for example, those receiving massive high-flow oxygen, often with a medical do-not-resuscitate/do-not-intubate order. “We established these units to do everything (medically) short of vents,” Dr. Vaughn said.

“We are having in-depth conversations about goals of care with patients soon after they arrive at the hospital. We know outcomes from ventilators are worse for COVID-positive patients who have comorbidities, and we’re using that information to inform these conversations. We’ve given scripts to clinicians to help guide them in leading these conversations. We can do other things than `use ventilators to manage their symptoms. But these are still difficult conversations,” Dr. Vaughn said.

“We also engaged palliative care early on and asked them to round with us on every [COVID] patient – until demand got too high.” The bottleneck has been the number of ICU beds available, she explained. “If you want your patient to come in and take that bed, make sure you’ve talked to the family about it.”

The COVID-19 team developed guidelines printed on pocket cards addressing critical care issues such as a refresher on how to treat acute respiratory distress syndrome and how to use vasopressors. (See the COVID-19 Continuing Medical Education Portal for web-accessible educational resources developed by Michigan Health).

It’s amazing how quickly patients can become very sick with COVID-19, Dr. Vaughn said. “One of the good things to happen from the beginning with our RICU is that a group of doctors became COVID care experts very quickly. We joined four to five hospitalists and their teams with each intensivist, so one critical care expert is there to do teaching and answer clinicians’ questions. The hospitalists coordinate the COVID care and talk to the families.”

Working on the front lines of this crisis, Dr. Vaughn said, has generated a powerful sense of purpose and camaraderie, creating bonds like in war time. “All of us on our days off feel a twinge of guilt for not being there in the hospital. The sense of gratitude we get from patients and families has been enormous, even when we were telling them bad news. That just brings us to tears.”

One of the hardest things for the doctors practicing above their typical scope of practice is that, when something bad happens, they can’t know whether it was a mistake on their part or not, she noted. “But I’ve never been so proud of our group or to be a hospitalist. No one has complained or pushed back. Everyone has responded by saying: ‘What can I do to help?’ ”
 

Enough work in hospital medicine

Hospitalists had not been deployed to care for ICU patients at Beth Israel Deaconess Medical Center (BIDMC) in Boston, a major hot spot for COVID-19, said Joseph Ming Wah Li, MD, SFHM, director of the hospital medicine program at BIDMC, when he spoke to The Hospitalist in mid-May. That’s because there were plenty of hospital medicine assignments to keep them busy. Dr. Li leads a service of 120 hospitalists practicing at four hospitals.

“As we speak today, we have 300 patients with COVID, with 70 or 80 of them in our ICU. I’m taking care of 17 patients today, 15 of them COVID-positive, and the other two placed in a former radiology holding suite adapted for COVID-negative patients. Our postanesthesia care unit is now an ICU filled with COVID patients,” he said.

“Half of my day is seeing patients and the other half I’m on Zoom calls. I’m also one of the resource allocation officers for BIDMC,” Dr. Li said. He helped to create a standard of care for the hospital, addressing what to do if there weren’t enough ICU beds or ventilators. “We’ve never actualized it and probably won’t, but it was important to go through this exercise, with a lot of discussion up front.”

Haki Laho, MD, an orthopedic hospitalist at New England Baptist Hospital (NEBH), also in Boston, has been redeployed to care for a different population of patients as his system tries to bunch patients. “All of a sudden – within hours and days – at the beginning of the pandemic and based on the recommendations, our whole system decided to stop all elective procedures and devote the resources to COVID,” he said.

NEBH is Beth Israel Lahey Health’s 141-bed orthopedic and surgical hospital, and the system has tried to keep the specialty facility COVID-19–free as much as possible, with the COVID-19 patients grouped together at BIDMC. Dr. Laho’s orthopedic hospitalist group, just five doctors, has been managing the influx of medical patients with multiple comorbidities – not COVID-19–infected but still a different kind of patient than they are used to.

“So far, so good. We’re dealing with it,” he said. “But if one of us got sick, the others would have to step up and do more shifts. We are physicians, internal medicine trained, but since my residency I hadn’t had to deal with these kinds of issues on a daily basis, such as setting up IV lines. I feel like I am back in residency mode.”
 

Convention Center medicine

Another Boston hospitalist, Amy Baughman, MD, who practices at Massachusetts General Hospital, is using her skills in a new setting, serving as a co-medical director at Boston Hope Medical Center, a 1,000-bed field hospital for patients with COVID-19. Open since April 10 and housed in the Boston Convention and Exhibition Center, it is a four-way collaboration between the Commonwealth of Massachusetts, the City of Boston, Partners HealthCare, and the Boston Health Care for the Homeless Program.

Boston Hope is divided into a post-acute care section for recovering COVID-19 patients and a respite section for undomiciled patients with COVID-19 who need a place to safely quarantine. Built for a maximum of 1,000 beds, it is currently using fewer, with 83 patients on the post-acute side and 73 on the respite side as of May 12. A total of 370 and 315, respectively, had been admitted through May 12.

The team had 5 days to put the field hospital together with the help of the Army National Guard. “During that first week I was installing hand sanitizer dispensers and making [personal protective equipment] signs. Everyone here has had to do things like that,” Dr. Baughman said. “We’ve had to be incredibly creative in our staffing, using doctors from primary care and subspecialties including dermatology, radiology, and orthopedics. We had to fast-track trainings on how to use EPIC and to provide post-acute COVID care. How do you simultaneously build a medical facility and lead teams to provide high quality care?”

Dr. Baughman still works hospitalist shifts half-time at Massachusetts General. Her prior experience providing post-acute care in the VA system was helpful in creating the post-acute level of care at Boston Hope.

“My medical director role involves supervising, staffing, and scheduling. My co-medical director, Dr. Kerri Palamara, and I also supervise the clinical care,” she said. “There are a lot of systems issues, like ordering labs or prescriptions, with couriers going back and forth. And we developed clinical pathways, such as for [deep vein thrombosis] prophylaxis or for COVID retesting to determine when it is safe to end a quarantine. We’re just now rolling out virtual specialist consultations,” she noted.

“It has gone incredibly well. So much of it has been about our ability and willingness to work hard, and take feedback and go forward. We don’t have time to harp on things. We have to be very solution oriented. At the same time, honestly, it’s been fun. Every single day is different,” Dr. Baughman said.

“It’s been an opportunity to use my skills in a totally new setting, and at a level of responsibility I haven’t had before, although that’s probably a common theme with COVID-19. I was put on this team because I am a hospitalist,” she said. “I think hospitalists have been the backbone of the response to COVID in this country. It’s been an opportunity for our specialty to shine. We need to embrace the opportunity.”
 

Balancing expertise and supervision

Mount Sinai Hospital (MSH) in Manhattan is in the New York epicenter of the COVID-19 crisis and has mobilized large numbers of pulmonary critical care and anesthesia physicians to staff up multiple ICUs for COVID-19 patients, said Andrew Dunn, MD, chief of the division of hospital medicine at Mount Sinai School of Medicine.

“My hospitalist group is covering many step-down units, medical wards, and atypical locations, providing advanced oxygen therapies, [bilevel positive airway pressure], high-flow nasal cannulas, and managing some patients on ventilators,” he said.

MSH has teaching services with house staff and nonteaching services. “We combined them into a unified service with house staff dispersed across all of the teams. We drafted a lot of nonhospitalists from different specialties to be attendings, and that has given us a tiered model, with a hospitalist supervising three or four nonhospitalist-led teams. Although the supervising hospitalists carry no patient caseloads of their own, this is primarily a clinical rather than an administrative role.”

At the peak, there were 40 rounding teams at MSH, each with a typical census of 15 patients or more, which meant that 10 supervisory hospitalists were responsible for 300 to 400 patients. “What we learned first was the need to balance the level of expertise. For example, a team may include a postgraduate year 3 resident and a radiology intern,” Dr. Dunn said. As COVID-19 census has started coming down, supervisory hospitalists are returning to direct care attending roles, and some hospitalists have been shared across the Mount Sinai system’s hospitals.

Dr. Dunn’s advice for hospitalists filling a supervisory role like this in a tiered model: Make sure you talk to your team the night before the first day of a scheduling block and try to address as many of their questions as possible. “If you wait until the morning of the shift to connect with them, anxiety will be high. But after going through a couple of scheduling cycles, we find that things are getting better. I think we’ve paid a lot of attention to the risks of burnout by our physicians. We’re using a model of 4 days on/4 off.”

Another variation on these themes is Joshua Shatzkes, MD, assistant professor of medicine and cardiology at Mount Sinai, who practices outpatient cardiology at MSH and in several off-site offices in Brooklyn. He saw early on that COVID-19 would have a huge effect on his practice, so he volunteered to help out with inpatient care. “I made it known to my chief that I was available, and I was deployed in the first week, after a weekend of cramming webinars and lectures on critical care and pulling out critical concepts that I already knew.”

Dr. Shatzkes said his career path led him into outpatient cardiology 11 years ago, where he was quickly too busy to see his patients when they went into the hospital, even though he missed hospital medicine. Working as a temporary hospitalist with the arrival of COVID-19, he has been invigorated and mobilized by the experience and reminded of why he went to medical school in the first place. “Each day’s shift went quickly but felt long. At the end of the day, I was tired but not exhausted. When I walked out of a patient’s room, they could tell, ‘This is a doctor who cared for me,’ ” he said.

After Dr. Shatzkes volunteered, he got the call from his division chief. “I was officially deployed for a 4-day shift at Mount Sinai and then as a backup.” On his first morning as an inpatient doctor, he was still getting oriented when calls started coming from the nurses. “I had five patients struggling to breathe. Their degree of hypoxia was remarkable. I kept them out of the ICU, at least for that day.”

Since then, he has continued to follow some of those patients in the hospital, along with some from his outpatient practice who were hospitalized, and others referred by colleagues, while remaining available to his outpatients through telemedicine. When this is all over, Dr. Shatzkes said, he would love to find a way to incorporate a hospital practice in his job – depending on the realities of New York traffic.

“Joshua is not a hospitalist, but he went on service and felt so fulfilled and rewarded, he asked me if he could stay on service,” Dr. Dunn said. “I also got an email from the nurse manager on the unit. They want him back.”

In the midst of the COVID-19 pandemic, health systems, hospitals, and hospitalists – especially in hot spots like New York, Detroit, or Boston – have been challenged to stretch limits, redefine roles, and redeploy critical staff in response to rapidly changing needs on the ground.

Many hospitalists are working above and beyond their normal duties, sometimes beyond their training, specialty, or comfort zone and are rising to the occasion in ways they never imagined. These include doing shifts in ICUs, working with ventilator patients, and reporting to other atypical sites of care like postanesthesia care units and post-acute or step-down units.

Valerie Vaughn, MD, MSc, a hospitalist with Michigan Medicine and assistant professor of medicine at the University of Michigan in Ann Arbor, was doing research on how to reduce overuse of antibiotics in hospitals when the COVID-19 crisis hit and dramatically redefined her job. “We were afraid that we might have 3,000 to 5,000 hospitalized COVID patients by now, based on predictive modeling done while the pandemic was still growing exponentially,” she explained. Although Michigan continues to have high COVID-19 infection rates, centered on nearby Detroit, “things are a lot better today than they were 4 weeks ago.”

Dr. Vaughn helped to mobilize a team of 25 hospitalists, along with other health care providers, who volunteered to manage COVID-19 patients in the ICU and other hospital units. She was asked to help develop an all-COVID unit called the Regional Infectious Containment Unit or RICU, which opened March 16. Then, when the RICU became full, it was supplemented by two COVID-19 Moderate Care Units staffed by hospitalists who had “learned the ropes” in the RICU.

Both of these new models were defined in relation to the ICUs at Michigan Medicine – which were doubling in capacity, up to 200 beds at last count – and to the provision of intensive-level and long-term ventilator care for the sickest patients. The moderate care units are for patients who are not on ventilators but still very sick, for example, those receiving massive high-flow oxygen, often with a medical do-not-resuscitate/do-not-intubate order. “We established these units to do everything (medically) short of vents,” Dr. Vaughn said.

“We are having in-depth conversations about goals of care with patients soon after they arrive at the hospital. We know outcomes from ventilators are worse for COVID-positive patients who have comorbidities, and we’re using that information to inform these conversations. We’ve given scripts to clinicians to help guide them in leading these conversations. We can do other things than `use ventilators to manage their symptoms. But these are still difficult conversations,” Dr. Vaughn said.

“We also engaged palliative care early on and asked them to round with us on every [COVID] patient – until demand got too high.” The bottleneck has been the number of ICU beds available, she explained. “If you want your patient to come in and take that bed, make sure you’ve talked to the family about it.”

The COVID-19 team developed guidelines printed on pocket cards addressing critical care issues such as a refresher on how to treat acute respiratory distress syndrome and how to use vasopressors. (See the COVID-19 Continuing Medical Education Portal for web-accessible educational resources developed by Michigan Health).

It’s amazing how quickly patients can become very sick with COVID-19, Dr. Vaughn said. “One of the good things to happen from the beginning with our RICU is that a group of doctors became COVID care experts very quickly. We joined four to five hospitalists and their teams with each intensivist, so one critical care expert is there to do teaching and answer clinicians’ questions. The hospitalists coordinate the COVID care and talk to the families.”

Working on the front lines of this crisis, Dr. Vaughn said, has generated a powerful sense of purpose and camaraderie, creating bonds like in war time. “All of us on our days off feel a twinge of guilt for not being there in the hospital. The sense of gratitude we get from patients and families has been enormous, even when we were telling them bad news. That just brings us to tears.”

One of the hardest things for the doctors practicing above their typical scope of practice is that, when something bad happens, they can’t know whether it was a mistake on their part or not, she noted. “But I’ve never been so proud of our group or to be a hospitalist. No one has complained or pushed back. Everyone has responded by saying: ‘What can I do to help?’ ”
 

Enough work in hospital medicine

Hospitalists had not been deployed to care for ICU patients at Beth Israel Deaconess Medical Center (BIDMC) in Boston, a major hot spot for COVID-19, said Joseph Ming Wah Li, MD, SFHM, director of the hospital medicine program at BIDMC, when he spoke to The Hospitalist in mid-May. That’s because there were plenty of hospital medicine assignments to keep them busy. Dr. Li leads a service of 120 hospitalists practicing at four hospitals.

“As we speak today, we have 300 patients with COVID, with 70 or 80 of them in our ICU. I’m taking care of 17 patients today, 15 of them COVID-positive, and the other two placed in a former radiology holding suite adapted for COVID-negative patients. Our postanesthesia care unit is now an ICU filled with COVID patients,” he said.

“Half of my day is seeing patients and the other half I’m on Zoom calls. I’m also one of the resource allocation officers for BIDMC,” Dr. Li said. He helped to create a standard of care for the hospital, addressing what to do if there weren’t enough ICU beds or ventilators. “We’ve never actualized it and probably won’t, but it was important to go through this exercise, with a lot of discussion up front.”

Haki Laho, MD, an orthopedic hospitalist at New England Baptist Hospital (NEBH), also in Boston, has been redeployed to care for a different population of patients as his system tries to bunch patients. “All of a sudden – within hours and days – at the beginning of the pandemic and based on the recommendations, our whole system decided to stop all elective procedures and devote the resources to COVID,” he said.

NEBH is Beth Israel Lahey Health’s 141-bed orthopedic and surgical hospital, and the system has tried to keep the specialty facility COVID-19–free as much as possible, with the COVID-19 patients grouped together at BIDMC. Dr. Laho’s orthopedic hospitalist group, just five doctors, has been managing the influx of medical patients with multiple comorbidities – not COVID-19–infected but still a different kind of patient than they are used to.

“So far, so good. We’re dealing with it,” he said. “But if one of us got sick, the others would have to step up and do more shifts. We are physicians, internal medicine trained, but since my residency I hadn’t had to deal with these kinds of issues on a daily basis, such as setting up IV lines. I feel like I am back in residency mode.”
 

Convention Center medicine

Another Boston hospitalist, Amy Baughman, MD, who practices at Massachusetts General Hospital, is using her skills in a new setting, serving as a co-medical director at Boston Hope Medical Center, a 1,000-bed field hospital for patients with COVID-19. Open since April 10 and housed in the Boston Convention and Exhibition Center, it is a four-way collaboration between the Commonwealth of Massachusetts, the City of Boston, Partners HealthCare, and the Boston Health Care for the Homeless Program.

Boston Hope is divided into a post-acute care section for recovering COVID-19 patients and a respite section for undomiciled patients with COVID-19 who need a place to safely quarantine. Built for a maximum of 1,000 beds, it is currently using fewer, with 83 patients on the post-acute side and 73 on the respite side as of May 12. A total of 370 and 315, respectively, had been admitted through May 12.

The team had 5 days to put the field hospital together with the help of the Army National Guard. “During that first week I was installing hand sanitizer dispensers and making [personal protective equipment] signs. Everyone here has had to do things like that,” Dr. Baughman said. “We’ve had to be incredibly creative in our staffing, using doctors from primary care and subspecialties including dermatology, radiology, and orthopedics. We had to fast-track trainings on how to use EPIC and to provide post-acute COVID care. How do you simultaneously build a medical facility and lead teams to provide high quality care?”

Dr. Baughman still works hospitalist shifts half-time at Massachusetts General. Her prior experience providing post-acute care in the VA system was helpful in creating the post-acute level of care at Boston Hope.

“My medical director role involves supervising, staffing, and scheduling. My co-medical director, Dr. Kerri Palamara, and I also supervise the clinical care,” she said. “There are a lot of systems issues, like ordering labs or prescriptions, with couriers going back and forth. And we developed clinical pathways, such as for [deep vein thrombosis] prophylaxis or for COVID retesting to determine when it is safe to end a quarantine. We’re just now rolling out virtual specialist consultations,” she noted.

“It has gone incredibly well. So much of it has been about our ability and willingness to work hard, and take feedback and go forward. We don’t have time to harp on things. We have to be very solution oriented. At the same time, honestly, it’s been fun. Every single day is different,” Dr. Baughman said.

“It’s been an opportunity to use my skills in a totally new setting, and at a level of responsibility I haven’t had before, although that’s probably a common theme with COVID-19. I was put on this team because I am a hospitalist,” she said. “I think hospitalists have been the backbone of the response to COVID in this country. It’s been an opportunity for our specialty to shine. We need to embrace the opportunity.”
 

Balancing expertise and supervision

Mount Sinai Hospital (MSH) in Manhattan is in the New York epicenter of the COVID-19 crisis and has mobilized large numbers of pulmonary critical care and anesthesia physicians to staff up multiple ICUs for COVID-19 patients, said Andrew Dunn, MD, chief of the division of hospital medicine at Mount Sinai School of Medicine.

“My hospitalist group is covering many step-down units, medical wards, and atypical locations, providing advanced oxygen therapies, [bilevel positive airway pressure], high-flow nasal cannulas, and managing some patients on ventilators,” he said.

MSH has teaching services with house staff and nonteaching services. “We combined them into a unified service with house staff dispersed across all of the teams. We drafted a lot of nonhospitalists from different specialties to be attendings, and that has given us a tiered model, with a hospitalist supervising three or four nonhospitalist-led teams. Although the supervising hospitalists carry no patient caseloads of their own, this is primarily a clinical rather than an administrative role.”

At the peak, there were 40 rounding teams at MSH, each with a typical census of 15 patients or more, which meant that 10 supervisory hospitalists were responsible for 300 to 400 patients. “What we learned first was the need to balance the level of expertise. For example, a team may include a postgraduate year 3 resident and a radiology intern,” Dr. Dunn said. As COVID-19 census has started coming down, supervisory hospitalists are returning to direct care attending roles, and some hospitalists have been shared across the Mount Sinai system’s hospitals.

Dr. Dunn’s advice for hospitalists filling a supervisory role like this in a tiered model: Make sure you talk to your team the night before the first day of a scheduling block and try to address as many of their questions as possible. “If you wait until the morning of the shift to connect with them, anxiety will be high. But after going through a couple of scheduling cycles, we find that things are getting better. I think we’ve paid a lot of attention to the risks of burnout by our physicians. We’re using a model of 4 days on/4 off.”

Another variation on these themes is Joshua Shatzkes, MD, assistant professor of medicine and cardiology at Mount Sinai, who practices outpatient cardiology at MSH and in several off-site offices in Brooklyn. He saw early on that COVID-19 would have a huge effect on his practice, so he volunteered to help out with inpatient care. “I made it known to my chief that I was available, and I was deployed in the first week, after a weekend of cramming webinars and lectures on critical care and pulling out critical concepts that I already knew.”

Dr. Shatzkes said his career path led him into outpatient cardiology 11 years ago, where he was quickly too busy to see his patients when they went into the hospital, even though he missed hospital medicine. Working as a temporary hospitalist with the arrival of COVID-19, he has been invigorated and mobilized by the experience and reminded of why he went to medical school in the first place. “Each day’s shift went quickly but felt long. At the end of the day, I was tired but not exhausted. When I walked out of a patient’s room, they could tell, ‘This is a doctor who cared for me,’ ” he said.

After Dr. Shatzkes volunteered, he got the call from his division chief. “I was officially deployed for a 4-day shift at Mount Sinai and then as a backup.” On his first morning as an inpatient doctor, he was still getting oriented when calls started coming from the nurses. “I had five patients struggling to breathe. Their degree of hypoxia was remarkable. I kept them out of the ICU, at least for that day.”

Since then, he has continued to follow some of those patients in the hospital, along with some from his outpatient practice who were hospitalized, and others referred by colleagues, while remaining available to his outpatients through telemedicine. When this is all over, Dr. Shatzkes said, he would love to find a way to incorporate a hospital practice in his job – depending on the realities of New York traffic.

“Joshua is not a hospitalist, but he went on service and felt so fulfilled and rewarded, he asked me if he could stay on service,” Dr. Dunn said. “I also got an email from the nurse manager on the unit. They want him back.”