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COVID-19: Thromboembolic events high despite prophylaxis
in a new large observational U.S. study.
“Despite very high rate of antithrombotic prophylaxis there were a high rate of thromboembolic events suggesting that we are probably not providing enough thromboprophylaxis,” lead author Gregory Piazza, MD, Brigham and Women’s Hospital, Boston, said in an interview.
“Standard prophylaxis as recommended in the guidelines is a low dose of low-molecular-weight heparin once daily, but these results suggest [patients] probably need higher doses,” he added.
However, Dr. Piazza cautioned that this is an observational study and randomized trials are needed to make changes in treatment strategies. Several such trials are currently underway.
The current study was published online ahead of print in the Nov. 3 issue of the Journal of the American College of Cardiology.
Rates similar to other very sick patients
The study showed that while thromboembolic complications were high, they were not as high as seen in some of the earlier studies from Asia and Europe, Dr. Piazza noted.
“The numbers we were seeing in early reports were so high we couldn’t figure out how that was possible,” he said. “Our study suggests that, in a U.S. population receiving thromboprophylaxis, the rate of thromboembolic complications [are] more in line with what we would expect to see in other very sick patients who end up in ICU.”
He suggested that the very high rates of thromboembolic complications in the early studies from Asia may have been because of the lack of thromboprophylaxis, which is not routine in hospitalized patients there. “Some of the earlier studies also used routine ultrasound and so picked up asymptomatic thrombotic events, which was not the case in our study. So our results are more representative of the U.S. population.”
Dr. Piazza attributed the high rate of thromboembolic complications being reported with COVID-19 to the sheer number of very sick patients being admitted to the hospital.
“We are accustomed to seeing a rare case of thrombosis despite prophylaxis in hospitalized patients, but we are seeing more in COVID patients. This is probably just because we have more critically ill patients,” he said.
“We are seeing an incredible influx of patients to the ICU that we have never experienced before, so the increase in thromboembolic complications is more obvious. In prior years we probably haven’t had enough critically ill patients at any one time to raise the flag about thromboprophylaxis,” he commented.
The study also found a high rate of cardiovascular complications. They are seeing an increase in the risk of MI, which is to be expected in such sick patients, but they also see quite a bit of new atrial fibrillation, myocarditis, and heart failure in patients who don’t always have underlying cardiovascular disease, he said.
“So this virus does appear to have a predilection to causing cardiovascular complications, but this is probably because it is making patients so sick,” Dr. Piazza said. “If flu was this virulent and resulted in such high rates of acute respiratory distress syndrome (ARDS), we would probably see similar cardiovascular complication rates.”
For the current report, the researchers analyzed a retrospective cohort of 1,114 patients with COVID-19 diagnosed through the Mass General Brigham integrated health network. Of these, 170 had been admitted to the ICU, 229 had been hospitalized but not treated in ICU, and 715 were outpatients. In terms of ethnicity, 22% were Hispanic/Latino and 44% were non-White.
Cardiovascular risk factors were common, with 36% of patients having hypertension, 29% hyperlipidemia, and 18% diabetes. Prophylactic anticoagulation was prescribed in 89% of patients with COVID-19 in the intensive care cohort and 85% of those in the hospitalized non–intensive care setting.
Results showed that major arterial or venous thromboembolism (VTE) occurred in 35% of the intensive care cohort, 2.6% of those hospitalized but not treated in ICU, and 0% of outpatients.
Major adverse cardiovascular events occurred in 46% of the intensive care cohort, 6.1% of those hospitalized but non-ICU, and 0% of outpatients.
Symptomatic VTE occurred in 27% of those admitted to ICU, 2.2% of those hospitalized but non-ICU, and 0% of outpatients.
“We found that outpatients had a very low rate of thromboembolic complications, with the vast majority of the risk being in hospitalized patients, especially those in ICU,” Dr. Piazza said.
“These results suggest that we don’t need routine thromboprophylaxis for all outpatients with COVID-19, but there will probably be some patients who need it – those with risk factors for thromboembolism.”
Catheter- and device-associated deep vein thrombosis accounted for 76.9% of the DVTs observed in the study.
“Our finding of high frequency of catheter-associated DVT supports the judicious use of central venous catheters that have been widely implemented, especially in the ICU, to minimize recurrent health care team exposure and facilitate monitoring,” the researchers wrote.
ARDS biggest risk factor
Of all the markers of disease severity, the presence of ARDS had the strongest association with adverse outcomes, including major arterial or VTE, major adverse cardiovascular events, symptomatic VTE, and death.
“The severe inflammatory state associated with ARDS and other complications of COVID-19 and its resultant hypercoagulability may explain, at least in part, the high frequency of thromboembolic events. Improved risk stratification, utilizing biochemical markers of inflammation and activated coagulation as well as clinical indicators, such as ARDS, may play an important role in the early identification of patients with an increased likelihood of developing symptomatic VTE or arterial thrombosis,” the researchers wrote. “They may benefit from full- or intermediate-intensity antithrombotic therapy rather than prophylactic anticoagulation.”
They point out that this study provides a cross-sectional view of the cardiovascular complications of COVID-19 in a large health care network, consisting of two academic medical centers serving the greater Boston area, several community hospitals, and numerous outpatient care sites.
“The study incorporates a wide scope of clinically meaningful cardiovascular endpoints and utilizes a rigorous process of event adjudication. Although data on patients with COVID-19 in the ICU have been the subject of most reports, our study provides insights into the broad spectrum of all hospitalized and outpatient populations,” the authors noted.
“The high frequency of arterial or venous thromboembolism in hospitalized patients despite routine thromboprophylaxis suggests the need for improved risk stratification and enhanced preventive efforts,” they concluded.
The study is continuing, and the researchers expect to have data on 10,000 patients by the end of winter.
Wait for randomized trials
In an accompanying editorial, Robert McBane, MD, Mayo Clinic, Rochester, Minn., said that these data provide important real-world arterial and venous thrombotic event rates across a large, integrated health care network and an experienced roster of clinician-scientists devoted to thrombosis research.
Noting that whether to interpret these results as alarming or reassuring requires a comparison of expected thromboembolic event rates separate from the pandemic, he pointed out that, while the overall VTE rate among ICU patients was high, the vast majority of these events were attributable to central venous lines, and apart from these, the event rates do not appear inflated relative to prior published incidence rates from the pre–COVID-19 era.
“It is therefore important to resist the urge to overprevent or overtreat patients and expose them to the serious risks of major bleeding,” Dr. McBane wrote, adding that “the systematized approach to delivery of guideline-driven VTE prophylaxis across this large, integrated health network likely contributed to the relatively low rates of serious thrombotic outcomes reported.”
He further noted that, as the majority of VTE events were related to central venous lines in ICU patients, “this underscores the importance of a bundled care approach to central venous line management with daily assessment of the continued necessity of central access.
“A number of important clinical trials aimed at optimizing thromboprophylaxis during hospitalization, following hospital dismissal, and in ambulatory settings are underway. Until available, the lessons of thoughtful anticoagulant prophylaxis and treatment guidelines harvested from years of clinical research appear to apply,” he concluded.
This study was funded, in part, by a research grant from Janssen Pharmaceuticals. Dr. Piazza has received research grant support from EKOS Corporation, Bayer, Bristol-Myers Squibb/Pfizer, Portola Pharmaceuticals, and Janssen Pharmaceuticals; and has received consulting fees from Amgen, Pfizer, Boston Scientific, Agile, and Thrombolex. Dr. McBane reported no relevant disclosures.
A version of this article originally appeared on Medscape.com.
in a new large observational U.S. study.
“Despite very high rate of antithrombotic prophylaxis there were a high rate of thromboembolic events suggesting that we are probably not providing enough thromboprophylaxis,” lead author Gregory Piazza, MD, Brigham and Women’s Hospital, Boston, said in an interview.
“Standard prophylaxis as recommended in the guidelines is a low dose of low-molecular-weight heparin once daily, but these results suggest [patients] probably need higher doses,” he added.
However, Dr. Piazza cautioned that this is an observational study and randomized trials are needed to make changes in treatment strategies. Several such trials are currently underway.
The current study was published online ahead of print in the Nov. 3 issue of the Journal of the American College of Cardiology.
Rates similar to other very sick patients
The study showed that while thromboembolic complications were high, they were not as high as seen in some of the earlier studies from Asia and Europe, Dr. Piazza noted.
“The numbers we were seeing in early reports were so high we couldn’t figure out how that was possible,” he said. “Our study suggests that, in a U.S. population receiving thromboprophylaxis, the rate of thromboembolic complications [are] more in line with what we would expect to see in other very sick patients who end up in ICU.”
He suggested that the very high rates of thromboembolic complications in the early studies from Asia may have been because of the lack of thromboprophylaxis, which is not routine in hospitalized patients there. “Some of the earlier studies also used routine ultrasound and so picked up asymptomatic thrombotic events, which was not the case in our study. So our results are more representative of the U.S. population.”
Dr. Piazza attributed the high rate of thromboembolic complications being reported with COVID-19 to the sheer number of very sick patients being admitted to the hospital.
“We are accustomed to seeing a rare case of thrombosis despite prophylaxis in hospitalized patients, but we are seeing more in COVID patients. This is probably just because we have more critically ill patients,” he said.
“We are seeing an incredible influx of patients to the ICU that we have never experienced before, so the increase in thromboembolic complications is more obvious. In prior years we probably haven’t had enough critically ill patients at any one time to raise the flag about thromboprophylaxis,” he commented.
The study also found a high rate of cardiovascular complications. They are seeing an increase in the risk of MI, which is to be expected in such sick patients, but they also see quite a bit of new atrial fibrillation, myocarditis, and heart failure in patients who don’t always have underlying cardiovascular disease, he said.
“So this virus does appear to have a predilection to causing cardiovascular complications, but this is probably because it is making patients so sick,” Dr. Piazza said. “If flu was this virulent and resulted in such high rates of acute respiratory distress syndrome (ARDS), we would probably see similar cardiovascular complication rates.”
For the current report, the researchers analyzed a retrospective cohort of 1,114 patients with COVID-19 diagnosed through the Mass General Brigham integrated health network. Of these, 170 had been admitted to the ICU, 229 had been hospitalized but not treated in ICU, and 715 were outpatients. In terms of ethnicity, 22% were Hispanic/Latino and 44% were non-White.
Cardiovascular risk factors were common, with 36% of patients having hypertension, 29% hyperlipidemia, and 18% diabetes. Prophylactic anticoagulation was prescribed in 89% of patients with COVID-19 in the intensive care cohort and 85% of those in the hospitalized non–intensive care setting.
Results showed that major arterial or venous thromboembolism (VTE) occurred in 35% of the intensive care cohort, 2.6% of those hospitalized but not treated in ICU, and 0% of outpatients.
Major adverse cardiovascular events occurred in 46% of the intensive care cohort, 6.1% of those hospitalized but non-ICU, and 0% of outpatients.
Symptomatic VTE occurred in 27% of those admitted to ICU, 2.2% of those hospitalized but non-ICU, and 0% of outpatients.
“We found that outpatients had a very low rate of thromboembolic complications, with the vast majority of the risk being in hospitalized patients, especially those in ICU,” Dr. Piazza said.
“These results suggest that we don’t need routine thromboprophylaxis for all outpatients with COVID-19, but there will probably be some patients who need it – those with risk factors for thromboembolism.”
Catheter- and device-associated deep vein thrombosis accounted for 76.9% of the DVTs observed in the study.
“Our finding of high frequency of catheter-associated DVT supports the judicious use of central venous catheters that have been widely implemented, especially in the ICU, to minimize recurrent health care team exposure and facilitate monitoring,” the researchers wrote.
ARDS biggest risk factor
Of all the markers of disease severity, the presence of ARDS had the strongest association with adverse outcomes, including major arterial or VTE, major adverse cardiovascular events, symptomatic VTE, and death.
“The severe inflammatory state associated with ARDS and other complications of COVID-19 and its resultant hypercoagulability may explain, at least in part, the high frequency of thromboembolic events. Improved risk stratification, utilizing biochemical markers of inflammation and activated coagulation as well as clinical indicators, such as ARDS, may play an important role in the early identification of patients with an increased likelihood of developing symptomatic VTE or arterial thrombosis,” the researchers wrote. “They may benefit from full- or intermediate-intensity antithrombotic therapy rather than prophylactic anticoagulation.”
They point out that this study provides a cross-sectional view of the cardiovascular complications of COVID-19 in a large health care network, consisting of two academic medical centers serving the greater Boston area, several community hospitals, and numerous outpatient care sites.
“The study incorporates a wide scope of clinically meaningful cardiovascular endpoints and utilizes a rigorous process of event adjudication. Although data on patients with COVID-19 in the ICU have been the subject of most reports, our study provides insights into the broad spectrum of all hospitalized and outpatient populations,” the authors noted.
“The high frequency of arterial or venous thromboembolism in hospitalized patients despite routine thromboprophylaxis suggests the need for improved risk stratification and enhanced preventive efforts,” they concluded.
The study is continuing, and the researchers expect to have data on 10,000 patients by the end of winter.
Wait for randomized trials
In an accompanying editorial, Robert McBane, MD, Mayo Clinic, Rochester, Minn., said that these data provide important real-world arterial and venous thrombotic event rates across a large, integrated health care network and an experienced roster of clinician-scientists devoted to thrombosis research.
Noting that whether to interpret these results as alarming or reassuring requires a comparison of expected thromboembolic event rates separate from the pandemic, he pointed out that, while the overall VTE rate among ICU patients was high, the vast majority of these events were attributable to central venous lines, and apart from these, the event rates do not appear inflated relative to prior published incidence rates from the pre–COVID-19 era.
“It is therefore important to resist the urge to overprevent or overtreat patients and expose them to the serious risks of major bleeding,” Dr. McBane wrote, adding that “the systematized approach to delivery of guideline-driven VTE prophylaxis across this large, integrated health network likely contributed to the relatively low rates of serious thrombotic outcomes reported.”
He further noted that, as the majority of VTE events were related to central venous lines in ICU patients, “this underscores the importance of a bundled care approach to central venous line management with daily assessment of the continued necessity of central access.
“A number of important clinical trials aimed at optimizing thromboprophylaxis during hospitalization, following hospital dismissal, and in ambulatory settings are underway. Until available, the lessons of thoughtful anticoagulant prophylaxis and treatment guidelines harvested from years of clinical research appear to apply,” he concluded.
This study was funded, in part, by a research grant from Janssen Pharmaceuticals. Dr. Piazza has received research grant support from EKOS Corporation, Bayer, Bristol-Myers Squibb/Pfizer, Portola Pharmaceuticals, and Janssen Pharmaceuticals; and has received consulting fees from Amgen, Pfizer, Boston Scientific, Agile, and Thrombolex. Dr. McBane reported no relevant disclosures.
A version of this article originally appeared on Medscape.com.
in a new large observational U.S. study.
“Despite very high rate of antithrombotic prophylaxis there were a high rate of thromboembolic events suggesting that we are probably not providing enough thromboprophylaxis,” lead author Gregory Piazza, MD, Brigham and Women’s Hospital, Boston, said in an interview.
“Standard prophylaxis as recommended in the guidelines is a low dose of low-molecular-weight heparin once daily, but these results suggest [patients] probably need higher doses,” he added.
However, Dr. Piazza cautioned that this is an observational study and randomized trials are needed to make changes in treatment strategies. Several such trials are currently underway.
The current study was published online ahead of print in the Nov. 3 issue of the Journal of the American College of Cardiology.
Rates similar to other very sick patients
The study showed that while thromboembolic complications were high, they were not as high as seen in some of the earlier studies from Asia and Europe, Dr. Piazza noted.
“The numbers we were seeing in early reports were so high we couldn’t figure out how that was possible,” he said. “Our study suggests that, in a U.S. population receiving thromboprophylaxis, the rate of thromboembolic complications [are] more in line with what we would expect to see in other very sick patients who end up in ICU.”
He suggested that the very high rates of thromboembolic complications in the early studies from Asia may have been because of the lack of thromboprophylaxis, which is not routine in hospitalized patients there. “Some of the earlier studies also used routine ultrasound and so picked up asymptomatic thrombotic events, which was not the case in our study. So our results are more representative of the U.S. population.”
Dr. Piazza attributed the high rate of thromboembolic complications being reported with COVID-19 to the sheer number of very sick patients being admitted to the hospital.
“We are accustomed to seeing a rare case of thrombosis despite prophylaxis in hospitalized patients, but we are seeing more in COVID patients. This is probably just because we have more critically ill patients,” he said.
“We are seeing an incredible influx of patients to the ICU that we have never experienced before, so the increase in thromboembolic complications is more obvious. In prior years we probably haven’t had enough critically ill patients at any one time to raise the flag about thromboprophylaxis,” he commented.
The study also found a high rate of cardiovascular complications. They are seeing an increase in the risk of MI, which is to be expected in such sick patients, but they also see quite a bit of new atrial fibrillation, myocarditis, and heart failure in patients who don’t always have underlying cardiovascular disease, he said.
“So this virus does appear to have a predilection to causing cardiovascular complications, but this is probably because it is making patients so sick,” Dr. Piazza said. “If flu was this virulent and resulted in such high rates of acute respiratory distress syndrome (ARDS), we would probably see similar cardiovascular complication rates.”
For the current report, the researchers analyzed a retrospective cohort of 1,114 patients with COVID-19 diagnosed through the Mass General Brigham integrated health network. Of these, 170 had been admitted to the ICU, 229 had been hospitalized but not treated in ICU, and 715 were outpatients. In terms of ethnicity, 22% were Hispanic/Latino and 44% were non-White.
Cardiovascular risk factors were common, with 36% of patients having hypertension, 29% hyperlipidemia, and 18% diabetes. Prophylactic anticoagulation was prescribed in 89% of patients with COVID-19 in the intensive care cohort and 85% of those in the hospitalized non–intensive care setting.
Results showed that major arterial or venous thromboembolism (VTE) occurred in 35% of the intensive care cohort, 2.6% of those hospitalized but not treated in ICU, and 0% of outpatients.
Major adverse cardiovascular events occurred in 46% of the intensive care cohort, 6.1% of those hospitalized but non-ICU, and 0% of outpatients.
Symptomatic VTE occurred in 27% of those admitted to ICU, 2.2% of those hospitalized but non-ICU, and 0% of outpatients.
“We found that outpatients had a very low rate of thromboembolic complications, with the vast majority of the risk being in hospitalized patients, especially those in ICU,” Dr. Piazza said.
“These results suggest that we don’t need routine thromboprophylaxis for all outpatients with COVID-19, but there will probably be some patients who need it – those with risk factors for thromboembolism.”
Catheter- and device-associated deep vein thrombosis accounted for 76.9% of the DVTs observed in the study.
“Our finding of high frequency of catheter-associated DVT supports the judicious use of central venous catheters that have been widely implemented, especially in the ICU, to minimize recurrent health care team exposure and facilitate monitoring,” the researchers wrote.
ARDS biggest risk factor
Of all the markers of disease severity, the presence of ARDS had the strongest association with adverse outcomes, including major arterial or VTE, major adverse cardiovascular events, symptomatic VTE, and death.
“The severe inflammatory state associated with ARDS and other complications of COVID-19 and its resultant hypercoagulability may explain, at least in part, the high frequency of thromboembolic events. Improved risk stratification, utilizing biochemical markers of inflammation and activated coagulation as well as clinical indicators, such as ARDS, may play an important role in the early identification of patients with an increased likelihood of developing symptomatic VTE or arterial thrombosis,” the researchers wrote. “They may benefit from full- or intermediate-intensity antithrombotic therapy rather than prophylactic anticoagulation.”
They point out that this study provides a cross-sectional view of the cardiovascular complications of COVID-19 in a large health care network, consisting of two academic medical centers serving the greater Boston area, several community hospitals, and numerous outpatient care sites.
“The study incorporates a wide scope of clinically meaningful cardiovascular endpoints and utilizes a rigorous process of event adjudication. Although data on patients with COVID-19 in the ICU have been the subject of most reports, our study provides insights into the broad spectrum of all hospitalized and outpatient populations,” the authors noted.
“The high frequency of arterial or venous thromboembolism in hospitalized patients despite routine thromboprophylaxis suggests the need for improved risk stratification and enhanced preventive efforts,” they concluded.
The study is continuing, and the researchers expect to have data on 10,000 patients by the end of winter.
Wait for randomized trials
In an accompanying editorial, Robert McBane, MD, Mayo Clinic, Rochester, Minn., said that these data provide important real-world arterial and venous thrombotic event rates across a large, integrated health care network and an experienced roster of clinician-scientists devoted to thrombosis research.
Noting that whether to interpret these results as alarming or reassuring requires a comparison of expected thromboembolic event rates separate from the pandemic, he pointed out that, while the overall VTE rate among ICU patients was high, the vast majority of these events were attributable to central venous lines, and apart from these, the event rates do not appear inflated relative to prior published incidence rates from the pre–COVID-19 era.
“It is therefore important to resist the urge to overprevent or overtreat patients and expose them to the serious risks of major bleeding,” Dr. McBane wrote, adding that “the systematized approach to delivery of guideline-driven VTE prophylaxis across this large, integrated health network likely contributed to the relatively low rates of serious thrombotic outcomes reported.”
He further noted that, as the majority of VTE events were related to central venous lines in ICU patients, “this underscores the importance of a bundled care approach to central venous line management with daily assessment of the continued necessity of central access.
“A number of important clinical trials aimed at optimizing thromboprophylaxis during hospitalization, following hospital dismissal, and in ambulatory settings are underway. Until available, the lessons of thoughtful anticoagulant prophylaxis and treatment guidelines harvested from years of clinical research appear to apply,” he concluded.
This study was funded, in part, by a research grant from Janssen Pharmaceuticals. Dr. Piazza has received research grant support from EKOS Corporation, Bayer, Bristol-Myers Squibb/Pfizer, Portola Pharmaceuticals, and Janssen Pharmaceuticals; and has received consulting fees from Amgen, Pfizer, Boston Scientific, Agile, and Thrombolex. Dr. McBane reported no relevant disclosures.
A version of this article originally appeared on Medscape.com.
PICC lines often used inappropriately in advanced CKD patients
Background: PICC insertion is associated with risk for venous thrombosis and stenosis. National guidelines recommend avoiding PICC lines in patients with CKD stage 3b (glomerular filtration rate less than 45 mL/min per 1.73 m2) in order to preserve venous integrity for future creation of arteriovenous fistula, which is the ideal vascular access for hemodialysis.
Study design: Prospective cohort.
Setting: 52 hospitals in Michigan.
Synopsis: Data obtained from inpatients within the Michigan Hospital Medicine Safety Consortium between 2013 and 2016 showed that, of 20,545 total PICCs placed, 23% were placed in patients with a glomerular filtration rate less than 45 mL/min per 1.73 m2, and 3.2% were placed in those receiving dialysis. PICC placement in advanced CKD was more common in the ICU than in the ward setting, and placement more frequently utilized multilumen instead of single-lumen catheters. PICC-related complications were not more common in advanced CKD but were more often seen in the ICU and with multilumen PICCs. About one-quarter of PICCs were used for durations of less than 5 days.
The study is limited by lack of data in a subset of patients who had no documented GFR (2.7%) or missing covariate data (2.7%). The inability to ascertain other clinical information, such as nephrology approval of PICC, functional AV fistula or other hemodialysis access, or PICC complications after discharge further limit the findings.
Hospitalists should first decide if a PICC line is truly indicated, and if so, carefully weigh the risks and benefits of PICC placement in patients with advanced CKD.
Bottom line: PICC placement is common and often inappropriate in hospitalized patients with advanced CKD.
Citation: Paje D et al. Use of peripherally inserted central catheters in patients with advanced chronic kidney disease A prospective cohort study. Ann Intern Med. 2019 Jun 4;171:10-8.
Dr. Hageman is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.
Background: PICC insertion is associated with risk for venous thrombosis and stenosis. National guidelines recommend avoiding PICC lines in patients with CKD stage 3b (glomerular filtration rate less than 45 mL/min per 1.73 m2) in order to preserve venous integrity for future creation of arteriovenous fistula, which is the ideal vascular access for hemodialysis.
Study design: Prospective cohort.
Setting: 52 hospitals in Michigan.
Synopsis: Data obtained from inpatients within the Michigan Hospital Medicine Safety Consortium between 2013 and 2016 showed that, of 20,545 total PICCs placed, 23% were placed in patients with a glomerular filtration rate less than 45 mL/min per 1.73 m2, and 3.2% were placed in those receiving dialysis. PICC placement in advanced CKD was more common in the ICU than in the ward setting, and placement more frequently utilized multilumen instead of single-lumen catheters. PICC-related complications were not more common in advanced CKD but were more often seen in the ICU and with multilumen PICCs. About one-quarter of PICCs were used for durations of less than 5 days.
The study is limited by lack of data in a subset of patients who had no documented GFR (2.7%) or missing covariate data (2.7%). The inability to ascertain other clinical information, such as nephrology approval of PICC, functional AV fistula or other hemodialysis access, or PICC complications after discharge further limit the findings.
Hospitalists should first decide if a PICC line is truly indicated, and if so, carefully weigh the risks and benefits of PICC placement in patients with advanced CKD.
Bottom line: PICC placement is common and often inappropriate in hospitalized patients with advanced CKD.
Citation: Paje D et al. Use of peripherally inserted central catheters in patients with advanced chronic kidney disease A prospective cohort study. Ann Intern Med. 2019 Jun 4;171:10-8.
Dr. Hageman is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.
Background: PICC insertion is associated with risk for venous thrombosis and stenosis. National guidelines recommend avoiding PICC lines in patients with CKD stage 3b (glomerular filtration rate less than 45 mL/min per 1.73 m2) in order to preserve venous integrity for future creation of arteriovenous fistula, which is the ideal vascular access for hemodialysis.
Study design: Prospective cohort.
Setting: 52 hospitals in Michigan.
Synopsis: Data obtained from inpatients within the Michigan Hospital Medicine Safety Consortium between 2013 and 2016 showed that, of 20,545 total PICCs placed, 23% were placed in patients with a glomerular filtration rate less than 45 mL/min per 1.73 m2, and 3.2% were placed in those receiving dialysis. PICC placement in advanced CKD was more common in the ICU than in the ward setting, and placement more frequently utilized multilumen instead of single-lumen catheters. PICC-related complications were not more common in advanced CKD but were more often seen in the ICU and with multilumen PICCs. About one-quarter of PICCs were used for durations of less than 5 days.
The study is limited by lack of data in a subset of patients who had no documented GFR (2.7%) or missing covariate data (2.7%). The inability to ascertain other clinical information, such as nephrology approval of PICC, functional AV fistula or other hemodialysis access, or PICC complications after discharge further limit the findings.
Hospitalists should first decide if a PICC line is truly indicated, and if so, carefully weigh the risks and benefits of PICC placement in patients with advanced CKD.
Bottom line: PICC placement is common and often inappropriate in hospitalized patients with advanced CKD.
Citation: Paje D et al. Use of peripherally inserted central catheters in patients with advanced chronic kidney disease A prospective cohort study. Ann Intern Med. 2019 Jun 4;171:10-8.
Dr. Hageman is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.
OSA diagnoses not carried forward to the inpatient setting
Obstructive sleep apnea diagnoses may not be carried over to the inpatient setting, with potentially negative consequences for clinical outcomes, quality of life, and health care costs, an investigator said at the virtual meeting of the American College of Chest Physicians.
In a retrospective, single-center study, nearly 40% of patients with obstructive sleep apnea (OSA) diagnosed in the outpatient setting did not have a corresponding diagnosis during hospitalization, according to researcher Nitasa Sahu, MD.*
The missed OSA diagnoses could have especially negative implications for patients who don’t continue on positive airway pressure (PAP) therapy during the hospital stay, said Dr. Sahu, a fellow in pulmonary/critical care at St. Luke’s University Health Network in Bethlehem, Pa.
The finding indicates a large-magnitude opportunity to improve health care through better communication and optimized care, according to the researcher.
“Obstructive sleep apnea is underrecognized, it’s underdiagnosed, and it has a lot of implications for a patient’s hospitalization,” she said in interview
Clinical pathways should be set up to ensure that patients with OSA are properly identified and use their prescribed treatment, according to Dr. Sahu.
“I think that should, and would, reduce overall health care costs, with better outcomes as well,” she said.
Pulmonologist Saadia A. Faiz, MD, FCCP, said she hoped this study, presented at a late-breaking abstract at the virtual meeting, would highlight the importance of OSA screening and call attention to barriers to screening that may be in place in the inpatient setting.
That’s especially important because, after admission, the focus is often on the cause of admission rather than underlying comorbidities such as OSA, said Dr. Faiz, professor in the department of pulmonary medicine at the University of Texas MD Anderson Cancer Center in Houston.
“Working in a cancer hospital, the focus is always on the cancer, so sometimes even the patient will dismiss issues with their sleep,” Dr. Faiz said of her own experience in an interview.
“Often with sleep apnea, for people in the general population, the reason they seek medical attention is because their spouse notices that they’re snoring, so it is something that is not as emphasized,” added Dr. Faiz, who was not involved in the study.
In their study, Dr. Sahu and coauthors reviewed electronic health record data for adults hospitalized on the general internal medicine service at Penn State Hershey Medical Center from January 2017 through 2018. They restricted their search to first admissions.
The researchers looked for ICD-9 codes indicating an OSA diagnosis during their inpatient admission. They looked for the same codes in the preceding 5 years to see if the patients had a prior outpatient OSA diagnosis.
The inpatient cohort included 13,067 patients, of whom 53% were male, 87% were White, and 77% were over 50 years of age. Comorbidities included hypertension in 42%, atrial fibrillation in 21%, type 2 diabetes mellitus in 14%, congestive heart failure in 15%, and prior stroke in 0.5%.
A total of 991 individuals in the inpatient cohort had a prior outpatient OSA diagnosis. Of that group, 376 patients (38%) did not have an inpatient OSA diagnosis on inpatient record, according to the reported study data.
That large proportion of discordant diagnoses suggests a lot of missed opportunities to provide OSA therapy in the inpatient setting and to reinforce chronic disease state management, according to Dr. Sahu and colleagues.
How those discordant OSA diagnoses impact length of stay, cost of care, and readmissions are unanswered questions that deserve further study, Dr. Sahu said.
Among patients who did not have outpatient OSA diagnoses, another 804 patients, or about 6%, ended up with an inpatient diagnosis during their hospitalization, the researchers also reported.
While a number of those inpatient OSA diagnoses could have been coded in error, it’s also possible that they were indeed cases of OSA that went unrecognized until the individuals were hospitalized, Dr. Sahu said.
Dr. Sahu had no relevant relationships to report related to the study. One of four study coauthors reported relationships with Boehringer-Ingelheim, Nitto Denko, and Galapagos.
SOURCE: Sahu N. CHEST 2020. Abstract.
*Correction, 11/3/20: An earlier version of this article misstated the name of Nitasa Sahu, MD.
Obstructive sleep apnea diagnoses may not be carried over to the inpatient setting, with potentially negative consequences for clinical outcomes, quality of life, and health care costs, an investigator said at the virtual meeting of the American College of Chest Physicians.
In a retrospective, single-center study, nearly 40% of patients with obstructive sleep apnea (OSA) diagnosed in the outpatient setting did not have a corresponding diagnosis during hospitalization, according to researcher Nitasa Sahu, MD.*
The missed OSA diagnoses could have especially negative implications for patients who don’t continue on positive airway pressure (PAP) therapy during the hospital stay, said Dr. Sahu, a fellow in pulmonary/critical care at St. Luke’s University Health Network in Bethlehem, Pa.
The finding indicates a large-magnitude opportunity to improve health care through better communication and optimized care, according to the researcher.
“Obstructive sleep apnea is underrecognized, it’s underdiagnosed, and it has a lot of implications for a patient’s hospitalization,” she said in interview
Clinical pathways should be set up to ensure that patients with OSA are properly identified and use their prescribed treatment, according to Dr. Sahu.
“I think that should, and would, reduce overall health care costs, with better outcomes as well,” she said.
Pulmonologist Saadia A. Faiz, MD, FCCP, said she hoped this study, presented at a late-breaking abstract at the virtual meeting, would highlight the importance of OSA screening and call attention to barriers to screening that may be in place in the inpatient setting.
That’s especially important because, after admission, the focus is often on the cause of admission rather than underlying comorbidities such as OSA, said Dr. Faiz, professor in the department of pulmonary medicine at the University of Texas MD Anderson Cancer Center in Houston.
“Working in a cancer hospital, the focus is always on the cancer, so sometimes even the patient will dismiss issues with their sleep,” Dr. Faiz said of her own experience in an interview.
“Often with sleep apnea, for people in the general population, the reason they seek medical attention is because their spouse notices that they’re snoring, so it is something that is not as emphasized,” added Dr. Faiz, who was not involved in the study.
In their study, Dr. Sahu and coauthors reviewed electronic health record data for adults hospitalized on the general internal medicine service at Penn State Hershey Medical Center from January 2017 through 2018. They restricted their search to first admissions.
The researchers looked for ICD-9 codes indicating an OSA diagnosis during their inpatient admission. They looked for the same codes in the preceding 5 years to see if the patients had a prior outpatient OSA diagnosis.
The inpatient cohort included 13,067 patients, of whom 53% were male, 87% were White, and 77% were over 50 years of age. Comorbidities included hypertension in 42%, atrial fibrillation in 21%, type 2 diabetes mellitus in 14%, congestive heart failure in 15%, and prior stroke in 0.5%.
A total of 991 individuals in the inpatient cohort had a prior outpatient OSA diagnosis. Of that group, 376 patients (38%) did not have an inpatient OSA diagnosis on inpatient record, according to the reported study data.
That large proportion of discordant diagnoses suggests a lot of missed opportunities to provide OSA therapy in the inpatient setting and to reinforce chronic disease state management, according to Dr. Sahu and colleagues.
How those discordant OSA diagnoses impact length of stay, cost of care, and readmissions are unanswered questions that deserve further study, Dr. Sahu said.
Among patients who did not have outpatient OSA diagnoses, another 804 patients, or about 6%, ended up with an inpatient diagnosis during their hospitalization, the researchers also reported.
While a number of those inpatient OSA diagnoses could have been coded in error, it’s also possible that they were indeed cases of OSA that went unrecognized until the individuals were hospitalized, Dr. Sahu said.
Dr. Sahu had no relevant relationships to report related to the study. One of four study coauthors reported relationships with Boehringer-Ingelheim, Nitto Denko, and Galapagos.
SOURCE: Sahu N. CHEST 2020. Abstract.
*Correction, 11/3/20: An earlier version of this article misstated the name of Nitasa Sahu, MD.
Obstructive sleep apnea diagnoses may not be carried over to the inpatient setting, with potentially negative consequences for clinical outcomes, quality of life, and health care costs, an investigator said at the virtual meeting of the American College of Chest Physicians.
In a retrospective, single-center study, nearly 40% of patients with obstructive sleep apnea (OSA) diagnosed in the outpatient setting did not have a corresponding diagnosis during hospitalization, according to researcher Nitasa Sahu, MD.*
The missed OSA diagnoses could have especially negative implications for patients who don’t continue on positive airway pressure (PAP) therapy during the hospital stay, said Dr. Sahu, a fellow in pulmonary/critical care at St. Luke’s University Health Network in Bethlehem, Pa.
The finding indicates a large-magnitude opportunity to improve health care through better communication and optimized care, according to the researcher.
“Obstructive sleep apnea is underrecognized, it’s underdiagnosed, and it has a lot of implications for a patient’s hospitalization,” she said in interview
Clinical pathways should be set up to ensure that patients with OSA are properly identified and use their prescribed treatment, according to Dr. Sahu.
“I think that should, and would, reduce overall health care costs, with better outcomes as well,” she said.
Pulmonologist Saadia A. Faiz, MD, FCCP, said she hoped this study, presented at a late-breaking abstract at the virtual meeting, would highlight the importance of OSA screening and call attention to barriers to screening that may be in place in the inpatient setting.
That’s especially important because, after admission, the focus is often on the cause of admission rather than underlying comorbidities such as OSA, said Dr. Faiz, professor in the department of pulmonary medicine at the University of Texas MD Anderson Cancer Center in Houston.
“Working in a cancer hospital, the focus is always on the cancer, so sometimes even the patient will dismiss issues with their sleep,” Dr. Faiz said of her own experience in an interview.
“Often with sleep apnea, for people in the general population, the reason they seek medical attention is because their spouse notices that they’re snoring, so it is something that is not as emphasized,” added Dr. Faiz, who was not involved in the study.
In their study, Dr. Sahu and coauthors reviewed electronic health record data for adults hospitalized on the general internal medicine service at Penn State Hershey Medical Center from January 2017 through 2018. They restricted their search to first admissions.
The researchers looked for ICD-9 codes indicating an OSA diagnosis during their inpatient admission. They looked for the same codes in the preceding 5 years to see if the patients had a prior outpatient OSA diagnosis.
The inpatient cohort included 13,067 patients, of whom 53% were male, 87% were White, and 77% were over 50 years of age. Comorbidities included hypertension in 42%, atrial fibrillation in 21%, type 2 diabetes mellitus in 14%, congestive heart failure in 15%, and prior stroke in 0.5%.
A total of 991 individuals in the inpatient cohort had a prior outpatient OSA diagnosis. Of that group, 376 patients (38%) did not have an inpatient OSA diagnosis on inpatient record, according to the reported study data.
That large proportion of discordant diagnoses suggests a lot of missed opportunities to provide OSA therapy in the inpatient setting and to reinforce chronic disease state management, according to Dr. Sahu and colleagues.
How those discordant OSA diagnoses impact length of stay, cost of care, and readmissions are unanswered questions that deserve further study, Dr. Sahu said.
Among patients who did not have outpatient OSA diagnoses, another 804 patients, or about 6%, ended up with an inpatient diagnosis during their hospitalization, the researchers also reported.
While a number of those inpatient OSA diagnoses could have been coded in error, it’s also possible that they were indeed cases of OSA that went unrecognized until the individuals were hospitalized, Dr. Sahu said.
Dr. Sahu had no relevant relationships to report related to the study. One of four study coauthors reported relationships with Boehringer-Ingelheim, Nitto Denko, and Galapagos.
SOURCE: Sahu N. CHEST 2020. Abstract.
*Correction, 11/3/20: An earlier version of this article misstated the name of Nitasa Sahu, MD.
FROM CHEST 2020
How do you manage common inpatient oncologic emergencies?
Three routinely encountered emergencies in the inpatient setting
In 2016, there were an estimated 15,338,988 people living with cancer in the United States.1 As such, it is important that hospitalists be proficient in managing oncologic emergencies that can arise during the natural history of cancer or from its treatment. This article will review three emergencies that are routinely encountered in the inpatient setting: malignant spinal cord compression (MSCC), hypercalcemia of malignancy (HCM), and febrile neutropenia (FN).
Case
Mr. Williams is a 56-year-old man with newly diagnosed metastatic prostate cancer, diabetes mellitus, peptic ulcer disease, and hypertension. He is admitted with back pain and lower extremity weakness worsening over 2 weeks. He denies loss of sensation or bowel and bladder incontinence and can walk. MRI confirms cord compression at T10. What initial and subsequent steroid doses would be of most benefit to administer?
Malignant spinal cord compression
Treatment of MSCC usually aims to preserve function rather than reverse established deficits. MSCC from epidural tumor metastasis develops in 5%-14% of all cancer cases,2 with back pain as the most common symptom. Nearly 60%-85% of patients have weakness at the time of diagnosis,3 and unfortunately, nearly two-thirds of patients will be nonambulatory at presentation.
While timely steroid administration in addition to definitive treatment may maintain ambulatory capacity at 1 year after therapy,4 there is no consensus on the optimal loading and maintenance dose and duration of steroids.
Overview of the data
Although there are no formal guidelines on optimal steroid dosing for MSCC, it is common practice for dexamethasone to be initially dosed at 10 mg followed by 4 mg every 4-6 hours.5 The use of higher doses of dexamethasone may result in improvement in neurologic deficits, but has higher risks for toxicity and is not universally supported in the literature.
A study conducted by Vecht and colleagues demonstrated few differences between initial high-dose and low-dose dexamethasone.6 Intravenous administration of either 10 mg or 100 mg dexamethasone, both followed by total 16 mg of dexamethasone orally per day, showed no significant difference in mobility or survival between the groups.
In a prospective study by Heimdal and colleagues that evaluated the relationship between dexamethasone dose and toxicity, higher doses of steroids had no meaningful impact on neurological symptoms and resulted in more severe side effects.7 Patients were either given 96-mg IV loading dose, gradually tapered over 2 weeks, or enrolled in the low-dose group in which they received 4-mg IV dexamethasone four times per day with a taper over 2 weeks. The high-dose group experienced side effects in 28.6% of patients, with 14.3% experiencing serious side effects. Meanwhile, 7.9% of the low-dose group exhibited some side effects, with none experiencing serious adverse effects.The high-dose group did not experience a significant increase in mobility (57.1 vs. 57.9%).
Key takeaways
Dexamthasone 10-mg oral or IV followed by 4 mg every 4-6 hours until definitive treatment is started is associated with improved neurologic outcomes and minimal adverse side effects. Higher doses of steroids are unlikely to offer more benefit. In patients with paraplegia or autonomic dysfunction, the ability to restore neurologic function is reduced and the burdens of steroid treatment may outweigh its benefits.5
Case continued
Mr. Williams completed treatment for MSCC but was still complaining of extreme lethargy and noticed an increase in thirst and no bowel movement in 5 days. His serum calcium was 14 mg/dL.
Hypercalcemia of malignancy
HCM is the most common paraneoplastic syndrome, observed in nearly 30% of patients with advanced cancer. It is a poor prognostic indicator, and approximately half of all patients with HCM will die within 30 days.8 Cancer is the most common reason for hypercalcemia in the inpatient setting9 and is most often associated with multiple myeloma, non–small cell lung cancer, breast cancer, renal cell carcinoma, non-Hodgkins lymphoma, and leukemia.
Hypercalcemia most often presents with cognitive changes and lethargy, anorexia, nausea, constipation, polyuria and polydipsia, and renal failure. Bradycardia and shortened QT interval are seen more with severe hypercalcemia.
Management of hypercalcemia of malignancy
Management of HCM depends on corrected calcium or ionized calcium levels, chronicity, degree of symptoms, and presence of renal failure. In general, mild asymptomatic hypercalcemia can be managed with outpatient care. Serum calcium greater than 14 mg/dL should be treated regardless of symptoms (Table 1).
For mild to moderate HCM, management involves saline administration to achieve euvolemia and calcitonin, which has temporizing effects. Early administration of IV bisphosphonates for moderate to severe HCM is beneficial because onset of action is 24-48 hours. Furosemide for management of HCM has fallen out of favor unless the patient develops hypervolemia. Denosumab has been Food and Drug Administration–approved for HCM refractory to bisphosphonate therapy and can manage HCM in 64% of patients who did not respond adequately to bisphosphonate therapy.10 Because it can be used in advanced renal failure without dose adjustment, it is first-line therapy in this population, although the risk for hypocalcemia is increased in renal failure. For patients with serum calcium greater than 18 mg/dL, worsening renal failure, or inability to tolerate IV fluids, dialysis with a low-calcium bath should be considered (Table 2).
Zoledronic acid versus pamidronate
A single dose of zoledronic acid normalizes the serum calcium concentration in 88% of patients, compared with 70% of those who received pamidronate, in a pooled analysis of two phase 3 trials.11 The median duration of normocalcemia was longer for those receiving zoledronic acid (32-43 days vs. 18 days). The efficacy of the 4-mg and 8-mg zoledronic acid doses were similar, but the 4-mg dose was recommended because of renal toxicity and increased mortality associated with the higher dose.Despite this data, many specialists maintain that pamidronate, which is less expensive, is of similar clinical efficacy to ZA.12
Key takeaways
Management of HCM should be determined by the severity of the calcium level. The mainstay of treatment includes hydration with normal saline, calcitonin ,and bisphosphonate therapy; zoledronic acid is preferred over pamidronate. For patients refractory to bisphosphonates or patients with renal insufficiency, denosumab should be used.
Case continued: Febrile neutropenia
Febrile neutropenia is defined as a single oral temperature of 100.9° F or a temperature of 100.4° F sustained over a 1-hour period in a patient with absolute neutrophil count (ANC) less than 1,000 cells/mL or ANC expected to decrease to less than 500 cells/mL within a 48-hour period.13 Up to 30% of patients with solid tumors develop febrile neutropenia after chemotherapy, and nearly 80% of patients with hematologic malignancy or after hematopoietic stem cell therapy (HSCT) experience it.
Even though an infectious etiology is identified in only 30%-40% of cases, all patients with febrile neutropenia should initially receive at least empiric gram-negative coverage. The mortality rate is nearly 70% in neutropenic patients who do not receive empiric antibiotics and is reduced to 4%-20% with antibiotics.14
Risk stratification for febrile neutropenia and early discharge
Talcott’s Rules, the Multinational Association for Supportive Care in Cancer (MASCC) score, and the Clinical Index of Stable Febrile Neutropenia (CISNE) are validated tools to determine low-risk febrile neutropenia patients (Tables 3 and 4). The Infectious Diseases Society of America guidelines validated the use of MASCC in 2002 but found that CISNE had better performance than other tools. Coyne and colleagues conducted a retrospective cohort study to assess these two risk stratification tools in the ED and found that the CISNE was 98.3% specific for identifying adverse outcomes, whereas the MASCC was 54.2% specific.15
A study by Talcott and colleagues used Talcott’s Rules to identify low-risk febrile neutropenia patients, who were randomized to early discharge with home intravenous antibiotics versus continued inpatient management. There were no significant differences in the primary outcomes, defined as any change in clinical status requiring medical evaluation.16 Another study suggested that discharge after 24 hours based on clinical stability with outpatient oral antibiotics were noninferior to standard inpatient and intravenous antibiotic therapy.17 A Cochrane review in 2013 of 22 randomized controlled trials determined that oral antibiotics were an acceptable treatment for low-risk patients.18
Key takeaways
Though the MASCC is highly sensitive in identifying low-risk febrile neutropenia patients, it should be used with clinical caution because up to 11% of patients characterized as low risk developed severe complications.19 If a low-risk patient with solid tumor malignancy has adequate home support, lives within an hour of the hospital, and has access to follow-up within 72 hours, oral antibiotics and early discharge can be considered.
Dr. Chokshi is assistant professor in the division of hospital medicine at Mount Sinai Hospital, New York. Dr. Smith is associate professor in the division of hematology/oncology at Mount Sinai Hospital.
QUIZ
Mrs. Smith is a 64-year-old woman with endometrial cancer with temperature of 100.4° F at home. She takes no antibiotics, has no other medical history, and was sent in from clinic and admitted for further management. She feels well, and preliminary infectious workup is negative. She has been afebrile for more than 24 hours, and her ANC is 600 cells/mL.
Her son’s soccer game is tomorrow, and she would like to be present. Her family is involved in her care. Under what conditions can she be discharged?
A. She should not be discharged until full course of empiric intravenous antibiotics is completed.
B. Consider discharge in another 24 hours if she remains afebrile.
C. Discharge if low risk by MASCC or CISNE, with oral doses of levofloxacin or moxifloxacin or oral ciprofloxacin and amoxicillin/clavulanic acid.
Answer: C. The patient has a solid tumor malignancy, is low risk by both MASCC and CISNE, and can most likely be discharged if she is clinically stable or improved. A 7-day course of antibiotics is recommended with close follow-up.
References
1. SEER. Cancer of Any Site - Cancer Stat Facts. https://seer.cancer.gov/statfacts/html/all.html. Accessed 2019 Jul 17.
2. Kwok Y et al. Clinical Approach to Metastatic Epidural Spinal Cord Compression. Hematol Oncol Clin North Am. 2006;20(6):1297-305.
3. Helweg-Larsen S et al. Prognostic factors in metastatic spinal cord compression: a prospective study using multivariate analysis of variables influencing survival and gait function in 153 patients. Int J Radiat Oncol Biol Phys. 2000;46(5):1163-9.
4. Sørensen P et al. Effect of high-dose dexamethasone in carcinomatous metastatic spinal cord compression treated with radiotherapy: A randomised trial. Eur J Cancer. 1994;30(1):22-7.
5. Skeoch G et al. Corticosteroid treatment for metastatic spinal cord compression: A review. Global Spine J. 2017;7(3):272-9.
6. Vecht C et al. Initial bolus of conventional versus high-dose dexamethasone in metastatic spinal cord compression. Neurology. 1989;39(9):1255-7.
7. Heimdal K et al. High incidence of serious side effects of high-dose dexamethasone treatment in patients with epidural spinal cord compression. J Neurooncol. 1992;12(2):141-4.
8. Ralston S et al. Cancer-associated hypercalcemia: Morbidity and mortality. Clinical experience in 126 treated patients. Ann Intern Med. 1990;112(7):499-504.
9. Lindner G et al. Hypercalcemia in the ED: Prevalence, etiology, and outcome. Am J Emerg Med. 2013;31(4):657-60.
10. Hu M et al. Denosumab for patients with persistent or relapsed hypercalcemia of malignancy despite recent bisphosphonate treatment. J Natl Cancer Inst. 2013;105(18):1417-20.
11. Major P et al. Zoledronic acid is superior to pamidronate in the treatment of hypercalcemia of malignancy: A pooled analysis of two randomized, controlled clinical trials. J Clin Oncol. 2001;19(2):558-67.
12. Stewart A. Clinical practice. Hypercalcemia associated with cancer. N Engl J Med. 2005;352(4):373-9.
13. Freifeld A et al. Executive summary: Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the Infectious Diseases Society of America. Clin Infect Dis. 2011;52(4):427-31.
14. Baden L et al. Prevention and treatment of cancer-related infections, version 2.2016, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2016;14(7):882-913.
15. Coyne C et al. Application of the MASCC and CISNE risk-stratification scores to identify low-risk febrile neutropenic patients in the emergency department. Ann Emerg Med. 2017;69(6):755-64.
16. Talcott J et al. Safety of early discharge for low-risk patients with febrile neutropenia: a multicenter randomized controlled trial. J Clin Oncol. 2011;29(30):3977-83.
17. Innes H et al. Oral antibiotics with early hospital discharge compared with in-patient intravenous antibiotics for low-risk febrile neutropenia in patients with cancer: A prospective randomised controlled single centre study. Br J Cancer. 2003;89(1):43-9.
18. Vidal L, et al. Oral versus intravenous antibiotic treatment for febrile neutropenia in cancer patients. Cochrane Database Syst. Rev. 2013.
19. Taplitz RA et al. Outpatient management of fever and neutropenia in adults treated for malignancy: American Society of Clinical Oncology and Infectious Diseases Society of America clinical practice guideline update. J Clin Oncol. 2018;36(14):1443-53.
Three routinely encountered emergencies in the inpatient setting
Three routinely encountered emergencies in the inpatient setting
In 2016, there were an estimated 15,338,988 people living with cancer in the United States.1 As such, it is important that hospitalists be proficient in managing oncologic emergencies that can arise during the natural history of cancer or from its treatment. This article will review three emergencies that are routinely encountered in the inpatient setting: malignant spinal cord compression (MSCC), hypercalcemia of malignancy (HCM), and febrile neutropenia (FN).
Case
Mr. Williams is a 56-year-old man with newly diagnosed metastatic prostate cancer, diabetes mellitus, peptic ulcer disease, and hypertension. He is admitted with back pain and lower extremity weakness worsening over 2 weeks. He denies loss of sensation or bowel and bladder incontinence and can walk. MRI confirms cord compression at T10. What initial and subsequent steroid doses would be of most benefit to administer?
Malignant spinal cord compression
Treatment of MSCC usually aims to preserve function rather than reverse established deficits. MSCC from epidural tumor metastasis develops in 5%-14% of all cancer cases,2 with back pain as the most common symptom. Nearly 60%-85% of patients have weakness at the time of diagnosis,3 and unfortunately, nearly two-thirds of patients will be nonambulatory at presentation.
While timely steroid administration in addition to definitive treatment may maintain ambulatory capacity at 1 year after therapy,4 there is no consensus on the optimal loading and maintenance dose and duration of steroids.
Overview of the data
Although there are no formal guidelines on optimal steroid dosing for MSCC, it is common practice for dexamethasone to be initially dosed at 10 mg followed by 4 mg every 4-6 hours.5 The use of higher doses of dexamethasone may result in improvement in neurologic deficits, but has higher risks for toxicity and is not universally supported in the literature.
A study conducted by Vecht and colleagues demonstrated few differences between initial high-dose and low-dose dexamethasone.6 Intravenous administration of either 10 mg or 100 mg dexamethasone, both followed by total 16 mg of dexamethasone orally per day, showed no significant difference in mobility or survival between the groups.
In a prospective study by Heimdal and colleagues that evaluated the relationship between dexamethasone dose and toxicity, higher doses of steroids had no meaningful impact on neurological symptoms and resulted in more severe side effects.7 Patients were either given 96-mg IV loading dose, gradually tapered over 2 weeks, or enrolled in the low-dose group in which they received 4-mg IV dexamethasone four times per day with a taper over 2 weeks. The high-dose group experienced side effects in 28.6% of patients, with 14.3% experiencing serious side effects. Meanwhile, 7.9% of the low-dose group exhibited some side effects, with none experiencing serious adverse effects.The high-dose group did not experience a significant increase in mobility (57.1 vs. 57.9%).
Key takeaways
Dexamthasone 10-mg oral or IV followed by 4 mg every 4-6 hours until definitive treatment is started is associated with improved neurologic outcomes and minimal adverse side effects. Higher doses of steroids are unlikely to offer more benefit. In patients with paraplegia or autonomic dysfunction, the ability to restore neurologic function is reduced and the burdens of steroid treatment may outweigh its benefits.5
Case continued
Mr. Williams completed treatment for MSCC but was still complaining of extreme lethargy and noticed an increase in thirst and no bowel movement in 5 days. His serum calcium was 14 mg/dL.
Hypercalcemia of malignancy
HCM is the most common paraneoplastic syndrome, observed in nearly 30% of patients with advanced cancer. It is a poor prognostic indicator, and approximately half of all patients with HCM will die within 30 days.8 Cancer is the most common reason for hypercalcemia in the inpatient setting9 and is most often associated with multiple myeloma, non–small cell lung cancer, breast cancer, renal cell carcinoma, non-Hodgkins lymphoma, and leukemia.
Hypercalcemia most often presents with cognitive changes and lethargy, anorexia, nausea, constipation, polyuria and polydipsia, and renal failure. Bradycardia and shortened QT interval are seen more with severe hypercalcemia.
Management of hypercalcemia of malignancy
Management of HCM depends on corrected calcium or ionized calcium levels, chronicity, degree of symptoms, and presence of renal failure. In general, mild asymptomatic hypercalcemia can be managed with outpatient care. Serum calcium greater than 14 mg/dL should be treated regardless of symptoms (Table 1).
For mild to moderate HCM, management involves saline administration to achieve euvolemia and calcitonin, which has temporizing effects. Early administration of IV bisphosphonates for moderate to severe HCM is beneficial because onset of action is 24-48 hours. Furosemide for management of HCM has fallen out of favor unless the patient develops hypervolemia. Denosumab has been Food and Drug Administration–approved for HCM refractory to bisphosphonate therapy and can manage HCM in 64% of patients who did not respond adequately to bisphosphonate therapy.10 Because it can be used in advanced renal failure without dose adjustment, it is first-line therapy in this population, although the risk for hypocalcemia is increased in renal failure. For patients with serum calcium greater than 18 mg/dL, worsening renal failure, or inability to tolerate IV fluids, dialysis with a low-calcium bath should be considered (Table 2).
Zoledronic acid versus pamidronate
A single dose of zoledronic acid normalizes the serum calcium concentration in 88% of patients, compared with 70% of those who received pamidronate, in a pooled analysis of two phase 3 trials.11 The median duration of normocalcemia was longer for those receiving zoledronic acid (32-43 days vs. 18 days). The efficacy of the 4-mg and 8-mg zoledronic acid doses were similar, but the 4-mg dose was recommended because of renal toxicity and increased mortality associated with the higher dose.Despite this data, many specialists maintain that pamidronate, which is less expensive, is of similar clinical efficacy to ZA.12
Key takeaways
Management of HCM should be determined by the severity of the calcium level. The mainstay of treatment includes hydration with normal saline, calcitonin ,and bisphosphonate therapy; zoledronic acid is preferred over pamidronate. For patients refractory to bisphosphonates or patients with renal insufficiency, denosumab should be used.
Case continued: Febrile neutropenia
Febrile neutropenia is defined as a single oral temperature of 100.9° F or a temperature of 100.4° F sustained over a 1-hour period in a patient with absolute neutrophil count (ANC) less than 1,000 cells/mL or ANC expected to decrease to less than 500 cells/mL within a 48-hour period.13 Up to 30% of patients with solid tumors develop febrile neutropenia after chemotherapy, and nearly 80% of patients with hematologic malignancy or after hematopoietic stem cell therapy (HSCT) experience it.
Even though an infectious etiology is identified in only 30%-40% of cases, all patients with febrile neutropenia should initially receive at least empiric gram-negative coverage. The mortality rate is nearly 70% in neutropenic patients who do not receive empiric antibiotics and is reduced to 4%-20% with antibiotics.14
Risk stratification for febrile neutropenia and early discharge
Talcott’s Rules, the Multinational Association for Supportive Care in Cancer (MASCC) score, and the Clinical Index of Stable Febrile Neutropenia (CISNE) are validated tools to determine low-risk febrile neutropenia patients (Tables 3 and 4). The Infectious Diseases Society of America guidelines validated the use of MASCC in 2002 but found that CISNE had better performance than other tools. Coyne and colleagues conducted a retrospective cohort study to assess these two risk stratification tools in the ED and found that the CISNE was 98.3% specific for identifying adverse outcomes, whereas the MASCC was 54.2% specific.15
A study by Talcott and colleagues used Talcott’s Rules to identify low-risk febrile neutropenia patients, who were randomized to early discharge with home intravenous antibiotics versus continued inpatient management. There were no significant differences in the primary outcomes, defined as any change in clinical status requiring medical evaluation.16 Another study suggested that discharge after 24 hours based on clinical stability with outpatient oral antibiotics were noninferior to standard inpatient and intravenous antibiotic therapy.17 A Cochrane review in 2013 of 22 randomized controlled trials determined that oral antibiotics were an acceptable treatment for low-risk patients.18
Key takeaways
Though the MASCC is highly sensitive in identifying low-risk febrile neutropenia patients, it should be used with clinical caution because up to 11% of patients characterized as low risk developed severe complications.19 If a low-risk patient with solid tumor malignancy has adequate home support, lives within an hour of the hospital, and has access to follow-up within 72 hours, oral antibiotics and early discharge can be considered.
Dr. Chokshi is assistant professor in the division of hospital medicine at Mount Sinai Hospital, New York. Dr. Smith is associate professor in the division of hematology/oncology at Mount Sinai Hospital.
QUIZ
Mrs. Smith is a 64-year-old woman with endometrial cancer with temperature of 100.4° F at home. She takes no antibiotics, has no other medical history, and was sent in from clinic and admitted for further management. She feels well, and preliminary infectious workup is negative. She has been afebrile for more than 24 hours, and her ANC is 600 cells/mL.
Her son’s soccer game is tomorrow, and she would like to be present. Her family is involved in her care. Under what conditions can she be discharged?
A. She should not be discharged until full course of empiric intravenous antibiotics is completed.
B. Consider discharge in another 24 hours if she remains afebrile.
C. Discharge if low risk by MASCC or CISNE, with oral doses of levofloxacin or moxifloxacin or oral ciprofloxacin and amoxicillin/clavulanic acid.
Answer: C. The patient has a solid tumor malignancy, is low risk by both MASCC and CISNE, and can most likely be discharged if she is clinically stable or improved. A 7-day course of antibiotics is recommended with close follow-up.
References
1. SEER. Cancer of Any Site - Cancer Stat Facts. https://seer.cancer.gov/statfacts/html/all.html. Accessed 2019 Jul 17.
2. Kwok Y et al. Clinical Approach to Metastatic Epidural Spinal Cord Compression. Hematol Oncol Clin North Am. 2006;20(6):1297-305.
3. Helweg-Larsen S et al. Prognostic factors in metastatic spinal cord compression: a prospective study using multivariate analysis of variables influencing survival and gait function in 153 patients. Int J Radiat Oncol Biol Phys. 2000;46(5):1163-9.
4. Sørensen P et al. Effect of high-dose dexamethasone in carcinomatous metastatic spinal cord compression treated with radiotherapy: A randomised trial. Eur J Cancer. 1994;30(1):22-7.
5. Skeoch G et al. Corticosteroid treatment for metastatic spinal cord compression: A review. Global Spine J. 2017;7(3):272-9.
6. Vecht C et al. Initial bolus of conventional versus high-dose dexamethasone in metastatic spinal cord compression. Neurology. 1989;39(9):1255-7.
7. Heimdal K et al. High incidence of serious side effects of high-dose dexamethasone treatment in patients with epidural spinal cord compression. J Neurooncol. 1992;12(2):141-4.
8. Ralston S et al. Cancer-associated hypercalcemia: Morbidity and mortality. Clinical experience in 126 treated patients. Ann Intern Med. 1990;112(7):499-504.
9. Lindner G et al. Hypercalcemia in the ED: Prevalence, etiology, and outcome. Am J Emerg Med. 2013;31(4):657-60.
10. Hu M et al. Denosumab for patients with persistent or relapsed hypercalcemia of malignancy despite recent bisphosphonate treatment. J Natl Cancer Inst. 2013;105(18):1417-20.
11. Major P et al. Zoledronic acid is superior to pamidronate in the treatment of hypercalcemia of malignancy: A pooled analysis of two randomized, controlled clinical trials. J Clin Oncol. 2001;19(2):558-67.
12. Stewart A. Clinical practice. Hypercalcemia associated with cancer. N Engl J Med. 2005;352(4):373-9.
13. Freifeld A et al. Executive summary: Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the Infectious Diseases Society of America. Clin Infect Dis. 2011;52(4):427-31.
14. Baden L et al. Prevention and treatment of cancer-related infections, version 2.2016, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2016;14(7):882-913.
15. Coyne C et al. Application of the MASCC and CISNE risk-stratification scores to identify low-risk febrile neutropenic patients in the emergency department. Ann Emerg Med. 2017;69(6):755-64.
16. Talcott J et al. Safety of early discharge for low-risk patients with febrile neutropenia: a multicenter randomized controlled trial. J Clin Oncol. 2011;29(30):3977-83.
17. Innes H et al. Oral antibiotics with early hospital discharge compared with in-patient intravenous antibiotics for low-risk febrile neutropenia in patients with cancer: A prospective randomised controlled single centre study. Br J Cancer. 2003;89(1):43-9.
18. Vidal L, et al. Oral versus intravenous antibiotic treatment for febrile neutropenia in cancer patients. Cochrane Database Syst. Rev. 2013.
19. Taplitz RA et al. Outpatient management of fever and neutropenia in adults treated for malignancy: American Society of Clinical Oncology and Infectious Diseases Society of America clinical practice guideline update. J Clin Oncol. 2018;36(14):1443-53.
In 2016, there were an estimated 15,338,988 people living with cancer in the United States.1 As such, it is important that hospitalists be proficient in managing oncologic emergencies that can arise during the natural history of cancer or from its treatment. This article will review three emergencies that are routinely encountered in the inpatient setting: malignant spinal cord compression (MSCC), hypercalcemia of malignancy (HCM), and febrile neutropenia (FN).
Case
Mr. Williams is a 56-year-old man with newly diagnosed metastatic prostate cancer, diabetes mellitus, peptic ulcer disease, and hypertension. He is admitted with back pain and lower extremity weakness worsening over 2 weeks. He denies loss of sensation or bowel and bladder incontinence and can walk. MRI confirms cord compression at T10. What initial and subsequent steroid doses would be of most benefit to administer?
Malignant spinal cord compression
Treatment of MSCC usually aims to preserve function rather than reverse established deficits. MSCC from epidural tumor metastasis develops in 5%-14% of all cancer cases,2 with back pain as the most common symptom. Nearly 60%-85% of patients have weakness at the time of diagnosis,3 and unfortunately, nearly two-thirds of patients will be nonambulatory at presentation.
While timely steroid administration in addition to definitive treatment may maintain ambulatory capacity at 1 year after therapy,4 there is no consensus on the optimal loading and maintenance dose and duration of steroids.
Overview of the data
Although there are no formal guidelines on optimal steroid dosing for MSCC, it is common practice for dexamethasone to be initially dosed at 10 mg followed by 4 mg every 4-6 hours.5 The use of higher doses of dexamethasone may result in improvement in neurologic deficits, but has higher risks for toxicity and is not universally supported in the literature.
A study conducted by Vecht and colleagues demonstrated few differences between initial high-dose and low-dose dexamethasone.6 Intravenous administration of either 10 mg or 100 mg dexamethasone, both followed by total 16 mg of dexamethasone orally per day, showed no significant difference in mobility or survival between the groups.
In a prospective study by Heimdal and colleagues that evaluated the relationship between dexamethasone dose and toxicity, higher doses of steroids had no meaningful impact on neurological symptoms and resulted in more severe side effects.7 Patients were either given 96-mg IV loading dose, gradually tapered over 2 weeks, or enrolled in the low-dose group in which they received 4-mg IV dexamethasone four times per day with a taper over 2 weeks. The high-dose group experienced side effects in 28.6% of patients, with 14.3% experiencing serious side effects. Meanwhile, 7.9% of the low-dose group exhibited some side effects, with none experiencing serious adverse effects.The high-dose group did not experience a significant increase in mobility (57.1 vs. 57.9%).
Key takeaways
Dexamthasone 10-mg oral or IV followed by 4 mg every 4-6 hours until definitive treatment is started is associated with improved neurologic outcomes and minimal adverse side effects. Higher doses of steroids are unlikely to offer more benefit. In patients with paraplegia or autonomic dysfunction, the ability to restore neurologic function is reduced and the burdens of steroid treatment may outweigh its benefits.5
Case continued
Mr. Williams completed treatment for MSCC but was still complaining of extreme lethargy and noticed an increase in thirst and no bowel movement in 5 days. His serum calcium was 14 mg/dL.
Hypercalcemia of malignancy
HCM is the most common paraneoplastic syndrome, observed in nearly 30% of patients with advanced cancer. It is a poor prognostic indicator, and approximately half of all patients with HCM will die within 30 days.8 Cancer is the most common reason for hypercalcemia in the inpatient setting9 and is most often associated with multiple myeloma, non–small cell lung cancer, breast cancer, renal cell carcinoma, non-Hodgkins lymphoma, and leukemia.
Hypercalcemia most often presents with cognitive changes and lethargy, anorexia, nausea, constipation, polyuria and polydipsia, and renal failure. Bradycardia and shortened QT interval are seen more with severe hypercalcemia.
Management of hypercalcemia of malignancy
Management of HCM depends on corrected calcium or ionized calcium levels, chronicity, degree of symptoms, and presence of renal failure. In general, mild asymptomatic hypercalcemia can be managed with outpatient care. Serum calcium greater than 14 mg/dL should be treated regardless of symptoms (Table 1).
For mild to moderate HCM, management involves saline administration to achieve euvolemia and calcitonin, which has temporizing effects. Early administration of IV bisphosphonates for moderate to severe HCM is beneficial because onset of action is 24-48 hours. Furosemide for management of HCM has fallen out of favor unless the patient develops hypervolemia. Denosumab has been Food and Drug Administration–approved for HCM refractory to bisphosphonate therapy and can manage HCM in 64% of patients who did not respond adequately to bisphosphonate therapy.10 Because it can be used in advanced renal failure without dose adjustment, it is first-line therapy in this population, although the risk for hypocalcemia is increased in renal failure. For patients with serum calcium greater than 18 mg/dL, worsening renal failure, or inability to tolerate IV fluids, dialysis with a low-calcium bath should be considered (Table 2).
Zoledronic acid versus pamidronate
A single dose of zoledronic acid normalizes the serum calcium concentration in 88% of patients, compared with 70% of those who received pamidronate, in a pooled analysis of two phase 3 trials.11 The median duration of normocalcemia was longer for those receiving zoledronic acid (32-43 days vs. 18 days). The efficacy of the 4-mg and 8-mg zoledronic acid doses were similar, but the 4-mg dose was recommended because of renal toxicity and increased mortality associated with the higher dose.Despite this data, many specialists maintain that pamidronate, which is less expensive, is of similar clinical efficacy to ZA.12
Key takeaways
Management of HCM should be determined by the severity of the calcium level. The mainstay of treatment includes hydration with normal saline, calcitonin ,and bisphosphonate therapy; zoledronic acid is preferred over pamidronate. For patients refractory to bisphosphonates or patients with renal insufficiency, denosumab should be used.
Case continued: Febrile neutropenia
Febrile neutropenia is defined as a single oral temperature of 100.9° F or a temperature of 100.4° F sustained over a 1-hour period in a patient with absolute neutrophil count (ANC) less than 1,000 cells/mL or ANC expected to decrease to less than 500 cells/mL within a 48-hour period.13 Up to 30% of patients with solid tumors develop febrile neutropenia after chemotherapy, and nearly 80% of patients with hematologic malignancy or after hematopoietic stem cell therapy (HSCT) experience it.
Even though an infectious etiology is identified in only 30%-40% of cases, all patients with febrile neutropenia should initially receive at least empiric gram-negative coverage. The mortality rate is nearly 70% in neutropenic patients who do not receive empiric antibiotics and is reduced to 4%-20% with antibiotics.14
Risk stratification for febrile neutropenia and early discharge
Talcott’s Rules, the Multinational Association for Supportive Care in Cancer (MASCC) score, and the Clinical Index of Stable Febrile Neutropenia (CISNE) are validated tools to determine low-risk febrile neutropenia patients (Tables 3 and 4). The Infectious Diseases Society of America guidelines validated the use of MASCC in 2002 but found that CISNE had better performance than other tools. Coyne and colleagues conducted a retrospective cohort study to assess these two risk stratification tools in the ED and found that the CISNE was 98.3% specific for identifying adverse outcomes, whereas the MASCC was 54.2% specific.15
A study by Talcott and colleagues used Talcott’s Rules to identify low-risk febrile neutropenia patients, who were randomized to early discharge with home intravenous antibiotics versus continued inpatient management. There were no significant differences in the primary outcomes, defined as any change in clinical status requiring medical evaluation.16 Another study suggested that discharge after 24 hours based on clinical stability with outpatient oral antibiotics were noninferior to standard inpatient and intravenous antibiotic therapy.17 A Cochrane review in 2013 of 22 randomized controlled trials determined that oral antibiotics were an acceptable treatment for low-risk patients.18
Key takeaways
Though the MASCC is highly sensitive in identifying low-risk febrile neutropenia patients, it should be used with clinical caution because up to 11% of patients characterized as low risk developed severe complications.19 If a low-risk patient with solid tumor malignancy has adequate home support, lives within an hour of the hospital, and has access to follow-up within 72 hours, oral antibiotics and early discharge can be considered.
Dr. Chokshi is assistant professor in the division of hospital medicine at Mount Sinai Hospital, New York. Dr. Smith is associate professor in the division of hematology/oncology at Mount Sinai Hospital.
QUIZ
Mrs. Smith is a 64-year-old woman with endometrial cancer with temperature of 100.4° F at home. She takes no antibiotics, has no other medical history, and was sent in from clinic and admitted for further management. She feels well, and preliminary infectious workup is negative. She has been afebrile for more than 24 hours, and her ANC is 600 cells/mL.
Her son’s soccer game is tomorrow, and she would like to be present. Her family is involved in her care. Under what conditions can she be discharged?
A. She should not be discharged until full course of empiric intravenous antibiotics is completed.
B. Consider discharge in another 24 hours if she remains afebrile.
C. Discharge if low risk by MASCC or CISNE, with oral doses of levofloxacin or moxifloxacin or oral ciprofloxacin and amoxicillin/clavulanic acid.
Answer: C. The patient has a solid tumor malignancy, is low risk by both MASCC and CISNE, and can most likely be discharged if she is clinically stable or improved. A 7-day course of antibiotics is recommended with close follow-up.
References
1. SEER. Cancer of Any Site - Cancer Stat Facts. https://seer.cancer.gov/statfacts/html/all.html. Accessed 2019 Jul 17.
2. Kwok Y et al. Clinical Approach to Metastatic Epidural Spinal Cord Compression. Hematol Oncol Clin North Am. 2006;20(6):1297-305.
3. Helweg-Larsen S et al. Prognostic factors in metastatic spinal cord compression: a prospective study using multivariate analysis of variables influencing survival and gait function in 153 patients. Int J Radiat Oncol Biol Phys. 2000;46(5):1163-9.
4. Sørensen P et al. Effect of high-dose dexamethasone in carcinomatous metastatic spinal cord compression treated with radiotherapy: A randomised trial. Eur J Cancer. 1994;30(1):22-7.
5. Skeoch G et al. Corticosteroid treatment for metastatic spinal cord compression: A review. Global Spine J. 2017;7(3):272-9.
6. Vecht C et al. Initial bolus of conventional versus high-dose dexamethasone in metastatic spinal cord compression. Neurology. 1989;39(9):1255-7.
7. Heimdal K et al. High incidence of serious side effects of high-dose dexamethasone treatment in patients with epidural spinal cord compression. J Neurooncol. 1992;12(2):141-4.
8. Ralston S et al. Cancer-associated hypercalcemia: Morbidity and mortality. Clinical experience in 126 treated patients. Ann Intern Med. 1990;112(7):499-504.
9. Lindner G et al. Hypercalcemia in the ED: Prevalence, etiology, and outcome. Am J Emerg Med. 2013;31(4):657-60.
10. Hu M et al. Denosumab for patients with persistent or relapsed hypercalcemia of malignancy despite recent bisphosphonate treatment. J Natl Cancer Inst. 2013;105(18):1417-20.
11. Major P et al. Zoledronic acid is superior to pamidronate in the treatment of hypercalcemia of malignancy: A pooled analysis of two randomized, controlled clinical trials. J Clin Oncol. 2001;19(2):558-67.
12. Stewart A. Clinical practice. Hypercalcemia associated with cancer. N Engl J Med. 2005;352(4):373-9.
13. Freifeld A et al. Executive summary: Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 update by the Infectious Diseases Society of America. Clin Infect Dis. 2011;52(4):427-31.
14. Baden L et al. Prevention and treatment of cancer-related infections, version 2.2016, NCCN clinical practice guidelines in oncology. J Natl Compr Canc Netw. 2016;14(7):882-913.
15. Coyne C et al. Application of the MASCC and CISNE risk-stratification scores to identify low-risk febrile neutropenic patients in the emergency department. Ann Emerg Med. 2017;69(6):755-64.
16. Talcott J et al. Safety of early discharge for low-risk patients with febrile neutropenia: a multicenter randomized controlled trial. J Clin Oncol. 2011;29(30):3977-83.
17. Innes H et al. Oral antibiotics with early hospital discharge compared with in-patient intravenous antibiotics for low-risk febrile neutropenia in patients with cancer: A prospective randomised controlled single centre study. Br J Cancer. 2003;89(1):43-9.
18. Vidal L, et al. Oral versus intravenous antibiotic treatment for febrile neutropenia in cancer patients. Cochrane Database Syst. Rev. 2013.
19. Taplitz RA et al. Outpatient management of fever and neutropenia in adults treated for malignancy: American Society of Clinical Oncology and Infectious Diseases Society of America clinical practice guideline update. J Clin Oncol. 2018;36(14):1443-53.
COVID spikes exacerbate health worker shortages in Rocky Mountains, Great Plains
In Montana, pandemic-induced staffing shortages have shuttered a clinic in the state’s capital, led a northwestern regional hospital to ask employees exposed to COVID-19 to continue to work and emptied a health department 400 miles to the east.
“Just one more person out and we wouldn’t be able to keep the surgeries going,” said Dr. Shelly Harkins, MD, chief medical officer of St. Peter’s Health in Helena, a city of roughly 32,000 where cases continue to spread. “When the virus is just all around you, it’s almost impossible to not be deemed a contact at some point. One case can take out a whole team of people in a blink of an eye.”
In North Dakota, where cases per resident are growing faster than any other state, hospitals may once again curtail elective surgeries and possibly seek government aid to hire more nurses if the situation gets worse, North Dakota Hospital Association President Tim Blasl said.
“How long can we run at this rate with the workforce that we have?” Blasl said. “You can have all the licensed beds you want, but if you don’t have anybody to staff those beds, it doesn’t do you any good.”
The northern Rocky Mountains, Great Plains and Upper Midwest are seeing the highest surge of COVID-19 cases in the nation, as some residents have ignored recommendations for curtailing the virus, such as wearing masks and avoiding large gatherings. Montana, Idaho, Utah, Wyoming, North Dakota, South Dakota, Nebraska, Iowa, and Wisconsin have recently ranked among the top 10 U.S. states in confirmed cases per 100,000 residents over a 7-day period, according to an analysis by the New York Times.
Such coronavirus infections – and the quarantines that occur because of them – are exacerbating the health care worker shortage that existed in these states well before the pandemic. Unlike in the nation’s metropolitan hubs, these outbreaks are scattered across hundreds of miles. And even in these states’ biggest cities, the ranks of medical professionals are in short supply. Specialists and registered nurses are sometimes harder to track down than ventilators, N95 masks or hospital beds. Without enough care providers, patients may not be able to get the medical attention they need.
Hospitals have asked staffers to cover extra shifts and learn new skills. They have brought in temporary workers from other parts of the country and transferred some patients to less-crowded hospitals. But, at St. Peter’s Health, if the hospital’s one kidney doctor gets sick or is told to quarantine, Dr. Harkins doesn’t expect to find a backup.
“We make a point to not have excessive staff because we have an obligation to keep the cost of health care down for a community – we just don’t have a lot of slack in our rope,” Dr. Harkins said. “What we don’t account for is a mass exodus of staff for 14 days.”
Some hospitals are already at patient capacity or are nearly there. That’s not just because of the growing number of COVID-19 patients. Elective surgeries have resumed, and medical emergencies don’t pause for a pandemic.
Some Montana hospitals formed agreements with local affiliates early in the pandemic to share staff if one came up short. But now that the disease is spreading fast – and widely – the hope is that their needs don’t peak all at once.
Montana state officials keep a list of primarily in-state volunteer workers ready to travel to towns with shortages of contact tracers, nurses and more. But during a press conference on Oct. 15, Democratic Gov. Steve Bullock said the state had exhausted that database, and its nationwide request for National Guard medical staffing hadn’t brought in new workers.
“If you are a registered nurse, licensed practical nurse, paramedic, EMT, CNA or contact tracer, and are able to join our workforce, please do consider joining our team,” Gov. Bullock said.
This month, Kalispell Regional Medical Center in northwestern Montana even stopped quarantining COVID-exposed staff who remain asymptomatic, a change allowed by Centers for Disease Control and Prevention guidelines for health facilities facing staffing shortages.
“That’s very telling for what staffing is going through right now,” said Andrea Lueck, a registered nurse at the center. “We’re so tight that employees are called off of quarantine.”
Financial pressure early in the pandemic led the hospital to furlough staff, but it had to bring most of them back to work because it needs those bodies more than ever. The regional hub is based in Flathead County, which has recorded the state’s second-highest number of active COVID-19 cases.
Mellody Sharpton, a hospital spokesperson, said hospital workers who are exposed to someone infected with the virus are tested within three to five days and monitored for symptoms. The hospital is also pulling in new workers, with 25 traveling health professionals on hand and another 25 temporary ones on the way.
But Ms. Sharpton said the best way to conserve the hospital’s workforce is to stop the disease surge in the community.
Earlier in the pandemic, Central Montana Medical Center in Lewistown, a town of fewer than 6,000, experienced an exodus of part-time workers or those close to retirement who decided their jobs weren’t worth the risk. The facility recently secured two traveling workers, but both backed out because they couldn’t find housing. And, so far, roughly 40 of the hospital’s 322 employees have missed work for reasons connected to COVID-19.
“We’re at a critical staffing shortage and have been since the beginning of COVID,” said Joanie Slaybaugh, Central Montana Medical Center’s director of human resources. “We’re small enough, everybody feels an obligation to protect themselves and to protect each other. But it doesn’t take much to take out our staff.”
Roosevelt County, where roughly 11,000 live on the northeastern edge of Montana, had one of the nation’s highest rates of new cases as of Oct. 15. But by the end of the month, the county health department will lose half of its registered nurses as one person is about to retire and another was hired through a grant that’s ending. That leaves only one registered nurse aside from its director, Patty Presser. The health department already had to close earlier during the pandemic because of COVID exposure and not enough staffers to cover the gap. Now, if Ms. Presser can’t find nurse replacements in time, she hopes volunteers will step in, though she added they typically stay for only a few weeks.
“I need someone to do immunizations for my community, and you don’t become an immunization nurse in 14 days,” she said. “We don’t have the workforce here to deal with this virus, not even right now, and then I’m going to have my best two people go.”
Back in Helena, Dr. Harkins said St. Peter’s Health had to close a specialty outpatient clinic that treats chronic diseases for two weeks at the end of September because the entire staff had to quarantine.
Now the hospital is considering having doctors take turns spending a week working from home, so that if another wave of quarantines hits in the hospital, at least one untainted person can be brought back to work. But that won’t help for some specialties, like the hospital’s sole kidney doctor.
Every time Dr. Harkins’ phone rings, she said, she takes a breath and hopes it’s not another case that will force a whole division to close.
“Because I think immediately of the hundreds of people that need that service and won’t have it for 14 days,” she said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
In Montana, pandemic-induced staffing shortages have shuttered a clinic in the state’s capital, led a northwestern regional hospital to ask employees exposed to COVID-19 to continue to work and emptied a health department 400 miles to the east.
“Just one more person out and we wouldn’t be able to keep the surgeries going,” said Dr. Shelly Harkins, MD, chief medical officer of St. Peter’s Health in Helena, a city of roughly 32,000 where cases continue to spread. “When the virus is just all around you, it’s almost impossible to not be deemed a contact at some point. One case can take out a whole team of people in a blink of an eye.”
In North Dakota, where cases per resident are growing faster than any other state, hospitals may once again curtail elective surgeries and possibly seek government aid to hire more nurses if the situation gets worse, North Dakota Hospital Association President Tim Blasl said.
“How long can we run at this rate with the workforce that we have?” Blasl said. “You can have all the licensed beds you want, but if you don’t have anybody to staff those beds, it doesn’t do you any good.”
The northern Rocky Mountains, Great Plains and Upper Midwest are seeing the highest surge of COVID-19 cases in the nation, as some residents have ignored recommendations for curtailing the virus, such as wearing masks and avoiding large gatherings. Montana, Idaho, Utah, Wyoming, North Dakota, South Dakota, Nebraska, Iowa, and Wisconsin have recently ranked among the top 10 U.S. states in confirmed cases per 100,000 residents over a 7-day period, according to an analysis by the New York Times.
Such coronavirus infections – and the quarantines that occur because of them – are exacerbating the health care worker shortage that existed in these states well before the pandemic. Unlike in the nation’s metropolitan hubs, these outbreaks are scattered across hundreds of miles. And even in these states’ biggest cities, the ranks of medical professionals are in short supply. Specialists and registered nurses are sometimes harder to track down than ventilators, N95 masks or hospital beds. Without enough care providers, patients may not be able to get the medical attention they need.
Hospitals have asked staffers to cover extra shifts and learn new skills. They have brought in temporary workers from other parts of the country and transferred some patients to less-crowded hospitals. But, at St. Peter’s Health, if the hospital’s one kidney doctor gets sick or is told to quarantine, Dr. Harkins doesn’t expect to find a backup.
“We make a point to not have excessive staff because we have an obligation to keep the cost of health care down for a community – we just don’t have a lot of slack in our rope,” Dr. Harkins said. “What we don’t account for is a mass exodus of staff for 14 days.”
Some hospitals are already at patient capacity or are nearly there. That’s not just because of the growing number of COVID-19 patients. Elective surgeries have resumed, and medical emergencies don’t pause for a pandemic.
Some Montana hospitals formed agreements with local affiliates early in the pandemic to share staff if one came up short. But now that the disease is spreading fast – and widely – the hope is that their needs don’t peak all at once.
Montana state officials keep a list of primarily in-state volunteer workers ready to travel to towns with shortages of contact tracers, nurses and more. But during a press conference on Oct. 15, Democratic Gov. Steve Bullock said the state had exhausted that database, and its nationwide request for National Guard medical staffing hadn’t brought in new workers.
“If you are a registered nurse, licensed practical nurse, paramedic, EMT, CNA or contact tracer, and are able to join our workforce, please do consider joining our team,” Gov. Bullock said.
This month, Kalispell Regional Medical Center in northwestern Montana even stopped quarantining COVID-exposed staff who remain asymptomatic, a change allowed by Centers for Disease Control and Prevention guidelines for health facilities facing staffing shortages.
“That’s very telling for what staffing is going through right now,” said Andrea Lueck, a registered nurse at the center. “We’re so tight that employees are called off of quarantine.”
Financial pressure early in the pandemic led the hospital to furlough staff, but it had to bring most of them back to work because it needs those bodies more than ever. The regional hub is based in Flathead County, which has recorded the state’s second-highest number of active COVID-19 cases.
Mellody Sharpton, a hospital spokesperson, said hospital workers who are exposed to someone infected with the virus are tested within three to five days and monitored for symptoms. The hospital is also pulling in new workers, with 25 traveling health professionals on hand and another 25 temporary ones on the way.
But Ms. Sharpton said the best way to conserve the hospital’s workforce is to stop the disease surge in the community.
Earlier in the pandemic, Central Montana Medical Center in Lewistown, a town of fewer than 6,000, experienced an exodus of part-time workers or those close to retirement who decided their jobs weren’t worth the risk. The facility recently secured two traveling workers, but both backed out because they couldn’t find housing. And, so far, roughly 40 of the hospital’s 322 employees have missed work for reasons connected to COVID-19.
“We’re at a critical staffing shortage and have been since the beginning of COVID,” said Joanie Slaybaugh, Central Montana Medical Center’s director of human resources. “We’re small enough, everybody feels an obligation to protect themselves and to protect each other. But it doesn’t take much to take out our staff.”
Roosevelt County, where roughly 11,000 live on the northeastern edge of Montana, had one of the nation’s highest rates of new cases as of Oct. 15. But by the end of the month, the county health department will lose half of its registered nurses as one person is about to retire and another was hired through a grant that’s ending. That leaves only one registered nurse aside from its director, Patty Presser. The health department already had to close earlier during the pandemic because of COVID exposure and not enough staffers to cover the gap. Now, if Ms. Presser can’t find nurse replacements in time, she hopes volunteers will step in, though she added they typically stay for only a few weeks.
“I need someone to do immunizations for my community, and you don’t become an immunization nurse in 14 days,” she said. “We don’t have the workforce here to deal with this virus, not even right now, and then I’m going to have my best two people go.”
Back in Helena, Dr. Harkins said St. Peter’s Health had to close a specialty outpatient clinic that treats chronic diseases for two weeks at the end of September because the entire staff had to quarantine.
Now the hospital is considering having doctors take turns spending a week working from home, so that if another wave of quarantines hits in the hospital, at least one untainted person can be brought back to work. But that won’t help for some specialties, like the hospital’s sole kidney doctor.
Every time Dr. Harkins’ phone rings, she said, she takes a breath and hopes it’s not another case that will force a whole division to close.
“Because I think immediately of the hundreds of people that need that service and won’t have it for 14 days,” she said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
In Montana, pandemic-induced staffing shortages have shuttered a clinic in the state’s capital, led a northwestern regional hospital to ask employees exposed to COVID-19 to continue to work and emptied a health department 400 miles to the east.
“Just one more person out and we wouldn’t be able to keep the surgeries going,” said Dr. Shelly Harkins, MD, chief medical officer of St. Peter’s Health in Helena, a city of roughly 32,000 where cases continue to spread. “When the virus is just all around you, it’s almost impossible to not be deemed a contact at some point. One case can take out a whole team of people in a blink of an eye.”
In North Dakota, where cases per resident are growing faster than any other state, hospitals may once again curtail elective surgeries and possibly seek government aid to hire more nurses if the situation gets worse, North Dakota Hospital Association President Tim Blasl said.
“How long can we run at this rate with the workforce that we have?” Blasl said. “You can have all the licensed beds you want, but if you don’t have anybody to staff those beds, it doesn’t do you any good.”
The northern Rocky Mountains, Great Plains and Upper Midwest are seeing the highest surge of COVID-19 cases in the nation, as some residents have ignored recommendations for curtailing the virus, such as wearing masks and avoiding large gatherings. Montana, Idaho, Utah, Wyoming, North Dakota, South Dakota, Nebraska, Iowa, and Wisconsin have recently ranked among the top 10 U.S. states in confirmed cases per 100,000 residents over a 7-day period, according to an analysis by the New York Times.
Such coronavirus infections – and the quarantines that occur because of them – are exacerbating the health care worker shortage that existed in these states well before the pandemic. Unlike in the nation’s metropolitan hubs, these outbreaks are scattered across hundreds of miles. And even in these states’ biggest cities, the ranks of medical professionals are in short supply. Specialists and registered nurses are sometimes harder to track down than ventilators, N95 masks or hospital beds. Without enough care providers, patients may not be able to get the medical attention they need.
Hospitals have asked staffers to cover extra shifts and learn new skills. They have brought in temporary workers from other parts of the country and transferred some patients to less-crowded hospitals. But, at St. Peter’s Health, if the hospital’s one kidney doctor gets sick or is told to quarantine, Dr. Harkins doesn’t expect to find a backup.
“We make a point to not have excessive staff because we have an obligation to keep the cost of health care down for a community – we just don’t have a lot of slack in our rope,” Dr. Harkins said. “What we don’t account for is a mass exodus of staff for 14 days.”
Some hospitals are already at patient capacity or are nearly there. That’s not just because of the growing number of COVID-19 patients. Elective surgeries have resumed, and medical emergencies don’t pause for a pandemic.
Some Montana hospitals formed agreements with local affiliates early in the pandemic to share staff if one came up short. But now that the disease is spreading fast – and widely – the hope is that their needs don’t peak all at once.
Montana state officials keep a list of primarily in-state volunteer workers ready to travel to towns with shortages of contact tracers, nurses and more. But during a press conference on Oct. 15, Democratic Gov. Steve Bullock said the state had exhausted that database, and its nationwide request for National Guard medical staffing hadn’t brought in new workers.
“If you are a registered nurse, licensed practical nurse, paramedic, EMT, CNA or contact tracer, and are able to join our workforce, please do consider joining our team,” Gov. Bullock said.
This month, Kalispell Regional Medical Center in northwestern Montana even stopped quarantining COVID-exposed staff who remain asymptomatic, a change allowed by Centers for Disease Control and Prevention guidelines for health facilities facing staffing shortages.
“That’s very telling for what staffing is going through right now,” said Andrea Lueck, a registered nurse at the center. “We’re so tight that employees are called off of quarantine.”
Financial pressure early in the pandemic led the hospital to furlough staff, but it had to bring most of them back to work because it needs those bodies more than ever. The regional hub is based in Flathead County, which has recorded the state’s second-highest number of active COVID-19 cases.
Mellody Sharpton, a hospital spokesperson, said hospital workers who are exposed to someone infected with the virus are tested within three to five days and monitored for symptoms. The hospital is also pulling in new workers, with 25 traveling health professionals on hand and another 25 temporary ones on the way.
But Ms. Sharpton said the best way to conserve the hospital’s workforce is to stop the disease surge in the community.
Earlier in the pandemic, Central Montana Medical Center in Lewistown, a town of fewer than 6,000, experienced an exodus of part-time workers or those close to retirement who decided their jobs weren’t worth the risk. The facility recently secured two traveling workers, but both backed out because they couldn’t find housing. And, so far, roughly 40 of the hospital’s 322 employees have missed work for reasons connected to COVID-19.
“We’re at a critical staffing shortage and have been since the beginning of COVID,” said Joanie Slaybaugh, Central Montana Medical Center’s director of human resources. “We’re small enough, everybody feels an obligation to protect themselves and to protect each other. But it doesn’t take much to take out our staff.”
Roosevelt County, where roughly 11,000 live on the northeastern edge of Montana, had one of the nation’s highest rates of new cases as of Oct. 15. But by the end of the month, the county health department will lose half of its registered nurses as one person is about to retire and another was hired through a grant that’s ending. That leaves only one registered nurse aside from its director, Patty Presser. The health department already had to close earlier during the pandemic because of COVID exposure and not enough staffers to cover the gap. Now, if Ms. Presser can’t find nurse replacements in time, she hopes volunteers will step in, though she added they typically stay for only a few weeks.
“I need someone to do immunizations for my community, and you don’t become an immunization nurse in 14 days,” she said. “We don’t have the workforce here to deal with this virus, not even right now, and then I’m going to have my best two people go.”
Back in Helena, Dr. Harkins said St. Peter’s Health had to close a specialty outpatient clinic that treats chronic diseases for two weeks at the end of September because the entire staff had to quarantine.
Now the hospital is considering having doctors take turns spending a week working from home, so that if another wave of quarantines hits in the hospital, at least one untainted person can be brought back to work. But that won’t help for some specialties, like the hospital’s sole kidney doctor.
Every time Dr. Harkins’ phone rings, she said, she takes a breath and hopes it’s not another case that will force a whole division to close.
“Because I think immediately of the hundreds of people that need that service and won’t have it for 14 days,” she said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Around the world in 24 hours: A snapshot of COVID’s global havoc
Some medical societies feature sessions at their annual meetings that feel like they’re 24 hours long, yet few have the courage to schedule a session that actually runs all day and all night. But the five societies sponsoring the IDWeek conference had that courage. The first 24 hours of the meeting was devoted to the most pressing infectious-disease crisis of the last 100 years: the COVID-19 pandemic. They called it “COVID-19: Chasing the Sun.”
Dr. Fauci predicts a vaccine answer in mid-November
In the first segment, at 10 am Eastern time, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and the nation’s top infectious-disease expert, began the day by noting that five of the six companies the US invested in to develop a vaccine are conducting phase 3 trials. He said, “we feel confident that we will have an answer likely in mid-November to the beginning of December as to whether we have a safe and effective vaccine”. He added he was “cautiously optimistic” that “we will have a safe and effective vaccine by the end of the year, which we can begin to distribute as we go into 2021.” He highlighted the COVID-19 Prevention Network website for more information on the trials.
Glaring racial health disparities in U.S.
Some of the most glaring health disparities surrounding COVID-19 in the United States were described by Carlos del Rio, MD, professor of medicine at Emory University in Atlanta, Georgia. He pointed out that while white people have about 23 cases per 10,000 population, Blacks have about 62 cases per 10,000, and Latinos have 73 cases per 10,000. While whites don’t see a huge jump in cases until age 80, he said, “among Blacks and Latinos you start seeing that huge increase at a younger age. In fact, starting at age 20, you start seeing a major, major change.”
COVID-19 diagnostics
Audrey Odom John, MD, PhD, chief of pediatric infectious diseases at Children’s Hospital of Philadelphia, is working on a new way of diagnosing COVID-19 infection in children by testing their breath. “We’re really taking advantage of a fundamental biological fact, which is that people stink,” she said. Breath shows the health of the body as a whole, “and it’s easy to see how breath volatiles might arise from a respiratory infection.” Testing breath is easy and inexpensive, which makes it particularly attractive as a potential test globally, she said.
Long-term effects of COVID-19
Post-COVID illness threatens to overwhelm the health system in the United States, even if only 1% of the 8 million people who have been infected have some sort of long-term deficit, “which would be a very conservative estimate,” said John O’Horo, MD, MPH, with the Mayo Clinic in Rochester, Minn. Neurologic dysfunction is going to be a “fairly significant thing to keep an eye on,” he added. Preeti Malani, MD, chief health officer in infectious diseases at the University of Michigan, Ann Arbor, said the emotional aspects of the illness are “striking” and may be the major long-term effect for most patients.
Challenging cases in COVID-19: Through fire and water
In a case presented to panelists during an afternoon session, a Mexican-born woman, 42, presents to urgent care with fever, dyspnea, dry cough, and pleuritic pain, for over a week. Multiple family members have had recent respiratory illness as well. She is obese, on no medications, was not traveling. She’s a nonsmoker and lives in a multigenerational household in the Mission District of San Francisco. Her heart rate is 116, respiratory rate is 36, and her oxygen saturation on room air is 77%. She is admitted to a local hospital and quickly declines, is intubated and started on hydroxychloroquine (HCQ). One day later she is transferred to a hospital for consideration of extracorporeal membrane oxygenation (ECMO).
Panelists were asked a variety of questions about how they would treat this patient. For example, would they continue HCQ? Ravina Kullar, PharmD, MPH, an infectious disease expert from Newport Beach, Calif., answered that she would not continue the HCQ because of lack of evidence and potential harms. Asked whether she would start remdesivir, Dr. Kullar said she would steer her away from that if the patient developed renal failure. Co-moderator Peter Chin-Hong, MD, a medical educator with the University of California, San Francisco, noted that contact tracing will be important as the patient returns to her housing-dense community.
In-hospital infection prevention
The CDC acknowledged aerosol spread of COVID-19 this month, but David Weber, MD, MPH, professor in infectious diseases at the University of North Carolina at Chapel Hill, said, “this does not change anything we need to do in the hospital,” as long as protective pandemic protocols continue to be followed.
There is no evidence, he noted, that SARS-CoV-2 is transmitted far enough that a hospitalized patient could infect people in other rooms or corridors or floors. Opening windows in COVID-19 patients’ rooms is “not an option,” he said, and could be harmful as fungal elements in outside air may introduce new pathogens. The degree to which improved ventilation systems reduce transmission has not been identified and studies are needed to look at that, he said.
Preventing COVID transmission in the community
Mary-Margaret Fill, MD, deputy state epidemiologist in Tennessee, highlighted COVID-19’s spread in prisons. As of mid-October, she said, there are more than 147,000 cases among the U.S. prison population and there have been 1,246 deaths. This translates to a case rate of about 9800 cases per 100,000 people, she said, “double the highest case rate for any state in the country and over three times greater than our national case rate of about 2,500 cases per 100,000 persons.”
Testing varies widely, she noted. For instance, some states test only new prisoners, and some test only when they are symptomatic. One of the strategies to fight this spread is having staff, who go in and out of the community, be assigned to work with only certain groups at a prison. Another is widespread testing of all prisoners. And when prisoners have to leave the prison for care or court dates, a third strategy would be quarantining them upon their return.
COVID-19 vaccines
As the session stretched into the evening in the United States, Mary Marovich, MD, director of vaccine research, AIDS division, with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health, said while each of the government-funded vaccine studies has its own trial, there are standardized objectives for direct comparisons. The studies are being conducted within the same clinical trial networks, and collaborative laboratories apply the same immunoassays and define the infections in the same way. They are all randomized, placebo-controlled trials and all but one have a 30,000-volunteer sample size. She said that while a vaccine is the goal to end the pandemic, monoclonal antibodies, such as those in convalescent plasma, “may serve as a critical bridge.”
The good, the bad, and the ugly during COVID-19 in Latin America
Latin America and the Caribbean are currently the regions hardest hit by COVID-19. Gustavo D. Lopardo, of the Asociacion Panamericana de Infectologia, noted that even before the pandemic Latin America suffered from widespread poverty and inequality. While overcrowding and poverty are determining factors in the spread of the virus, diabetes and obesity – both highly prevalent – are worsening COVID outcomes.
The countries of the region have dealt with asynchronous waves of transmission within their borders by implementing different containment strategies, with dissimilar results. The presenters covered the spectrum of the pandemic, from the “ugly” in Peru, which has the highest mortality rate in the region, to the “good” in Uruguay, where testing is “winning against COVID-19.” Paradoxically, Chile has both the highest cumulative incidence and the lowest case fatality rate of COVID-19 in the region.
In the social and political turmoil imposed by COVID-19, Clóvis Arns da Cunha, MD, president of the Brazilian Society of Infectious Diseases and professor at the Federal University of Paraná, pointed out that “fake news [has become] a public health problem in Brazil” and elsewhere.
Diagnostics and therapeutics in Latin America
Eleven of the 15 countries with the highest death rate in the world are located in Latin America or the Caribbean. Dr. Arns de Cunha pointed out that tests are hard to come by and inadequate diagnostic testing is a major problem. Latin American countries have not been able to compete with the United States and Europe in purchasing polymerase chain reaction test kits from China and South Korea. The test is the best diagnostic tool in the first week of symptoms, but its scale-up has proved to be a challenge in Latin America.
Furthermore, the most sensitive serological markers, CLIA and ECLIA, which perform best after 2 weeks of symptom onset, are not widely available in Latin America where many patients do not have access to the public health system. The detection of silent hypoxemia in symptomatic patients with COVID-19 can save lives; hence, Arns da Cunha praised the program that distributed 100,000 digital oximeters to hundreds of cities in Brazil, targeting vulnerable populations.
The COVID-19 experience in Japan
Takuya Yamagishi, MD, PhD, chief of the Antimicrobial Resistance Research Center at the National Institute of Infectious Diseases in Japan, played an instrumental role in the epidemiological investigation that took place on the Diamond Princess Cruise Ship in February 2020. That COVID-19 outbreak is the largest disease outbreak involving a cruise ship to date, with 712 confirmed COVID-19 cases and 13 deaths.
The ship-based quarantine prompted a massive public health response with unique challenges. In those early days, investigators uncovered important facts about COVID-19 epidemiology, generating hot debates regarding the public health strategy at the time. Notably, the majority of asymptomatically infected persons remained asymptomatic throughout the course of the infection, transmission from asymptomatic cases was almost as likely as transmission from symptomatic cases, and isolation of passengers in their cabins prevented inter-cabin transmission but not intra-cabin transmission.
Swift response in Asia Pacific region
Infectious-disease experts from Taiwan, Singapore, and Australia, who have been at the forefront of clinical care, research, and policy-making, spoke about their experiences.
Taiwan was one of the first countries to adopt a swift response to COVID-19, shortly after they recognized an outbreak of pneumonia of unknown etiology in China and long before the WHO declared a public health emergency, said Ping-Ing Lee, MD, PhD, from the National Taiwan University Children’s Hospital.
The country began onboard health checks on flights from Wuhan as early as Dec. 31, 2019. Dr. Lee attributed Taiwan’s success in prevention and control of COVID-19 to the rigorous use of face masks and environmental disinfection procedures. Regarding the country’s antilockdown stance, he said, “Lockdown may be effective; however, it is associated with a tremendous economic loss.”
In his presentation on remdesivir vs corticosteroids, David Lye, MBBS, said, “I think remdesivir as an antiviral seems to work well given early, but steroids will need to be studied further in terms of its conflicting evidence in multiple well-designed RCTs as well as [their] potential side effects.” He is director of the Infectious Disease Research and Training Office, National Centre for Infectious Diseases, Singapore.
Allen C. Cheng, MBBS, PhD, of Monash University in Melbourne, noted that “control is possible. We seemed to have controlled this twice at the moment with fairly draconian action, but every day does matter.”
China past the first wave
China has already passed the first wave, explained Lei Zhou, MD, of the Chinese Center for Disease Control and Prevention, but there are still some small-scale resurgences. So far a total of four waves have been identified. She also mentioned that contact tracing is intense and highlighted the case of Xinfadi Market in Beijing, the site of an outbreak in June 2020.
Gui-Qiang Wang, MD, from the Department of Infectious Disease, Peking University First Hospital, emphasized the importance of a chest CT for the diagnosis of COVID-19. “In the early stage of the disease, patients may not show any symptoms; however, on CT scan you can see pneumonia. Also, early intervention of high-risk groups and monitoring of warning indicators for disease progression is extremely important,” he said.
“Early antiviral therapy is expected to stop progression, but still needs evaluation,” he said. “Convalescent plasma is safe and effective, but its source is limited; steroid therapy needs to explore appropriate population and timing; and thymosin α is safe, and its effect on outcomes needs large-sample clinical trial.”
Time to Call for an ‘Arab CDC?’
The eastern Mediterranean is geographically, politically, economically, and religiously a very distinct and sensitive region, and “COVID-19 is an added insult to this already frail region of the world,” said Zaid Haddadin, MD, Vanderbilt University Medical Center, Nashville, Tenn.
Poor healthcare and poor public health services are a consequence of weak and fragile governments and infrastructure, the result of war and regional conflicts in many countries. Millions of war refugees live in camps with high population densities and shared facilities, which makes social distancing and community mitigation very challenging. Moreover, the culture includes frequent large social gatherings. Millions of pilgrims visit holy sites in different cities in these countries. There is also movement due to trade and tourism. Travel restrictions are challenging, and there is limited comprehension of precautionary measures.
Najwa Khuri-Bulos, professor of pediatrics and infectious diseases at the University of Jordan, was part of a task force headed by the country’s Ministry of Health. A lockdown was implemented, which helped flatten the curve, but the loosening of restrictions has led to a recent increase in cases. She said, “No country can succeed in controlling spread without the regional collaboration. Perhaps it is time to adopt the call for an Arab CDC.”
Africa is “not out of the woods yet”
The Africa CDC has three key pillars as the foundation for their COVID-19 strategy: preventing transmission, preventing deaths, and preventing social harm, according to Raji Tajudeen, MBBS, FWACP, MPH, head of the agency’s Public Health Institutes and Research Division. Africa, with 1.5 million cases of COVID-19, accounts for 5% of global cases. With a recovery rate of 83% and a case fatality rate of 2.4%, the African continent has fared much better than the rest of the world. “Significant improvements have been made, but we are not out of the woods yet,” he cautioned.
Richard Lessells, PhD, from the University of KwaZulu-Natal, agreed. “Unfortunately, South Africa has not been spared from the worst effects of this pandemic despite what you might read in the press and scientific coverage.” He added, “Over 50% of cases and up to two thirds of the deaths in the African region are coming from South Africa.” A bigger challenge for South Africa has been maintaining essential health services during the COVID-19 pandemic, especially since it is also at the heart of the HIV pandemic. On the brighter side, HIV itself has not emerged as a risk factor for COVID-19 infection or severe disease in South Africa.
Dimie Ogoina, MBBS, FWACP, president of the Nigerian Infectious Diseases Society, stated that COVID-19 has significantly affected access to healthcare in Nigeria, particularly immunizations and antenatal care. Immunization uptake is likely to have dropped by 50% in the country.
Diagnostic pitfalls in COVID-19
Technical errors associated with the SARS-CoV-2 diagnostic pipeline are a major source of variations in diagnosis, explained Jim Huggett, PhD, senior lecturer, analytical microbiology, University of Surrey, Guildford, England. He believes that PCR assays are currently too biased for a single cutoff to be broadly used, and false-positive signals are most likely because of contamination.
Dana Wolf, MD, Clinical Virology Unit, Hadassah Hebrew University Medical Center in Israel, presented a large-scale data analysis of more than 133,000 pooled samples. Such a pooling strategy appeared to be highly efficient for a wide range of prevalence rates (<1% to 6%). “Our empirical evidence strongly projects on the feasibility and benefits of pooling in the current pandemic setting, to enhance continued surveillance, control, and community reopening,” she said.
Corine Geurts van Kessel, MD, PhD, Department of Virology, Erasmus University Rotterdam (the Netherlands), discussing antibodies testing for SARS-CoV-2, pointed out that disease severity can affect testing accuracy. “Reinfection cases tell us that we cannot rely on immunity acquired by natural infection to confer herd immunity,” she said.
Misinformation in the first digital pandemic
The world is not only facing a devastating pandemic, but also an alarming “infodemic” of misinformation. Between January and March 2020, a new COVID-19–related tweet appeared on Twitter every 45 milliseconds. Müge Çevik, MD, MSc, MRCP, an infectious disease clinician, scientist, and science communicator, said that “the greatest challenge for science communication is reaching the audience.”
People have always been skeptical of science reporting by journalists and would rather have scientists communicate with them directly, she noted. Science communication plays a dual role. “On one hand is the need to promote science to a wide audience in order to inform and educate and inspire the next generation of scientists, and on the other hand there is also a need to engage effectively in public dialogue,” she added. Dr. Çevik and colleagues think that “The responsibility of academics should not end with finding the truth. It should end after communicating it.”
Treatment in the ICU
Matteo Bassetti, MD, with the University of Genoa (Italy), who was asked about when to use remdesivir in the intensive care unit and for how long, said, “In the majority of cases, 5 days is probably enough.” However, if there is high viremia, he said, physicians may choose to continue the regimen beyond 5 days. Data show it is important to prescribe this drug for patients with oxygen support in an early phase, within 10 days of the first symptoms, he added. “In the late phase, there is a very limited role for remdesivir, as we know that we are already out of the viremic phase.” He also emphasized that there is no role for hydroxychloroquine or lopinavir-ritonavir.
Breaking the chains of transmission
During the wrap-up session, former US CDC Director Tom Frieden, MD, said, “We’re not even halfway through it” about the pandemic trajectory. “And we have to be very clear that the risk of explosive spread will not end with a vaccine.” He is now president and CEO of Resolve to Save Lives.
Different parts of the world will have very different experiences, Dr. Frieden said, noting that Africa, where 4% of the population is older than 65, has a very different risk level than Europe and the United States, where 10%-20% of people are in older age groups.
“We need a one-two punch,” he noted, first preventing spread, and when it does happen, boxing it in. Mask wearing is essential. “States in the US that mandated universal mask-wearing experienced much more rapid declines (in cases) for every 5 days the mandate was in place.”
Michael Ryan, MD, executive director for the WHO’s Health Emergencies Programme, added, “We need to collectively recommit to winning this game. We know how to break the chains of transmission. We need recommitment to a scientific, societal, and political strategy, and an alliance – a contract – between those entities to try to move us forward.”
This article first appeared on Medscape.com.
Some medical societies feature sessions at their annual meetings that feel like they’re 24 hours long, yet few have the courage to schedule a session that actually runs all day and all night. But the five societies sponsoring the IDWeek conference had that courage. The first 24 hours of the meeting was devoted to the most pressing infectious-disease crisis of the last 100 years: the COVID-19 pandemic. They called it “COVID-19: Chasing the Sun.”
Dr. Fauci predicts a vaccine answer in mid-November
In the first segment, at 10 am Eastern time, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and the nation’s top infectious-disease expert, began the day by noting that five of the six companies the US invested in to develop a vaccine are conducting phase 3 trials. He said, “we feel confident that we will have an answer likely in mid-November to the beginning of December as to whether we have a safe and effective vaccine”. He added he was “cautiously optimistic” that “we will have a safe and effective vaccine by the end of the year, which we can begin to distribute as we go into 2021.” He highlighted the COVID-19 Prevention Network website for more information on the trials.
Glaring racial health disparities in U.S.
Some of the most glaring health disparities surrounding COVID-19 in the United States were described by Carlos del Rio, MD, professor of medicine at Emory University in Atlanta, Georgia. He pointed out that while white people have about 23 cases per 10,000 population, Blacks have about 62 cases per 10,000, and Latinos have 73 cases per 10,000. While whites don’t see a huge jump in cases until age 80, he said, “among Blacks and Latinos you start seeing that huge increase at a younger age. In fact, starting at age 20, you start seeing a major, major change.”
COVID-19 diagnostics
Audrey Odom John, MD, PhD, chief of pediatric infectious diseases at Children’s Hospital of Philadelphia, is working on a new way of diagnosing COVID-19 infection in children by testing their breath. “We’re really taking advantage of a fundamental biological fact, which is that people stink,” she said. Breath shows the health of the body as a whole, “and it’s easy to see how breath volatiles might arise from a respiratory infection.” Testing breath is easy and inexpensive, which makes it particularly attractive as a potential test globally, she said.
Long-term effects of COVID-19
Post-COVID illness threatens to overwhelm the health system in the United States, even if only 1% of the 8 million people who have been infected have some sort of long-term deficit, “which would be a very conservative estimate,” said John O’Horo, MD, MPH, with the Mayo Clinic in Rochester, Minn. Neurologic dysfunction is going to be a “fairly significant thing to keep an eye on,” he added. Preeti Malani, MD, chief health officer in infectious diseases at the University of Michigan, Ann Arbor, said the emotional aspects of the illness are “striking” and may be the major long-term effect for most patients.
Challenging cases in COVID-19: Through fire and water
In a case presented to panelists during an afternoon session, a Mexican-born woman, 42, presents to urgent care with fever, dyspnea, dry cough, and pleuritic pain, for over a week. Multiple family members have had recent respiratory illness as well. She is obese, on no medications, was not traveling. She’s a nonsmoker and lives in a multigenerational household in the Mission District of San Francisco. Her heart rate is 116, respiratory rate is 36, and her oxygen saturation on room air is 77%. She is admitted to a local hospital and quickly declines, is intubated and started on hydroxychloroquine (HCQ). One day later she is transferred to a hospital for consideration of extracorporeal membrane oxygenation (ECMO).
Panelists were asked a variety of questions about how they would treat this patient. For example, would they continue HCQ? Ravina Kullar, PharmD, MPH, an infectious disease expert from Newport Beach, Calif., answered that she would not continue the HCQ because of lack of evidence and potential harms. Asked whether she would start remdesivir, Dr. Kullar said she would steer her away from that if the patient developed renal failure. Co-moderator Peter Chin-Hong, MD, a medical educator with the University of California, San Francisco, noted that contact tracing will be important as the patient returns to her housing-dense community.
In-hospital infection prevention
The CDC acknowledged aerosol spread of COVID-19 this month, but David Weber, MD, MPH, professor in infectious diseases at the University of North Carolina at Chapel Hill, said, “this does not change anything we need to do in the hospital,” as long as protective pandemic protocols continue to be followed.
There is no evidence, he noted, that SARS-CoV-2 is transmitted far enough that a hospitalized patient could infect people in other rooms or corridors or floors. Opening windows in COVID-19 patients’ rooms is “not an option,” he said, and could be harmful as fungal elements in outside air may introduce new pathogens. The degree to which improved ventilation systems reduce transmission has not been identified and studies are needed to look at that, he said.
Preventing COVID transmission in the community
Mary-Margaret Fill, MD, deputy state epidemiologist in Tennessee, highlighted COVID-19’s spread in prisons. As of mid-October, she said, there are more than 147,000 cases among the U.S. prison population and there have been 1,246 deaths. This translates to a case rate of about 9800 cases per 100,000 people, she said, “double the highest case rate for any state in the country and over three times greater than our national case rate of about 2,500 cases per 100,000 persons.”
Testing varies widely, she noted. For instance, some states test only new prisoners, and some test only when they are symptomatic. One of the strategies to fight this spread is having staff, who go in and out of the community, be assigned to work with only certain groups at a prison. Another is widespread testing of all prisoners. And when prisoners have to leave the prison for care or court dates, a third strategy would be quarantining them upon their return.
COVID-19 vaccines
As the session stretched into the evening in the United States, Mary Marovich, MD, director of vaccine research, AIDS division, with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health, said while each of the government-funded vaccine studies has its own trial, there are standardized objectives for direct comparisons. The studies are being conducted within the same clinical trial networks, and collaborative laboratories apply the same immunoassays and define the infections in the same way. They are all randomized, placebo-controlled trials and all but one have a 30,000-volunteer sample size. She said that while a vaccine is the goal to end the pandemic, monoclonal antibodies, such as those in convalescent plasma, “may serve as a critical bridge.”
The good, the bad, and the ugly during COVID-19 in Latin America
Latin America and the Caribbean are currently the regions hardest hit by COVID-19. Gustavo D. Lopardo, of the Asociacion Panamericana de Infectologia, noted that even before the pandemic Latin America suffered from widespread poverty and inequality. While overcrowding and poverty are determining factors in the spread of the virus, diabetes and obesity – both highly prevalent – are worsening COVID outcomes.
The countries of the region have dealt with asynchronous waves of transmission within their borders by implementing different containment strategies, with dissimilar results. The presenters covered the spectrum of the pandemic, from the “ugly” in Peru, which has the highest mortality rate in the region, to the “good” in Uruguay, where testing is “winning against COVID-19.” Paradoxically, Chile has both the highest cumulative incidence and the lowest case fatality rate of COVID-19 in the region.
In the social and political turmoil imposed by COVID-19, Clóvis Arns da Cunha, MD, president of the Brazilian Society of Infectious Diseases and professor at the Federal University of Paraná, pointed out that “fake news [has become] a public health problem in Brazil” and elsewhere.
Diagnostics and therapeutics in Latin America
Eleven of the 15 countries with the highest death rate in the world are located in Latin America or the Caribbean. Dr. Arns de Cunha pointed out that tests are hard to come by and inadequate diagnostic testing is a major problem. Latin American countries have not been able to compete with the United States and Europe in purchasing polymerase chain reaction test kits from China and South Korea. The test is the best diagnostic tool in the first week of symptoms, but its scale-up has proved to be a challenge in Latin America.
Furthermore, the most sensitive serological markers, CLIA and ECLIA, which perform best after 2 weeks of symptom onset, are not widely available in Latin America where many patients do not have access to the public health system. The detection of silent hypoxemia in symptomatic patients with COVID-19 can save lives; hence, Arns da Cunha praised the program that distributed 100,000 digital oximeters to hundreds of cities in Brazil, targeting vulnerable populations.
The COVID-19 experience in Japan
Takuya Yamagishi, MD, PhD, chief of the Antimicrobial Resistance Research Center at the National Institute of Infectious Diseases in Japan, played an instrumental role in the epidemiological investigation that took place on the Diamond Princess Cruise Ship in February 2020. That COVID-19 outbreak is the largest disease outbreak involving a cruise ship to date, with 712 confirmed COVID-19 cases and 13 deaths.
The ship-based quarantine prompted a massive public health response with unique challenges. In those early days, investigators uncovered important facts about COVID-19 epidemiology, generating hot debates regarding the public health strategy at the time. Notably, the majority of asymptomatically infected persons remained asymptomatic throughout the course of the infection, transmission from asymptomatic cases was almost as likely as transmission from symptomatic cases, and isolation of passengers in their cabins prevented inter-cabin transmission but not intra-cabin transmission.
Swift response in Asia Pacific region
Infectious-disease experts from Taiwan, Singapore, and Australia, who have been at the forefront of clinical care, research, and policy-making, spoke about their experiences.
Taiwan was one of the first countries to adopt a swift response to COVID-19, shortly after they recognized an outbreak of pneumonia of unknown etiology in China and long before the WHO declared a public health emergency, said Ping-Ing Lee, MD, PhD, from the National Taiwan University Children’s Hospital.
The country began onboard health checks on flights from Wuhan as early as Dec. 31, 2019. Dr. Lee attributed Taiwan’s success in prevention and control of COVID-19 to the rigorous use of face masks and environmental disinfection procedures. Regarding the country’s antilockdown stance, he said, “Lockdown may be effective; however, it is associated with a tremendous economic loss.”
In his presentation on remdesivir vs corticosteroids, David Lye, MBBS, said, “I think remdesivir as an antiviral seems to work well given early, but steroids will need to be studied further in terms of its conflicting evidence in multiple well-designed RCTs as well as [their] potential side effects.” He is director of the Infectious Disease Research and Training Office, National Centre for Infectious Diseases, Singapore.
Allen C. Cheng, MBBS, PhD, of Monash University in Melbourne, noted that “control is possible. We seemed to have controlled this twice at the moment with fairly draconian action, but every day does matter.”
China past the first wave
China has already passed the first wave, explained Lei Zhou, MD, of the Chinese Center for Disease Control and Prevention, but there are still some small-scale resurgences. So far a total of four waves have been identified. She also mentioned that contact tracing is intense and highlighted the case of Xinfadi Market in Beijing, the site of an outbreak in June 2020.
Gui-Qiang Wang, MD, from the Department of Infectious Disease, Peking University First Hospital, emphasized the importance of a chest CT for the diagnosis of COVID-19. “In the early stage of the disease, patients may not show any symptoms; however, on CT scan you can see pneumonia. Also, early intervention of high-risk groups and monitoring of warning indicators for disease progression is extremely important,” he said.
“Early antiviral therapy is expected to stop progression, but still needs evaluation,” he said. “Convalescent plasma is safe and effective, but its source is limited; steroid therapy needs to explore appropriate population and timing; and thymosin α is safe, and its effect on outcomes needs large-sample clinical trial.”
Time to Call for an ‘Arab CDC?’
The eastern Mediterranean is geographically, politically, economically, and religiously a very distinct and sensitive region, and “COVID-19 is an added insult to this already frail region of the world,” said Zaid Haddadin, MD, Vanderbilt University Medical Center, Nashville, Tenn.
Poor healthcare and poor public health services are a consequence of weak and fragile governments and infrastructure, the result of war and regional conflicts in many countries. Millions of war refugees live in camps with high population densities and shared facilities, which makes social distancing and community mitigation very challenging. Moreover, the culture includes frequent large social gatherings. Millions of pilgrims visit holy sites in different cities in these countries. There is also movement due to trade and tourism. Travel restrictions are challenging, and there is limited comprehension of precautionary measures.
Najwa Khuri-Bulos, professor of pediatrics and infectious diseases at the University of Jordan, was part of a task force headed by the country’s Ministry of Health. A lockdown was implemented, which helped flatten the curve, but the loosening of restrictions has led to a recent increase in cases. She said, “No country can succeed in controlling spread without the regional collaboration. Perhaps it is time to adopt the call for an Arab CDC.”
Africa is “not out of the woods yet”
The Africa CDC has three key pillars as the foundation for their COVID-19 strategy: preventing transmission, preventing deaths, and preventing social harm, according to Raji Tajudeen, MBBS, FWACP, MPH, head of the agency’s Public Health Institutes and Research Division. Africa, with 1.5 million cases of COVID-19, accounts for 5% of global cases. With a recovery rate of 83% and a case fatality rate of 2.4%, the African continent has fared much better than the rest of the world. “Significant improvements have been made, but we are not out of the woods yet,” he cautioned.
Richard Lessells, PhD, from the University of KwaZulu-Natal, agreed. “Unfortunately, South Africa has not been spared from the worst effects of this pandemic despite what you might read in the press and scientific coverage.” He added, “Over 50% of cases and up to two thirds of the deaths in the African region are coming from South Africa.” A bigger challenge for South Africa has been maintaining essential health services during the COVID-19 pandemic, especially since it is also at the heart of the HIV pandemic. On the brighter side, HIV itself has not emerged as a risk factor for COVID-19 infection or severe disease in South Africa.
Dimie Ogoina, MBBS, FWACP, president of the Nigerian Infectious Diseases Society, stated that COVID-19 has significantly affected access to healthcare in Nigeria, particularly immunizations and antenatal care. Immunization uptake is likely to have dropped by 50% in the country.
Diagnostic pitfalls in COVID-19
Technical errors associated with the SARS-CoV-2 diagnostic pipeline are a major source of variations in diagnosis, explained Jim Huggett, PhD, senior lecturer, analytical microbiology, University of Surrey, Guildford, England. He believes that PCR assays are currently too biased for a single cutoff to be broadly used, and false-positive signals are most likely because of contamination.
Dana Wolf, MD, Clinical Virology Unit, Hadassah Hebrew University Medical Center in Israel, presented a large-scale data analysis of more than 133,000 pooled samples. Such a pooling strategy appeared to be highly efficient for a wide range of prevalence rates (<1% to 6%). “Our empirical evidence strongly projects on the feasibility and benefits of pooling in the current pandemic setting, to enhance continued surveillance, control, and community reopening,” she said.
Corine Geurts van Kessel, MD, PhD, Department of Virology, Erasmus University Rotterdam (the Netherlands), discussing antibodies testing for SARS-CoV-2, pointed out that disease severity can affect testing accuracy. “Reinfection cases tell us that we cannot rely on immunity acquired by natural infection to confer herd immunity,” she said.
Misinformation in the first digital pandemic
The world is not only facing a devastating pandemic, but also an alarming “infodemic” of misinformation. Between January and March 2020, a new COVID-19–related tweet appeared on Twitter every 45 milliseconds. Müge Çevik, MD, MSc, MRCP, an infectious disease clinician, scientist, and science communicator, said that “the greatest challenge for science communication is reaching the audience.”
People have always been skeptical of science reporting by journalists and would rather have scientists communicate with them directly, she noted. Science communication plays a dual role. “On one hand is the need to promote science to a wide audience in order to inform and educate and inspire the next generation of scientists, and on the other hand there is also a need to engage effectively in public dialogue,” she added. Dr. Çevik and colleagues think that “The responsibility of academics should not end with finding the truth. It should end after communicating it.”
Treatment in the ICU
Matteo Bassetti, MD, with the University of Genoa (Italy), who was asked about when to use remdesivir in the intensive care unit and for how long, said, “In the majority of cases, 5 days is probably enough.” However, if there is high viremia, he said, physicians may choose to continue the regimen beyond 5 days. Data show it is important to prescribe this drug for patients with oxygen support in an early phase, within 10 days of the first symptoms, he added. “In the late phase, there is a very limited role for remdesivir, as we know that we are already out of the viremic phase.” He also emphasized that there is no role for hydroxychloroquine or lopinavir-ritonavir.
Breaking the chains of transmission
During the wrap-up session, former US CDC Director Tom Frieden, MD, said, “We’re not even halfway through it” about the pandemic trajectory. “And we have to be very clear that the risk of explosive spread will not end with a vaccine.” He is now president and CEO of Resolve to Save Lives.
Different parts of the world will have very different experiences, Dr. Frieden said, noting that Africa, where 4% of the population is older than 65, has a very different risk level than Europe and the United States, where 10%-20% of people are in older age groups.
“We need a one-two punch,” he noted, first preventing spread, and when it does happen, boxing it in. Mask wearing is essential. “States in the US that mandated universal mask-wearing experienced much more rapid declines (in cases) for every 5 days the mandate was in place.”
Michael Ryan, MD, executive director for the WHO’s Health Emergencies Programme, added, “We need to collectively recommit to winning this game. We know how to break the chains of transmission. We need recommitment to a scientific, societal, and political strategy, and an alliance – a contract – between those entities to try to move us forward.”
This article first appeared on Medscape.com.
Some medical societies feature sessions at their annual meetings that feel like they’re 24 hours long, yet few have the courage to schedule a session that actually runs all day and all night. But the five societies sponsoring the IDWeek conference had that courage. The first 24 hours of the meeting was devoted to the most pressing infectious-disease crisis of the last 100 years: the COVID-19 pandemic. They called it “COVID-19: Chasing the Sun.”
Dr. Fauci predicts a vaccine answer in mid-November
In the first segment, at 10 am Eastern time, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases and the nation’s top infectious-disease expert, began the day by noting that five of the six companies the US invested in to develop a vaccine are conducting phase 3 trials. He said, “we feel confident that we will have an answer likely in mid-November to the beginning of December as to whether we have a safe and effective vaccine”. He added he was “cautiously optimistic” that “we will have a safe and effective vaccine by the end of the year, which we can begin to distribute as we go into 2021.” He highlighted the COVID-19 Prevention Network website for more information on the trials.
Glaring racial health disparities in U.S.
Some of the most glaring health disparities surrounding COVID-19 in the United States were described by Carlos del Rio, MD, professor of medicine at Emory University in Atlanta, Georgia. He pointed out that while white people have about 23 cases per 10,000 population, Blacks have about 62 cases per 10,000, and Latinos have 73 cases per 10,000. While whites don’t see a huge jump in cases until age 80, he said, “among Blacks and Latinos you start seeing that huge increase at a younger age. In fact, starting at age 20, you start seeing a major, major change.”
COVID-19 diagnostics
Audrey Odom John, MD, PhD, chief of pediatric infectious diseases at Children’s Hospital of Philadelphia, is working on a new way of diagnosing COVID-19 infection in children by testing their breath. “We’re really taking advantage of a fundamental biological fact, which is that people stink,” she said. Breath shows the health of the body as a whole, “and it’s easy to see how breath volatiles might arise from a respiratory infection.” Testing breath is easy and inexpensive, which makes it particularly attractive as a potential test globally, she said.
Long-term effects of COVID-19
Post-COVID illness threatens to overwhelm the health system in the United States, even if only 1% of the 8 million people who have been infected have some sort of long-term deficit, “which would be a very conservative estimate,” said John O’Horo, MD, MPH, with the Mayo Clinic in Rochester, Minn. Neurologic dysfunction is going to be a “fairly significant thing to keep an eye on,” he added. Preeti Malani, MD, chief health officer in infectious diseases at the University of Michigan, Ann Arbor, said the emotional aspects of the illness are “striking” and may be the major long-term effect for most patients.
Challenging cases in COVID-19: Through fire and water
In a case presented to panelists during an afternoon session, a Mexican-born woman, 42, presents to urgent care with fever, dyspnea, dry cough, and pleuritic pain, for over a week. Multiple family members have had recent respiratory illness as well. She is obese, on no medications, was not traveling. She’s a nonsmoker and lives in a multigenerational household in the Mission District of San Francisco. Her heart rate is 116, respiratory rate is 36, and her oxygen saturation on room air is 77%. She is admitted to a local hospital and quickly declines, is intubated and started on hydroxychloroquine (HCQ). One day later she is transferred to a hospital for consideration of extracorporeal membrane oxygenation (ECMO).
Panelists were asked a variety of questions about how they would treat this patient. For example, would they continue HCQ? Ravina Kullar, PharmD, MPH, an infectious disease expert from Newport Beach, Calif., answered that she would not continue the HCQ because of lack of evidence and potential harms. Asked whether she would start remdesivir, Dr. Kullar said she would steer her away from that if the patient developed renal failure. Co-moderator Peter Chin-Hong, MD, a medical educator with the University of California, San Francisco, noted that contact tracing will be important as the patient returns to her housing-dense community.
In-hospital infection prevention
The CDC acknowledged aerosol spread of COVID-19 this month, but David Weber, MD, MPH, professor in infectious diseases at the University of North Carolina at Chapel Hill, said, “this does not change anything we need to do in the hospital,” as long as protective pandemic protocols continue to be followed.
There is no evidence, he noted, that SARS-CoV-2 is transmitted far enough that a hospitalized patient could infect people in other rooms or corridors or floors. Opening windows in COVID-19 patients’ rooms is “not an option,” he said, and could be harmful as fungal elements in outside air may introduce new pathogens. The degree to which improved ventilation systems reduce transmission has not been identified and studies are needed to look at that, he said.
Preventing COVID transmission in the community
Mary-Margaret Fill, MD, deputy state epidemiologist in Tennessee, highlighted COVID-19’s spread in prisons. As of mid-October, she said, there are more than 147,000 cases among the U.S. prison population and there have been 1,246 deaths. This translates to a case rate of about 9800 cases per 100,000 people, she said, “double the highest case rate for any state in the country and over three times greater than our national case rate of about 2,500 cases per 100,000 persons.”
Testing varies widely, she noted. For instance, some states test only new prisoners, and some test only when they are symptomatic. One of the strategies to fight this spread is having staff, who go in and out of the community, be assigned to work with only certain groups at a prison. Another is widespread testing of all prisoners. And when prisoners have to leave the prison for care or court dates, a third strategy would be quarantining them upon their return.
COVID-19 vaccines
As the session stretched into the evening in the United States, Mary Marovich, MD, director of vaccine research, AIDS division, with the National Institute of Allergy and Infectious Diseases and the National Institutes of Health, said while each of the government-funded vaccine studies has its own trial, there are standardized objectives for direct comparisons. The studies are being conducted within the same clinical trial networks, and collaborative laboratories apply the same immunoassays and define the infections in the same way. They are all randomized, placebo-controlled trials and all but one have a 30,000-volunteer sample size. She said that while a vaccine is the goal to end the pandemic, monoclonal antibodies, such as those in convalescent plasma, “may serve as a critical bridge.”
The good, the bad, and the ugly during COVID-19 in Latin America
Latin America and the Caribbean are currently the regions hardest hit by COVID-19. Gustavo D. Lopardo, of the Asociacion Panamericana de Infectologia, noted that even before the pandemic Latin America suffered from widespread poverty and inequality. While overcrowding and poverty are determining factors in the spread of the virus, diabetes and obesity – both highly prevalent – are worsening COVID outcomes.
The countries of the region have dealt with asynchronous waves of transmission within their borders by implementing different containment strategies, with dissimilar results. The presenters covered the spectrum of the pandemic, from the “ugly” in Peru, which has the highest mortality rate in the region, to the “good” in Uruguay, where testing is “winning against COVID-19.” Paradoxically, Chile has both the highest cumulative incidence and the lowest case fatality rate of COVID-19 in the region.
In the social and political turmoil imposed by COVID-19, Clóvis Arns da Cunha, MD, president of the Brazilian Society of Infectious Diseases and professor at the Federal University of Paraná, pointed out that “fake news [has become] a public health problem in Brazil” and elsewhere.
Diagnostics and therapeutics in Latin America
Eleven of the 15 countries with the highest death rate in the world are located in Latin America or the Caribbean. Dr. Arns de Cunha pointed out that tests are hard to come by and inadequate diagnostic testing is a major problem. Latin American countries have not been able to compete with the United States and Europe in purchasing polymerase chain reaction test kits from China and South Korea. The test is the best diagnostic tool in the first week of symptoms, but its scale-up has proved to be a challenge in Latin America.
Furthermore, the most sensitive serological markers, CLIA and ECLIA, which perform best after 2 weeks of symptom onset, are not widely available in Latin America where many patients do not have access to the public health system. The detection of silent hypoxemia in symptomatic patients with COVID-19 can save lives; hence, Arns da Cunha praised the program that distributed 100,000 digital oximeters to hundreds of cities in Brazil, targeting vulnerable populations.
The COVID-19 experience in Japan
Takuya Yamagishi, MD, PhD, chief of the Antimicrobial Resistance Research Center at the National Institute of Infectious Diseases in Japan, played an instrumental role in the epidemiological investigation that took place on the Diamond Princess Cruise Ship in February 2020. That COVID-19 outbreak is the largest disease outbreak involving a cruise ship to date, with 712 confirmed COVID-19 cases and 13 deaths.
The ship-based quarantine prompted a massive public health response with unique challenges. In those early days, investigators uncovered important facts about COVID-19 epidemiology, generating hot debates regarding the public health strategy at the time. Notably, the majority of asymptomatically infected persons remained asymptomatic throughout the course of the infection, transmission from asymptomatic cases was almost as likely as transmission from symptomatic cases, and isolation of passengers in their cabins prevented inter-cabin transmission but not intra-cabin transmission.
Swift response in Asia Pacific region
Infectious-disease experts from Taiwan, Singapore, and Australia, who have been at the forefront of clinical care, research, and policy-making, spoke about their experiences.
Taiwan was one of the first countries to adopt a swift response to COVID-19, shortly after they recognized an outbreak of pneumonia of unknown etiology in China and long before the WHO declared a public health emergency, said Ping-Ing Lee, MD, PhD, from the National Taiwan University Children’s Hospital.
The country began onboard health checks on flights from Wuhan as early as Dec. 31, 2019. Dr. Lee attributed Taiwan’s success in prevention and control of COVID-19 to the rigorous use of face masks and environmental disinfection procedures. Regarding the country’s antilockdown stance, he said, “Lockdown may be effective; however, it is associated with a tremendous economic loss.”
In his presentation on remdesivir vs corticosteroids, David Lye, MBBS, said, “I think remdesivir as an antiviral seems to work well given early, but steroids will need to be studied further in terms of its conflicting evidence in multiple well-designed RCTs as well as [their] potential side effects.” He is director of the Infectious Disease Research and Training Office, National Centre for Infectious Diseases, Singapore.
Allen C. Cheng, MBBS, PhD, of Monash University in Melbourne, noted that “control is possible. We seemed to have controlled this twice at the moment with fairly draconian action, but every day does matter.”
China past the first wave
China has already passed the first wave, explained Lei Zhou, MD, of the Chinese Center for Disease Control and Prevention, but there are still some small-scale resurgences. So far a total of four waves have been identified. She also mentioned that contact tracing is intense and highlighted the case of Xinfadi Market in Beijing, the site of an outbreak in June 2020.
Gui-Qiang Wang, MD, from the Department of Infectious Disease, Peking University First Hospital, emphasized the importance of a chest CT for the diagnosis of COVID-19. “In the early stage of the disease, patients may not show any symptoms; however, on CT scan you can see pneumonia. Also, early intervention of high-risk groups and monitoring of warning indicators for disease progression is extremely important,” he said.
“Early antiviral therapy is expected to stop progression, but still needs evaluation,” he said. “Convalescent plasma is safe and effective, but its source is limited; steroid therapy needs to explore appropriate population and timing; and thymosin α is safe, and its effect on outcomes needs large-sample clinical trial.”
Time to Call for an ‘Arab CDC?’
The eastern Mediterranean is geographically, politically, economically, and religiously a very distinct and sensitive region, and “COVID-19 is an added insult to this already frail region of the world,” said Zaid Haddadin, MD, Vanderbilt University Medical Center, Nashville, Tenn.
Poor healthcare and poor public health services are a consequence of weak and fragile governments and infrastructure, the result of war and regional conflicts in many countries. Millions of war refugees live in camps with high population densities and shared facilities, which makes social distancing and community mitigation very challenging. Moreover, the culture includes frequent large social gatherings. Millions of pilgrims visit holy sites in different cities in these countries. There is also movement due to trade and tourism. Travel restrictions are challenging, and there is limited comprehension of precautionary measures.
Najwa Khuri-Bulos, professor of pediatrics and infectious diseases at the University of Jordan, was part of a task force headed by the country’s Ministry of Health. A lockdown was implemented, which helped flatten the curve, but the loosening of restrictions has led to a recent increase in cases. She said, “No country can succeed in controlling spread without the regional collaboration. Perhaps it is time to adopt the call for an Arab CDC.”
Africa is “not out of the woods yet”
The Africa CDC has three key pillars as the foundation for their COVID-19 strategy: preventing transmission, preventing deaths, and preventing social harm, according to Raji Tajudeen, MBBS, FWACP, MPH, head of the agency’s Public Health Institutes and Research Division. Africa, with 1.5 million cases of COVID-19, accounts for 5% of global cases. With a recovery rate of 83% and a case fatality rate of 2.4%, the African continent has fared much better than the rest of the world. “Significant improvements have been made, but we are not out of the woods yet,” he cautioned.
Richard Lessells, PhD, from the University of KwaZulu-Natal, agreed. “Unfortunately, South Africa has not been spared from the worst effects of this pandemic despite what you might read in the press and scientific coverage.” He added, “Over 50% of cases and up to two thirds of the deaths in the African region are coming from South Africa.” A bigger challenge for South Africa has been maintaining essential health services during the COVID-19 pandemic, especially since it is also at the heart of the HIV pandemic. On the brighter side, HIV itself has not emerged as a risk factor for COVID-19 infection or severe disease in South Africa.
Dimie Ogoina, MBBS, FWACP, president of the Nigerian Infectious Diseases Society, stated that COVID-19 has significantly affected access to healthcare in Nigeria, particularly immunizations and antenatal care. Immunization uptake is likely to have dropped by 50% in the country.
Diagnostic pitfalls in COVID-19
Technical errors associated with the SARS-CoV-2 diagnostic pipeline are a major source of variations in diagnosis, explained Jim Huggett, PhD, senior lecturer, analytical microbiology, University of Surrey, Guildford, England. He believes that PCR assays are currently too biased for a single cutoff to be broadly used, and false-positive signals are most likely because of contamination.
Dana Wolf, MD, Clinical Virology Unit, Hadassah Hebrew University Medical Center in Israel, presented a large-scale data analysis of more than 133,000 pooled samples. Such a pooling strategy appeared to be highly efficient for a wide range of prevalence rates (<1% to 6%). “Our empirical evidence strongly projects on the feasibility and benefits of pooling in the current pandemic setting, to enhance continued surveillance, control, and community reopening,” she said.
Corine Geurts van Kessel, MD, PhD, Department of Virology, Erasmus University Rotterdam (the Netherlands), discussing antibodies testing for SARS-CoV-2, pointed out that disease severity can affect testing accuracy. “Reinfection cases tell us that we cannot rely on immunity acquired by natural infection to confer herd immunity,” she said.
Misinformation in the first digital pandemic
The world is not only facing a devastating pandemic, but also an alarming “infodemic” of misinformation. Between January and March 2020, a new COVID-19–related tweet appeared on Twitter every 45 milliseconds. Müge Çevik, MD, MSc, MRCP, an infectious disease clinician, scientist, and science communicator, said that “the greatest challenge for science communication is reaching the audience.”
People have always been skeptical of science reporting by journalists and would rather have scientists communicate with them directly, she noted. Science communication plays a dual role. “On one hand is the need to promote science to a wide audience in order to inform and educate and inspire the next generation of scientists, and on the other hand there is also a need to engage effectively in public dialogue,” she added. Dr. Çevik and colleagues think that “The responsibility of academics should not end with finding the truth. It should end after communicating it.”
Treatment in the ICU
Matteo Bassetti, MD, with the University of Genoa (Italy), who was asked about when to use remdesivir in the intensive care unit and for how long, said, “In the majority of cases, 5 days is probably enough.” However, if there is high viremia, he said, physicians may choose to continue the regimen beyond 5 days. Data show it is important to prescribe this drug for patients with oxygen support in an early phase, within 10 days of the first symptoms, he added. “In the late phase, there is a very limited role for remdesivir, as we know that we are already out of the viremic phase.” He also emphasized that there is no role for hydroxychloroquine or lopinavir-ritonavir.
Breaking the chains of transmission
During the wrap-up session, former US CDC Director Tom Frieden, MD, said, “We’re not even halfway through it” about the pandemic trajectory. “And we have to be very clear that the risk of explosive spread will not end with a vaccine.” He is now president and CEO of Resolve to Save Lives.
Different parts of the world will have very different experiences, Dr. Frieden said, noting that Africa, where 4% of the population is older than 65, has a very different risk level than Europe and the United States, where 10%-20% of people are in older age groups.
“We need a one-two punch,” he noted, first preventing spread, and when it does happen, boxing it in. Mask wearing is essential. “States in the US that mandated universal mask-wearing experienced much more rapid declines (in cases) for every 5 days the mandate was in place.”
Michael Ryan, MD, executive director for the WHO’s Health Emergencies Programme, added, “We need to collectively recommit to winning this game. We know how to break the chains of transmission. We need recommitment to a scientific, societal, and political strategy, and an alliance – a contract – between those entities to try to move us forward.”
This article first appeared on Medscape.com.
FROM IDWEEK 2020
COVID-19 a new opportunity for suicide prevention
The ongoing COVID-19 pandemic poses clear threats to mental well-being, but an increase in suicide is not inevitable if appropriate action is taken, one expert says.
“Increases in suicide rates should not be a foregone conclusion, even with the negative effects of the pandemic. If the lessons of suicide prevention research are heeded during and after the pandemic, this potential for increased risk could be substantially mitigated,” writes Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, in an invited communication in JAMA Psychiatry.
“This is a moment in history when suicide prevention must be prioritized as a serious public health concern,” she writes.
Mitigating suicide risk
Although evidence from the first 6 months of the pandemic reveal specific effects on suicide risk, real-time data on suicide deaths are not available in most regions of the world. From emerging data from several countries, there is no evidence of increased suicide rates during the pandemic thus far, Moutier notes.
Still, a number of pandemic-related risk factors could increase individual and population suicide risk.
They include deterioration or recurrence of serious mental illness; increased isolation, loneliness, and bereavement; increased use of drugs and alcohol; job loss and other financial stressors; and increases in domestic violence.
There are mitigating strategies for each of these “threats to suicide risk.” The science is “very clear,” Moutier told Medscape Medical News.
“Suicide risk is never a situation of inevitability. It’s dynamic, with multiple forces at play in each individual and in the population. Lives can be saved simply by making people feel more connected to each other, that they are part of a larger community,” she added.
The political will
Moutier notes that prior to the pandemic, four countries ― Finland, Norway, Sweden, and Australia ― had fully implemented national suicide prevention plans and had achieved reductions in their national suicide rates. However, in the United States, the suicide rate has been steadily increasing since 1999.
A Centers for Disease Control and Prevention survey released in August 2020 found that 40% of US adults reported symptoms of depression, anxiety, or increased substance use during COVID-19 and that about 11% reported suicidal ideation in the past month, all increases from prior surveys.
COVID-19 presents a “new and urgent opportunity” to focus political will, federal investments, and the global community on suicide prevention, Moutier writes.
“The political will to address suicide has actually moved in the right direction during COVID, as evidenced by a number of pieces of legislation that have suddenly found their way to passing that we’ve been working on for years,” she said in an interview.
One example, she said, is the National Suicide Hotline Designation Act, signed into law earlier this month by President Donald Trump.
As previously reported, under the law, beginning in July 2022, Americans experiencing a mental health crisis will be able to dial 9-8-8 and be connected to the services and counselors at the National Suicide Prevention Lifeline.
Moutier reports no relevant financial relationships.
This article first appeared on Medscape.com.
The ongoing COVID-19 pandemic poses clear threats to mental well-being, but an increase in suicide is not inevitable if appropriate action is taken, one expert says.
“Increases in suicide rates should not be a foregone conclusion, even with the negative effects of the pandemic. If the lessons of suicide prevention research are heeded during and after the pandemic, this potential for increased risk could be substantially mitigated,” writes Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, in an invited communication in JAMA Psychiatry.
“This is a moment in history when suicide prevention must be prioritized as a serious public health concern,” she writes.
Mitigating suicide risk
Although evidence from the first 6 months of the pandemic reveal specific effects on suicide risk, real-time data on suicide deaths are not available in most regions of the world. From emerging data from several countries, there is no evidence of increased suicide rates during the pandemic thus far, Moutier notes.
Still, a number of pandemic-related risk factors could increase individual and population suicide risk.
They include deterioration or recurrence of serious mental illness; increased isolation, loneliness, and bereavement; increased use of drugs and alcohol; job loss and other financial stressors; and increases in domestic violence.
There are mitigating strategies for each of these “threats to suicide risk.” The science is “very clear,” Moutier told Medscape Medical News.
“Suicide risk is never a situation of inevitability. It’s dynamic, with multiple forces at play in each individual and in the population. Lives can be saved simply by making people feel more connected to each other, that they are part of a larger community,” she added.
The political will
Moutier notes that prior to the pandemic, four countries ― Finland, Norway, Sweden, and Australia ― had fully implemented national suicide prevention plans and had achieved reductions in their national suicide rates. However, in the United States, the suicide rate has been steadily increasing since 1999.
A Centers for Disease Control and Prevention survey released in August 2020 found that 40% of US adults reported symptoms of depression, anxiety, or increased substance use during COVID-19 and that about 11% reported suicidal ideation in the past month, all increases from prior surveys.
COVID-19 presents a “new and urgent opportunity” to focus political will, federal investments, and the global community on suicide prevention, Moutier writes.
“The political will to address suicide has actually moved in the right direction during COVID, as evidenced by a number of pieces of legislation that have suddenly found their way to passing that we’ve been working on for years,” she said in an interview.
One example, she said, is the National Suicide Hotline Designation Act, signed into law earlier this month by President Donald Trump.
As previously reported, under the law, beginning in July 2022, Americans experiencing a mental health crisis will be able to dial 9-8-8 and be connected to the services and counselors at the National Suicide Prevention Lifeline.
Moutier reports no relevant financial relationships.
This article first appeared on Medscape.com.
The ongoing COVID-19 pandemic poses clear threats to mental well-being, but an increase in suicide is not inevitable if appropriate action is taken, one expert says.
“Increases in suicide rates should not be a foregone conclusion, even with the negative effects of the pandemic. If the lessons of suicide prevention research are heeded during and after the pandemic, this potential for increased risk could be substantially mitigated,” writes Christine Moutier, MD, chief medical officer of the American Foundation for Suicide Prevention, in an invited communication in JAMA Psychiatry.
“This is a moment in history when suicide prevention must be prioritized as a serious public health concern,” she writes.
Mitigating suicide risk
Although evidence from the first 6 months of the pandemic reveal specific effects on suicide risk, real-time data on suicide deaths are not available in most regions of the world. From emerging data from several countries, there is no evidence of increased suicide rates during the pandemic thus far, Moutier notes.
Still, a number of pandemic-related risk factors could increase individual and population suicide risk.
They include deterioration or recurrence of serious mental illness; increased isolation, loneliness, and bereavement; increased use of drugs and alcohol; job loss and other financial stressors; and increases in domestic violence.
There are mitigating strategies for each of these “threats to suicide risk.” The science is “very clear,” Moutier told Medscape Medical News.
“Suicide risk is never a situation of inevitability. It’s dynamic, with multiple forces at play in each individual and in the population. Lives can be saved simply by making people feel more connected to each other, that they are part of a larger community,” she added.
The political will
Moutier notes that prior to the pandemic, four countries ― Finland, Norway, Sweden, and Australia ― had fully implemented national suicide prevention plans and had achieved reductions in their national suicide rates. However, in the United States, the suicide rate has been steadily increasing since 1999.
A Centers for Disease Control and Prevention survey released in August 2020 found that 40% of US adults reported symptoms of depression, anxiety, or increased substance use during COVID-19 and that about 11% reported suicidal ideation in the past month, all increases from prior surveys.
COVID-19 presents a “new and urgent opportunity” to focus political will, federal investments, and the global community on suicide prevention, Moutier writes.
“The political will to address suicide has actually moved in the right direction during COVID, as evidenced by a number of pieces of legislation that have suddenly found their way to passing that we’ve been working on for years,” she said in an interview.
One example, she said, is the National Suicide Hotline Designation Act, signed into law earlier this month by President Donald Trump.
As previously reported, under the law, beginning in July 2022, Americans experiencing a mental health crisis will be able to dial 9-8-8 and be connected to the services and counselors at the National Suicide Prevention Lifeline.
Moutier reports no relevant financial relationships.
This article first appeared on Medscape.com.
Florida will investigate all COVID-19 deaths
The Florida Department of Health will investigate the state’s 16,000 coronavirus deaths due to questions about the integrity of the data, according to an announcement issued Wednesday.
State health department officials said the “fatality data reported to the state consistently presents confusion and warrants a rigorous review.” The review is meant to “ensure data integrity.”
“During a pandemic, the public must be able to rely on accurate public health data to make informed decisions,” Scott Rivkees, the surgeon general for Florida, said in the statement.
Among the 95 deaths reported Wednesday for instance, 16 had more than a 2-month separation between the time of testing positive for COVID-19 and passing away, and 5 cases had a 3-month gap. In addition, 11 of the deaths occurred more than a month ago.
The health department then listed data for all 95 cases, including the age, gender, county and the dates of test positivity and death. Palm Beach County had 50 of the COVID-19 deaths.
“To ensure the accuracy of COVID-19 related deaths, the department will be performing additional reviews of all deaths,” Rivkees said. “Timely and accurate data remains a top priority of the Department of Health.”
Last week, Jose Oliva, speaker of the Florida House of Representatives, said medical examiner reports were “often lacking in rigor.” House Democrats then said Republicans were trying to “downplay the death toll,” according to the South Florida Sun Sentinel .
Fred Piccolo Jr., a spokesman for Florida Gov. Ron DeSantis, told the newspaper Wednesday that officials have struggled to obtain timely data. Labs sometimes report test results from weeks before, he added.
“It’s really one of those things that you gotta know if someone is dying of COVID or if they’re not,” Piccolo said. “Then you can legitimately say, here are the numbers.”
Sources
Florida Department of Health, “Florida Surgeon General Implements Additional Review Process for Fatalities Attributed to COVID-19 to Ensure Data Integrity.”
South Florida Sun Sentinel, “Florida to investigate all COVID-19 deaths after questions about ‘integrity’ of data.”
WebMD Health News © 2020
This article first appeared on Medscape.com.
The Florida Department of Health will investigate the state’s 16,000 coronavirus deaths due to questions about the integrity of the data, according to an announcement issued Wednesday.
State health department officials said the “fatality data reported to the state consistently presents confusion and warrants a rigorous review.” The review is meant to “ensure data integrity.”
“During a pandemic, the public must be able to rely on accurate public health data to make informed decisions,” Scott Rivkees, the surgeon general for Florida, said in the statement.
Among the 95 deaths reported Wednesday for instance, 16 had more than a 2-month separation between the time of testing positive for COVID-19 and passing away, and 5 cases had a 3-month gap. In addition, 11 of the deaths occurred more than a month ago.
The health department then listed data for all 95 cases, including the age, gender, county and the dates of test positivity and death. Palm Beach County had 50 of the COVID-19 deaths.
“To ensure the accuracy of COVID-19 related deaths, the department will be performing additional reviews of all deaths,” Rivkees said. “Timely and accurate data remains a top priority of the Department of Health.”
Last week, Jose Oliva, speaker of the Florida House of Representatives, said medical examiner reports were “often lacking in rigor.” House Democrats then said Republicans were trying to “downplay the death toll,” according to the South Florida Sun Sentinel .
Fred Piccolo Jr., a spokesman for Florida Gov. Ron DeSantis, told the newspaper Wednesday that officials have struggled to obtain timely data. Labs sometimes report test results from weeks before, he added.
“It’s really one of those things that you gotta know if someone is dying of COVID or if they’re not,” Piccolo said. “Then you can legitimately say, here are the numbers.”
Sources
Florida Department of Health, “Florida Surgeon General Implements Additional Review Process for Fatalities Attributed to COVID-19 to Ensure Data Integrity.”
South Florida Sun Sentinel, “Florida to investigate all COVID-19 deaths after questions about ‘integrity’ of data.”
WebMD Health News © 2020
This article first appeared on Medscape.com.
The Florida Department of Health will investigate the state’s 16,000 coronavirus deaths due to questions about the integrity of the data, according to an announcement issued Wednesday.
State health department officials said the “fatality data reported to the state consistently presents confusion and warrants a rigorous review.” The review is meant to “ensure data integrity.”
“During a pandemic, the public must be able to rely on accurate public health data to make informed decisions,” Scott Rivkees, the surgeon general for Florida, said in the statement.
Among the 95 deaths reported Wednesday for instance, 16 had more than a 2-month separation between the time of testing positive for COVID-19 and passing away, and 5 cases had a 3-month gap. In addition, 11 of the deaths occurred more than a month ago.
The health department then listed data for all 95 cases, including the age, gender, county and the dates of test positivity and death. Palm Beach County had 50 of the COVID-19 deaths.
“To ensure the accuracy of COVID-19 related deaths, the department will be performing additional reviews of all deaths,” Rivkees said. “Timely and accurate data remains a top priority of the Department of Health.”
Last week, Jose Oliva, speaker of the Florida House of Representatives, said medical examiner reports were “often lacking in rigor.” House Democrats then said Republicans were trying to “downplay the death toll,” according to the South Florida Sun Sentinel .
Fred Piccolo Jr., a spokesman for Florida Gov. Ron DeSantis, told the newspaper Wednesday that officials have struggled to obtain timely data. Labs sometimes report test results from weeks before, he added.
“It’s really one of those things that you gotta know if someone is dying of COVID or if they’re not,” Piccolo said. “Then you can legitimately say, here are the numbers.”
Sources
Florida Department of Health, “Florida Surgeon General Implements Additional Review Process for Fatalities Attributed to COVID-19 to Ensure Data Integrity.”
South Florida Sun Sentinel, “Florida to investigate all COVID-19 deaths after questions about ‘integrity’ of data.”
WebMD Health News © 2020
This article first appeared on Medscape.com.
When should students resume sports after a COVID-19 diagnosis?
Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.
There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.
“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”
Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
Limited data
The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.
Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.
“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”
Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.
“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.
Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”
Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”
Mitigating risk
COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”
When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”
If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.
Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.
Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”
Dr. Bernhardt had no relevant disclosures.
Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.
There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.
“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”
Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
Limited data
The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.
Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.
“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”
Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.
“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.
Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”
Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”
Mitigating risk
COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”
When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”
If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.
Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.
Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”
Dr. Bernhardt had no relevant disclosures.
Many student athletes who test positive for COVID-19 likely can have an uneventful return to their sports after they have rested for 2 weeks in quarantine, doctors suggest.
There are reasons for caution, however, especially when a patient has symptoms that indicate possible cardiac involvement. In these cases, patients should undergo cardiac testing before a physician clears them to return to play, according to guidance from professional associations. Reports of myocarditis in college athletes who tested positive for SARS-CoV-2 but were asymptomatic are among the reasons for concern. Myocarditis may increase the risk of sudden death during exercise.
“The thing that you need to keep in mind is that this is not just a respiratory illness,” David T. Bernhardt, MD, professor of pediatrics, orthopedics, and rehabilitation at the University of Wisconsin in Madison, said in a presentation at the annual meeting of the American Academy of Pediatrics, held virtually this year. High school and college athletes have had cardiac, neurologic, hematologic, and renal problems that “can complicate their recovery and their return to sport.”
Still, children who test positive for COVID-19 tend to have mild illness and often are asymptomatic. “It is more than likely going to be safe for the majority of the student athletes who are in the elementary and middle school age to return to sport,” said Dr. Bernhardt. Given that 18-year-old college freshmen have had cardiac complications, there may be reason for more caution with high school students.
Limited data
The AAP has released interim guidance on returning to sports and recommends that primary care physicians clear all patients with COVID-19 before they resume training. Physicians should screen for cardiac symptoms such as chest pain, shortness of breath, fatigue, palpitations, or syncope.
Those with severe illness should be restricted from exercise and participation for 3-6 months. Primary care physicians, preferably in consultation with pediatric cardiologists, should clear athletes who experience severe illness.
“Most of the recommendations come from the fact that we simply do not know what we do not know with COVID-19,” Susannah Briskin, MD, a coauthor of the interim guidance, said in an interview. “We have to be cautious in returning individuals to play and closely monitor them as we learn more about the disease process and its effect on kids.”
Patients with severe illness could include those who were hospitalized and experienced hypotension or arrhythmias, required intubation or extracorporeal membrane oxygenation (ECMO) support, had kidney or cardiac failure, or developed multisystem inflammatory syndrome in children (MIS-C), said Dr. Briskin, a specialist in pediatric sports medicine at Case Western Reserve University, Cleveland.
“The majority of COVID-19 cases will not present like this in kids. We have no idea how common myocarditis is in kids post infection. We do know that, if anyone has chest pain, shortness of breath, excessive fatigue, syncope [passing out], or arrhythmia [feeling of their heart skipping beats], they should undergo further evaluation for myocarditis,” Dr. Briskin said.
Patients who are asymptomatic or have mild symptoms should rest for 14 days after their positive test. After their infectious period has passed, a doctor should assess for any concerning cardiac symptoms. “Anyone with prolonged fever or moderate symptoms should see their pediatrician and have an EKG performed, at a minimum, prior to return to sports,” Dr. Briskin said. “Anyone with an abnormal EKG or concerning signs or symptoms should be referred on to pediatric cardiology for a further assessment.”
Most patients who Dr. Briskin has seen have been asymptomatic or mildly symptomatic. “They have done well with a gradual return to physical activity,” she said. “We recommend a gradual return so individuals can be monitored for any signs or symptoms concerning for myocarditis. The far majority of individuals likely have an uneventful return to play.”
Mitigating risk
COVID-19 adds elements of uncertainty and complexity to the usual process of mitigating risk in sports, Dr. Bernhardt noted in his lecture. “You are dealing with an infection that we do not know a lot about,” he said. “And we are trying to mitigate risk not only for the individual who may or may not have underlying health problems, but you are also trying to mitigate risk for anybody else involved with the sport, including athletic trainers and team physicians, coaches, spectators, custodial staff, people working at a snack shack, and all the other people that can be involved in a typical sporting type of atmosphere.”
When patients do return to play after an illness, they should gradually increase the training load to avoid injury. In addition, clinicians should screen for depression and anxiety using tools such as the Four-Item Patient Health Questionnaire (PHQ-4) when they see patients. “The pandemic has been quite stressful for everybody, including our high school student athletes,” Dr. Bernhardt said. “Giving everybody a PHQ-4 when they come into clinic right now probably makes sense in terms of the stress levels that all of us are experiencing.”
If a patient screens positive, take additional history and refer for more in-depth mental health evaluation and treatment if warranted. Sharing breathing and relaxation exercises, promoting healthy behaviors, and paying attention to unhealthy strategies also may help, Dr. Bernhardt suggested.
Ultimately, determining when an athlete with COVID-19 can be medically cleared to return to play may be a challenge. There are limited data on epidemiology and clinical presentations that could help identify cardiac injury related to the disease, Dr. Bernhardt said. Guidance from the American College of Cardiology provides a framework for evaluating athletes for return to play, and pediatric cardiologists have discussed how the guidance relates to a pediatric population. Cardiac assessments may include measures of biomarkers such as troponin, B-type natriuretic peptide, and sedimentation rate, along with electrocardiograms, echocardiograms, and cardiac MRI.
Beyond return-to-play decisions, encourage the use of cloth face coverings on the sidelines and away from the playing field, and stress proper quarantining, Dr. Briskin added. Too often, she hears about children not quarantining properly. “Individuals with a known exposure should be quarantined in their house – ideally in a separate room from everyone else. ... When they come out of their room, they should wash their hands well and wear a cloth face covering. They should not be eating with other people.”
Dr. Bernhardt had no relevant disclosures.
FROM AAP 2020
No mortality benefit after intensive glucose control once Hb A1c curves equalize
Background: A previous study reported that a median of 5.6 years of intensive versus standard glucose lowering in veterans with type 2 diabetes resulted in significantly reduced risk of major cardiovascular events after 10 years of combined intervention and observational follow-up. 
Study design: Prospective cohort.
Setting: Veterans Affairs Healthcare System.
Synopsis: In the original trial, 1,791 veterans were randomly assigned to receive either intensive or standard glucose control therapy. After conclusion of that study, 1,655 participants were followed using central databases, and 1,391 also provided data via surveys and chart review. Initially the difference in the glycated hemoglobin (Hb A1c) curves between the two groups averaged 1.5%, but it declined to 0.2%-0.3% 3 years after the trial ended. The median Hb A1c then stabilized to 8% in both groups.
Over a period of 15 years of combined intervention and posttrial follow-up, the risks of major cardiovascular events or death were not lower in the intensive-therapy group (hazard ratio for composite outcome, 0.91; 95% confidence interval, 0.78-1.06; P = .23; HR for death, 1.02; 95% CI, 0.88-1.18). The risk of major cardiovascular disease outcomes was reduced during the approximately 10-year interval of separation of the Hb A1c curves (HR, 0.83; 95% CI, 0.70-0.99), but it did not persist after equalization of Hb A1c levels (HR, 1.26; 95% CI, 0.90-1.75). Limitations include the observational study design, the study population of mostly older men, and reliance on administrative data for outcomes.
Bottom line: More than 5 years of intensive glucose lowering, compared with standard therapy, did not show significantly lower risks of cardiovascular events or mortality once the glycated hemoglobin curves equalized during follow-up in years 11-15.
Citation: Reaven PD et al. Intensive glucose control in patients with type 2 diabetes – 15-year follow-up. New Engl J Med. 2019 Jun 6;380(23):2215-24.
Dr. Burke is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.
Background: A previous study reported that a median of 5.6 years of intensive versus standard glucose lowering in veterans with type 2 diabetes resulted in significantly reduced risk of major cardiovascular events after 10 years of combined intervention and observational follow-up.
Study design: Prospective cohort.
Setting: Veterans Affairs Healthcare System.
Synopsis: In the original trial, 1,791 veterans were randomly assigned to receive either intensive or standard glucose control therapy. After conclusion of that study, 1,655 participants were followed using central databases, and 1,391 also provided data via surveys and chart review. Initially the difference in the glycated hemoglobin (Hb A1c) curves between the two groups averaged 1.5%, but it declined to 0.2%-0.3% 3 years after the trial ended. The median Hb A1c then stabilized to 8% in both groups.
Over a period of 15 years of combined intervention and posttrial follow-up, the risks of major cardiovascular events or death were not lower in the intensive-therapy group (hazard ratio for composite outcome, 0.91; 95% confidence interval, 0.78-1.06; P = .23; HR for death, 1.02; 95% CI, 0.88-1.18). The risk of major cardiovascular disease outcomes was reduced during the approximately 10-year interval of separation of the Hb A1c curves (HR, 0.83; 95% CI, 0.70-0.99), but it did not persist after equalization of Hb A1c levels (HR, 1.26; 95% CI, 0.90-1.75). Limitations include the observational study design, the study population of mostly older men, and reliance on administrative data for outcomes.
Bottom line: More than 5 years of intensive glucose lowering, compared with standard therapy, did not show significantly lower risks of cardiovascular events or mortality once the glycated hemoglobin curves equalized during follow-up in years 11-15.
Citation: Reaven PD et al. Intensive glucose control in patients with type 2 diabetes – 15-year follow-up. New Engl J Med. 2019 Jun 6;380(23):2215-24.
Dr. Burke is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.
Background: A previous study reported that a median of 5.6 years of intensive versus standard glucose lowering in veterans with type 2 diabetes resulted in significantly reduced risk of major cardiovascular events after 10 years of combined intervention and observational follow-up.
Study design: Prospective cohort.
Setting: Veterans Affairs Healthcare System.
Synopsis: In the original trial, 1,791 veterans were randomly assigned to receive either intensive or standard glucose control therapy. After conclusion of that study, 1,655 participants were followed using central databases, and 1,391 also provided data via surveys and chart review. Initially the difference in the glycated hemoglobin (Hb A1c) curves between the two groups averaged 1.5%, but it declined to 0.2%-0.3% 3 years after the trial ended. The median Hb A1c then stabilized to 8% in both groups.
Over a period of 15 years of combined intervention and posttrial follow-up, the risks of major cardiovascular events or death were not lower in the intensive-therapy group (hazard ratio for composite outcome, 0.91; 95% confidence interval, 0.78-1.06; P = .23; HR for death, 1.02; 95% CI, 0.88-1.18). The risk of major cardiovascular disease outcomes was reduced during the approximately 10-year interval of separation of the Hb A1c curves (HR, 0.83; 95% CI, 0.70-0.99), but it did not persist after equalization of Hb A1c levels (HR, 1.26; 95% CI, 0.90-1.75). Limitations include the observational study design, the study population of mostly older men, and reliance on administrative data for outcomes.
Bottom line: More than 5 years of intensive glucose lowering, compared with standard therapy, did not show significantly lower risks of cardiovascular events or mortality once the glycated hemoglobin curves equalized during follow-up in years 11-15.
Citation: Reaven PD et al. Intensive glucose control in patients with type 2 diabetes – 15-year follow-up. New Engl J Med. 2019 Jun 6;380(23):2215-24.
Dr. Burke is a hospitalist at Vanderbilt University Medical Center, Nashville, Tenn.