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Antibody testing suggests COVID-19 cases are being missed

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The number of COVID-19 infections in the community may be “substantially greater” than totals confirmed by authorities, based on SARS-CoV-2 antibody testing among a random sample of adults in Los Angeles County, Calif.

Testing of 863 people on April 10-11 revealed that 35 (4.06%) were positive for SARS-CoV-2–specific antibodies (IgM or IgG), and after adjustment for test sensitivity and specificity, the weighted prevalence for the entire sample was 4.65%, Neeraj Sood, PhD, of the University of Southern California, Los Angeles, and associates wrote in JAMA.

The estimate of 4.65% “implies that approximately 367,000 adults [in Los Angeles County] had SARS-CoV-2 antibodies, which is substantially greater than the 8,430 cumulative number of confirmed infections in the county on April 10,” they wrote.

It also suggests that fatality rates based on the larger number of infections may be lower than rates based on confirmed cases. “In addition, contact tracing methods to limit the spread of infection will face considerable challenges,” Dr. Sood and associates said.



Test positivity varied by race/ethnicity, sex, and income. The proportion of non-Hispanic blacks with a positive result was 6.94%, compared with 4.42% for non-Hispanic whites, 2.10% for Hispanics, and 3.85% for others. Men were much more likely than women to be positive for SARS-CoV-2: 5.18% vs. 3.31%, the investigators said.

Household income favored the middle ground. Those individuals making less than $50,000 a year had a positivity rate of 5.14% and those with an income of $100,000 or more had a rate of 4.90%, but only 1.58% of those making $50,000-$99,999 tested positive, they reported.

The authors reported numerous sources of nonprofit organization support.

SOURCE: Sood N et al. JAMA 2020 May 18. doi: 10.1001/jama.2020.8279.

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The number of COVID-19 infections in the community may be “substantially greater” than totals confirmed by authorities, based on SARS-CoV-2 antibody testing among a random sample of adults in Los Angeles County, Calif.

Testing of 863 people on April 10-11 revealed that 35 (4.06%) were positive for SARS-CoV-2–specific antibodies (IgM or IgG), and after adjustment for test sensitivity and specificity, the weighted prevalence for the entire sample was 4.65%, Neeraj Sood, PhD, of the University of Southern California, Los Angeles, and associates wrote in JAMA.

The estimate of 4.65% “implies that approximately 367,000 adults [in Los Angeles County] had SARS-CoV-2 antibodies, which is substantially greater than the 8,430 cumulative number of confirmed infections in the county on April 10,” they wrote.

It also suggests that fatality rates based on the larger number of infections may be lower than rates based on confirmed cases. “In addition, contact tracing methods to limit the spread of infection will face considerable challenges,” Dr. Sood and associates said.



Test positivity varied by race/ethnicity, sex, and income. The proportion of non-Hispanic blacks with a positive result was 6.94%, compared with 4.42% for non-Hispanic whites, 2.10% for Hispanics, and 3.85% for others. Men were much more likely than women to be positive for SARS-CoV-2: 5.18% vs. 3.31%, the investigators said.

Household income favored the middle ground. Those individuals making less than $50,000 a year had a positivity rate of 5.14% and those with an income of $100,000 or more had a rate of 4.90%, but only 1.58% of those making $50,000-$99,999 tested positive, they reported.

The authors reported numerous sources of nonprofit organization support.

SOURCE: Sood N et al. JAMA 2020 May 18. doi: 10.1001/jama.2020.8279.

 

The number of COVID-19 infections in the community may be “substantially greater” than totals confirmed by authorities, based on SARS-CoV-2 antibody testing among a random sample of adults in Los Angeles County, Calif.

Testing of 863 people on April 10-11 revealed that 35 (4.06%) were positive for SARS-CoV-2–specific antibodies (IgM or IgG), and after adjustment for test sensitivity and specificity, the weighted prevalence for the entire sample was 4.65%, Neeraj Sood, PhD, of the University of Southern California, Los Angeles, and associates wrote in JAMA.

The estimate of 4.65% “implies that approximately 367,000 adults [in Los Angeles County] had SARS-CoV-2 antibodies, which is substantially greater than the 8,430 cumulative number of confirmed infections in the county on April 10,” they wrote.

It also suggests that fatality rates based on the larger number of infections may be lower than rates based on confirmed cases. “In addition, contact tracing methods to limit the spread of infection will face considerable challenges,” Dr. Sood and associates said.



Test positivity varied by race/ethnicity, sex, and income. The proportion of non-Hispanic blacks with a positive result was 6.94%, compared with 4.42% for non-Hispanic whites, 2.10% for Hispanics, and 3.85% for others. Men were much more likely than women to be positive for SARS-CoV-2: 5.18% vs. 3.31%, the investigators said.

Household income favored the middle ground. Those individuals making less than $50,000 a year had a positivity rate of 5.14% and those with an income of $100,000 or more had a rate of 4.90%, but only 1.58% of those making $50,000-$99,999 tested positive, they reported.

The authors reported numerous sources of nonprofit organization support.

SOURCE: Sood N et al. JAMA 2020 May 18. doi: 10.1001/jama.2020.8279.

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COVID-19 in kids: Severe illness most common in infants, teens

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Children and young adults in all age groups can develop severe illness after SARS-CoV-2 infection, but the oldest and youngest appear most likely to be hospitalized and possibly critically ill, based on data from a retrospective cohort study of 177 pediatric patients seen at a single center.

“Although children and young adults clearly are susceptible to SARS-CoV-2 infection, attention has focused primarily on their potential role in influencing spread and community transmission rather than the potential severity of infection in children and young adults themselves,” wrote Roberta L. DeBiasi, MD, chief of the division of pediatric infectious diseases at Children’s National Hospital, Washington, and colleagues.

In a study published in the Journal of Pediatrics, the researchers reviewed data from 44 hospitalized and 133 non-hospitalized children and young adults infected with SARS-CoV-2. Of the 44 hospitalized patients, 35 were noncritically ill and 9 were critically ill. The study population ranged from 0.1-34 years of age, with a median of 10 years, which was similar between hospitalized and nonhospitalized patients. However, the median age of critically ill patients was significantly higher, compared with noncritically ill patients (17 years vs. 4 years). All age groups were represented in all cohorts. “However, we noted a bimodal distribution of patients less than 1 year of age and patients greater than 15 years of age representing the largest proportion of patients within the SARS-CoV-2–infected hospitalized and critically ill cohorts,” the researchers noted. Children less than 1 year and adolescents/young adults over 15 years each represented 32% of the 44 hospitalized patients.

Overall, 39% of the 177 patients had underlying medical conditions, the most frequent of which was asthma (20%), which was not significantly more common between hospitalized/nonhospitalized patients or critically ill/noncritically ill patients. Patients also presented with neurologic conditions (6%), diabetes (3%), obesity (2%), cardiac conditions (3%), hematologic conditions (3%) and oncologic conditions (1%). Underlying conditions occurred more commonly in the hospitalized cohort (63%) than in the nonhospitalized cohort (32%).

Neurologic disorders, cardiac conditions, hematologic conditions, and oncologic conditions were significantly more common in hospitalized patients, but not significantly more common among those critically ill versus noncritically ill.

About 76% of the patients presented with respiratory symptoms including rhinorrhea, congestion, sore throat, cough, or shortness of breath – with or without fever; 66% had fevers; and 48% had both respiratory symptoms and fever. Shortness of breath was significantly more common among hospitalized patients versus nonhospitalized patients (26% vs. 12%), but less severe respiratory symptoms were significantly more common among nonhospitalized patients, the researchers noted.

Other symptoms – such as diarrhea, vomiting, chest pain, and loss of sense or smell occurred in a small percentage of patients – but were not more likely to occur in any of the cohorts.

Among the critically ill patients, eight of nine needed some level of respiratory support, and four were on ventilators.

“One patient had features consistent with the recently emerged Kawasaki disease–like presentation with hyperinflammatory state, hypotension, and profound myocardial depression,” Dr. DiBiasi and associates noted.

The researchers found coinfection with routine coronavirus, respiratory syncytial virus, or rhinovirus/enterovirus in 4 of 63 (6%) patients, but the clinical impact of these coinfections are unclear.

The study findings were limited by several factors including the retrospective design and the ongoing transmission of COVID-19 in the Washington area, the researchers noted. “One potential bias of this study is our regional role in providing critical care for young adults age 21-35 years with COVID-19.” In addition, “we plan to address the role of race and ethnicity after validation of current administrative data and have elected to defer this analysis until completed.”

“Our findings highlight the potential for severe disease in this age group and inform other regions to anticipate and prepare their COVID-19 response to include a significant burden of hospitalized and critically ill children and young adults. As SARS-CoV-2 spreads within the United States, regional differences may be apparent based on virus and host factors that are yet to be identified,” Dr. DeBiasi and colleagues concluded.

Robin Steinhorn, MD, serves as an associate editor for the Journal of Pediatrics. The other researchers declared no conflicts of interest.

SOURCE: DeBiasi RL et al. J Pediatr. 2020 May 6. doi: 10.1016/j.jpeds.2020.05.007.

This article was updated 5/19/20.

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Children and young adults in all age groups can develop severe illness after SARS-CoV-2 infection, but the oldest and youngest appear most likely to be hospitalized and possibly critically ill, based on data from a retrospective cohort study of 177 pediatric patients seen at a single center.

“Although children and young adults clearly are susceptible to SARS-CoV-2 infection, attention has focused primarily on their potential role in influencing spread and community transmission rather than the potential severity of infection in children and young adults themselves,” wrote Roberta L. DeBiasi, MD, chief of the division of pediatric infectious diseases at Children’s National Hospital, Washington, and colleagues.

In a study published in the Journal of Pediatrics, the researchers reviewed data from 44 hospitalized and 133 non-hospitalized children and young adults infected with SARS-CoV-2. Of the 44 hospitalized patients, 35 were noncritically ill and 9 were critically ill. The study population ranged from 0.1-34 years of age, with a median of 10 years, which was similar between hospitalized and nonhospitalized patients. However, the median age of critically ill patients was significantly higher, compared with noncritically ill patients (17 years vs. 4 years). All age groups were represented in all cohorts. “However, we noted a bimodal distribution of patients less than 1 year of age and patients greater than 15 years of age representing the largest proportion of patients within the SARS-CoV-2–infected hospitalized and critically ill cohorts,” the researchers noted. Children less than 1 year and adolescents/young adults over 15 years each represented 32% of the 44 hospitalized patients.

Overall, 39% of the 177 patients had underlying medical conditions, the most frequent of which was asthma (20%), which was not significantly more common between hospitalized/nonhospitalized patients or critically ill/noncritically ill patients. Patients also presented with neurologic conditions (6%), diabetes (3%), obesity (2%), cardiac conditions (3%), hematologic conditions (3%) and oncologic conditions (1%). Underlying conditions occurred more commonly in the hospitalized cohort (63%) than in the nonhospitalized cohort (32%).

Neurologic disorders, cardiac conditions, hematologic conditions, and oncologic conditions were significantly more common in hospitalized patients, but not significantly more common among those critically ill versus noncritically ill.

About 76% of the patients presented with respiratory symptoms including rhinorrhea, congestion, sore throat, cough, or shortness of breath – with or without fever; 66% had fevers; and 48% had both respiratory symptoms and fever. Shortness of breath was significantly more common among hospitalized patients versus nonhospitalized patients (26% vs. 12%), but less severe respiratory symptoms were significantly more common among nonhospitalized patients, the researchers noted.

Other symptoms – such as diarrhea, vomiting, chest pain, and loss of sense or smell occurred in a small percentage of patients – but were not more likely to occur in any of the cohorts.

Among the critically ill patients, eight of nine needed some level of respiratory support, and four were on ventilators.

“One patient had features consistent with the recently emerged Kawasaki disease–like presentation with hyperinflammatory state, hypotension, and profound myocardial depression,” Dr. DiBiasi and associates noted.

The researchers found coinfection with routine coronavirus, respiratory syncytial virus, or rhinovirus/enterovirus in 4 of 63 (6%) patients, but the clinical impact of these coinfections are unclear.

The study findings were limited by several factors including the retrospective design and the ongoing transmission of COVID-19 in the Washington area, the researchers noted. “One potential bias of this study is our regional role in providing critical care for young adults age 21-35 years with COVID-19.” In addition, “we plan to address the role of race and ethnicity after validation of current administrative data and have elected to defer this analysis until completed.”

“Our findings highlight the potential for severe disease in this age group and inform other regions to anticipate and prepare their COVID-19 response to include a significant burden of hospitalized and critically ill children and young adults. As SARS-CoV-2 spreads within the United States, regional differences may be apparent based on virus and host factors that are yet to be identified,” Dr. DeBiasi and colleagues concluded.

Robin Steinhorn, MD, serves as an associate editor for the Journal of Pediatrics. The other researchers declared no conflicts of interest.

SOURCE: DeBiasi RL et al. J Pediatr. 2020 May 6. doi: 10.1016/j.jpeds.2020.05.007.

This article was updated 5/19/20.

Children and young adults in all age groups can develop severe illness after SARS-CoV-2 infection, but the oldest and youngest appear most likely to be hospitalized and possibly critically ill, based on data from a retrospective cohort study of 177 pediatric patients seen at a single center.

“Although children and young adults clearly are susceptible to SARS-CoV-2 infection, attention has focused primarily on their potential role in influencing spread and community transmission rather than the potential severity of infection in children and young adults themselves,” wrote Roberta L. DeBiasi, MD, chief of the division of pediatric infectious diseases at Children’s National Hospital, Washington, and colleagues.

In a study published in the Journal of Pediatrics, the researchers reviewed data from 44 hospitalized and 133 non-hospitalized children and young adults infected with SARS-CoV-2. Of the 44 hospitalized patients, 35 were noncritically ill and 9 were critically ill. The study population ranged from 0.1-34 years of age, with a median of 10 years, which was similar between hospitalized and nonhospitalized patients. However, the median age of critically ill patients was significantly higher, compared with noncritically ill patients (17 years vs. 4 years). All age groups were represented in all cohorts. “However, we noted a bimodal distribution of patients less than 1 year of age and patients greater than 15 years of age representing the largest proportion of patients within the SARS-CoV-2–infected hospitalized and critically ill cohorts,” the researchers noted. Children less than 1 year and adolescents/young adults over 15 years each represented 32% of the 44 hospitalized patients.

Overall, 39% of the 177 patients had underlying medical conditions, the most frequent of which was asthma (20%), which was not significantly more common between hospitalized/nonhospitalized patients or critically ill/noncritically ill patients. Patients also presented with neurologic conditions (6%), diabetes (3%), obesity (2%), cardiac conditions (3%), hematologic conditions (3%) and oncologic conditions (1%). Underlying conditions occurred more commonly in the hospitalized cohort (63%) than in the nonhospitalized cohort (32%).

Neurologic disorders, cardiac conditions, hematologic conditions, and oncologic conditions were significantly more common in hospitalized patients, but not significantly more common among those critically ill versus noncritically ill.

About 76% of the patients presented with respiratory symptoms including rhinorrhea, congestion, sore throat, cough, or shortness of breath – with or without fever; 66% had fevers; and 48% had both respiratory symptoms and fever. Shortness of breath was significantly more common among hospitalized patients versus nonhospitalized patients (26% vs. 12%), but less severe respiratory symptoms were significantly more common among nonhospitalized patients, the researchers noted.

Other symptoms – such as diarrhea, vomiting, chest pain, and loss of sense or smell occurred in a small percentage of patients – but were not more likely to occur in any of the cohorts.

Among the critically ill patients, eight of nine needed some level of respiratory support, and four were on ventilators.

“One patient had features consistent with the recently emerged Kawasaki disease–like presentation with hyperinflammatory state, hypotension, and profound myocardial depression,” Dr. DiBiasi and associates noted.

The researchers found coinfection with routine coronavirus, respiratory syncytial virus, or rhinovirus/enterovirus in 4 of 63 (6%) patients, but the clinical impact of these coinfections are unclear.

The study findings were limited by several factors including the retrospective design and the ongoing transmission of COVID-19 in the Washington area, the researchers noted. “One potential bias of this study is our regional role in providing critical care for young adults age 21-35 years with COVID-19.” In addition, “we plan to address the role of race and ethnicity after validation of current administrative data and have elected to defer this analysis until completed.”

“Our findings highlight the potential for severe disease in this age group and inform other regions to anticipate and prepare their COVID-19 response to include a significant burden of hospitalized and critically ill children and young adults. As SARS-CoV-2 spreads within the United States, regional differences may be apparent based on virus and host factors that are yet to be identified,” Dr. DeBiasi and colleagues concluded.

Robin Steinhorn, MD, serves as an associate editor for the Journal of Pediatrics. The other researchers declared no conflicts of interest.

SOURCE: DeBiasi RL et al. J Pediatr. 2020 May 6. doi: 10.1016/j.jpeds.2020.05.007.

This article was updated 5/19/20.

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Time to change WHO definition of osteoporosis, say experts

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It is time to broaden the definition of osteoporosis used in clinical guidelines, states an article published in Age and Ageing, the official journal of the British Geriatrics Society.

The authors recommend that the World Health Organization and the International Society for Clinical Densitometry consider a broader definition of osteoporosis, which encompasses clinical diagnosis, providing clear guidance on communicating bone mineral density (BMD) results to patients.

The WHO definition of osteoporosis, which is endorsed as a diagnostic threshold in current U.K. and European guidance, still relies purely on BMD testing (T score of −2.5 SD or more). The authors say this definition no longer relates to the population for whom osteoporosis drugs are recommended.



In the past 15 years, they write, there has been a change in the field of osteoporosis, namely to base osteoporosis management not just on absolute values of BMD but also on broader consideration of future fracture risk. This change has been underpinned by observations that the majority of patients with a fragility fracture do not have osteoporotic BMD.

Coauthor Zoe Paskins, MBChB, a senior lecturer at Keele (England) University and clinical lead for the osteoporosis service in North Staffordshire, argues that many people with osteoporosis do not receive the treatment they need because of inconsistencies in how the condition is diagnosed around the world, resulting in confusion for both clinicians and patients.

“We think it is time for the WHO to reconsider the definition of osteoporosis, which is now more than 25 years old. A new definition is needed to acknowledge that it is possible, in some circumstances, to give a clinical diagnosis of osteoporosis in those who have osteoporotic fractures. In our view, this would help address current confusion and improve uptake of treatments,” she said.

This article first appeared on Univadis.

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It is time to broaden the definition of osteoporosis used in clinical guidelines, states an article published in Age and Ageing, the official journal of the British Geriatrics Society.

The authors recommend that the World Health Organization and the International Society for Clinical Densitometry consider a broader definition of osteoporosis, which encompasses clinical diagnosis, providing clear guidance on communicating bone mineral density (BMD) results to patients.

The WHO definition of osteoporosis, which is endorsed as a diagnostic threshold in current U.K. and European guidance, still relies purely on BMD testing (T score of −2.5 SD or more). The authors say this definition no longer relates to the population for whom osteoporosis drugs are recommended.



In the past 15 years, they write, there has been a change in the field of osteoporosis, namely to base osteoporosis management not just on absolute values of BMD but also on broader consideration of future fracture risk. This change has been underpinned by observations that the majority of patients with a fragility fracture do not have osteoporotic BMD.

Coauthor Zoe Paskins, MBChB, a senior lecturer at Keele (England) University and clinical lead for the osteoporosis service in North Staffordshire, argues that many people with osteoporosis do not receive the treatment they need because of inconsistencies in how the condition is diagnosed around the world, resulting in confusion for both clinicians and patients.

“We think it is time for the WHO to reconsider the definition of osteoporosis, which is now more than 25 years old. A new definition is needed to acknowledge that it is possible, in some circumstances, to give a clinical diagnosis of osteoporosis in those who have osteoporotic fractures. In our view, this would help address current confusion and improve uptake of treatments,” she said.

This article first appeared on Univadis.

It is time to broaden the definition of osteoporosis used in clinical guidelines, states an article published in Age and Ageing, the official journal of the British Geriatrics Society.

The authors recommend that the World Health Organization and the International Society for Clinical Densitometry consider a broader definition of osteoporosis, which encompasses clinical diagnosis, providing clear guidance on communicating bone mineral density (BMD) results to patients.

The WHO definition of osteoporosis, which is endorsed as a diagnostic threshold in current U.K. and European guidance, still relies purely on BMD testing (T score of −2.5 SD or more). The authors say this definition no longer relates to the population for whom osteoporosis drugs are recommended.



In the past 15 years, they write, there has been a change in the field of osteoporosis, namely to base osteoporosis management not just on absolute values of BMD but also on broader consideration of future fracture risk. This change has been underpinned by observations that the majority of patients with a fragility fracture do not have osteoporotic BMD.

Coauthor Zoe Paskins, MBChB, a senior lecturer at Keele (England) University and clinical lead for the osteoporosis service in North Staffordshire, argues that many people with osteoporosis do not receive the treatment they need because of inconsistencies in how the condition is diagnosed around the world, resulting in confusion for both clinicians and patients.

“We think it is time for the WHO to reconsider the definition of osteoporosis, which is now more than 25 years old. A new definition is needed to acknowledge that it is possible, in some circumstances, to give a clinical diagnosis of osteoporosis in those who have osteoporotic fractures. In our view, this would help address current confusion and improve uptake of treatments,” she said.

This article first appeared on Univadis.

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Glucose control linked to COVID-19 outcomes in largest-yet study

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The strong link between glucose control and COVID-19 outcomes has been reaffirmed in the largest study thus far of hospitalized patients with preexisting type 2 diabetes.

The retrospective, multicenter study, from 7,337 hospitalized patients with COVID-19, was published online in Cell Metabolism by Lihua Zhu, Renmin Hospital of Wuhan University, China, and colleagues.

The study finds that, while the presence of type 2 diabetes per se is a risk factor for worse COVID-19 outcomes, better glycemic control among those with preexisting type 2 diabetes appears to be associated with significant reductions in adverse outcomes and death.

“We were surprised to see such favorable outcomes in the well-controlled blood glucose group among patients with COVID-19 and preexisting type 2 diabetes,” senior author Hongliang Li, also of Renmin Hospital, said in a statement.

“Considering that people with diabetes had much higher risk for death and various complications, and there are no specific drugs for COVID-19, our findings indicate that controlling blood glucose well may act as an effective auxiliary approach to improve the prognosis of patients with COVID-19 and preexisting diabetes,” Dr. Li added.

Asked to comment on the findings, David Klonoff, MD, medical director of the Diabetes Research Institute at Mills–Peninsula Medical Center, San Mateo, Calif., cautioned that the way in which the “well-controlled” diabetes group was distinguished from the “poorly controlled” one in this study used a “nonstandard method for distinguishing these groups based on variability.”

So “there was a great deal of overlap between the two groups,” he observed.
 

Diabetes itself was associated with worse COVID-19 outcomes

Of the 7,337 participants with confirmed COVID-19 in the Chinese study, 13% (952) had preexisting type 2 diabetes while the other 6,385 did not have diabetes.

Median ages were 62 years for those with and 53 years for those without diabetes. As has been reported several times since the pandemic began, the presence of diabetes was associated with a worse COVID-19 prognosis.

Those with preexisting diabetes received significantly more antibiotics, antifungals, systemic corticosteroids, immunoglobulin, antihypertensive drugs, and vasoactive drugs than did those without diabetes. They were also more likely to receive oxygen inhalation (76.9% vs. 61.2%), noninvasive ventilation (10.2% vs. 3.9%), and invasive ventilation (3.6% vs. 0.7%).



Over 28 days starting with the day of admission, the type 2 diabetes group was significantly more likely to die compared with those without diabetes (7.8% vs. 2.7%; P < .001), with a crude hazard ratio of 2.90 (P < .001). After adjustments for age, gender, and COVID-19 severity, the diabetes group was still significantly more likely to die, with a hazard ratio of 1.49 (P = .005).

Those with diabetes were also significantly more likely to develop acute respiratory distress syndrome (adjusted hazard ratio, 1.44), acute kidney injury (3.01), and septic shock (1.95).

“The results were unequivocal to implicate diabetes mellitus in higher risk of death and other detrimental outcomes of COVID-19,” the authors wrote, although they caution “there were notable differences in the covariate distributions between the two groups.”

With T2D, tighter glycemic control predicted better outcome

Among the 952 with COVID-19 and type 2 diabetes, 282 individuals had “well-controlled” blood glucose, ranging from 3.9 to 10.0 mmol/L (~70 - 180 mg/dL) with median 6.4 mmol/L (115 mg/dL) and hemoglobin A1c of 7.3%.

The other 528 were “poorly controlled,” defined as the lowest fasting glucose level 3.9 mmol/L or above and the highest 2-hour postprandial glucose exceeding 10.0 mmol/L, with median 10.9 mmol/L (196 mg/dL) and HbA1c of 8.1%.

Just as with the diabetes vs. no diabetes comparison, those in the “well-controlled” blood glucose group had lower use of antivirals, antibiotics, antifungals, systemic corticosteroids, immunoglobulin, and vasoactive drugs.

They also were less likely to require oxygen inhalation (70.2% vs. 83.5%), non-invasive ventilation (4.6% vs. 11.9%), invasive ventilation (0% vs. 4.2%), and extracorporeal membrane oxygenation (0% vs. 0.8%).

In-hospital death was significantly lower in the “well-controlled” group (1.1% vs. 11.0%; crude hazard ratio, 0.09; P < .001). After adjustments for the previous factors plus site effect, the difference remained significant (0.13; P < .001). Adjusted hazard ratio for acute respiratory distress syndrome was 0.41 (P < .001) and for acute heart injury it was 0.21 (P = .003).
 

Stress hyperglycemia in COVID-19 associated with greater mortality

Klonoff was senior author on a previous study from the United States that showed that both diabetes and uncontrolled hyperglycemia among people without prior diabetes – the latter “presumably due to stress,” he said – were strong predictors of mortality among hospitalized patients with COVID-19.

The new Chinese research only looks at individuals with previously diagnosed type 2 diabetes, Klonoff pointed out in an interview.

“The article by Zhu et al. did not look at outcomes of hospitalized COVID-19 patients with uncontrolled hyperglycemia. Per [the U.S. study], in COVID-19 stress hyperglycemia, compared to diabetes, was associated with greater mortality.”

In addition, although international guidance now advises optimizing blood glucose levels in all patients with hyperglycemia and COVID-19, it’s actually not yet totally clear which in-target range improves COVID-19 prognosis the best, Dr. Klonoff said.

He is now working on a study aimed at answering that question.

The researchers have disclosed no relevant financial relationships. Dr. Klonoff is a consultant to Abbott, Ascensia, Dexcom, EOFlow, Fractyl, Lifecare, Novo, Roche, and ThirdWayv.

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

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The strong link between glucose control and COVID-19 outcomes has been reaffirmed in the largest study thus far of hospitalized patients with preexisting type 2 diabetes.

The retrospective, multicenter study, from 7,337 hospitalized patients with COVID-19, was published online in Cell Metabolism by Lihua Zhu, Renmin Hospital of Wuhan University, China, and colleagues.

The study finds that, while the presence of type 2 diabetes per se is a risk factor for worse COVID-19 outcomes, better glycemic control among those with preexisting type 2 diabetes appears to be associated with significant reductions in adverse outcomes and death.

“We were surprised to see such favorable outcomes in the well-controlled blood glucose group among patients with COVID-19 and preexisting type 2 diabetes,” senior author Hongliang Li, also of Renmin Hospital, said in a statement.

“Considering that people with diabetes had much higher risk for death and various complications, and there are no specific drugs for COVID-19, our findings indicate that controlling blood glucose well may act as an effective auxiliary approach to improve the prognosis of patients with COVID-19 and preexisting diabetes,” Dr. Li added.

Asked to comment on the findings, David Klonoff, MD, medical director of the Diabetes Research Institute at Mills–Peninsula Medical Center, San Mateo, Calif., cautioned that the way in which the “well-controlled” diabetes group was distinguished from the “poorly controlled” one in this study used a “nonstandard method for distinguishing these groups based on variability.”

So “there was a great deal of overlap between the two groups,” he observed.
 

Diabetes itself was associated with worse COVID-19 outcomes

Of the 7,337 participants with confirmed COVID-19 in the Chinese study, 13% (952) had preexisting type 2 diabetes while the other 6,385 did not have diabetes.

Median ages were 62 years for those with and 53 years for those without diabetes. As has been reported several times since the pandemic began, the presence of diabetes was associated with a worse COVID-19 prognosis.

Those with preexisting diabetes received significantly more antibiotics, antifungals, systemic corticosteroids, immunoglobulin, antihypertensive drugs, and vasoactive drugs than did those without diabetes. They were also more likely to receive oxygen inhalation (76.9% vs. 61.2%), noninvasive ventilation (10.2% vs. 3.9%), and invasive ventilation (3.6% vs. 0.7%).



Over 28 days starting with the day of admission, the type 2 diabetes group was significantly more likely to die compared with those without diabetes (7.8% vs. 2.7%; P < .001), with a crude hazard ratio of 2.90 (P < .001). After adjustments for age, gender, and COVID-19 severity, the diabetes group was still significantly more likely to die, with a hazard ratio of 1.49 (P = .005).

Those with diabetes were also significantly more likely to develop acute respiratory distress syndrome (adjusted hazard ratio, 1.44), acute kidney injury (3.01), and septic shock (1.95).

“The results were unequivocal to implicate diabetes mellitus in higher risk of death and other detrimental outcomes of COVID-19,” the authors wrote, although they caution “there were notable differences in the covariate distributions between the two groups.”

With T2D, tighter glycemic control predicted better outcome

Among the 952 with COVID-19 and type 2 diabetes, 282 individuals had “well-controlled” blood glucose, ranging from 3.9 to 10.0 mmol/L (~70 - 180 mg/dL) with median 6.4 mmol/L (115 mg/dL) and hemoglobin A1c of 7.3%.

The other 528 were “poorly controlled,” defined as the lowest fasting glucose level 3.9 mmol/L or above and the highest 2-hour postprandial glucose exceeding 10.0 mmol/L, with median 10.9 mmol/L (196 mg/dL) and HbA1c of 8.1%.

Just as with the diabetes vs. no diabetes comparison, those in the “well-controlled” blood glucose group had lower use of antivirals, antibiotics, antifungals, systemic corticosteroids, immunoglobulin, and vasoactive drugs.

They also were less likely to require oxygen inhalation (70.2% vs. 83.5%), non-invasive ventilation (4.6% vs. 11.9%), invasive ventilation (0% vs. 4.2%), and extracorporeal membrane oxygenation (0% vs. 0.8%).

In-hospital death was significantly lower in the “well-controlled” group (1.1% vs. 11.0%; crude hazard ratio, 0.09; P < .001). After adjustments for the previous factors plus site effect, the difference remained significant (0.13; P < .001). Adjusted hazard ratio for acute respiratory distress syndrome was 0.41 (P < .001) and for acute heart injury it was 0.21 (P = .003).
 

Stress hyperglycemia in COVID-19 associated with greater mortality

Klonoff was senior author on a previous study from the United States that showed that both diabetes and uncontrolled hyperglycemia among people without prior diabetes – the latter “presumably due to stress,” he said – were strong predictors of mortality among hospitalized patients with COVID-19.

The new Chinese research only looks at individuals with previously diagnosed type 2 diabetes, Klonoff pointed out in an interview.

“The article by Zhu et al. did not look at outcomes of hospitalized COVID-19 patients with uncontrolled hyperglycemia. Per [the U.S. study], in COVID-19 stress hyperglycemia, compared to diabetes, was associated with greater mortality.”

In addition, although international guidance now advises optimizing blood glucose levels in all patients with hyperglycemia and COVID-19, it’s actually not yet totally clear which in-target range improves COVID-19 prognosis the best, Dr. Klonoff said.

He is now working on a study aimed at answering that question.

The researchers have disclosed no relevant financial relationships. Dr. Klonoff is a consultant to Abbott, Ascensia, Dexcom, EOFlow, Fractyl, Lifecare, Novo, Roche, and ThirdWayv.

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

The strong link between glucose control and COVID-19 outcomes has been reaffirmed in the largest study thus far of hospitalized patients with preexisting type 2 diabetes.

The retrospective, multicenter study, from 7,337 hospitalized patients with COVID-19, was published online in Cell Metabolism by Lihua Zhu, Renmin Hospital of Wuhan University, China, and colleagues.

The study finds that, while the presence of type 2 diabetes per se is a risk factor for worse COVID-19 outcomes, better glycemic control among those with preexisting type 2 diabetes appears to be associated with significant reductions in adverse outcomes and death.

“We were surprised to see such favorable outcomes in the well-controlled blood glucose group among patients with COVID-19 and preexisting type 2 diabetes,” senior author Hongliang Li, also of Renmin Hospital, said in a statement.

“Considering that people with diabetes had much higher risk for death and various complications, and there are no specific drugs for COVID-19, our findings indicate that controlling blood glucose well may act as an effective auxiliary approach to improve the prognosis of patients with COVID-19 and preexisting diabetes,” Dr. Li added.

Asked to comment on the findings, David Klonoff, MD, medical director of the Diabetes Research Institute at Mills–Peninsula Medical Center, San Mateo, Calif., cautioned that the way in which the “well-controlled” diabetes group was distinguished from the “poorly controlled” one in this study used a “nonstandard method for distinguishing these groups based on variability.”

So “there was a great deal of overlap between the two groups,” he observed.
 

Diabetes itself was associated with worse COVID-19 outcomes

Of the 7,337 participants with confirmed COVID-19 in the Chinese study, 13% (952) had preexisting type 2 diabetes while the other 6,385 did not have diabetes.

Median ages were 62 years for those with and 53 years for those without diabetes. As has been reported several times since the pandemic began, the presence of diabetes was associated with a worse COVID-19 prognosis.

Those with preexisting diabetes received significantly more antibiotics, antifungals, systemic corticosteroids, immunoglobulin, antihypertensive drugs, and vasoactive drugs than did those without diabetes. They were also more likely to receive oxygen inhalation (76.9% vs. 61.2%), noninvasive ventilation (10.2% vs. 3.9%), and invasive ventilation (3.6% vs. 0.7%).



Over 28 days starting with the day of admission, the type 2 diabetes group was significantly more likely to die compared with those without diabetes (7.8% vs. 2.7%; P < .001), with a crude hazard ratio of 2.90 (P < .001). After adjustments for age, gender, and COVID-19 severity, the diabetes group was still significantly more likely to die, with a hazard ratio of 1.49 (P = .005).

Those with diabetes were also significantly more likely to develop acute respiratory distress syndrome (adjusted hazard ratio, 1.44), acute kidney injury (3.01), and septic shock (1.95).

“The results were unequivocal to implicate diabetes mellitus in higher risk of death and other detrimental outcomes of COVID-19,” the authors wrote, although they caution “there were notable differences in the covariate distributions between the two groups.”

With T2D, tighter glycemic control predicted better outcome

Among the 952 with COVID-19 and type 2 diabetes, 282 individuals had “well-controlled” blood glucose, ranging from 3.9 to 10.0 mmol/L (~70 - 180 mg/dL) with median 6.4 mmol/L (115 mg/dL) and hemoglobin A1c of 7.3%.

The other 528 were “poorly controlled,” defined as the lowest fasting glucose level 3.9 mmol/L or above and the highest 2-hour postprandial glucose exceeding 10.0 mmol/L, with median 10.9 mmol/L (196 mg/dL) and HbA1c of 8.1%.

Just as with the diabetes vs. no diabetes comparison, those in the “well-controlled” blood glucose group had lower use of antivirals, antibiotics, antifungals, systemic corticosteroids, immunoglobulin, and vasoactive drugs.

They also were less likely to require oxygen inhalation (70.2% vs. 83.5%), non-invasive ventilation (4.6% vs. 11.9%), invasive ventilation (0% vs. 4.2%), and extracorporeal membrane oxygenation (0% vs. 0.8%).

In-hospital death was significantly lower in the “well-controlled” group (1.1% vs. 11.0%; crude hazard ratio, 0.09; P < .001). After adjustments for the previous factors plus site effect, the difference remained significant (0.13; P < .001). Adjusted hazard ratio for acute respiratory distress syndrome was 0.41 (P < .001) and for acute heart injury it was 0.21 (P = .003).
 

Stress hyperglycemia in COVID-19 associated with greater mortality

Klonoff was senior author on a previous study from the United States that showed that both diabetes and uncontrolled hyperglycemia among people without prior diabetes – the latter “presumably due to stress,” he said – were strong predictors of mortality among hospitalized patients with COVID-19.

The new Chinese research only looks at individuals with previously diagnosed type 2 diabetes, Klonoff pointed out in an interview.

“The article by Zhu et al. did not look at outcomes of hospitalized COVID-19 patients with uncontrolled hyperglycemia. Per [the U.S. study], in COVID-19 stress hyperglycemia, compared to diabetes, was associated with greater mortality.”

In addition, although international guidance now advises optimizing blood glucose levels in all patients with hyperglycemia and COVID-19, it’s actually not yet totally clear which in-target range improves COVID-19 prognosis the best, Dr. Klonoff said.

He is now working on a study aimed at answering that question.

The researchers have disclosed no relevant financial relationships. Dr. Klonoff is a consultant to Abbott, Ascensia, Dexcom, EOFlow, Fractyl, Lifecare, Novo, Roche, and ThirdWayv.

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

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COVID-19 triggers new bariatric/metabolic surgery guidance

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New recommendations for the management of metabolic and bariatric surgery candidates during and after the COVID-19 pandemic shift the focus from body mass index (BMI) alone to medical conditions most likely to be ameliorated by the procedures.

Meant as a guide for both surgeons and referring clinicians, the document was published online May 7 as a Personal View in Lancet Diabetes & Endocrinology.

“Millions of elective operations have been on hold because of COVID-19. ... In the next few months, we’re going to face a huge backlog of procedures of all types. Even when we resume doing surgery it’s not going to be business as usual for many months. ... Hospital clinicians and managers want to make decisions about who’s going to get those slots first,” lead author of the international 23-member writing panel, Francesco Rubino, MD, told Medscape Medical News.

Rubino is professor of metabolic and bariatric surgery at King’s College Hospital, London, UK.

The recommendations include a guide for prioritizing patients eligible for bariatric or metabolic surgery – the former referring to when it’s performed primarily for obesity and the latter for type 2 diabetes – once the pandemic restrictions on nonessential surgery are lifted.

Rather than prioritizing patients by BMI, the scheme focuses on medical comorbidities to place patients into “expedited” or “standard” access categories.



Historically, bariatric and metabolic surgery have had a low uptake due to factors such as lack of insurance coverage and stigma, with many physicians inappropriately viewing it as risky, ineffective, and/or as a “last resort” treatment, Rubino said.

“They don’t refer for surgery even though we have all the evidence that the benefits for patients are unquestionable,” he added.

Because of that background, “in the situation of limited capacity, patients with obesity and type 2 diabetes are likely to be penalized compared to any other conditions that need elective surgery,” Rubino stressed.

Asked to comment, Scott Kahan, MD, director of the National Center for Weight and Wellness in Washington, D.C., called the document a “really valuable thought piece.”

Noting that only about 1% to 2% of people who are eligible for bariatric or metabolic surgery actually undergo the procedures, Kahan said, “because so few people get the surgery we’ve never really run into a situation of undersupply or overdemand.

“But, as we’re moving forward, one would think that we will run into that scenario. So, better prioritizing and triaging patients likely will be more important down the line, given how effective surgery has been shown to be now, both short term and long term.”

Risks of obesity, shifting away from BMI as the main metric

The new document extensively discusses the risks of obesity – including now as a major COVID-19 risk factor – and the benefits of the procedures and risks of delaying them.

It also addresses ongoing management of patients who had bariatric/metabolic surgery in the past and nonsurgical treatment to mitigate harm until patients can undergo the procedures.

Another important problem the document addresses, Rubino said, is the current BMI-focused bariatric/metabolic surgery criteria (≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity).

“BMI is an epidemiological measure, not a measure of disease. But we select patients for bariatric surgery by saying who is eligible [without assessing] who has more or less severe disease, and who is at more or less risk for short-term complications from the disease compared to others,” he explained. “We don’t have any mechanism, even in normal times, let alone during a pandemic, to differentiate between patients who need surgery sooner rather than later.”

Indeed, Kahan said, “Traditionally we tend to oversimplify risk stratification in terms of how heavy people are. While that is one factor of importance, it’s far from the only factor and may not be the most important factor.”

In “someone who is relatively lighter but sicker, it would be sensible, in my mind, to prioritize them for a potentially curative procedure compared with someone who is heavier – even much heavier – but is not as sick,” he added.
 

 

 

“Pandemic forces us to do what was long overdue”

The document confirms that bariatric/metabolic surgery should remain suspended during the most intense phase of the COVID-19 pandemic and only resume once overall restrictions on nonessential surgeries are lifted.

Exceptions are limited to emergency endoscopic interventions for complications of prior surgery, such as hemorrhage or leaks.

A section offers guidance for pharmacologic and other nonsurgical options to mitigate harm from delaying the procedures including use of drugs that promote weight loss, such as glucagonlike peptide-1 receptor agonists and/or sodium-glucose cotransporter 2 inhibitors.

Once less-urgent surgeries are allowed to resume, a prioritization scheme addresses which patients should receive “expedited access” (risk of harm if delayed beyond 90 days) versus “standard access” (unlikely to deteriorate within 6 months) within three indication categories: “diabetes (metabolic) surgery,” “obesity (bariatric) surgery,” or “adjuvant bariatric and metabolic surgery.”

Examples of patients who would qualify for “expedited” access in the “diabetes surgery” category include those with an A1c of 8% or greater despite use of two or more oral medications or insulin use, those with a history of cardiovascular disease, and/or those with stage 3-4 chronic kidney disease.

For the “obesity surgery” group, priority patients include those with a BMI of 60 kg/m2 or greater or with severe obesity hypoventilation syndrome or severe sleep apnea.

And for the adjuvant category, those requiring weight loss to allow for other treatments, such as organ transplants, would be expedited.

Individuals with less-severe obesity or chronic conditions could have their surgeries put off until a later date.

The panel also recommends that even though keyhole surgery involves aerosol-generating techniques that could increase the risk for coronavirus infection, laparoscopic approaches are still preferred over open procedures because they carry lower risks for complications and result in shorter hospital stays, thereby lowering infection risk.

Appropriate personal protective equipment is, of course, advised for use by clinicians.

Kahan said of the document: “I think it’s a very sensible piece where they’re thinking through things that haven’t really needed to be thought through all that much. That’s partly with respect to COVID-19, but even beyond that I think this will be a valuable platform going forward.”

Indeed, Rubino said, “The pandemic forces us to do what was long overdue.”

Rubino has reported being on advisory boards for GI Dynamics, Keyron, and Novo Nordisk, has reported receiving consulting fees and research grants from Ethicon Endo-Surgery and Medtronic. Kahan has reported no relevant financial relationships.

This article first appeared on Medscape.com.

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New recommendations for the management of metabolic and bariatric surgery candidates during and after the COVID-19 pandemic shift the focus from body mass index (BMI) alone to medical conditions most likely to be ameliorated by the procedures.

Meant as a guide for both surgeons and referring clinicians, the document was published online May 7 as a Personal View in Lancet Diabetes & Endocrinology.

“Millions of elective operations have been on hold because of COVID-19. ... In the next few months, we’re going to face a huge backlog of procedures of all types. Even when we resume doing surgery it’s not going to be business as usual for many months. ... Hospital clinicians and managers want to make decisions about who’s going to get those slots first,” lead author of the international 23-member writing panel, Francesco Rubino, MD, told Medscape Medical News.

Rubino is professor of metabolic and bariatric surgery at King’s College Hospital, London, UK.

The recommendations include a guide for prioritizing patients eligible for bariatric or metabolic surgery – the former referring to when it’s performed primarily for obesity and the latter for type 2 diabetes – once the pandemic restrictions on nonessential surgery are lifted.

Rather than prioritizing patients by BMI, the scheme focuses on medical comorbidities to place patients into “expedited” or “standard” access categories.



Historically, bariatric and metabolic surgery have had a low uptake due to factors such as lack of insurance coverage and stigma, with many physicians inappropriately viewing it as risky, ineffective, and/or as a “last resort” treatment, Rubino said.

“They don’t refer for surgery even though we have all the evidence that the benefits for patients are unquestionable,” he added.

Because of that background, “in the situation of limited capacity, patients with obesity and type 2 diabetes are likely to be penalized compared to any other conditions that need elective surgery,” Rubino stressed.

Asked to comment, Scott Kahan, MD, director of the National Center for Weight and Wellness in Washington, D.C., called the document a “really valuable thought piece.”

Noting that only about 1% to 2% of people who are eligible for bariatric or metabolic surgery actually undergo the procedures, Kahan said, “because so few people get the surgery we’ve never really run into a situation of undersupply or overdemand.

“But, as we’re moving forward, one would think that we will run into that scenario. So, better prioritizing and triaging patients likely will be more important down the line, given how effective surgery has been shown to be now, both short term and long term.”

Risks of obesity, shifting away from BMI as the main metric

The new document extensively discusses the risks of obesity – including now as a major COVID-19 risk factor – and the benefits of the procedures and risks of delaying them.

It also addresses ongoing management of patients who had bariatric/metabolic surgery in the past and nonsurgical treatment to mitigate harm until patients can undergo the procedures.

Another important problem the document addresses, Rubino said, is the current BMI-focused bariatric/metabolic surgery criteria (≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity).

“BMI is an epidemiological measure, not a measure of disease. But we select patients for bariatric surgery by saying who is eligible [without assessing] who has more or less severe disease, and who is at more or less risk for short-term complications from the disease compared to others,” he explained. “We don’t have any mechanism, even in normal times, let alone during a pandemic, to differentiate between patients who need surgery sooner rather than later.”

Indeed, Kahan said, “Traditionally we tend to oversimplify risk stratification in terms of how heavy people are. While that is one factor of importance, it’s far from the only factor and may not be the most important factor.”

In “someone who is relatively lighter but sicker, it would be sensible, in my mind, to prioritize them for a potentially curative procedure compared with someone who is heavier – even much heavier – but is not as sick,” he added.
 

 

 

“Pandemic forces us to do what was long overdue”

The document confirms that bariatric/metabolic surgery should remain suspended during the most intense phase of the COVID-19 pandemic and only resume once overall restrictions on nonessential surgeries are lifted.

Exceptions are limited to emergency endoscopic interventions for complications of prior surgery, such as hemorrhage or leaks.

A section offers guidance for pharmacologic and other nonsurgical options to mitigate harm from delaying the procedures including use of drugs that promote weight loss, such as glucagonlike peptide-1 receptor agonists and/or sodium-glucose cotransporter 2 inhibitors.

Once less-urgent surgeries are allowed to resume, a prioritization scheme addresses which patients should receive “expedited access” (risk of harm if delayed beyond 90 days) versus “standard access” (unlikely to deteriorate within 6 months) within three indication categories: “diabetes (metabolic) surgery,” “obesity (bariatric) surgery,” or “adjuvant bariatric and metabolic surgery.”

Examples of patients who would qualify for “expedited” access in the “diabetes surgery” category include those with an A1c of 8% or greater despite use of two or more oral medications or insulin use, those with a history of cardiovascular disease, and/or those with stage 3-4 chronic kidney disease.

For the “obesity surgery” group, priority patients include those with a BMI of 60 kg/m2 or greater or with severe obesity hypoventilation syndrome or severe sleep apnea.

And for the adjuvant category, those requiring weight loss to allow for other treatments, such as organ transplants, would be expedited.

Individuals with less-severe obesity or chronic conditions could have their surgeries put off until a later date.

The panel also recommends that even though keyhole surgery involves aerosol-generating techniques that could increase the risk for coronavirus infection, laparoscopic approaches are still preferred over open procedures because they carry lower risks for complications and result in shorter hospital stays, thereby lowering infection risk.

Appropriate personal protective equipment is, of course, advised for use by clinicians.

Kahan said of the document: “I think it’s a very sensible piece where they’re thinking through things that haven’t really needed to be thought through all that much. That’s partly with respect to COVID-19, but even beyond that I think this will be a valuable platform going forward.”

Indeed, Rubino said, “The pandemic forces us to do what was long overdue.”

Rubino has reported being on advisory boards for GI Dynamics, Keyron, and Novo Nordisk, has reported receiving consulting fees and research grants from Ethicon Endo-Surgery and Medtronic. Kahan has reported no relevant financial relationships.

This article first appeared on Medscape.com.

New recommendations for the management of metabolic and bariatric surgery candidates during and after the COVID-19 pandemic shift the focus from body mass index (BMI) alone to medical conditions most likely to be ameliorated by the procedures.

Meant as a guide for both surgeons and referring clinicians, the document was published online May 7 as a Personal View in Lancet Diabetes & Endocrinology.

“Millions of elective operations have been on hold because of COVID-19. ... In the next few months, we’re going to face a huge backlog of procedures of all types. Even when we resume doing surgery it’s not going to be business as usual for many months. ... Hospital clinicians and managers want to make decisions about who’s going to get those slots first,” lead author of the international 23-member writing panel, Francesco Rubino, MD, told Medscape Medical News.

Rubino is professor of metabolic and bariatric surgery at King’s College Hospital, London, UK.

The recommendations include a guide for prioritizing patients eligible for bariatric or metabolic surgery – the former referring to when it’s performed primarily for obesity and the latter for type 2 diabetes – once the pandemic restrictions on nonessential surgery are lifted.

Rather than prioritizing patients by BMI, the scheme focuses on medical comorbidities to place patients into “expedited” or “standard” access categories.



Historically, bariatric and metabolic surgery have had a low uptake due to factors such as lack of insurance coverage and stigma, with many physicians inappropriately viewing it as risky, ineffective, and/or as a “last resort” treatment, Rubino said.

“They don’t refer for surgery even though we have all the evidence that the benefits for patients are unquestionable,” he added.

Because of that background, “in the situation of limited capacity, patients with obesity and type 2 diabetes are likely to be penalized compared to any other conditions that need elective surgery,” Rubino stressed.

Asked to comment, Scott Kahan, MD, director of the National Center for Weight and Wellness in Washington, D.C., called the document a “really valuable thought piece.”

Noting that only about 1% to 2% of people who are eligible for bariatric or metabolic surgery actually undergo the procedures, Kahan said, “because so few people get the surgery we’ve never really run into a situation of undersupply or overdemand.

“But, as we’re moving forward, one would think that we will run into that scenario. So, better prioritizing and triaging patients likely will be more important down the line, given how effective surgery has been shown to be now, both short term and long term.”

Risks of obesity, shifting away from BMI as the main metric

The new document extensively discusses the risks of obesity – including now as a major COVID-19 risk factor – and the benefits of the procedures and risks of delaying them.

It also addresses ongoing management of patients who had bariatric/metabolic surgery in the past and nonsurgical treatment to mitigate harm until patients can undergo the procedures.

Another important problem the document addresses, Rubino said, is the current BMI-focused bariatric/metabolic surgery criteria (≥ 40 kg/m2 or ≥ 35 kg/m2 with at least one obesity-related comorbidity).

“BMI is an epidemiological measure, not a measure of disease. But we select patients for bariatric surgery by saying who is eligible [without assessing] who has more or less severe disease, and who is at more or less risk for short-term complications from the disease compared to others,” he explained. “We don’t have any mechanism, even in normal times, let alone during a pandemic, to differentiate between patients who need surgery sooner rather than later.”

Indeed, Kahan said, “Traditionally we tend to oversimplify risk stratification in terms of how heavy people are. While that is one factor of importance, it’s far from the only factor and may not be the most important factor.”

In “someone who is relatively lighter but sicker, it would be sensible, in my mind, to prioritize them for a potentially curative procedure compared with someone who is heavier – even much heavier – but is not as sick,” he added.
 

 

 

“Pandemic forces us to do what was long overdue”

The document confirms that bariatric/metabolic surgery should remain suspended during the most intense phase of the COVID-19 pandemic and only resume once overall restrictions on nonessential surgeries are lifted.

Exceptions are limited to emergency endoscopic interventions for complications of prior surgery, such as hemorrhage or leaks.

A section offers guidance for pharmacologic and other nonsurgical options to mitigate harm from delaying the procedures including use of drugs that promote weight loss, such as glucagonlike peptide-1 receptor agonists and/or sodium-glucose cotransporter 2 inhibitors.

Once less-urgent surgeries are allowed to resume, a prioritization scheme addresses which patients should receive “expedited access” (risk of harm if delayed beyond 90 days) versus “standard access” (unlikely to deteriorate within 6 months) within three indication categories: “diabetes (metabolic) surgery,” “obesity (bariatric) surgery,” or “adjuvant bariatric and metabolic surgery.”

Examples of patients who would qualify for “expedited” access in the “diabetes surgery” category include those with an A1c of 8% or greater despite use of two or more oral medications or insulin use, those with a history of cardiovascular disease, and/or those with stage 3-4 chronic kidney disease.

For the “obesity surgery” group, priority patients include those with a BMI of 60 kg/m2 or greater or with severe obesity hypoventilation syndrome or severe sleep apnea.

And for the adjuvant category, those requiring weight loss to allow for other treatments, such as organ transplants, would be expedited.

Individuals with less-severe obesity or chronic conditions could have their surgeries put off until a later date.

The panel also recommends that even though keyhole surgery involves aerosol-generating techniques that could increase the risk for coronavirus infection, laparoscopic approaches are still preferred over open procedures because they carry lower risks for complications and result in shorter hospital stays, thereby lowering infection risk.

Appropriate personal protective equipment is, of course, advised for use by clinicians.

Kahan said of the document: “I think it’s a very sensible piece where they’re thinking through things that haven’t really needed to be thought through all that much. That’s partly with respect to COVID-19, but even beyond that I think this will be a valuable platform going forward.”

Indeed, Rubino said, “The pandemic forces us to do what was long overdue.”

Rubino has reported being on advisory boards for GI Dynamics, Keyron, and Novo Nordisk, has reported receiving consulting fees and research grants from Ethicon Endo-Surgery and Medtronic. Kahan has reported no relevant financial relationships.

This article first appeared on Medscape.com.

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Lessons learned during the COVID-19 pandemic

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Each day, we’re inundated with news about the COVID-19 pandemic and how it continues to strain our health care system and resources. With more than 1.15 million positive cases in the United States and over 67,000 deaths as of this writing, it has been a scary yet humbling experience for everyone. There is no doubt this pandemic will be a defining moment in health care for several reasons. From supply chain disruptions and personal protective equipment (PPE) and ventilator shortages to exhausted caregivers – both physically and mentally – this event has pushed the envelope on finding answers from federal and state authorities. Hospital administrations are working harder than ever to rise to the challenge and do what is best for their frontline staff and, more importantly, the patients and the communities they serve.

The provider experience during COVID-19

Dr. Jashanpreet Singh

Hospitalists are in a unique situation as frontline providers. Managing daily throughput of patients has always been a key role for the specialty. They also play an integral role in their own care teams alongside nurses, trainees, case managers, pharmacists, and others in cohorted COVID-19 units. Now more than ever, such a geographic placement of patients is quickly emerging as a must-have staffing model to reduce risk of cross-contamination and preserving critical PPE supplies. This heightened awareness, coupled with anxiety, sometimes leads to added stress and burnout risk for hospitalists.

Communication is critical in creating situational awareness and reducing anxiety within the teams. This is exactly where hospitalists can lead:

  • Active presence in hospital incident command centers and infection control boards
  • Close coordination with emergency medicine colleagues and bed placement navigators
  • Developing protocols for appropriate testing
  • Frequent daily huddles to discuss current state- and hospital-level testing guidelines
  • Close involvement in the hospital operations committee
  • Advocating for or securing more testing or supplies, especially PPE
  • Effective communication about changes in PPE requirements and conservation strategies as per the Centers for Disease Control and Prevention, State Department of Health, and the hospital infection control board
  • Crisis-driven changes, including development and review of triage and treatment protocols and elective procedure cancellations
  • Census numbers and capacity/staffing adjustments within the team to meet temporary dips and surges in on-service patient volumes
  • Frontline caregiver mental and physical health assessment

Daily huddles at key times (e.g., at shift start and end times) can help to identify these barriers. If operational issues arise, there should be a clear channel to escalate them to senior leadership.

Hospitalists could also use several strategies proven to improve staff morale and resilience. For instance, take this time to connect with friends and family virtually, unplug when off from work, explore one’s spiritual self through meditation and prayers, spend time with nature, exercise daily, seek humor, and develop or work on one’s hobby.
 

 

 

The patient experience during COVID-19

Some intriguing data is also being released about patient experience during the pandemic. A Press Ganey analysis of 350,000 comments between January and March 2020 shows that patients are looking for more information about their condition, primarily COVID-19 test delays and result notification time. There is also hypervigilance in patients’ minds about hand hygiene and overall cleanliness of the hospital. Patients also seek clarification and transparent explanation of their caregiver’s bedside mannerisms – for example, why did they gown up before entering – and their daily care plans.

Patients have been appreciative of providers and recognize the personal risk frontline staff put themselves through. Communication transparency seems to mitigate concerns about delays of care especially caused by operational challenges as a result of the pandemic.

In surveys specifically related to experiences including COVID-19, patients were more likely to rate more areas of service lower than in surveys that did not mention COVID-19. The patients also seemed to put more value on the quality of instructions and information they received and on perception of providers’ respect and listening abilities. These insights could prove invaluable in improving care delivery by hospitalists.

Isolation of patients has been shown in multiple studies to have negative outcomes. These patients are up to twice as likely to have an adverse event, and seven times more likely to have treatment-related avoidable adversity, poorer perceived patient experience, and overall perception of being cared for “less.” Add to this a higher level of depression and mental strain, and these patients quickly become “unsatisfied.”

At the ED level, the willingness to let family be present for care was the key area of concern listed – a metric that has changed rapidly since the early days of the pandemic.

The bottom line is these are trying times for everyone – both for providers and patients. Both look up to health system and group leadership for reassurance. Patients and families recognize the risks frontline providers are assuming. However, transparent communication across all levels is the key. Silos are disappearing and team based care is taking center stage.

Beyond the current public health crisis, these efforts will go a long way to create unshakable trust between health systems, providers, patients, and their loved ones.

Dr. Singh is currently the chief of inpatient operations at Adena Health System in Chillicothe, Ohio, where he also has key roles in medical informatics and health IT. He is also the president-elect of the Central Ohio Chapter of SHM.

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Each day, we’re inundated with news about the COVID-19 pandemic and how it continues to strain our health care system and resources. With more than 1.15 million positive cases in the United States and over 67,000 deaths as of this writing, it has been a scary yet humbling experience for everyone. There is no doubt this pandemic will be a defining moment in health care for several reasons. From supply chain disruptions and personal protective equipment (PPE) and ventilator shortages to exhausted caregivers – both physically and mentally – this event has pushed the envelope on finding answers from federal and state authorities. Hospital administrations are working harder than ever to rise to the challenge and do what is best for their frontline staff and, more importantly, the patients and the communities they serve.

The provider experience during COVID-19

Dr. Jashanpreet Singh

Hospitalists are in a unique situation as frontline providers. Managing daily throughput of patients has always been a key role for the specialty. They also play an integral role in their own care teams alongside nurses, trainees, case managers, pharmacists, and others in cohorted COVID-19 units. Now more than ever, such a geographic placement of patients is quickly emerging as a must-have staffing model to reduce risk of cross-contamination and preserving critical PPE supplies. This heightened awareness, coupled with anxiety, sometimes leads to added stress and burnout risk for hospitalists.

Communication is critical in creating situational awareness and reducing anxiety within the teams. This is exactly where hospitalists can lead:

  • Active presence in hospital incident command centers and infection control boards
  • Close coordination with emergency medicine colleagues and bed placement navigators
  • Developing protocols for appropriate testing
  • Frequent daily huddles to discuss current state- and hospital-level testing guidelines
  • Close involvement in the hospital operations committee
  • Advocating for or securing more testing or supplies, especially PPE
  • Effective communication about changes in PPE requirements and conservation strategies as per the Centers for Disease Control and Prevention, State Department of Health, and the hospital infection control board
  • Crisis-driven changes, including development and review of triage and treatment protocols and elective procedure cancellations
  • Census numbers and capacity/staffing adjustments within the team to meet temporary dips and surges in on-service patient volumes
  • Frontline caregiver mental and physical health assessment

Daily huddles at key times (e.g., at shift start and end times) can help to identify these barriers. If operational issues arise, there should be a clear channel to escalate them to senior leadership.

Hospitalists could also use several strategies proven to improve staff morale and resilience. For instance, take this time to connect with friends and family virtually, unplug when off from work, explore one’s spiritual self through meditation and prayers, spend time with nature, exercise daily, seek humor, and develop or work on one’s hobby.
 

 

 

The patient experience during COVID-19

Some intriguing data is also being released about patient experience during the pandemic. A Press Ganey analysis of 350,000 comments between January and March 2020 shows that patients are looking for more information about their condition, primarily COVID-19 test delays and result notification time. There is also hypervigilance in patients’ minds about hand hygiene and overall cleanliness of the hospital. Patients also seek clarification and transparent explanation of their caregiver’s bedside mannerisms – for example, why did they gown up before entering – and their daily care plans.

Patients have been appreciative of providers and recognize the personal risk frontline staff put themselves through. Communication transparency seems to mitigate concerns about delays of care especially caused by operational challenges as a result of the pandemic.

In surveys specifically related to experiences including COVID-19, patients were more likely to rate more areas of service lower than in surveys that did not mention COVID-19. The patients also seemed to put more value on the quality of instructions and information they received and on perception of providers’ respect and listening abilities. These insights could prove invaluable in improving care delivery by hospitalists.

Isolation of patients has been shown in multiple studies to have negative outcomes. These patients are up to twice as likely to have an adverse event, and seven times more likely to have treatment-related avoidable adversity, poorer perceived patient experience, and overall perception of being cared for “less.” Add to this a higher level of depression and mental strain, and these patients quickly become “unsatisfied.”

At the ED level, the willingness to let family be present for care was the key area of concern listed – a metric that has changed rapidly since the early days of the pandemic.

The bottom line is these are trying times for everyone – both for providers and patients. Both look up to health system and group leadership for reassurance. Patients and families recognize the risks frontline providers are assuming. However, transparent communication across all levels is the key. Silos are disappearing and team based care is taking center stage.

Beyond the current public health crisis, these efforts will go a long way to create unshakable trust between health systems, providers, patients, and their loved ones.

Dr. Singh is currently the chief of inpatient operations at Adena Health System in Chillicothe, Ohio, where he also has key roles in medical informatics and health IT. He is also the president-elect of the Central Ohio Chapter of SHM.

Each day, we’re inundated with news about the COVID-19 pandemic and how it continues to strain our health care system and resources. With more than 1.15 million positive cases in the United States and over 67,000 deaths as of this writing, it has been a scary yet humbling experience for everyone. There is no doubt this pandemic will be a defining moment in health care for several reasons. From supply chain disruptions and personal protective equipment (PPE) and ventilator shortages to exhausted caregivers – both physically and mentally – this event has pushed the envelope on finding answers from federal and state authorities. Hospital administrations are working harder than ever to rise to the challenge and do what is best for their frontline staff and, more importantly, the patients and the communities they serve.

The provider experience during COVID-19

Dr. Jashanpreet Singh

Hospitalists are in a unique situation as frontline providers. Managing daily throughput of patients has always been a key role for the specialty. They also play an integral role in their own care teams alongside nurses, trainees, case managers, pharmacists, and others in cohorted COVID-19 units. Now more than ever, such a geographic placement of patients is quickly emerging as a must-have staffing model to reduce risk of cross-contamination and preserving critical PPE supplies. This heightened awareness, coupled with anxiety, sometimes leads to added stress and burnout risk for hospitalists.

Communication is critical in creating situational awareness and reducing anxiety within the teams. This is exactly where hospitalists can lead:

  • Active presence in hospital incident command centers and infection control boards
  • Close coordination with emergency medicine colleagues and bed placement navigators
  • Developing protocols for appropriate testing
  • Frequent daily huddles to discuss current state- and hospital-level testing guidelines
  • Close involvement in the hospital operations committee
  • Advocating for or securing more testing or supplies, especially PPE
  • Effective communication about changes in PPE requirements and conservation strategies as per the Centers for Disease Control and Prevention, State Department of Health, and the hospital infection control board
  • Crisis-driven changes, including development and review of triage and treatment protocols and elective procedure cancellations
  • Census numbers and capacity/staffing adjustments within the team to meet temporary dips and surges in on-service patient volumes
  • Frontline caregiver mental and physical health assessment

Daily huddles at key times (e.g., at shift start and end times) can help to identify these barriers. If operational issues arise, there should be a clear channel to escalate them to senior leadership.

Hospitalists could also use several strategies proven to improve staff morale and resilience. For instance, take this time to connect with friends and family virtually, unplug when off from work, explore one’s spiritual self through meditation and prayers, spend time with nature, exercise daily, seek humor, and develop or work on one’s hobby.
 

 

 

The patient experience during COVID-19

Some intriguing data is also being released about patient experience during the pandemic. A Press Ganey analysis of 350,000 comments between January and March 2020 shows that patients are looking for more information about their condition, primarily COVID-19 test delays and result notification time. There is also hypervigilance in patients’ minds about hand hygiene and overall cleanliness of the hospital. Patients also seek clarification and transparent explanation of their caregiver’s bedside mannerisms – for example, why did they gown up before entering – and their daily care plans.

Patients have been appreciative of providers and recognize the personal risk frontline staff put themselves through. Communication transparency seems to mitigate concerns about delays of care especially caused by operational challenges as a result of the pandemic.

In surveys specifically related to experiences including COVID-19, patients were more likely to rate more areas of service lower than in surveys that did not mention COVID-19. The patients also seemed to put more value on the quality of instructions and information they received and on perception of providers’ respect and listening abilities. These insights could prove invaluable in improving care delivery by hospitalists.

Isolation of patients has been shown in multiple studies to have negative outcomes. These patients are up to twice as likely to have an adverse event, and seven times more likely to have treatment-related avoidable adversity, poorer perceived patient experience, and overall perception of being cared for “less.” Add to this a higher level of depression and mental strain, and these patients quickly become “unsatisfied.”

At the ED level, the willingness to let family be present for care was the key area of concern listed – a metric that has changed rapidly since the early days of the pandemic.

The bottom line is these are trying times for everyone – both for providers and patients. Both look up to health system and group leadership for reassurance. Patients and families recognize the risks frontline providers are assuming. However, transparent communication across all levels is the key. Silos are disappearing and team based care is taking center stage.

Beyond the current public health crisis, these efforts will go a long way to create unshakable trust between health systems, providers, patients, and their loved ones.

Dr. Singh is currently the chief of inpatient operations at Adena Health System in Chillicothe, Ohio, where he also has key roles in medical informatics and health IT. He is also the president-elect of the Central Ohio Chapter of SHM.

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Bariatric surgery in advanced heart failure wins transplant eligibility

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Bariatric surgery is a safe and effective means for obese patients with advanced heart failure supported by a left ventricular assist device to qualify for heart transplantation, Praneet Wander, MD, reported in an abstract released as part of the annual Digestive Disease Week®.

She presented a systematic review and meta-analysis of nine retrospective or cross-sectional cohort studies totaling 86 patients with a left ventricular assist device (LVAD) and advanced heart failure who had a mean body mass index (BMI) of 44.8 kg/m2 when they underwent bariatric surgery at an average age of 44 years and 33.2 kg/m2 at follow-up a mean of 14.3 months later.

Of the 86 patients, 50 (58%) were able to drop their BMI below 35, a requirement for inclusion on the heart transplant waiting list, noted Dr. Wander, a gastroenterology fellow at Hofstra University, Hempstead, N.Y., and North Shore LIJ Hospital in Manhasset, N.Y.

“A lot of bariatric surgeons don’t feel comfortable operating on patients who have a low ejection fraction,” she explained in an interview. “This study should encourage bariatric surgeons to do procedures even in patients with advanced heart failure so they can meet the BMI requirement for heart transplantation.”

Even if patients don’t actually undergo heart transplantation because of the perpetual donor organ shortage or inability to meet non–BMI-related eligibility criteria, they gain other major benefits from bariatric surgery: Their blood pressure goes down, their diabetes improves, and they become better able to engage in physical activity, she added.

Of the 86 patients in the meta-analysis, 84 underwent laparoscopic sleeve gastrectomy. That’s the preferred bariatric operation in patients with advanced heart failure at the Mayo Clinic as well, according to Andres J. Acosta, MD, PhD, a gastroenterologist at the medical center in Rochester, Minn.

There’s less weight loss achieved than with an open Roux-en-Y gastric bypass, but it’s a simpler operation in these high-risk patients, who typically have multiple comorbid conditions, he explained.

He predicted that Dr. Wander’s study will indeed influence bariatric surgeons at tertiary medical centers around the country to become more willing to consider weight-loss surgery in patients with advanced heart failure, while those in community practice will likely continue to be most comfortable operating on more stable patients with minimal comorbidities aside from their obesity.

“Data such as [these] will be reassuring to bariatric surgery programs such as ours, where we’re able to say: ‘Yes, there are risks, but these patients will benefit in the long term if we assume those risks,’ ” Dr. Acosta said.

He’s confident that, in the near future, the preferred form of bariatric surgery in patients with advanced heart failure will be a minimally invasive procedure performed endoscopically by gastroenterologists. He and his Mayo Clinic colleagues have already established a track record of success with endoscopic sleeve gastrectomy in patients with advanced kidney, liver, or lung disease in order to make them eligible for transplantation, as well as for the ancillary benefits provided by massive weight loss.

“There’s a little less weight loss than with laparoscopic sleeve gastrectomy, but it’s a significantly less risky operation. Shorter operative time, shorter hospital length of stay, less risk of infections and leaks,” he said in an interview. “We haven’t done it yet in heart disease, but I think based on this study this should be the next step at Mayo.”

Radha Gopalan, MD, director of heart failure and transplantation at Banner–University Medical Center in Phoenix, pronounced Dr. Wander’s meta-analysis “a positive study that’s very supportive of what we’re doing at our center.

“At a busy heart transplant center like ours, we are comfortable managing these patients, so the bariatric surgeons are reassured that the heart failure team is behind them. The risk of the procedure is mitigated by the availability of the multidisciplinary team to get the patient with obesity and heart failure through the surgery,” he explained.

Dr. Gopalan heads a novel bariatric heart failure program at Banner. While Dr. Wander’s meta-analysis focused on bariatric surgery in heart failure patients on LVAD circulatory support, Dr. Gopalan and colleagues are moving the intervention upstream. Roughly roughly 80% of patients in his bariatric heart failure program who meet criteria for LVAD implantation are now offered bariatric surgery before an LVAD is put in.

“I am moving away from putting the LVAD in first and then doing bariatric surgery. We have gotten comfortable taking these patients for bariatric surgery with inotropic support before going to the LVAD, which has the potential to even eliminate the requirement for an LVAD. Some patients get so much better that they become transplant ineligible,” Dr. Gopalan said.

Dr. Wander reported having no financial conflicts regarding her study, conducted free of commercial support.

SOURCE: Wander P. DDW 2020 Abstract, #Mo2010.

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Bariatric surgery is a safe and effective means for obese patients with advanced heart failure supported by a left ventricular assist device to qualify for heart transplantation, Praneet Wander, MD, reported in an abstract released as part of the annual Digestive Disease Week®.

She presented a systematic review and meta-analysis of nine retrospective or cross-sectional cohort studies totaling 86 patients with a left ventricular assist device (LVAD) and advanced heart failure who had a mean body mass index (BMI) of 44.8 kg/m2 when they underwent bariatric surgery at an average age of 44 years and 33.2 kg/m2 at follow-up a mean of 14.3 months later.

Of the 86 patients, 50 (58%) were able to drop their BMI below 35, a requirement for inclusion on the heart transplant waiting list, noted Dr. Wander, a gastroenterology fellow at Hofstra University, Hempstead, N.Y., and North Shore LIJ Hospital in Manhasset, N.Y.

“A lot of bariatric surgeons don’t feel comfortable operating on patients who have a low ejection fraction,” she explained in an interview. “This study should encourage bariatric surgeons to do procedures even in patients with advanced heart failure so they can meet the BMI requirement for heart transplantation.”

Even if patients don’t actually undergo heart transplantation because of the perpetual donor organ shortage or inability to meet non–BMI-related eligibility criteria, they gain other major benefits from bariatric surgery: Their blood pressure goes down, their diabetes improves, and they become better able to engage in physical activity, she added.

Of the 86 patients in the meta-analysis, 84 underwent laparoscopic sleeve gastrectomy. That’s the preferred bariatric operation in patients with advanced heart failure at the Mayo Clinic as well, according to Andres J. Acosta, MD, PhD, a gastroenterologist at the medical center in Rochester, Minn.

There’s less weight loss achieved than with an open Roux-en-Y gastric bypass, but it’s a simpler operation in these high-risk patients, who typically have multiple comorbid conditions, he explained.

He predicted that Dr. Wander’s study will indeed influence bariatric surgeons at tertiary medical centers around the country to become more willing to consider weight-loss surgery in patients with advanced heart failure, while those in community practice will likely continue to be most comfortable operating on more stable patients with minimal comorbidities aside from their obesity.

“Data such as [these] will be reassuring to bariatric surgery programs such as ours, where we’re able to say: ‘Yes, there are risks, but these patients will benefit in the long term if we assume those risks,’ ” Dr. Acosta said.

He’s confident that, in the near future, the preferred form of bariatric surgery in patients with advanced heart failure will be a minimally invasive procedure performed endoscopically by gastroenterologists. He and his Mayo Clinic colleagues have already established a track record of success with endoscopic sleeve gastrectomy in patients with advanced kidney, liver, or lung disease in order to make them eligible for transplantation, as well as for the ancillary benefits provided by massive weight loss.

“There’s a little less weight loss than with laparoscopic sleeve gastrectomy, but it’s a significantly less risky operation. Shorter operative time, shorter hospital length of stay, less risk of infections and leaks,” he said in an interview. “We haven’t done it yet in heart disease, but I think based on this study this should be the next step at Mayo.”

Radha Gopalan, MD, director of heart failure and transplantation at Banner–University Medical Center in Phoenix, pronounced Dr. Wander’s meta-analysis “a positive study that’s very supportive of what we’re doing at our center.

“At a busy heart transplant center like ours, we are comfortable managing these patients, so the bariatric surgeons are reassured that the heart failure team is behind them. The risk of the procedure is mitigated by the availability of the multidisciplinary team to get the patient with obesity and heart failure through the surgery,” he explained.

Dr. Gopalan heads a novel bariatric heart failure program at Banner. While Dr. Wander’s meta-analysis focused on bariatric surgery in heart failure patients on LVAD circulatory support, Dr. Gopalan and colleagues are moving the intervention upstream. Roughly roughly 80% of patients in his bariatric heart failure program who meet criteria for LVAD implantation are now offered bariatric surgery before an LVAD is put in.

“I am moving away from putting the LVAD in first and then doing bariatric surgery. We have gotten comfortable taking these patients for bariatric surgery with inotropic support before going to the LVAD, which has the potential to even eliminate the requirement for an LVAD. Some patients get so much better that they become transplant ineligible,” Dr. Gopalan said.

Dr. Wander reported having no financial conflicts regarding her study, conducted free of commercial support.

SOURCE: Wander P. DDW 2020 Abstract, #Mo2010.

Bariatric surgery is a safe and effective means for obese patients with advanced heart failure supported by a left ventricular assist device to qualify for heart transplantation, Praneet Wander, MD, reported in an abstract released as part of the annual Digestive Disease Week®.

She presented a systematic review and meta-analysis of nine retrospective or cross-sectional cohort studies totaling 86 patients with a left ventricular assist device (LVAD) and advanced heart failure who had a mean body mass index (BMI) of 44.8 kg/m2 when they underwent bariatric surgery at an average age of 44 years and 33.2 kg/m2 at follow-up a mean of 14.3 months later.

Of the 86 patients, 50 (58%) were able to drop their BMI below 35, a requirement for inclusion on the heart transplant waiting list, noted Dr. Wander, a gastroenterology fellow at Hofstra University, Hempstead, N.Y., and North Shore LIJ Hospital in Manhasset, N.Y.

“A lot of bariatric surgeons don’t feel comfortable operating on patients who have a low ejection fraction,” she explained in an interview. “This study should encourage bariatric surgeons to do procedures even in patients with advanced heart failure so they can meet the BMI requirement for heart transplantation.”

Even if patients don’t actually undergo heart transplantation because of the perpetual donor organ shortage or inability to meet non–BMI-related eligibility criteria, they gain other major benefits from bariatric surgery: Their blood pressure goes down, their diabetes improves, and they become better able to engage in physical activity, she added.

Of the 86 patients in the meta-analysis, 84 underwent laparoscopic sleeve gastrectomy. That’s the preferred bariatric operation in patients with advanced heart failure at the Mayo Clinic as well, according to Andres J. Acosta, MD, PhD, a gastroenterologist at the medical center in Rochester, Minn.

There’s less weight loss achieved than with an open Roux-en-Y gastric bypass, but it’s a simpler operation in these high-risk patients, who typically have multiple comorbid conditions, he explained.

He predicted that Dr. Wander’s study will indeed influence bariatric surgeons at tertiary medical centers around the country to become more willing to consider weight-loss surgery in patients with advanced heart failure, while those in community practice will likely continue to be most comfortable operating on more stable patients with minimal comorbidities aside from their obesity.

“Data such as [these] will be reassuring to bariatric surgery programs such as ours, where we’re able to say: ‘Yes, there are risks, but these patients will benefit in the long term if we assume those risks,’ ” Dr. Acosta said.

He’s confident that, in the near future, the preferred form of bariatric surgery in patients with advanced heart failure will be a minimally invasive procedure performed endoscopically by gastroenterologists. He and his Mayo Clinic colleagues have already established a track record of success with endoscopic sleeve gastrectomy in patients with advanced kidney, liver, or lung disease in order to make them eligible for transplantation, as well as for the ancillary benefits provided by massive weight loss.

“There’s a little less weight loss than with laparoscopic sleeve gastrectomy, but it’s a significantly less risky operation. Shorter operative time, shorter hospital length of stay, less risk of infections and leaks,” he said in an interview. “We haven’t done it yet in heart disease, but I think based on this study this should be the next step at Mayo.”

Radha Gopalan, MD, director of heart failure and transplantation at Banner–University Medical Center in Phoenix, pronounced Dr. Wander’s meta-analysis “a positive study that’s very supportive of what we’re doing at our center.

“At a busy heart transplant center like ours, we are comfortable managing these patients, so the bariatric surgeons are reassured that the heart failure team is behind them. The risk of the procedure is mitigated by the availability of the multidisciplinary team to get the patient with obesity and heart failure through the surgery,” he explained.

Dr. Gopalan heads a novel bariatric heart failure program at Banner. While Dr. Wander’s meta-analysis focused on bariatric surgery in heart failure patients on LVAD circulatory support, Dr. Gopalan and colleagues are moving the intervention upstream. Roughly roughly 80% of patients in his bariatric heart failure program who meet criteria for LVAD implantation are now offered bariatric surgery before an LVAD is put in.

“I am moving away from putting the LVAD in first and then doing bariatric surgery. We have gotten comfortable taking these patients for bariatric surgery with inotropic support before going to the LVAD, which has the potential to even eliminate the requirement for an LVAD. Some patients get so much better that they become transplant ineligible,” Dr. Gopalan said.

Dr. Wander reported having no financial conflicts regarding her study, conducted free of commercial support.

SOURCE: Wander P. DDW 2020 Abstract, #Mo2010.

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Hazard pay included in new COVID-19 relief bill

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Hazard pay for frontline health care workers – an idea that has been championed by President Donald J. Trump and Senate Minority Leader Chuck Schumer, among others – is included in a just-released COVID-19 relief package assembled by Democrats in the House of Representatives.

The $3 trillion HEROES Act requests a reported $200 billion for a Heroes Fund that would award hazard pay to essential workers, including those in the health field, according to a report in the Washington Post.

But it is far from a done deal. “The Democrats’ spending bill is a Pelosi-led pipe dream written in private,” said House Republican Leader Kevin McCarthy (Calif.) in a Fox News interview posted May 12 on Facebook.

Senate Majority Leader Mitch McConnell condemned the package. “This is exactly the wrong approach,” he said in a prepared statement that instead laid out a variety of liability protections, which he said should be the first priority.

“We are not going to let health care heroes emerge from this crisis facing a tidal wave of medical malpractice lawsuits so that trial lawyers can line their pockets,” said Sen. McConnell, adding that his plan would “raise the liability threshold for COVID-related malpractice lawsuits.”

Ingrida Lusis, vice president of government affairs and health policy at the American Nurses Association, said in an interview that the ANA had lobbied for hazard pay and was told it would be in the next relief package.

“Though there is an inherent risk in the nursing profession, we think that this is really critical to ensuring that we have a workforce to meet the intense demands of this pandemic,” said Ms. Lusis.

“If health care workers are not treated and compensated appropriately for what they’re going through right now, then we may not have a next generation that will want to enter the field,” she said.

Various nursing organizations, nurses’ unions, and health care unions, such as the American Federation of State, County and Municipal Employees (AFSCME) and the Service Employees International Union, have advocated for hazard pay.

Physicians’ organizations have not been vocal on the issue, however. The American Medical Association, for instance, pushed for hazard pay for residents but has not made any further public statements. An AMA spokesman said that the group was monitoring the situation but declined further comment.

Multiple online petitions seeking hazard pay for health care workers have been circulated, including one seeking the same $600 bump for essential workers that was given out as part of unemployment benefits in the first COVID-19 relief package. More than 1.2 million had signed the petition as of May 12.
 

‘Heroes fund’

The president first suggested hazard pay for health care workers on March 30 Fox News broadcast. “These are really brave people,” he said, adding that the administration was considering different ways of boosting pay, primarily through hospitals.

“We are asking the hospitals to do it and to consider something, including bonuses,” said Trump. “If anybody’s entitled to it, they are.”

On April 7, Sen. Schumer proposed a “Heroes Fund.” It would give public, private, and tribal frontline employees – including doctors, nurses, first responders, and transit, grocery, and postal workers – a $13 per hour raise up to $25,000 in additional pay through Dec. 31 for workers earning up to $200,000 and $5,000 in additional pay for those earning more than $200,000. It would also provide a $15,000 signing bonus to those who agree to take on such a position.

Rep. Matt Cartwright (D-Pa.) introduced a bill in mid-April, the Coronavirus Frontline Workers Fair Pay Act (HR 6709), that would provide similar pay increases. Health care workers would receive an additional $13 per hour. It would be retroactive to Jan. 31, 2020, and would be available through the end of 2020.

Molly Kinder of the Brookings Institution, a self-described nonpartisan Washington policy institute, estimates that Sen. Schumer’s proposal would represent the equivalent of double-time pay for the average low-wage worker, a 50% pay increase for a mail carrier, a 20% boost for a pharmacist, and less than a 15% increase for a surgeon, as determined from median 2018 wages.

Before the House Democrats unveiled their bill, Isabel Soto of the center-right group American Action Forum estimated that a $13 per hour wage increase could cost $398.9 billion just from the end of March to the end of September. A great proportion of that amount – $264 billion – would go to some 10 million health care workers, Ms. Soto calculated.
 

 

 

Some already offering pay boost

A few states and hospital systems are already offering hazard pay.

On April 12, Massachusetts agreed to give about 6,500 AFSCME union members who work at state human services facilities and group homes a $5 or a $10 per hour pay increase, depending on duties. It was to stay in effect until at least May 30.

Maine Governor Janet Mills (D) also agreed to increase pay by $3-$5 an hour for AFSCME workers in state correctional and mental health facilities beginning March 29.

In New York City, the biggest hospital network, Northwell Health, in late April gave 45,000 workers – including nurses, physicians, respiratory therapists, environmental services workers, housekeepers, and people in outpatient and corporate roles – a lump sum bonus payment of up to $2,500 and 1 week of paid time off. The money came out of the system’s general fund.

“As an organization, we want to continue to support, motivate and inspire our team members,” said Northwell President and CEO Michael Dowling in a statement at the time.

On April 2, New York–Presbyterian Hospital’s chair of the department of surgery, Craig Smith, MD, announced that the facility was “providing a $1,250 bonus for everyone who has worked in or supported the COVID-19 front lines, for at least 1 week.”

Advocate Aurora, with 15 hospitals and 32,000 employees in Wisconsin, said in early April that it was giving increases of $6.25-$15.00 an hour at least through the end of May.

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

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Hazard pay for frontline health care workers – an idea that has been championed by President Donald J. Trump and Senate Minority Leader Chuck Schumer, among others – is included in a just-released COVID-19 relief package assembled by Democrats in the House of Representatives.

The $3 trillion HEROES Act requests a reported $200 billion for a Heroes Fund that would award hazard pay to essential workers, including those in the health field, according to a report in the Washington Post.

But it is far from a done deal. “The Democrats’ spending bill is a Pelosi-led pipe dream written in private,” said House Republican Leader Kevin McCarthy (Calif.) in a Fox News interview posted May 12 on Facebook.

Senate Majority Leader Mitch McConnell condemned the package. “This is exactly the wrong approach,” he said in a prepared statement that instead laid out a variety of liability protections, which he said should be the first priority.

“We are not going to let health care heroes emerge from this crisis facing a tidal wave of medical malpractice lawsuits so that trial lawyers can line their pockets,” said Sen. McConnell, adding that his plan would “raise the liability threshold for COVID-related malpractice lawsuits.”

Ingrida Lusis, vice president of government affairs and health policy at the American Nurses Association, said in an interview that the ANA had lobbied for hazard pay and was told it would be in the next relief package.

“Though there is an inherent risk in the nursing profession, we think that this is really critical to ensuring that we have a workforce to meet the intense demands of this pandemic,” said Ms. Lusis.

“If health care workers are not treated and compensated appropriately for what they’re going through right now, then we may not have a next generation that will want to enter the field,” she said.

Various nursing organizations, nurses’ unions, and health care unions, such as the American Federation of State, County and Municipal Employees (AFSCME) and the Service Employees International Union, have advocated for hazard pay.

Physicians’ organizations have not been vocal on the issue, however. The American Medical Association, for instance, pushed for hazard pay for residents but has not made any further public statements. An AMA spokesman said that the group was monitoring the situation but declined further comment.

Multiple online petitions seeking hazard pay for health care workers have been circulated, including one seeking the same $600 bump for essential workers that was given out as part of unemployment benefits in the first COVID-19 relief package. More than 1.2 million had signed the petition as of May 12.
 

‘Heroes fund’

The president first suggested hazard pay for health care workers on March 30 Fox News broadcast. “These are really brave people,” he said, adding that the administration was considering different ways of boosting pay, primarily through hospitals.

“We are asking the hospitals to do it and to consider something, including bonuses,” said Trump. “If anybody’s entitled to it, they are.”

On April 7, Sen. Schumer proposed a “Heroes Fund.” It would give public, private, and tribal frontline employees – including doctors, nurses, first responders, and transit, grocery, and postal workers – a $13 per hour raise up to $25,000 in additional pay through Dec. 31 for workers earning up to $200,000 and $5,000 in additional pay for those earning more than $200,000. It would also provide a $15,000 signing bonus to those who agree to take on such a position.

Rep. Matt Cartwright (D-Pa.) introduced a bill in mid-April, the Coronavirus Frontline Workers Fair Pay Act (HR 6709), that would provide similar pay increases. Health care workers would receive an additional $13 per hour. It would be retroactive to Jan. 31, 2020, and would be available through the end of 2020.

Molly Kinder of the Brookings Institution, a self-described nonpartisan Washington policy institute, estimates that Sen. Schumer’s proposal would represent the equivalent of double-time pay for the average low-wage worker, a 50% pay increase for a mail carrier, a 20% boost for a pharmacist, and less than a 15% increase for a surgeon, as determined from median 2018 wages.

Before the House Democrats unveiled their bill, Isabel Soto of the center-right group American Action Forum estimated that a $13 per hour wage increase could cost $398.9 billion just from the end of March to the end of September. A great proportion of that amount – $264 billion – would go to some 10 million health care workers, Ms. Soto calculated.
 

 

 

Some already offering pay boost

A few states and hospital systems are already offering hazard pay.

On April 12, Massachusetts agreed to give about 6,500 AFSCME union members who work at state human services facilities and group homes a $5 or a $10 per hour pay increase, depending on duties. It was to stay in effect until at least May 30.

Maine Governor Janet Mills (D) also agreed to increase pay by $3-$5 an hour for AFSCME workers in state correctional and mental health facilities beginning March 29.

In New York City, the biggest hospital network, Northwell Health, in late April gave 45,000 workers – including nurses, physicians, respiratory therapists, environmental services workers, housekeepers, and people in outpatient and corporate roles – a lump sum bonus payment of up to $2,500 and 1 week of paid time off. The money came out of the system’s general fund.

“As an organization, we want to continue to support, motivate and inspire our team members,” said Northwell President and CEO Michael Dowling in a statement at the time.

On April 2, New York–Presbyterian Hospital’s chair of the department of surgery, Craig Smith, MD, announced that the facility was “providing a $1,250 bonus for everyone who has worked in or supported the COVID-19 front lines, for at least 1 week.”

Advocate Aurora, with 15 hospitals and 32,000 employees in Wisconsin, said in early April that it was giving increases of $6.25-$15.00 an hour at least through the end of May.

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

Hazard pay for frontline health care workers – an idea that has been championed by President Donald J. Trump and Senate Minority Leader Chuck Schumer, among others – is included in a just-released COVID-19 relief package assembled by Democrats in the House of Representatives.

The $3 trillion HEROES Act requests a reported $200 billion for a Heroes Fund that would award hazard pay to essential workers, including those in the health field, according to a report in the Washington Post.

But it is far from a done deal. “The Democrats’ spending bill is a Pelosi-led pipe dream written in private,” said House Republican Leader Kevin McCarthy (Calif.) in a Fox News interview posted May 12 on Facebook.

Senate Majority Leader Mitch McConnell condemned the package. “This is exactly the wrong approach,” he said in a prepared statement that instead laid out a variety of liability protections, which he said should be the first priority.

“We are not going to let health care heroes emerge from this crisis facing a tidal wave of medical malpractice lawsuits so that trial lawyers can line their pockets,” said Sen. McConnell, adding that his plan would “raise the liability threshold for COVID-related malpractice lawsuits.”

Ingrida Lusis, vice president of government affairs and health policy at the American Nurses Association, said in an interview that the ANA had lobbied for hazard pay and was told it would be in the next relief package.

“Though there is an inherent risk in the nursing profession, we think that this is really critical to ensuring that we have a workforce to meet the intense demands of this pandemic,” said Ms. Lusis.

“If health care workers are not treated and compensated appropriately for what they’re going through right now, then we may not have a next generation that will want to enter the field,” she said.

Various nursing organizations, nurses’ unions, and health care unions, such as the American Federation of State, County and Municipal Employees (AFSCME) and the Service Employees International Union, have advocated for hazard pay.

Physicians’ organizations have not been vocal on the issue, however. The American Medical Association, for instance, pushed for hazard pay for residents but has not made any further public statements. An AMA spokesman said that the group was monitoring the situation but declined further comment.

Multiple online petitions seeking hazard pay for health care workers have been circulated, including one seeking the same $600 bump for essential workers that was given out as part of unemployment benefits in the first COVID-19 relief package. More than 1.2 million had signed the petition as of May 12.
 

‘Heroes fund’

The president first suggested hazard pay for health care workers on March 30 Fox News broadcast. “These are really brave people,” he said, adding that the administration was considering different ways of boosting pay, primarily through hospitals.

“We are asking the hospitals to do it and to consider something, including bonuses,” said Trump. “If anybody’s entitled to it, they are.”

On April 7, Sen. Schumer proposed a “Heroes Fund.” It would give public, private, and tribal frontline employees – including doctors, nurses, first responders, and transit, grocery, and postal workers – a $13 per hour raise up to $25,000 in additional pay through Dec. 31 for workers earning up to $200,000 and $5,000 in additional pay for those earning more than $200,000. It would also provide a $15,000 signing bonus to those who agree to take on such a position.

Rep. Matt Cartwright (D-Pa.) introduced a bill in mid-April, the Coronavirus Frontline Workers Fair Pay Act (HR 6709), that would provide similar pay increases. Health care workers would receive an additional $13 per hour. It would be retroactive to Jan. 31, 2020, and would be available through the end of 2020.

Molly Kinder of the Brookings Institution, a self-described nonpartisan Washington policy institute, estimates that Sen. Schumer’s proposal would represent the equivalent of double-time pay for the average low-wage worker, a 50% pay increase for a mail carrier, a 20% boost for a pharmacist, and less than a 15% increase for a surgeon, as determined from median 2018 wages.

Before the House Democrats unveiled their bill, Isabel Soto of the center-right group American Action Forum estimated that a $13 per hour wage increase could cost $398.9 billion just from the end of March to the end of September. A great proportion of that amount – $264 billion – would go to some 10 million health care workers, Ms. Soto calculated.
 

 

 

Some already offering pay boost

A few states and hospital systems are already offering hazard pay.

On April 12, Massachusetts agreed to give about 6,500 AFSCME union members who work at state human services facilities and group homes a $5 or a $10 per hour pay increase, depending on duties. It was to stay in effect until at least May 30.

Maine Governor Janet Mills (D) also agreed to increase pay by $3-$5 an hour for AFSCME workers in state correctional and mental health facilities beginning March 29.

In New York City, the biggest hospital network, Northwell Health, in late April gave 45,000 workers – including nurses, physicians, respiratory therapists, environmental services workers, housekeepers, and people in outpatient and corporate roles – a lump sum bonus payment of up to $2,500 and 1 week of paid time off. The money came out of the system’s general fund.

“As an organization, we want to continue to support, motivate and inspire our team members,” said Northwell President and CEO Michael Dowling in a statement at the time.

On April 2, New York–Presbyterian Hospital’s chair of the department of surgery, Craig Smith, MD, announced that the facility was “providing a $1,250 bonus for everyone who has worked in or supported the COVID-19 front lines, for at least 1 week.”

Advocate Aurora, with 15 hospitals and 32,000 employees in Wisconsin, said in early April that it was giving increases of $6.25-$15.00 an hour at least through the end of May.

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

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Summary of the IDSA guidelines on the diagnosis of COVID-19

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The Infectious Diseases Society of America (IDSA) recently issued guidelines on the diagnosis of COVID-19.

Courtesy NIAID-RML

These guidelines were developed using a rigorous evidence-based approach, the GRADE framework, which involved identifying the important questions that need to be addressed ahead of time and, later, integrating the best available evidence into the recommendations.

The Food and Drug Administration’s Emergency Use Authorization is useful for understanding any recommendations related to COVID-19 testing. Under usual FDA approval, a manufacturer has to submit data on the performance of a test in human subjects. Under the Emergency Use Authorization for development and approval of SARS-CoV-2 testing, approval is based on “acceptable analytical accuracy,” meaning that a test is assessed using manufactured reagents. The approved test is not tested in real-world clinical situations prior to FDA approval, and the test’s sensitivity and specificity are not well described.

IDSA formulated 15 recommendations, of which the most relevant to primary care clinicians are described and discussed below. The complete set of recommendations can be viewed on the IDSA website:

Recommendation 1

The IDSA panel recommends a SARS-CoV-2 nucleic acid amplification test in symptomatic individuals in the community suspected of having COVID-19, even when the clinical suspicion is low (strong recommendation, very low certainty of evidence). The panel placed a high value on accurate assessment of COVID-19 with the intent of minimizing overdiagnosis of COVID-19 using clinical diagnosis alone. Without testing, the rate of overdiagnosis ranges from 62% to 98%.

If patients are misdiagnosed as having COVID-19, they may spend unnecessary time in quarantine and then may stop taking appropriate safety precautions to protect themselves from infection.

Recommendation 2

The IDSA panel suggests collecting nasopharyngeal, or mid-turbinate or nasal swabs, rather than oropharyngeal swabs or saliva alone for SARS-CoV-2 RNA testing in symptomatic individuals with upper respiratory tract infection or influenza-like illness suspected of having COVID-19 (conditional recommendation, very low certainty of evidence).

The rationale for this recommendation is that comparative data showed a much lower sensitivity for oral sampling, compared with nasopharyngeal, mid-turbinate, or nasal sampling.

The average sensitivity of oral swabs is 56%, compared with nasopharyngeal at 97%, mid-turbinate at 100%, and nasal sampling at 95%. Given these test characteristics, there are far less false-negative tests with nasopharyngeal, mid-turbinate, and nasal swabs. Fewer false negatives means fewer instances of incorrectly telling COVID-19–positive patients that they do not have the illness. An exciting new area of testing that is being evaluated is saliva, which appears to have a sensitivity of 85%.

Dr. Neil Skolnik

Recommendation 3

The IDSA panel suggests that nasal and mid-turbinate swab specimens may be collected for SARS-CoV-2 RNA testing by either patients or health care providers in symptomatic individuals with upper respiratory tract infection or influenza-like illness suspected of having COVID-19 (conditional recommendation, low certainty of evidence).

This recommendation is particularly exciting because patient self-collection provides the potential for health care personnel to avoid exposure to infection, as can occur when health care personnel are swabbing a patient; this is ow testing has been done at most testing centers.

While the data are limited, it appears that patient self-collection of nasal or mid-turbinate swabs results in similar detection rates as occurs with health care personnel–collected nasopharyngeal swabs.

Recommendation 6

The IDSA panel suggests repeating viral RNA testing when the initial test is negative (versus performing a single test) in symptomatic individuals with an intermediate or high clinical suspicion of COVID-19 (conditional recommendation, low certainty of evidence).

Since none of the tests are perfect and any can have false negatives, the panel places a high value on detecting infection when present. If there is a low clinical likelihood of disease, the panel recommends not retesting. When the clinical likelihood of COVID-19 is moderate to high, in the event that the initial test is negative, the panel recommends retesting for COVID-19 1-2 days after the initial test.

Recommendation 8

The IDSA panel suggests SARS-CoV-2 RNA testing in asymptomatic individuals who are either known or suspected to have been exposed to COVID-19 (conditional recommendation, very low certainty of evidence).

For this recommendation, a known contact is defined as someone who has had direct contact with a confirmed case.

A suspected exposure occurs when someone is working or living in a congregate setting such as long-term care, a correctional facility, or a cruise ship in which there is an outbreak. The time frame during which to do post-exposure testing is five to seven days after the exposure.

Recommendation 10

The IDSA panel recommends direct SARS-CoV-2 RNA testing in asymptomatic individuals with no known contact with COVID-19 who are being hospitalized in areas with a high prevalence of COVID-19 in the community (conditional recommendation, very low certainty of evidence).

The idea is to do rapid testing to identify individuals entering the hospital either for other illnesses or for procedures, in order to be able to institute appropriate precautions and decrease the likelihood of nosocomial transmission and/or transmission to health care personnel. It is worth noting that the recommendations do not address testing in areas with a low or intermediate prevalence of COVID-19. In the absence of an official guideline-based-recommendation, the decision about testing needs to made by the local hospital system.

Recommendations 11, 12, and 13

The IDSA panel recommends SARS-CoV-2 RNA testing in immunocompromised asymptomatic individuals who are being admitted to the hospital and in asymptomatic individuals prior to receiving immunosuppressive therapy regardless of exposure to COVID-19. It is also recommended to test asymptomatic individuals planning to undergo major surgery.

The rationale for this recommendation is that patients who are to receive chemotherapy, other immunosuppressive procedures, or surgery are at high risk if they have COVID-19 and may be better off delaying the procedure.

Some additional issues were addressed, though not in the form of additional recommendations. It was clarified that some individuals remain nucleic acid positive after their symptoms resolve, and sometimes even after seroconversion. It is not clear if those individuals remain infectious to others. The recommendations did not address serologic testing for public health surveillance.
 

Dr. Skolnik is professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.

SOURCE: Hanson KE et al. Infectious Diseases Society of America guidelines on the diagnosis of COVID-19.




 

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The Infectious Diseases Society of America (IDSA) recently issued guidelines on the diagnosis of COVID-19.

Courtesy NIAID-RML

These guidelines were developed using a rigorous evidence-based approach, the GRADE framework, which involved identifying the important questions that need to be addressed ahead of time and, later, integrating the best available evidence into the recommendations.

The Food and Drug Administration’s Emergency Use Authorization is useful for understanding any recommendations related to COVID-19 testing. Under usual FDA approval, a manufacturer has to submit data on the performance of a test in human subjects. Under the Emergency Use Authorization for development and approval of SARS-CoV-2 testing, approval is based on “acceptable analytical accuracy,” meaning that a test is assessed using manufactured reagents. The approved test is not tested in real-world clinical situations prior to FDA approval, and the test’s sensitivity and specificity are not well described.

IDSA formulated 15 recommendations, of which the most relevant to primary care clinicians are described and discussed below. The complete set of recommendations can be viewed on the IDSA website:

Recommendation 1

The IDSA panel recommends a SARS-CoV-2 nucleic acid amplification test in symptomatic individuals in the community suspected of having COVID-19, even when the clinical suspicion is low (strong recommendation, very low certainty of evidence). The panel placed a high value on accurate assessment of COVID-19 with the intent of minimizing overdiagnosis of COVID-19 using clinical diagnosis alone. Without testing, the rate of overdiagnosis ranges from 62% to 98%.

If patients are misdiagnosed as having COVID-19, they may spend unnecessary time in quarantine and then may stop taking appropriate safety precautions to protect themselves from infection.

Recommendation 2

The IDSA panel suggests collecting nasopharyngeal, or mid-turbinate or nasal swabs, rather than oropharyngeal swabs or saliva alone for SARS-CoV-2 RNA testing in symptomatic individuals with upper respiratory tract infection or influenza-like illness suspected of having COVID-19 (conditional recommendation, very low certainty of evidence).

The rationale for this recommendation is that comparative data showed a much lower sensitivity for oral sampling, compared with nasopharyngeal, mid-turbinate, or nasal sampling.

The average sensitivity of oral swabs is 56%, compared with nasopharyngeal at 97%, mid-turbinate at 100%, and nasal sampling at 95%. Given these test characteristics, there are far less false-negative tests with nasopharyngeal, mid-turbinate, and nasal swabs. Fewer false negatives means fewer instances of incorrectly telling COVID-19–positive patients that they do not have the illness. An exciting new area of testing that is being evaluated is saliva, which appears to have a sensitivity of 85%.

Dr. Neil Skolnik

Recommendation 3

The IDSA panel suggests that nasal and mid-turbinate swab specimens may be collected for SARS-CoV-2 RNA testing by either patients or health care providers in symptomatic individuals with upper respiratory tract infection or influenza-like illness suspected of having COVID-19 (conditional recommendation, low certainty of evidence).

This recommendation is particularly exciting because patient self-collection provides the potential for health care personnel to avoid exposure to infection, as can occur when health care personnel are swabbing a patient; this is ow testing has been done at most testing centers.

While the data are limited, it appears that patient self-collection of nasal or mid-turbinate swabs results in similar detection rates as occurs with health care personnel–collected nasopharyngeal swabs.

Recommendation 6

The IDSA panel suggests repeating viral RNA testing when the initial test is negative (versus performing a single test) in symptomatic individuals with an intermediate or high clinical suspicion of COVID-19 (conditional recommendation, low certainty of evidence).

Since none of the tests are perfect and any can have false negatives, the panel places a high value on detecting infection when present. If there is a low clinical likelihood of disease, the panel recommends not retesting. When the clinical likelihood of COVID-19 is moderate to high, in the event that the initial test is negative, the panel recommends retesting for COVID-19 1-2 days after the initial test.

Recommendation 8

The IDSA panel suggests SARS-CoV-2 RNA testing in asymptomatic individuals who are either known or suspected to have been exposed to COVID-19 (conditional recommendation, very low certainty of evidence).

For this recommendation, a known contact is defined as someone who has had direct contact with a confirmed case.

A suspected exposure occurs when someone is working or living in a congregate setting such as long-term care, a correctional facility, or a cruise ship in which there is an outbreak. The time frame during which to do post-exposure testing is five to seven days after the exposure.

Recommendation 10

The IDSA panel recommends direct SARS-CoV-2 RNA testing in asymptomatic individuals with no known contact with COVID-19 who are being hospitalized in areas with a high prevalence of COVID-19 in the community (conditional recommendation, very low certainty of evidence).

The idea is to do rapid testing to identify individuals entering the hospital either for other illnesses or for procedures, in order to be able to institute appropriate precautions and decrease the likelihood of nosocomial transmission and/or transmission to health care personnel. It is worth noting that the recommendations do not address testing in areas with a low or intermediate prevalence of COVID-19. In the absence of an official guideline-based-recommendation, the decision about testing needs to made by the local hospital system.

Recommendations 11, 12, and 13

The IDSA panel recommends SARS-CoV-2 RNA testing in immunocompromised asymptomatic individuals who are being admitted to the hospital and in asymptomatic individuals prior to receiving immunosuppressive therapy regardless of exposure to COVID-19. It is also recommended to test asymptomatic individuals planning to undergo major surgery.

The rationale for this recommendation is that patients who are to receive chemotherapy, other immunosuppressive procedures, or surgery are at high risk if they have COVID-19 and may be better off delaying the procedure.

Some additional issues were addressed, though not in the form of additional recommendations. It was clarified that some individuals remain nucleic acid positive after their symptoms resolve, and sometimes even after seroconversion. It is not clear if those individuals remain infectious to others. The recommendations did not address serologic testing for public health surveillance.
 

Dr. Skolnik is professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.

SOURCE: Hanson KE et al. Infectious Diseases Society of America guidelines on the diagnosis of COVID-19.




 

The Infectious Diseases Society of America (IDSA) recently issued guidelines on the diagnosis of COVID-19.

Courtesy NIAID-RML

These guidelines were developed using a rigorous evidence-based approach, the GRADE framework, which involved identifying the important questions that need to be addressed ahead of time and, later, integrating the best available evidence into the recommendations.

The Food and Drug Administration’s Emergency Use Authorization is useful for understanding any recommendations related to COVID-19 testing. Under usual FDA approval, a manufacturer has to submit data on the performance of a test in human subjects. Under the Emergency Use Authorization for development and approval of SARS-CoV-2 testing, approval is based on “acceptable analytical accuracy,” meaning that a test is assessed using manufactured reagents. The approved test is not tested in real-world clinical situations prior to FDA approval, and the test’s sensitivity and specificity are not well described.

IDSA formulated 15 recommendations, of which the most relevant to primary care clinicians are described and discussed below. The complete set of recommendations can be viewed on the IDSA website:

Recommendation 1

The IDSA panel recommends a SARS-CoV-2 nucleic acid amplification test in symptomatic individuals in the community suspected of having COVID-19, even when the clinical suspicion is low (strong recommendation, very low certainty of evidence). The panel placed a high value on accurate assessment of COVID-19 with the intent of minimizing overdiagnosis of COVID-19 using clinical diagnosis alone. Without testing, the rate of overdiagnosis ranges from 62% to 98%.

If patients are misdiagnosed as having COVID-19, they may spend unnecessary time in quarantine and then may stop taking appropriate safety precautions to protect themselves from infection.

Recommendation 2

The IDSA panel suggests collecting nasopharyngeal, or mid-turbinate or nasal swabs, rather than oropharyngeal swabs or saliva alone for SARS-CoV-2 RNA testing in symptomatic individuals with upper respiratory tract infection or influenza-like illness suspected of having COVID-19 (conditional recommendation, very low certainty of evidence).

The rationale for this recommendation is that comparative data showed a much lower sensitivity for oral sampling, compared with nasopharyngeal, mid-turbinate, or nasal sampling.

The average sensitivity of oral swabs is 56%, compared with nasopharyngeal at 97%, mid-turbinate at 100%, and nasal sampling at 95%. Given these test characteristics, there are far less false-negative tests with nasopharyngeal, mid-turbinate, and nasal swabs. Fewer false negatives means fewer instances of incorrectly telling COVID-19–positive patients that they do not have the illness. An exciting new area of testing that is being evaluated is saliva, which appears to have a sensitivity of 85%.

Dr. Neil Skolnik

Recommendation 3

The IDSA panel suggests that nasal and mid-turbinate swab specimens may be collected for SARS-CoV-2 RNA testing by either patients or health care providers in symptomatic individuals with upper respiratory tract infection or influenza-like illness suspected of having COVID-19 (conditional recommendation, low certainty of evidence).

This recommendation is particularly exciting because patient self-collection provides the potential for health care personnel to avoid exposure to infection, as can occur when health care personnel are swabbing a patient; this is ow testing has been done at most testing centers.

While the data are limited, it appears that patient self-collection of nasal or mid-turbinate swabs results in similar detection rates as occurs with health care personnel–collected nasopharyngeal swabs.

Recommendation 6

The IDSA panel suggests repeating viral RNA testing when the initial test is negative (versus performing a single test) in symptomatic individuals with an intermediate or high clinical suspicion of COVID-19 (conditional recommendation, low certainty of evidence).

Since none of the tests are perfect and any can have false negatives, the panel places a high value on detecting infection when present. If there is a low clinical likelihood of disease, the panel recommends not retesting. When the clinical likelihood of COVID-19 is moderate to high, in the event that the initial test is negative, the panel recommends retesting for COVID-19 1-2 days after the initial test.

Recommendation 8

The IDSA panel suggests SARS-CoV-2 RNA testing in asymptomatic individuals who are either known or suspected to have been exposed to COVID-19 (conditional recommendation, very low certainty of evidence).

For this recommendation, a known contact is defined as someone who has had direct contact with a confirmed case.

A suspected exposure occurs when someone is working or living in a congregate setting such as long-term care, a correctional facility, or a cruise ship in which there is an outbreak. The time frame during which to do post-exposure testing is five to seven days after the exposure.

Recommendation 10

The IDSA panel recommends direct SARS-CoV-2 RNA testing in asymptomatic individuals with no known contact with COVID-19 who are being hospitalized in areas with a high prevalence of COVID-19 in the community (conditional recommendation, very low certainty of evidence).

The idea is to do rapid testing to identify individuals entering the hospital either for other illnesses or for procedures, in order to be able to institute appropriate precautions and decrease the likelihood of nosocomial transmission and/or transmission to health care personnel. It is worth noting that the recommendations do not address testing in areas with a low or intermediate prevalence of COVID-19. In the absence of an official guideline-based-recommendation, the decision about testing needs to made by the local hospital system.

Recommendations 11, 12, and 13

The IDSA panel recommends SARS-CoV-2 RNA testing in immunocompromised asymptomatic individuals who are being admitted to the hospital and in asymptomatic individuals prior to receiving immunosuppressive therapy regardless of exposure to COVID-19. It is also recommended to test asymptomatic individuals planning to undergo major surgery.

The rationale for this recommendation is that patients who are to receive chemotherapy, other immunosuppressive procedures, or surgery are at high risk if they have COVID-19 and may be better off delaying the procedure.

Some additional issues were addressed, though not in the form of additional recommendations. It was clarified that some individuals remain nucleic acid positive after their symptoms resolve, and sometimes even after seroconversion. It is not clear if those individuals remain infectious to others. The recommendations did not address serologic testing for public health surveillance.
 

Dr. Skolnik is professor of family and community medicine at the Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Jefferson Health.

SOURCE: Hanson KE et al. Infectious Diseases Society of America guidelines on the diagnosis of COVID-19.




 

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ER docs ask, “Where are our patients?”

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The COVID-19 pandemic is fraught with unexpected twists, among them a dramatic plunge in emergency department patient volumes, according to an expert panel on unanticipated consequences of pandemic care hosted by the presidents of the Society of Critical Care Medicine and the American College of Emergency Physicians.*

Dr. Donald M. Yealy

“At the peak of exposure to COVID-19 illness or infection, ED volumes in my system, which are really not much different from others across the country, were cut in half, if not more. And those changes happened across virtually every form of ED presentation, from the highest acuity to the lowest. We’re now beyond our highest level of exposure to COVID-19 clinically symptomatic patients in western Pennsylvania, but that recovery in volume hasn’t occurred yet, although there are some embers,” explained Donald M. Yealy, MD, professor and chair of the department of emergency medicine at the University of Pittsburgh.

He and other panelists also addressed some of the other unanticipated developments in the COVID-19 pandemic, including a recently recognized childhood manifestation called for now COVID-associated pediatric multisystem inflammatory syndrome, an anticipated massive second wave of non-COVID patients expected to present late to EDs and primary care clinics after having avoided needed medical care out of fear of infection, and the pandemic’s negative impact upon medical education.
 

Who’s not showing up in the ED

Dr. Yealy said that across the country, the number of patients arriving in EDs with acute ST-elevation MI, stroke, trauma, and other highest-acuity presentations is down substantially. But the volume of patients with more routine, bread-and-butter conditions typically seen in EDs is down even more.

“You might say, if I was designing from the insurance side, this is exactly what I’d hope for. I’ve heard that some people on the insurance-only side of the business really are experiencing a pretty good deal right now: They’re collecting premiums and not having to pay out on the ED or hospital side,” he said.
 

Tweaking the public health message on seeking medical care

Dr. Lewis J. Kaplan

“One of the unanticipated casualties of the pandemic are the patients who don’t have it. It will take a whole lot of work and coordinated effort to re-engage with those patients,” predicted SCCM President Lewis J. Kaplan, MD, professor of surgery at the University of Pennsylvania, Philadelphia.

Evie G. Marcolini, MD, described what she believes is necessary now: “We need to have a big focus on getting the word out to the public that acute MI, stroke, and other acute injuries are still a time-sensitive problem and they warrant at least a call to their physician or consideration of coming in to the ED.

Dr. Evie Marcolini

“I think when we started out, we were telling people, ‘Don’t come in.’ Now we’re trying to dial it back a little bit and say, ‘Listen, there are things you really do need to come in for. And we will keep you safe,’” said Dr. Marcolini, an emergency medicine and neurocritical care specialist at Dartmouth-Hitchcock Medical Center, Hanover, N.H.

“It is safe,” Dr. Yealy agreed. “The safest place in the world to be right now is the ED. Everybody’s cordoned off. There’s way more PPE [personal protective equipment]. There’s a level of precision now that should have existed but never did in our previous influenza seasons. So we have something very unique to offer, and we can put people’s minds at rest.”

He spoke of a coming “tsunami of untreated illness.”

“My concern is there is a significant subset of people who are not only eschewing ED care but staying away from their primary care provider. My fear is that we’re not as well aware of this,” he said. “Together with our primary care partners, we have to figure out ways to reach the people who are ignoring illnesses and injuries that they’re making long-term decisions about without realizing it. We have to find a way to reach those people and say it’s okay to reach for care.”

SCCM Immediate Past President Heatherlee Bailey, MD, also sees a problematic looming wave.

“I’m quite concerned about the coming second wave of non-COVID patients who’ve sat home with their worsening renal failure that’s gone from 2 to 5 because they’ve been taking a lot of NSAIDs, or the individual who’s had several TIAs that self-resolved, and we’ve missed an opportunity to prevent some significant disease. At some point they’re going to come back, and we need to figure out how to get these individuals hooked up with care, either through the ED or with their primary care provider, to prevent these potential bad outcomes,” said Dr. Bailey of the Durham (N.C.) Veterans Affairs Medical Center.
 

 

 

Interim guidance for pediatricians on an alarming new syndrome

Edward E. Conway Jr., MD, recalled that early in the U.S. pandemic, pediatricians felt a sense of relief that children appeared to be spared from severe COVID-19 disease. But, in just the past few weeks, a new syndrome has emerged. New York City has recorded more than 100 cases of what’s provisionally being called COVID-associated pediatric multisystem inflammatory syndrome. Dr. Conway and others are working with the Centers for Disease Control and Prevention to develop a case definition for the syndrome, first reported by pediatricians in Italy and the United Kingdom.

“We’re trying to get the word out to general pediatricians as to the common signs and symptoms that should prompt parents to bring their children in for medical care,” according to Dr. Conway, chief of pediatric critical care medicine and vice-chair of pediatrics at Jacobi Medical Center in New York.

Ninety percent of affected children have abdominal symptoms early on, including abdominal pain, diarrhea, emesis, or enteritis upon imaging. A nondescript rash, headache, conjunctivitis, and irritability are common, cough much less so – under 25%.

“The thought is that if any one of these is associated with a fever lasting more than 4 days, we suggest these children be brought in and seen by a pediatrician. We don’t have a formal guideline – we’re working on that – but basically the current recommendation is to screen them initially with a CBC with differential, a chem 10, and liver function tests, but also to look for inflammatory markers that we see in our COVID patients. We’ve been quite surprised: These patients have C-reactive proteins of about 240 mg/L on average, ferritin is quite high at around 1,200 ng/mL, and d-dimers of 2,300 ng/mL. We’ve also found very high brain natriuretic peptides and troponins in these patients,” according to Dr. Conway.

Analogies have been made between this COVID-19 pediatric syndrome and Kawasaki disease. Dr. Conway is unconvinced.

“This is quite different from Kawasaki in that these children are usually thrombocytopenic and usually present with DIC [disseminated intravascular coagulation], and the d-dimers are extraordinarily high, compared to what we’re used to seeing in pediatric patients,” he said.

Symptomatic children with laboratory red flags should be hospitalized. Most of the affected New York City children have recovered after 5 or 6 days in the pediatric ICU with empiric treatment using intravenous immunoglobulin (IVIG), corticosteroids, and/or interleukin-6 inhibitors. However, five recent deaths are now under study.

Dr. Yealy commented that this new pediatric syndrome is “really interesting,” but to date, it affects only a very small percentage of children, and children overall have been much less affected by the pandemic than are adults.

“The populations being disproportionately impacted are the elderly, the elderly, the elderly, and then other vulnerable populations, particularly congregants and the poor,” he said. “At my site, three-quarters of the patients coming in are either patients at assisted-living facilities or work at one of those congregant facilities.”
 

The pandemic’s impact on medical education

In many hospitals, grand rounds are being done virtually via videoconferencing, often with attendant challenges in asking and answering questions. Hospital patient volumes are diminished. Medical students aren’t coming in to do clinical rotations. Medical students and residents can’t travel to interview for future residencies or jobs.

“It’s affecting education across all of the components of medicine. It’s hard to say how long this pandemic is going to last. We’re all trying to be innovative in using online tools, but I believe it’s going to have a long-lasting effect on our education system,” Dr. Marcolini predicted.

Remote interface while working from home has become frustrating, especially during peak Internet use hours.

“It’s staggering how slow my home system has become in comparison to what’s wired at work. Now many times when you try to get into your work system from home, you time out while you’re waiting for the next piece of information to come across,” Dr. Kaplan commented.

All panel participants reported having no financial conflicts of interest.

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The COVID-19 pandemic is fraught with unexpected twists, among them a dramatic plunge in emergency department patient volumes, according to an expert panel on unanticipated consequences of pandemic care hosted by the presidents of the Society of Critical Care Medicine and the American College of Emergency Physicians.*

Dr. Donald M. Yealy

“At the peak of exposure to COVID-19 illness or infection, ED volumes in my system, which are really not much different from others across the country, were cut in half, if not more. And those changes happened across virtually every form of ED presentation, from the highest acuity to the lowest. We’re now beyond our highest level of exposure to COVID-19 clinically symptomatic patients in western Pennsylvania, but that recovery in volume hasn’t occurred yet, although there are some embers,” explained Donald M. Yealy, MD, professor and chair of the department of emergency medicine at the University of Pittsburgh.

He and other panelists also addressed some of the other unanticipated developments in the COVID-19 pandemic, including a recently recognized childhood manifestation called for now COVID-associated pediatric multisystem inflammatory syndrome, an anticipated massive second wave of non-COVID patients expected to present late to EDs and primary care clinics after having avoided needed medical care out of fear of infection, and the pandemic’s negative impact upon medical education.
 

Who’s not showing up in the ED

Dr. Yealy said that across the country, the number of patients arriving in EDs with acute ST-elevation MI, stroke, trauma, and other highest-acuity presentations is down substantially. But the volume of patients with more routine, bread-and-butter conditions typically seen in EDs is down even more.

“You might say, if I was designing from the insurance side, this is exactly what I’d hope for. I’ve heard that some people on the insurance-only side of the business really are experiencing a pretty good deal right now: They’re collecting premiums and not having to pay out on the ED or hospital side,” he said.
 

Tweaking the public health message on seeking medical care

Dr. Lewis J. Kaplan

“One of the unanticipated casualties of the pandemic are the patients who don’t have it. It will take a whole lot of work and coordinated effort to re-engage with those patients,” predicted SCCM President Lewis J. Kaplan, MD, professor of surgery at the University of Pennsylvania, Philadelphia.

Evie G. Marcolini, MD, described what she believes is necessary now: “We need to have a big focus on getting the word out to the public that acute MI, stroke, and other acute injuries are still a time-sensitive problem and they warrant at least a call to their physician or consideration of coming in to the ED.

Dr. Evie Marcolini

“I think when we started out, we were telling people, ‘Don’t come in.’ Now we’re trying to dial it back a little bit and say, ‘Listen, there are things you really do need to come in for. And we will keep you safe,’” said Dr. Marcolini, an emergency medicine and neurocritical care specialist at Dartmouth-Hitchcock Medical Center, Hanover, N.H.

“It is safe,” Dr. Yealy agreed. “The safest place in the world to be right now is the ED. Everybody’s cordoned off. There’s way more PPE [personal protective equipment]. There’s a level of precision now that should have existed but never did in our previous influenza seasons. So we have something very unique to offer, and we can put people’s minds at rest.”

He spoke of a coming “tsunami of untreated illness.”

“My concern is there is a significant subset of people who are not only eschewing ED care but staying away from their primary care provider. My fear is that we’re not as well aware of this,” he said. “Together with our primary care partners, we have to figure out ways to reach the people who are ignoring illnesses and injuries that they’re making long-term decisions about without realizing it. We have to find a way to reach those people and say it’s okay to reach for care.”

SCCM Immediate Past President Heatherlee Bailey, MD, also sees a problematic looming wave.

“I’m quite concerned about the coming second wave of non-COVID patients who’ve sat home with their worsening renal failure that’s gone from 2 to 5 because they’ve been taking a lot of NSAIDs, or the individual who’s had several TIAs that self-resolved, and we’ve missed an opportunity to prevent some significant disease. At some point they’re going to come back, and we need to figure out how to get these individuals hooked up with care, either through the ED or with their primary care provider, to prevent these potential bad outcomes,” said Dr. Bailey of the Durham (N.C.) Veterans Affairs Medical Center.
 

 

 

Interim guidance for pediatricians on an alarming new syndrome

Edward E. Conway Jr., MD, recalled that early in the U.S. pandemic, pediatricians felt a sense of relief that children appeared to be spared from severe COVID-19 disease. But, in just the past few weeks, a new syndrome has emerged. New York City has recorded more than 100 cases of what’s provisionally being called COVID-associated pediatric multisystem inflammatory syndrome. Dr. Conway and others are working with the Centers for Disease Control and Prevention to develop a case definition for the syndrome, first reported by pediatricians in Italy and the United Kingdom.

“We’re trying to get the word out to general pediatricians as to the common signs and symptoms that should prompt parents to bring their children in for medical care,” according to Dr. Conway, chief of pediatric critical care medicine and vice-chair of pediatrics at Jacobi Medical Center in New York.

Ninety percent of affected children have abdominal symptoms early on, including abdominal pain, diarrhea, emesis, or enteritis upon imaging. A nondescript rash, headache, conjunctivitis, and irritability are common, cough much less so – under 25%.

“The thought is that if any one of these is associated with a fever lasting more than 4 days, we suggest these children be brought in and seen by a pediatrician. We don’t have a formal guideline – we’re working on that – but basically the current recommendation is to screen them initially with a CBC with differential, a chem 10, and liver function tests, but also to look for inflammatory markers that we see in our COVID patients. We’ve been quite surprised: These patients have C-reactive proteins of about 240 mg/L on average, ferritin is quite high at around 1,200 ng/mL, and d-dimers of 2,300 ng/mL. We’ve also found very high brain natriuretic peptides and troponins in these patients,” according to Dr. Conway.

Analogies have been made between this COVID-19 pediatric syndrome and Kawasaki disease. Dr. Conway is unconvinced.

“This is quite different from Kawasaki in that these children are usually thrombocytopenic and usually present with DIC [disseminated intravascular coagulation], and the d-dimers are extraordinarily high, compared to what we’re used to seeing in pediatric patients,” he said.

Symptomatic children with laboratory red flags should be hospitalized. Most of the affected New York City children have recovered after 5 or 6 days in the pediatric ICU with empiric treatment using intravenous immunoglobulin (IVIG), corticosteroids, and/or interleukin-6 inhibitors. However, five recent deaths are now under study.

Dr. Yealy commented that this new pediatric syndrome is “really interesting,” but to date, it affects only a very small percentage of children, and children overall have been much less affected by the pandemic than are adults.

“The populations being disproportionately impacted are the elderly, the elderly, the elderly, and then other vulnerable populations, particularly congregants and the poor,” he said. “At my site, three-quarters of the patients coming in are either patients at assisted-living facilities or work at one of those congregant facilities.”
 

The pandemic’s impact on medical education

In many hospitals, grand rounds are being done virtually via videoconferencing, often with attendant challenges in asking and answering questions. Hospital patient volumes are diminished. Medical students aren’t coming in to do clinical rotations. Medical students and residents can’t travel to interview for future residencies or jobs.

“It’s affecting education across all of the components of medicine. It’s hard to say how long this pandemic is going to last. We’re all trying to be innovative in using online tools, but I believe it’s going to have a long-lasting effect on our education system,” Dr. Marcolini predicted.

Remote interface while working from home has become frustrating, especially during peak Internet use hours.

“It’s staggering how slow my home system has become in comparison to what’s wired at work. Now many times when you try to get into your work system from home, you time out while you’re waiting for the next piece of information to come across,” Dr. Kaplan commented.

All panel participants reported having no financial conflicts of interest.

The COVID-19 pandemic is fraught with unexpected twists, among them a dramatic plunge in emergency department patient volumes, according to an expert panel on unanticipated consequences of pandemic care hosted by the presidents of the Society of Critical Care Medicine and the American College of Emergency Physicians.*

Dr. Donald M. Yealy

“At the peak of exposure to COVID-19 illness or infection, ED volumes in my system, which are really not much different from others across the country, were cut in half, if not more. And those changes happened across virtually every form of ED presentation, from the highest acuity to the lowest. We’re now beyond our highest level of exposure to COVID-19 clinically symptomatic patients in western Pennsylvania, but that recovery in volume hasn’t occurred yet, although there are some embers,” explained Donald M. Yealy, MD, professor and chair of the department of emergency medicine at the University of Pittsburgh.

He and other panelists also addressed some of the other unanticipated developments in the COVID-19 pandemic, including a recently recognized childhood manifestation called for now COVID-associated pediatric multisystem inflammatory syndrome, an anticipated massive second wave of non-COVID patients expected to present late to EDs and primary care clinics after having avoided needed medical care out of fear of infection, and the pandemic’s negative impact upon medical education.
 

Who’s not showing up in the ED

Dr. Yealy said that across the country, the number of patients arriving in EDs with acute ST-elevation MI, stroke, trauma, and other highest-acuity presentations is down substantially. But the volume of patients with more routine, bread-and-butter conditions typically seen in EDs is down even more.

“You might say, if I was designing from the insurance side, this is exactly what I’d hope for. I’ve heard that some people on the insurance-only side of the business really are experiencing a pretty good deal right now: They’re collecting premiums and not having to pay out on the ED or hospital side,” he said.
 

Tweaking the public health message on seeking medical care

Dr. Lewis J. Kaplan

“One of the unanticipated casualties of the pandemic are the patients who don’t have it. It will take a whole lot of work and coordinated effort to re-engage with those patients,” predicted SCCM President Lewis J. Kaplan, MD, professor of surgery at the University of Pennsylvania, Philadelphia.

Evie G. Marcolini, MD, described what she believes is necessary now: “We need to have a big focus on getting the word out to the public that acute MI, stroke, and other acute injuries are still a time-sensitive problem and they warrant at least a call to their physician or consideration of coming in to the ED.

Dr. Evie Marcolini

“I think when we started out, we were telling people, ‘Don’t come in.’ Now we’re trying to dial it back a little bit and say, ‘Listen, there are things you really do need to come in for. And we will keep you safe,’” said Dr. Marcolini, an emergency medicine and neurocritical care specialist at Dartmouth-Hitchcock Medical Center, Hanover, N.H.

“It is safe,” Dr. Yealy agreed. “The safest place in the world to be right now is the ED. Everybody’s cordoned off. There’s way more PPE [personal protective equipment]. There’s a level of precision now that should have existed but never did in our previous influenza seasons. So we have something very unique to offer, and we can put people’s minds at rest.”

He spoke of a coming “tsunami of untreated illness.”

“My concern is there is a significant subset of people who are not only eschewing ED care but staying away from their primary care provider. My fear is that we’re not as well aware of this,” he said. “Together with our primary care partners, we have to figure out ways to reach the people who are ignoring illnesses and injuries that they’re making long-term decisions about without realizing it. We have to find a way to reach those people and say it’s okay to reach for care.”

SCCM Immediate Past President Heatherlee Bailey, MD, also sees a problematic looming wave.

“I’m quite concerned about the coming second wave of non-COVID patients who’ve sat home with their worsening renal failure that’s gone from 2 to 5 because they’ve been taking a lot of NSAIDs, or the individual who’s had several TIAs that self-resolved, and we’ve missed an opportunity to prevent some significant disease. At some point they’re going to come back, and we need to figure out how to get these individuals hooked up with care, either through the ED or with their primary care provider, to prevent these potential bad outcomes,” said Dr. Bailey of the Durham (N.C.) Veterans Affairs Medical Center.
 

 

 

Interim guidance for pediatricians on an alarming new syndrome

Edward E. Conway Jr., MD, recalled that early in the U.S. pandemic, pediatricians felt a sense of relief that children appeared to be spared from severe COVID-19 disease. But, in just the past few weeks, a new syndrome has emerged. New York City has recorded more than 100 cases of what’s provisionally being called COVID-associated pediatric multisystem inflammatory syndrome. Dr. Conway and others are working with the Centers for Disease Control and Prevention to develop a case definition for the syndrome, first reported by pediatricians in Italy and the United Kingdom.

“We’re trying to get the word out to general pediatricians as to the common signs and symptoms that should prompt parents to bring their children in for medical care,” according to Dr. Conway, chief of pediatric critical care medicine and vice-chair of pediatrics at Jacobi Medical Center in New York.

Ninety percent of affected children have abdominal symptoms early on, including abdominal pain, diarrhea, emesis, or enteritis upon imaging. A nondescript rash, headache, conjunctivitis, and irritability are common, cough much less so – under 25%.

“The thought is that if any one of these is associated with a fever lasting more than 4 days, we suggest these children be brought in and seen by a pediatrician. We don’t have a formal guideline – we’re working on that – but basically the current recommendation is to screen them initially with a CBC with differential, a chem 10, and liver function tests, but also to look for inflammatory markers that we see in our COVID patients. We’ve been quite surprised: These patients have C-reactive proteins of about 240 mg/L on average, ferritin is quite high at around 1,200 ng/mL, and d-dimers of 2,300 ng/mL. We’ve also found very high brain natriuretic peptides and troponins in these patients,” according to Dr. Conway.

Analogies have been made between this COVID-19 pediatric syndrome and Kawasaki disease. Dr. Conway is unconvinced.

“This is quite different from Kawasaki in that these children are usually thrombocytopenic and usually present with DIC [disseminated intravascular coagulation], and the d-dimers are extraordinarily high, compared to what we’re used to seeing in pediatric patients,” he said.

Symptomatic children with laboratory red flags should be hospitalized. Most of the affected New York City children have recovered after 5 or 6 days in the pediatric ICU with empiric treatment using intravenous immunoglobulin (IVIG), corticosteroids, and/or interleukin-6 inhibitors. However, five recent deaths are now under study.

Dr. Yealy commented that this new pediatric syndrome is “really interesting,” but to date, it affects only a very small percentage of children, and children overall have been much less affected by the pandemic than are adults.

“The populations being disproportionately impacted are the elderly, the elderly, the elderly, and then other vulnerable populations, particularly congregants and the poor,” he said. “At my site, three-quarters of the patients coming in are either patients at assisted-living facilities or work at one of those congregant facilities.”
 

The pandemic’s impact on medical education

In many hospitals, grand rounds are being done virtually via videoconferencing, often with attendant challenges in asking and answering questions. Hospital patient volumes are diminished. Medical students aren’t coming in to do clinical rotations. Medical students and residents can’t travel to interview for future residencies or jobs.

“It’s affecting education across all of the components of medicine. It’s hard to say how long this pandemic is going to last. We’re all trying to be innovative in using online tools, but I believe it’s going to have a long-lasting effect on our education system,” Dr. Marcolini predicted.

Remote interface while working from home has become frustrating, especially during peak Internet use hours.

“It’s staggering how slow my home system has become in comparison to what’s wired at work. Now many times when you try to get into your work system from home, you time out while you’re waiting for the next piece of information to come across,” Dr. Kaplan commented.

All panel participants reported having no financial conflicts of interest.

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