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Benefit of combined ascorbic acid, corticosteroids, and thiamine in septic shock remains unproven

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Mon, 10/25/2021 - 12:57

Background: Sepsis is a common reason for hospitalization, and studies of the combination of ascorbic acid, corticosteroids, and thiamine have had conflicting results.

Study design: Double-blind randomized controlled trial.

Setting: 14 hospitals in the United States.

Synopsis: A total of 205 patients were randomly assigned to receive parenteral ascorbic acid, hydrocortisone, and thiamine every 6 hours for 4 days or placebo in matching volumes and time points. The primary outcome was change in the Sequential Organ Failure Assessment (SOFA) score between enrollment and 72 hours. There was no statistically significant difference in SOFA scores (adjusted mean difference, –0.8; 95% CI, –1.7 to 0.2; P = .12), kidney failure (adjusted risk difference, 0.03; 95% CI, –0.1 to 0.2; P = .58), or 30-day mortality (HR, 1.3; 95% CI 0.8-2.2; P = .26) between the two groups. Adverse effects included hyperglycemia, hypernatremia, and new hospital-acquired infection.

Bottom line: The combination of ascorbic acid, corticosteroids, and thiamine in patients with septic shock does not improve SOFA score.

Citation: Moskowitz A et al. Effect of ascorbic acid, corticosteroids, and thiamine on organ injury in septic shock: The ACTS randomized clinical trial. JAMA. 2020;324(7):642-50.

Dr. Wallenhorst is a hospitalist and palliative medicine physician at the Lexington (Ky) VA Health Care System.

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Background: Sepsis is a common reason for hospitalization, and studies of the combination of ascorbic acid, corticosteroids, and thiamine have had conflicting results.

Study design: Double-blind randomized controlled trial.

Setting: 14 hospitals in the United States.

Synopsis: A total of 205 patients were randomly assigned to receive parenteral ascorbic acid, hydrocortisone, and thiamine every 6 hours for 4 days or placebo in matching volumes and time points. The primary outcome was change in the Sequential Organ Failure Assessment (SOFA) score between enrollment and 72 hours. There was no statistically significant difference in SOFA scores (adjusted mean difference, –0.8; 95% CI, –1.7 to 0.2; P = .12), kidney failure (adjusted risk difference, 0.03; 95% CI, –0.1 to 0.2; P = .58), or 30-day mortality (HR, 1.3; 95% CI 0.8-2.2; P = .26) between the two groups. Adverse effects included hyperglycemia, hypernatremia, and new hospital-acquired infection.

Bottom line: The combination of ascorbic acid, corticosteroids, and thiamine in patients with septic shock does not improve SOFA score.

Citation: Moskowitz A et al. Effect of ascorbic acid, corticosteroids, and thiamine on organ injury in septic shock: The ACTS randomized clinical trial. JAMA. 2020;324(7):642-50.

Dr. Wallenhorst is a hospitalist and palliative medicine physician at the Lexington (Ky) VA Health Care System.

Background: Sepsis is a common reason for hospitalization, and studies of the combination of ascorbic acid, corticosteroids, and thiamine have had conflicting results.

Study design: Double-blind randomized controlled trial.

Setting: 14 hospitals in the United States.

Synopsis: A total of 205 patients were randomly assigned to receive parenteral ascorbic acid, hydrocortisone, and thiamine every 6 hours for 4 days or placebo in matching volumes and time points. The primary outcome was change in the Sequential Organ Failure Assessment (SOFA) score between enrollment and 72 hours. There was no statistically significant difference in SOFA scores (adjusted mean difference, –0.8; 95% CI, –1.7 to 0.2; P = .12), kidney failure (adjusted risk difference, 0.03; 95% CI, –0.1 to 0.2; P = .58), or 30-day mortality (HR, 1.3; 95% CI 0.8-2.2; P = .26) between the two groups. Adverse effects included hyperglycemia, hypernatremia, and new hospital-acquired infection.

Bottom line: The combination of ascorbic acid, corticosteroids, and thiamine in patients with septic shock does not improve SOFA score.

Citation: Moskowitz A et al. Effect of ascorbic acid, corticosteroids, and thiamine on organ injury in septic shock: The ACTS randomized clinical trial. JAMA. 2020;324(7):642-50.

Dr. Wallenhorst is a hospitalist and palliative medicine physician at the Lexington (Ky) VA Health Care System.

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New prescription for loop diuretic improves 30-day heart failure outcomes

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Mon, 10/25/2021 - 12:54

Background: In patients with heart failure, loop diuretics are used to manage symptoms. However, the effect of loop diuretics on morbidity and mortality is not well studied.

Dr. Peter Wallenhorst


Study design: Retrospective matched cohort study.

Setting: OPTIMIZE-HF registry.

Synopsis: Using the data from the OPTIMIZE-HF registry to develop a matched cohort of 2,191 pairs of patients, researchers showed that patients hospitalized for heart failure who were not previously taking any diuretic had significantly better 30-day clinical outcomes if they were discharged on a loop diuretic. Specifically, a loop diuretic on discharge resulted in a lower 30-day all-cause mortality (hazard ratio, 0.73; 95% CI, 0.57-0.94; P = .016) and a lower risk of 30-day heart failure readmission (HR, 0.79; 95% CI, 0.63-0.99; P = .037), compared with patients not discharged on a loop diuretic.

Neither of these associations was statistically significant during a 60-day follow-up, and the authors acknowledge that significant 30-day associations may be sensitive to an unmeasured confounder.

Bottom line: Starting an outpatient loop diuretic on discharge for patients hospitalized for heart failure improves 30-day all-cause mortality and lowers the risk of 30-day heart failure readmission.

Citation: Faselis C et al. Loop diuretic prescription and 30-day outcomes in older patients with heart failure. J Am Coll Cardiol. 2020;76:669-79.

Dr. Wallenhorst is a hospitalist and palliative medicine physician at the Lexington (Ky) VA Health Care System.

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Background: In patients with heart failure, loop diuretics are used to manage symptoms. However, the effect of loop diuretics on morbidity and mortality is not well studied.

Dr. Peter Wallenhorst


Study design: Retrospective matched cohort study.

Setting: OPTIMIZE-HF registry.

Synopsis: Using the data from the OPTIMIZE-HF registry to develop a matched cohort of 2,191 pairs of patients, researchers showed that patients hospitalized for heart failure who were not previously taking any diuretic had significantly better 30-day clinical outcomes if they were discharged on a loop diuretic. Specifically, a loop diuretic on discharge resulted in a lower 30-day all-cause mortality (hazard ratio, 0.73; 95% CI, 0.57-0.94; P = .016) and a lower risk of 30-day heart failure readmission (HR, 0.79; 95% CI, 0.63-0.99; P = .037), compared with patients not discharged on a loop diuretic.

Neither of these associations was statistically significant during a 60-day follow-up, and the authors acknowledge that significant 30-day associations may be sensitive to an unmeasured confounder.

Bottom line: Starting an outpatient loop diuretic on discharge for patients hospitalized for heart failure improves 30-day all-cause mortality and lowers the risk of 30-day heart failure readmission.

Citation: Faselis C et al. Loop diuretic prescription and 30-day outcomes in older patients with heart failure. J Am Coll Cardiol. 2020;76:669-79.

Dr. Wallenhorst is a hospitalist and palliative medicine physician at the Lexington (Ky) VA Health Care System.

Background: In patients with heart failure, loop diuretics are used to manage symptoms. However, the effect of loop diuretics on morbidity and mortality is not well studied.

Dr. Peter Wallenhorst


Study design: Retrospective matched cohort study.

Setting: OPTIMIZE-HF registry.

Synopsis: Using the data from the OPTIMIZE-HF registry to develop a matched cohort of 2,191 pairs of patients, researchers showed that patients hospitalized for heart failure who were not previously taking any diuretic had significantly better 30-day clinical outcomes if they were discharged on a loop diuretic. Specifically, a loop diuretic on discharge resulted in a lower 30-day all-cause mortality (hazard ratio, 0.73; 95% CI, 0.57-0.94; P = .016) and a lower risk of 30-day heart failure readmission (HR, 0.79; 95% CI, 0.63-0.99; P = .037), compared with patients not discharged on a loop diuretic.

Neither of these associations was statistically significant during a 60-day follow-up, and the authors acknowledge that significant 30-day associations may be sensitive to an unmeasured confounder.

Bottom line: Starting an outpatient loop diuretic on discharge for patients hospitalized for heart failure improves 30-day all-cause mortality and lowers the risk of 30-day heart failure readmission.

Citation: Faselis C et al. Loop diuretic prescription and 30-day outcomes in older patients with heart failure. J Am Coll Cardiol. 2020;76:669-79.

Dr. Wallenhorst is a hospitalist and palliative medicine physician at the Lexington (Ky) VA Health Care System.

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COVID-19 ICU visit restrictions add to staff stress, burnout

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Fri, 10/22/2021 - 13:00

During the COVID-19 pandemic, visitation in intensive care units has been restricted for obvious safety reasons, but such restrictions have contributed to the already serious strains on staff, results of a survey indicate.

Among 91 residents, nurse practitioners, and physician assistants who work in ICUs in the Emory Healthcare system, in Atlanta, two-thirds agreed that visitation restrictions were necessary, but nearly three-fourths said that the restrictions had a negative effect on their job satisfaction, and slightly more than half reported experiencing symptoms of burnout, wrote Nicole Herbst, MD, and Joanne Kuntz, MD, from Emory University School of Medicine.

“Because families are not present at bedside, restrictive visitation policies have necessitated that communication with families be more intentional and planned than before the COVID-19 pandemic. Understanding the ways these restrictions impact providers and patients can help guide future interventions to improve communication with families and reduce provider burnout,” the authors wrote in a poster presentation at the American College of Chest Physicians (CHEST) 2021 Annual Meeting.
 

Valid concerns, negative effects

“During the COVID pandemic, we fell back into old ways of doing things, where parents were restricted from the bedsides of patients in the intensive care unit. And I think we have shown over the last decade that family presence at the bedside significantly improves outcomes for patients and also helps clinicians caring for those patients,” commented Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford, in an interview.

“We had good reason to exclude visitors because we were worried about their own safety and their own health, but now 18 months into this pandemic, we know how to prevent COVID. We know now how to safely walk into the room of a patient who has COVID and walk out of it and not get infected. There’s no reason why we can’t relax these restrictions and allow families to be there with their loved ones,” continued Dr. Carroll, who was not involved in the study.

With visitation limited or banned outright, ICU staff have had to replace face-to-face discussion with more intentional, planned, and time-consuming methods, such as telephone calls and online video.

At the time of the survey, only two visitors were allowed to see patients in end-of-life situations in Emory ICUs. Exceptions to this rule were rare.
 

Study details

ICU staff members were asked about their communication practices, their attitudes about the effect of the restrictions on communication with families and job satisfaction, and about symptoms of burnout, using a validated single-item measure.

A total of 91 practitioners completed most of the survey questions. The results showed that more than half of all respondents (57.9%) reported spending more time communicating with families than they had the previous year.

A large majority (90.5%) also said that video communication (for example, with a tablet, personal device, or computer) was as effective or more effective than telephone communication.

In all, 64.3% of practitioners agreed that visitation restrictions were appropriate, but 71.4% said that the restrictions had a negative effect on their job satisfaction, and 51.8% reported experiencing symptoms of burnout, such as stress, low energy, exhaustion, or lack of motivation.

Casey Cable, MD, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center, Richmond, Virginia, who was not involved in the study, did her fellowship at Emory. She told this news organization that the study findings might be skewed a bit by subjective impressions.

“I work in a level I trauma unit providing tertiary medical care, and we’re using more video to communicate with family members, more iPads,” she said. “Their finding is interesting that people felt that they were communicating more with family members, and I wonder if that’s a type of recall bias, because at the bedside, you can have a conversation, as opposed to actively talking to family members by calling them, videoing them, or whatnot, and I think that sticks in our head more, about putting in more effort. I don’t know if we are spending more time communicating with family or if that’s what we just recall.”

She agreed with the authors that visitation restrictions have a definite negative effect on job satisfaction and that they cause feelings of burnout.

“It’s tough not having families at bedside and offering them support. When visitors are not able to see how sick their family members are, it complicates discussions about end-of-life care, transitioning to comfort care, or maybe not doing everything,” she said.

No funding source for the study was reported. Dr. Herbst, Dr. Kuntz, Dr. Carroll, and Dr. Cable have disclosed no relevant financial relationships.

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

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During the COVID-19 pandemic, visitation in intensive care units has been restricted for obvious safety reasons, but such restrictions have contributed to the already serious strains on staff, results of a survey indicate.

Among 91 residents, nurse practitioners, and physician assistants who work in ICUs in the Emory Healthcare system, in Atlanta, two-thirds agreed that visitation restrictions were necessary, but nearly three-fourths said that the restrictions had a negative effect on their job satisfaction, and slightly more than half reported experiencing symptoms of burnout, wrote Nicole Herbst, MD, and Joanne Kuntz, MD, from Emory University School of Medicine.

“Because families are not present at bedside, restrictive visitation policies have necessitated that communication with families be more intentional and planned than before the COVID-19 pandemic. Understanding the ways these restrictions impact providers and patients can help guide future interventions to improve communication with families and reduce provider burnout,” the authors wrote in a poster presentation at the American College of Chest Physicians (CHEST) 2021 Annual Meeting.
 

Valid concerns, negative effects

“During the COVID pandemic, we fell back into old ways of doing things, where parents were restricted from the bedsides of patients in the intensive care unit. And I think we have shown over the last decade that family presence at the bedside significantly improves outcomes for patients and also helps clinicians caring for those patients,” commented Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford, in an interview.

“We had good reason to exclude visitors because we were worried about their own safety and their own health, but now 18 months into this pandemic, we know how to prevent COVID. We know now how to safely walk into the room of a patient who has COVID and walk out of it and not get infected. There’s no reason why we can’t relax these restrictions and allow families to be there with their loved ones,” continued Dr. Carroll, who was not involved in the study.

With visitation limited or banned outright, ICU staff have had to replace face-to-face discussion with more intentional, planned, and time-consuming methods, such as telephone calls and online video.

At the time of the survey, only two visitors were allowed to see patients in end-of-life situations in Emory ICUs. Exceptions to this rule were rare.
 

Study details

ICU staff members were asked about their communication practices, their attitudes about the effect of the restrictions on communication with families and job satisfaction, and about symptoms of burnout, using a validated single-item measure.

A total of 91 practitioners completed most of the survey questions. The results showed that more than half of all respondents (57.9%) reported spending more time communicating with families than they had the previous year.

A large majority (90.5%) also said that video communication (for example, with a tablet, personal device, or computer) was as effective or more effective than telephone communication.

In all, 64.3% of practitioners agreed that visitation restrictions were appropriate, but 71.4% said that the restrictions had a negative effect on their job satisfaction, and 51.8% reported experiencing symptoms of burnout, such as stress, low energy, exhaustion, or lack of motivation.

Casey Cable, MD, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center, Richmond, Virginia, who was not involved in the study, did her fellowship at Emory. She told this news organization that the study findings might be skewed a bit by subjective impressions.

“I work in a level I trauma unit providing tertiary medical care, and we’re using more video to communicate with family members, more iPads,” she said. “Their finding is interesting that people felt that they were communicating more with family members, and I wonder if that’s a type of recall bias, because at the bedside, you can have a conversation, as opposed to actively talking to family members by calling them, videoing them, or whatnot, and I think that sticks in our head more, about putting in more effort. I don’t know if we are spending more time communicating with family or if that’s what we just recall.”

She agreed with the authors that visitation restrictions have a definite negative effect on job satisfaction and that they cause feelings of burnout.

“It’s tough not having families at bedside and offering them support. When visitors are not able to see how sick their family members are, it complicates discussions about end-of-life care, transitioning to comfort care, or maybe not doing everything,” she said.

No funding source for the study was reported. Dr. Herbst, Dr. Kuntz, Dr. Carroll, and Dr. Cable have disclosed no relevant financial relationships.

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

During the COVID-19 pandemic, visitation in intensive care units has been restricted for obvious safety reasons, but such restrictions have contributed to the already serious strains on staff, results of a survey indicate.

Among 91 residents, nurse practitioners, and physician assistants who work in ICUs in the Emory Healthcare system, in Atlanta, two-thirds agreed that visitation restrictions were necessary, but nearly three-fourths said that the restrictions had a negative effect on their job satisfaction, and slightly more than half reported experiencing symptoms of burnout, wrote Nicole Herbst, MD, and Joanne Kuntz, MD, from Emory University School of Medicine.

“Because families are not present at bedside, restrictive visitation policies have necessitated that communication with families be more intentional and planned than before the COVID-19 pandemic. Understanding the ways these restrictions impact providers and patients can help guide future interventions to improve communication with families and reduce provider burnout,” the authors wrote in a poster presentation at the American College of Chest Physicians (CHEST) 2021 Annual Meeting.
 

Valid concerns, negative effects

“During the COVID pandemic, we fell back into old ways of doing things, where parents were restricted from the bedsides of patients in the intensive care unit. And I think we have shown over the last decade that family presence at the bedside significantly improves outcomes for patients and also helps clinicians caring for those patients,” commented Christopher Carroll, MD, FCCP, from Connecticut Children’s Medical Center, Hartford, in an interview.

“We had good reason to exclude visitors because we were worried about their own safety and their own health, but now 18 months into this pandemic, we know how to prevent COVID. We know now how to safely walk into the room of a patient who has COVID and walk out of it and not get infected. There’s no reason why we can’t relax these restrictions and allow families to be there with their loved ones,” continued Dr. Carroll, who was not involved in the study.

With visitation limited or banned outright, ICU staff have had to replace face-to-face discussion with more intentional, planned, and time-consuming methods, such as telephone calls and online video.

At the time of the survey, only two visitors were allowed to see patients in end-of-life situations in Emory ICUs. Exceptions to this rule were rare.
 

Study details

ICU staff members were asked about their communication practices, their attitudes about the effect of the restrictions on communication with families and job satisfaction, and about symptoms of burnout, using a validated single-item measure.

A total of 91 practitioners completed most of the survey questions. The results showed that more than half of all respondents (57.9%) reported spending more time communicating with families than they had the previous year.

A large majority (90.5%) also said that video communication (for example, with a tablet, personal device, or computer) was as effective or more effective than telephone communication.

In all, 64.3% of practitioners agreed that visitation restrictions were appropriate, but 71.4% said that the restrictions had a negative effect on their job satisfaction, and 51.8% reported experiencing symptoms of burnout, such as stress, low energy, exhaustion, or lack of motivation.

Casey Cable, MD, a pulmonary disease and critical care specialist at Virginia Commonwealth Medical Center, Richmond, Virginia, who was not involved in the study, did her fellowship at Emory. She told this news organization that the study findings might be skewed a bit by subjective impressions.

“I work in a level I trauma unit providing tertiary medical care, and we’re using more video to communicate with family members, more iPads,” she said. “Their finding is interesting that people felt that they were communicating more with family members, and I wonder if that’s a type of recall bias, because at the bedside, you can have a conversation, as opposed to actively talking to family members by calling them, videoing them, or whatnot, and I think that sticks in our head more, about putting in more effort. I don’t know if we are spending more time communicating with family or if that’s what we just recall.”

She agreed with the authors that visitation restrictions have a definite negative effect on job satisfaction and that they cause feelings of burnout.

“It’s tough not having families at bedside and offering them support. When visitors are not able to see how sick their family members are, it complicates discussions about end-of-life care, transitioning to comfort care, or maybe not doing everything,” she said.

No funding source for the study was reported. Dr. Herbst, Dr. Kuntz, Dr. Carroll, and Dr. Cable have disclosed no relevant financial relationships.

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

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Sepsis multiplies in-hospital mortality risk in COPD

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Fri, 10/22/2021 - 13:01

Although slightly fewer than 1% of hospitalizations for chronic obstructive pulmonary disease (COPD) are complicated by sepsis, this complication increases the risk for in-hospital mortality fivefold, investigators who studied a representative national sample found.

Among nearly 7 million hospitalizations in which the primary diagnosis was COPD, nearly 65,000 (0.93%) patients experienced sepsis as a complication. In all, 31% of patients with COPD and sepsis were discharged from the hospital to another care facility, and 19% of patients died in hospital, report Harshil Shah, MD, from Guthrie Corning (N.Y.) Hospital and colleagues.

“Our study highlights the need for better risk stratification in patients with COPD developing sepsis to improve the outcomes. Further studies are warranted to consider factoring some of the modifiable factors into account and to ameliorate the outcomes of sepsis during COPD hospitalizations,” Dr. Shah and colleagues write in a poster presented during the at the annual meeting of the American College of Chest Physicians, held virtually this year.

COPD has been associated with increased risk for sepsis because of the use of corticosteroids, underlying comorbidities, and, potentially, because of impaired barrier function, the authors note.
 

Nationwide sample

To determine the effects of sepsis and predictors of poor outcomes among patients hospitalized for COPD, the investigators used standard diagnostic codes to identify patients with a primary diagnosis of COPD from the Nationwide Inpatient Sample for the period 2007 through 2018 and sepsis from codes in secondary fields in the International Classification of Diseases (9th/10th Editions) Clinical Modification.

They identified a total of 6,940,615 hospitalizations in which the primary diagnosis was COPD; in 64,748 of those cases, sepsis was a complication.

As noted, the in-hospital death rate, one of two primary outcomes, was 19% for patients with COPD and sepsis, and the rate of discharge to other facilities was 31%.

In analysis adjusted for confounding factors, sepsis was associated with an odds ratio for mortality of 4.9 (P < .01) and an OR for discharge to a facility of 2.2 (P < .01).

With regard to trends, the investigators saw that, although the adjusted odds for in-hospital mortality remained stable over time, discharge to facilities increased significantly. In 2007, the adjusted OR was 2.2, whereas in 2018, it was 2.6 (P for trend = .02).

Predictors of in-hospital mortality among patients with sepsis included increasing age (OR, not shown), White ethnicity (OR, 1.2), treatment in the Northeast region (OR, 1.4), disseminated intravascular coagulation (OR, 3.7), pneumococcal infection (OR, 1.2), congestive heart failure (OR, 1.2), and renal failure (OR, 1.4; P < .01 for all comparisons).
 

Mortality risk for many patients

A COPD specialist who was not involved in the study told this news organization that sepsis is an uncommon but serious complication, not just for patients with COPD but also for those with other severe illnesses.

“Sepsis has a high risk for mortality whether a person has COPD or not,” commented David M. Mannino III MD, FCCP, FERS, professor of medicine at the University of Kentucky, Lexington, and a cofounder and co–medical director of the COPD Foundation.

“It’s not surprising that sepsis is lethal in this population; the question is, if you have COPD, are you more likely to have sepsis? And I think the answer is probably yes. The connection there is that people with COPD have a higher risk for pneumonia, and pneumonia itself is probably one of the biggest risk factors, or certainly an important risk factor, for the development of sepsis,” he said in an interview.

It would be interesting to see the relationship between sepsis and in-hospital mortality for patients with other chronic diseases or people without COPD, he said, and he would have liked to have seen more detailed information about trends over time than Dr. Shah and colleagues provided.

No funding source for the study was reported. Dr. Shah and colleagues and Dr. Mannino have disclosed no relevant financial relationships.

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

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Although slightly fewer than 1% of hospitalizations for chronic obstructive pulmonary disease (COPD) are complicated by sepsis, this complication increases the risk for in-hospital mortality fivefold, investigators who studied a representative national sample found.

Among nearly 7 million hospitalizations in which the primary diagnosis was COPD, nearly 65,000 (0.93%) patients experienced sepsis as a complication. In all, 31% of patients with COPD and sepsis were discharged from the hospital to another care facility, and 19% of patients died in hospital, report Harshil Shah, MD, from Guthrie Corning (N.Y.) Hospital and colleagues.

“Our study highlights the need for better risk stratification in patients with COPD developing sepsis to improve the outcomes. Further studies are warranted to consider factoring some of the modifiable factors into account and to ameliorate the outcomes of sepsis during COPD hospitalizations,” Dr. Shah and colleagues write in a poster presented during the at the annual meeting of the American College of Chest Physicians, held virtually this year.

COPD has been associated with increased risk for sepsis because of the use of corticosteroids, underlying comorbidities, and, potentially, because of impaired barrier function, the authors note.
 

Nationwide sample

To determine the effects of sepsis and predictors of poor outcomes among patients hospitalized for COPD, the investigators used standard diagnostic codes to identify patients with a primary diagnosis of COPD from the Nationwide Inpatient Sample for the period 2007 through 2018 and sepsis from codes in secondary fields in the International Classification of Diseases (9th/10th Editions) Clinical Modification.

They identified a total of 6,940,615 hospitalizations in which the primary diagnosis was COPD; in 64,748 of those cases, sepsis was a complication.

As noted, the in-hospital death rate, one of two primary outcomes, was 19% for patients with COPD and sepsis, and the rate of discharge to other facilities was 31%.

In analysis adjusted for confounding factors, sepsis was associated with an odds ratio for mortality of 4.9 (P < .01) and an OR for discharge to a facility of 2.2 (P < .01).

With regard to trends, the investigators saw that, although the adjusted odds for in-hospital mortality remained stable over time, discharge to facilities increased significantly. In 2007, the adjusted OR was 2.2, whereas in 2018, it was 2.6 (P for trend = .02).

Predictors of in-hospital mortality among patients with sepsis included increasing age (OR, not shown), White ethnicity (OR, 1.2), treatment in the Northeast region (OR, 1.4), disseminated intravascular coagulation (OR, 3.7), pneumococcal infection (OR, 1.2), congestive heart failure (OR, 1.2), and renal failure (OR, 1.4; P < .01 for all comparisons).
 

Mortality risk for many patients

A COPD specialist who was not involved in the study told this news organization that sepsis is an uncommon but serious complication, not just for patients with COPD but also for those with other severe illnesses.

“Sepsis has a high risk for mortality whether a person has COPD or not,” commented David M. Mannino III MD, FCCP, FERS, professor of medicine at the University of Kentucky, Lexington, and a cofounder and co–medical director of the COPD Foundation.

“It’s not surprising that sepsis is lethal in this population; the question is, if you have COPD, are you more likely to have sepsis? And I think the answer is probably yes. The connection there is that people with COPD have a higher risk for pneumonia, and pneumonia itself is probably one of the biggest risk factors, or certainly an important risk factor, for the development of sepsis,” he said in an interview.

It would be interesting to see the relationship between sepsis and in-hospital mortality for patients with other chronic diseases or people without COPD, he said, and he would have liked to have seen more detailed information about trends over time than Dr. Shah and colleagues provided.

No funding source for the study was reported. Dr. Shah and colleagues and Dr. Mannino have disclosed no relevant financial relationships.

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

Although slightly fewer than 1% of hospitalizations for chronic obstructive pulmonary disease (COPD) are complicated by sepsis, this complication increases the risk for in-hospital mortality fivefold, investigators who studied a representative national sample found.

Among nearly 7 million hospitalizations in which the primary diagnosis was COPD, nearly 65,000 (0.93%) patients experienced sepsis as a complication. In all, 31% of patients with COPD and sepsis were discharged from the hospital to another care facility, and 19% of patients died in hospital, report Harshil Shah, MD, from Guthrie Corning (N.Y.) Hospital and colleagues.

“Our study highlights the need for better risk stratification in patients with COPD developing sepsis to improve the outcomes. Further studies are warranted to consider factoring some of the modifiable factors into account and to ameliorate the outcomes of sepsis during COPD hospitalizations,” Dr. Shah and colleagues write in a poster presented during the at the annual meeting of the American College of Chest Physicians, held virtually this year.

COPD has been associated with increased risk for sepsis because of the use of corticosteroids, underlying comorbidities, and, potentially, because of impaired barrier function, the authors note.
 

Nationwide sample

To determine the effects of sepsis and predictors of poor outcomes among patients hospitalized for COPD, the investigators used standard diagnostic codes to identify patients with a primary diagnosis of COPD from the Nationwide Inpatient Sample for the period 2007 through 2018 and sepsis from codes in secondary fields in the International Classification of Diseases (9th/10th Editions) Clinical Modification.

They identified a total of 6,940,615 hospitalizations in which the primary diagnosis was COPD; in 64,748 of those cases, sepsis was a complication.

As noted, the in-hospital death rate, one of two primary outcomes, was 19% for patients with COPD and sepsis, and the rate of discharge to other facilities was 31%.

In analysis adjusted for confounding factors, sepsis was associated with an odds ratio for mortality of 4.9 (P < .01) and an OR for discharge to a facility of 2.2 (P < .01).

With regard to trends, the investigators saw that, although the adjusted odds for in-hospital mortality remained stable over time, discharge to facilities increased significantly. In 2007, the adjusted OR was 2.2, whereas in 2018, it was 2.6 (P for trend = .02).

Predictors of in-hospital mortality among patients with sepsis included increasing age (OR, not shown), White ethnicity (OR, 1.2), treatment in the Northeast region (OR, 1.4), disseminated intravascular coagulation (OR, 3.7), pneumococcal infection (OR, 1.2), congestive heart failure (OR, 1.2), and renal failure (OR, 1.4; P < .01 for all comparisons).
 

Mortality risk for many patients

A COPD specialist who was not involved in the study told this news organization that sepsis is an uncommon but serious complication, not just for patients with COPD but also for those with other severe illnesses.

“Sepsis has a high risk for mortality whether a person has COPD or not,” commented David M. Mannino III MD, FCCP, FERS, professor of medicine at the University of Kentucky, Lexington, and a cofounder and co–medical director of the COPD Foundation.

“It’s not surprising that sepsis is lethal in this population; the question is, if you have COPD, are you more likely to have sepsis? And I think the answer is probably yes. The connection there is that people with COPD have a higher risk for pneumonia, and pneumonia itself is probably one of the biggest risk factors, or certainly an important risk factor, for the development of sepsis,” he said in an interview.

It would be interesting to see the relationship between sepsis and in-hospital mortality for patients with other chronic diseases or people without COPD, he said, and he would have liked to have seen more detailed information about trends over time than Dr. Shah and colleagues provided.

No funding source for the study was reported. Dr. Shah and colleagues and Dr. Mannino have disclosed no relevant financial relationships.

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

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Symptoms persist in patients after acute COVID-19

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Background: A large proportion of Italian patients with COVID-19 presented with symptoms, most commonly cough, fever, dyspnea, myalgias, anosmia, and gastrointestinal symptoms. Information is lacking on persistent symptoms after recovery.

Dr. Taylor Walker


Study design: Retrospective observational study.

Setting: Hospital system in Rome.

Synopsis: A postacute outpatient service for individuals discharged after recovery from COVID-19 was established. All patients who met World Health Organization criteria for discontinuation of quarantine (no fever for 3 consecutive days, improved symptoms, and two negative SARS-CoV-2 tests 24 hours apart) were offered a comprehensive medical assessment. Patients were asked to retrospectively recount the presence or absence of symptoms during the acute phase of COVID-19 and whether each symptom persisted at the time of the visit.

From April 21 to May 29, 2020, 179 patients were potentially eligible; 143 ultimately were included. During hospitalization, 72.7% of participants had evidence of interstitial pneumonia. Patients were assessed a mean of 60.3 days after onset of the first COVID-19 symptom. Only 18 (12.6%) were completely free of any COVID-19–related symptoms, 32% had one or two symptoms, and 55% had three or more. Worsened quality of life was observed among 44.1% of patients.

Bottom line: 87.4% of patients who had recovered from COVID-19 reported persistence of at least one symptom, particularly fatigue and dyspnea.

Citation: Carfi A et al. Persistent symptoms in patients after acute COVID-19. JAMA. 2020;324(6):603-5.

Dr. Walker is a hospitalist at the Lexington (Ky.) VA Health Care System.

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Background: A large proportion of Italian patients with COVID-19 presented with symptoms, most commonly cough, fever, dyspnea, myalgias, anosmia, and gastrointestinal symptoms. Information is lacking on persistent symptoms after recovery.

Dr. Taylor Walker


Study design: Retrospective observational study.

Setting: Hospital system in Rome.

Synopsis: A postacute outpatient service for individuals discharged after recovery from COVID-19 was established. All patients who met World Health Organization criteria for discontinuation of quarantine (no fever for 3 consecutive days, improved symptoms, and two negative SARS-CoV-2 tests 24 hours apart) were offered a comprehensive medical assessment. Patients were asked to retrospectively recount the presence or absence of symptoms during the acute phase of COVID-19 and whether each symptom persisted at the time of the visit.

From April 21 to May 29, 2020, 179 patients were potentially eligible; 143 ultimately were included. During hospitalization, 72.7% of participants had evidence of interstitial pneumonia. Patients were assessed a mean of 60.3 days after onset of the first COVID-19 symptom. Only 18 (12.6%) were completely free of any COVID-19–related symptoms, 32% had one or two symptoms, and 55% had three or more. Worsened quality of life was observed among 44.1% of patients.

Bottom line: 87.4% of patients who had recovered from COVID-19 reported persistence of at least one symptom, particularly fatigue and dyspnea.

Citation: Carfi A et al. Persistent symptoms in patients after acute COVID-19. JAMA. 2020;324(6):603-5.

Dr. Walker is a hospitalist at the Lexington (Ky.) VA Health Care System.

Background: A large proportion of Italian patients with COVID-19 presented with symptoms, most commonly cough, fever, dyspnea, myalgias, anosmia, and gastrointestinal symptoms. Information is lacking on persistent symptoms after recovery.

Dr. Taylor Walker


Study design: Retrospective observational study.

Setting: Hospital system in Rome.

Synopsis: A postacute outpatient service for individuals discharged after recovery from COVID-19 was established. All patients who met World Health Organization criteria for discontinuation of quarantine (no fever for 3 consecutive days, improved symptoms, and two negative SARS-CoV-2 tests 24 hours apart) were offered a comprehensive medical assessment. Patients were asked to retrospectively recount the presence or absence of symptoms during the acute phase of COVID-19 and whether each symptom persisted at the time of the visit.

From April 21 to May 29, 2020, 179 patients were potentially eligible; 143 ultimately were included. During hospitalization, 72.7% of participants had evidence of interstitial pneumonia. Patients were assessed a mean of 60.3 days after onset of the first COVID-19 symptom. Only 18 (12.6%) were completely free of any COVID-19–related symptoms, 32% had one or two symptoms, and 55% had three or more. Worsened quality of life was observed among 44.1% of patients.

Bottom line: 87.4% of patients who had recovered from COVID-19 reported persistence of at least one symptom, particularly fatigue and dyspnea.

Citation: Carfi A et al. Persistent symptoms in patients after acute COVID-19. JAMA. 2020;324(6):603-5.

Dr. Walker is a hospitalist at the Lexington (Ky.) VA Health Care System.

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Comorbidities larger factor than race in COVID ICU deaths?

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Racial/ethnic disparities in COVID-19 mortality rates may be related more to comorbidities than to demographics, suggest authors of a new study.

Researchers compared the length of stay in intensive care units in two suburban hospitals for patients with severe SARS-CoV-2 infections. Their study shows that although the incidence of comorbidities and rates of use of mechanical ventilation and death were higher among Black patients than among patients of other races, length of stay in the ICU was generally similar for patients of all races. The study was conducted by Tripti Kumar, DO, from Lankenau Medical Center, Wynnewood, Pennsylvania, and colleagues.

“Racial disparities are observed in the United States concerning COVID-19, and studies have discovered that minority populations are at ongoing risk for health inequity,” Dr. Kumar said in a narrated e-poster presented during the American College of Chest Physicians (CHEST) 2021 Annual Meeting.

“Primary prevention initiatives should take precedence in mitigating the effect that comorbidities have on these vulnerable populations to help reduce necessity for mechanical ventilation, hospital length of stay, and overall mortality,” she said.
 

Higher death rates for Black patients

At the time the study was conducted, the COVID-19 death rate in the United States had topped 500,000 (as of this writing, it stands at 726,000). Of those who died, 22.4% were Black, 18.1% were Hispanic, and 3.6% were of Asian descent. The numbers of COVID-19 diagnoses and deaths were significantly higher in U.S. counties where the proportions of Black residents were higher, the authors note.

To see whether differences in COVID-19 outcomes were reflected in ICU length of stay, the researchers conducted a retrospective chart review of data on 162 patients admitted to ICUs at Paoli Hospital and Lankenau Medical Center, both in the suburban Philadelphia town of Wynnewood.

All patients were diagnosed with COVID-19 from March through June 2020.

In all, 60% of the study population were Black, 35% were White, 3% were Asian, and 2% were Hispanic. Women composed 46% of the sample.

The average length of ICU stay, which was the primary endpoint, was similar among Black patients (15.4 days), White patients (15.5 days), and Asians (16 days). The shortest average hospital stay was among Hispanic patients, at 11.3 days.

The investigators determined that among all races, the prevalence of type 2 diabetesobesityhypertension, and smoking was highest among Black patients.

Overall, nearly 85% of patients required mechanical ventilation. Among the patients who required it, 86% were Black, 84% were White, 66% were Hispanic, and 75% were Asian.

Overall mortality was 62%. It was higher among Black patients, at 60%, than among White patients, at 33%. The investigators did not report mortality rates for Hispanic or Asian patients.
 

Missing data

Demondes Haynes, MD, FCCP, professor of medicine in the Division of Pulmonary and Critical Care and associate dean for admissions at the University of Mississippi Medical Center and School of Medicine, Jackson, who was not involved in the study, told this news organization that there are some gaps in the study that make it difficult to draw strong conclusions about the findings.

“For sure, comorbidities contribute a great deal to mortality, but is there something else going on? I think this poster is incomplete in that it cannot answer that question,” he said in an interview.

He noted that the use of retrospective rather than prospective data makes it hard to account for potential confounders.

“I agree that these findings show the potential contribution of comorbidities, but to me, this is a little incomplete to make that a definitive statement,” he said.

“I can’t argue with their recommendation for primary prevention – we definitely want to do primary prevention to decrease comorbidities. Would it decrease overall mortality? It might, it sure might, for just COVID-19 I’d say no, we need more information.”

No funding source for the study was reported. Dr. Kumar and colleagues and Dr. Haynes reported no relevant financial relationships.

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

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Racial/ethnic disparities in COVID-19 mortality rates may be related more to comorbidities than to demographics, suggest authors of a new study.

Researchers compared the length of stay in intensive care units in two suburban hospitals for patients with severe SARS-CoV-2 infections. Their study shows that although the incidence of comorbidities and rates of use of mechanical ventilation and death were higher among Black patients than among patients of other races, length of stay in the ICU was generally similar for patients of all races. The study was conducted by Tripti Kumar, DO, from Lankenau Medical Center, Wynnewood, Pennsylvania, and colleagues.

“Racial disparities are observed in the United States concerning COVID-19, and studies have discovered that minority populations are at ongoing risk for health inequity,” Dr. Kumar said in a narrated e-poster presented during the American College of Chest Physicians (CHEST) 2021 Annual Meeting.

“Primary prevention initiatives should take precedence in mitigating the effect that comorbidities have on these vulnerable populations to help reduce necessity for mechanical ventilation, hospital length of stay, and overall mortality,” she said.
 

Higher death rates for Black patients

At the time the study was conducted, the COVID-19 death rate in the United States had topped 500,000 (as of this writing, it stands at 726,000). Of those who died, 22.4% were Black, 18.1% were Hispanic, and 3.6% were of Asian descent. The numbers of COVID-19 diagnoses and deaths were significantly higher in U.S. counties where the proportions of Black residents were higher, the authors note.

To see whether differences in COVID-19 outcomes were reflected in ICU length of stay, the researchers conducted a retrospective chart review of data on 162 patients admitted to ICUs at Paoli Hospital and Lankenau Medical Center, both in the suburban Philadelphia town of Wynnewood.

All patients were diagnosed with COVID-19 from March through June 2020.

In all, 60% of the study population were Black, 35% were White, 3% were Asian, and 2% were Hispanic. Women composed 46% of the sample.

The average length of ICU stay, which was the primary endpoint, was similar among Black patients (15.4 days), White patients (15.5 days), and Asians (16 days). The shortest average hospital stay was among Hispanic patients, at 11.3 days.

The investigators determined that among all races, the prevalence of type 2 diabetesobesityhypertension, and smoking was highest among Black patients.

Overall, nearly 85% of patients required mechanical ventilation. Among the patients who required it, 86% were Black, 84% were White, 66% were Hispanic, and 75% were Asian.

Overall mortality was 62%. It was higher among Black patients, at 60%, than among White patients, at 33%. The investigators did not report mortality rates for Hispanic or Asian patients.
 

Missing data

Demondes Haynes, MD, FCCP, professor of medicine in the Division of Pulmonary and Critical Care and associate dean for admissions at the University of Mississippi Medical Center and School of Medicine, Jackson, who was not involved in the study, told this news organization that there are some gaps in the study that make it difficult to draw strong conclusions about the findings.

“For sure, comorbidities contribute a great deal to mortality, but is there something else going on? I think this poster is incomplete in that it cannot answer that question,” he said in an interview.

He noted that the use of retrospective rather than prospective data makes it hard to account for potential confounders.

“I agree that these findings show the potential contribution of comorbidities, but to me, this is a little incomplete to make that a definitive statement,” he said.

“I can’t argue with their recommendation for primary prevention – we definitely want to do primary prevention to decrease comorbidities. Would it decrease overall mortality? It might, it sure might, for just COVID-19 I’d say no, we need more information.”

No funding source for the study was reported. Dr. Kumar and colleagues and Dr. Haynes reported no relevant financial relationships.

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

Racial/ethnic disparities in COVID-19 mortality rates may be related more to comorbidities than to demographics, suggest authors of a new study.

Researchers compared the length of stay in intensive care units in two suburban hospitals for patients with severe SARS-CoV-2 infections. Their study shows that although the incidence of comorbidities and rates of use of mechanical ventilation and death were higher among Black patients than among patients of other races, length of stay in the ICU was generally similar for patients of all races. The study was conducted by Tripti Kumar, DO, from Lankenau Medical Center, Wynnewood, Pennsylvania, and colleagues.

“Racial disparities are observed in the United States concerning COVID-19, and studies have discovered that minority populations are at ongoing risk for health inequity,” Dr. Kumar said in a narrated e-poster presented during the American College of Chest Physicians (CHEST) 2021 Annual Meeting.

“Primary prevention initiatives should take precedence in mitigating the effect that comorbidities have on these vulnerable populations to help reduce necessity for mechanical ventilation, hospital length of stay, and overall mortality,” she said.
 

Higher death rates for Black patients

At the time the study was conducted, the COVID-19 death rate in the United States had topped 500,000 (as of this writing, it stands at 726,000). Of those who died, 22.4% were Black, 18.1% were Hispanic, and 3.6% were of Asian descent. The numbers of COVID-19 diagnoses and deaths were significantly higher in U.S. counties where the proportions of Black residents were higher, the authors note.

To see whether differences in COVID-19 outcomes were reflected in ICU length of stay, the researchers conducted a retrospective chart review of data on 162 patients admitted to ICUs at Paoli Hospital and Lankenau Medical Center, both in the suburban Philadelphia town of Wynnewood.

All patients were diagnosed with COVID-19 from March through June 2020.

In all, 60% of the study population were Black, 35% were White, 3% were Asian, and 2% were Hispanic. Women composed 46% of the sample.

The average length of ICU stay, which was the primary endpoint, was similar among Black patients (15.4 days), White patients (15.5 days), and Asians (16 days). The shortest average hospital stay was among Hispanic patients, at 11.3 days.

The investigators determined that among all races, the prevalence of type 2 diabetesobesityhypertension, and smoking was highest among Black patients.

Overall, nearly 85% of patients required mechanical ventilation. Among the patients who required it, 86% were Black, 84% were White, 66% were Hispanic, and 75% were Asian.

Overall mortality was 62%. It was higher among Black patients, at 60%, than among White patients, at 33%. The investigators did not report mortality rates for Hispanic or Asian patients.
 

Missing data

Demondes Haynes, MD, FCCP, professor of medicine in the Division of Pulmonary and Critical Care and associate dean for admissions at the University of Mississippi Medical Center and School of Medicine, Jackson, who was not involved in the study, told this news organization that there are some gaps in the study that make it difficult to draw strong conclusions about the findings.

“For sure, comorbidities contribute a great deal to mortality, but is there something else going on? I think this poster is incomplete in that it cannot answer that question,” he said in an interview.

He noted that the use of retrospective rather than prospective data makes it hard to account for potential confounders.

“I agree that these findings show the potential contribution of comorbidities, but to me, this is a little incomplete to make that a definitive statement,” he said.

“I can’t argue with their recommendation for primary prevention – we definitely want to do primary prevention to decrease comorbidities. Would it decrease overall mortality? It might, it sure might, for just COVID-19 I’d say no, we need more information.”

No funding source for the study was reported. Dr. Kumar and colleagues and Dr. Haynes reported no relevant financial relationships.

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

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FDA authorizes boosters for Moderna, J&J, allows mix-and-match

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Wed, 10/20/2021 - 18:43

 

The U.S. Food and Drug Administration (FDA) has authorized booster doses for the Moderna and Johnson & Johnson COVID-19 vaccines, while also allowing boosters to be given interchangeably with any of the other vaccines, in people who are eligible to get them.

The move to amend the Emergency Use Authorization for these vaccines gives the vaccine experts on the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices latitude to recommend a mix-and-match strategy if they feel the science supports it.

The committee convenes Oct. 21 for a day-long meeting to make its recommendations for additional doses.

People who’ve previously received two doses of the Moderna mRNA vaccine, which is now called Spikevax, are eligible for a third dose of any COVID-19 vaccine if they are 6 months past their second dose and are:

  • 65 years of age or older
  • 18 to 64 years of age, but at high risk for severe COVID-19 because of an underlying health condition
  • 18 to 64 years of age and at high risk for exposure to the SARS-CoV-2 virus because they live in a group setting, such as a prison or care home, or work in a risky occupation, such as healthcare

People who’ve previously received a dose of the Johnson & Johnson vaccine are eligible for a second dose of any COVID-19 vaccine if they are over the age of 18 and at least 2 months past their vaccination.

“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, MD, in a news release. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death.

“The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”

A version of this article was first published on Medscape.com.

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The U.S. Food and Drug Administration (FDA) has authorized booster doses for the Moderna and Johnson & Johnson COVID-19 vaccines, while also allowing boosters to be given interchangeably with any of the other vaccines, in people who are eligible to get them.

The move to amend the Emergency Use Authorization for these vaccines gives the vaccine experts on the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices latitude to recommend a mix-and-match strategy if they feel the science supports it.

The committee convenes Oct. 21 for a day-long meeting to make its recommendations for additional doses.

People who’ve previously received two doses of the Moderna mRNA vaccine, which is now called Spikevax, are eligible for a third dose of any COVID-19 vaccine if they are 6 months past their second dose and are:

  • 65 years of age or older
  • 18 to 64 years of age, but at high risk for severe COVID-19 because of an underlying health condition
  • 18 to 64 years of age and at high risk for exposure to the SARS-CoV-2 virus because they live in a group setting, such as a prison or care home, or work in a risky occupation, such as healthcare

People who’ve previously received a dose of the Johnson & Johnson vaccine are eligible for a second dose of any COVID-19 vaccine if they are over the age of 18 and at least 2 months past their vaccination.

“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, MD, in a news release. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death.

“The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”

A version of this article was first published on Medscape.com.

 

The U.S. Food and Drug Administration (FDA) has authorized booster doses for the Moderna and Johnson & Johnson COVID-19 vaccines, while also allowing boosters to be given interchangeably with any of the other vaccines, in people who are eligible to get them.

The move to amend the Emergency Use Authorization for these vaccines gives the vaccine experts on the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices latitude to recommend a mix-and-match strategy if they feel the science supports it.

The committee convenes Oct. 21 for a day-long meeting to make its recommendations for additional doses.

People who’ve previously received two doses of the Moderna mRNA vaccine, which is now called Spikevax, are eligible for a third dose of any COVID-19 vaccine if they are 6 months past their second dose and are:

  • 65 years of age or older
  • 18 to 64 years of age, but at high risk for severe COVID-19 because of an underlying health condition
  • 18 to 64 years of age and at high risk for exposure to the SARS-CoV-2 virus because they live in a group setting, such as a prison or care home, or work in a risky occupation, such as healthcare

People who’ve previously received a dose of the Johnson & Johnson vaccine are eligible for a second dose of any COVID-19 vaccine if they are over the age of 18 and at least 2 months past their vaccination.

“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, MD, in a news release. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death.

“The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”

A version of this article was first published on Medscape.com.

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Geographic cohorting increased direct care time and interruptions

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Thu, 10/21/2021 - 14:03

Background: Geographic cohorting localizes hospitalist teams to a single unit. It has previously been shown to improve outcomes.

Dr. Joseph Sweigart


Design: Prospective time and motion study.

Setting: 11 geographically cohorted services and 4 noncohorted teams at Indiana University Health, a large academic medical center.

Synopsis: Geotracking was used to monitor time spent inside and outside of patient rooms for 17 hospitalists over at least 6 weeks. Eight hospitalists were also directly observed. Both groups spent roughly three times more time outside patient rooms than inside. Geographic cohorting was associated with longer patient visits (ranging from 69.6 to 101.7 minutes per day depending on team structure) and a higher percentage of time in patient rooms. Interruptions were more common with geographic cohorting. These hospitalists were interrupted every 14 minutes in the morning and every 8 minutes in the afternoon. Of these interruptions, 62% were face-to-face, 25% were electronic, and 13% were both simultaneously.

An important limitation of this study is that the investigators did not evaluate clinical outcomes or provider satisfaction. This may give some pause to the widespread push toward geographic cohorting.

Bottom line: More frequent interruptions may partially offset potential increases in patient-hospitalist interactions achieved through geographic cohorting.

Citation: Kara A et al. A time motion study evaluating the impact of geographic cohorting of hospitalists. J Hosp Med. 2020;15:338-44.

Dr. Sweigart is a hospitalist at the Lexington (Ky.) VA Health Care System.

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Background: Geographic cohorting localizes hospitalist teams to a single unit. It has previously been shown to improve outcomes.

Dr. Joseph Sweigart


Design: Prospective time and motion study.

Setting: 11 geographically cohorted services and 4 noncohorted teams at Indiana University Health, a large academic medical center.

Synopsis: Geotracking was used to monitor time spent inside and outside of patient rooms for 17 hospitalists over at least 6 weeks. Eight hospitalists were also directly observed. Both groups spent roughly three times more time outside patient rooms than inside. Geographic cohorting was associated with longer patient visits (ranging from 69.6 to 101.7 minutes per day depending on team structure) and a higher percentage of time in patient rooms. Interruptions were more common with geographic cohorting. These hospitalists were interrupted every 14 minutes in the morning and every 8 minutes in the afternoon. Of these interruptions, 62% were face-to-face, 25% were electronic, and 13% were both simultaneously.

An important limitation of this study is that the investigators did not evaluate clinical outcomes or provider satisfaction. This may give some pause to the widespread push toward geographic cohorting.

Bottom line: More frequent interruptions may partially offset potential increases in patient-hospitalist interactions achieved through geographic cohorting.

Citation: Kara A et al. A time motion study evaluating the impact of geographic cohorting of hospitalists. J Hosp Med. 2020;15:338-44.

Dr. Sweigart is a hospitalist at the Lexington (Ky.) VA Health Care System.

Background: Geographic cohorting localizes hospitalist teams to a single unit. It has previously been shown to improve outcomes.

Dr. Joseph Sweigart


Design: Prospective time and motion study.

Setting: 11 geographically cohorted services and 4 noncohorted teams at Indiana University Health, a large academic medical center.

Synopsis: Geotracking was used to monitor time spent inside and outside of patient rooms for 17 hospitalists over at least 6 weeks. Eight hospitalists were also directly observed. Both groups spent roughly three times more time outside patient rooms than inside. Geographic cohorting was associated with longer patient visits (ranging from 69.6 to 101.7 minutes per day depending on team structure) and a higher percentage of time in patient rooms. Interruptions were more common with geographic cohorting. These hospitalists were interrupted every 14 minutes in the morning and every 8 minutes in the afternoon. Of these interruptions, 62% were face-to-face, 25% were electronic, and 13% were both simultaneously.

An important limitation of this study is that the investigators did not evaluate clinical outcomes or provider satisfaction. This may give some pause to the widespread push toward geographic cohorting.

Bottom line: More frequent interruptions may partially offset potential increases in patient-hospitalist interactions achieved through geographic cohorting.

Citation: Kara A et al. A time motion study evaluating the impact of geographic cohorting of hospitalists. J Hosp Med. 2020;15:338-44.

Dr. Sweigart is a hospitalist at the Lexington (Ky.) VA Health Care System.

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No benefit from lower temps for out-of-hospital cardiac arrest

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Wed, 10/20/2021 - 10:16

For comatose survivors of out-of-hospital cardiac arrest (OHCA), moderate hypothermia to a target body temperature of 31°C did not improve outcomes, compared with guideline-recommended mild hypothermia (target temp 34°C) in the CAPITAL CHILL study.

The results “do not support the use of moderate therapeutic hypothermia to improve neurologic outcomes in comatose survivors of out-of-hospital cardiac arrest,” write the investigators led by Michel Le May, MD, from the University of Ottawa Heart Institute, Ontario, Canada.

The CAPITAL CHILL results were first presented at the American College of Cardiology (ACC) 2021 Scientific Sessions in May.   

They have now been published online, October 19, in JAMA. 
 

High rates of brain injury and death

Comatose survivors of OHCA have high rates of severe brain injury and death. Current guidelines recommend targeted temperature management at 32°C to 36°C for 24 hours. However, small studies have suggested a potential benefit of targeting lower body temperatures.

In the CAPITAL CHILL study of 367 OHCA patients who were comatose on admission, there were no statistically significant differences in the primary composite outcome of all-cause mortality or poor neurologic outcome at 180 days with mild-versus-moderate hypothermia.

The primary composite outcome occurred in 89 of 184 (48.4%) patients in the moderate hypothermia group and 83 of 183 (45.4%) patients in the mild hypothermia group — a risk difference of 3.0% (95% confidence interval [CI], 7.2% - 13.2%) and relative risk of 1.07 (95% CI, 0.86 - 1.33; P = .56).

There was also no significant difference when looking at the individual components of mortality (43.5% vs 41.0%) and poor neurologic outcome (Disability Rating Scale score >5: 4.9% vs 4.4%).

The baseline characteristics of patients were similar in the moderate and mild hypothermia groups. The lack of a significant difference in the primary outcome was consistent after adjusting for baseline covariates as well as across all subgroups.

The rates of secondary outcomes were also similar between the two groups, except for a longer length of stay in the intensive care unit in the moderate hypothermia group compared with the mild hypothermia group, which would likely add to overall costs.

The researchers note that the Targeted Hypothermia vs Targeted Normothermia After Out-of-Hospital Cardiac Arrest (TTM2) trial recently reported that targeted hypothermia at 33°C did not improve survival at 180 days compared with targeted normothermia at 37.5°C or less.

The CAPITAL CHILL study “adds to the spectrum of target temperature management, as it did not find any benefit of even further lowering temperatures to 31°C,” the study team says.

They caution that most patients in the trial had cardiac arrest secondary to a primary cardiac etiology and therefore the findings may not be applicable to cardiac arrest of all etiologies.

It’s also possible that the trial was underpowered to detect clinically important differences between moderate and mild hypothermia. Also, the number of patients presenting with a nonshockable rhythm was relatively small, and further study may be worthwhile in this subgroup, they say.

For now, however, the CAPITAL CHILL results provide no support for a lower target temperature of 31°C to improve outcomes in OHCA patients, Dr. Le May and colleagues conclude.

CAPITAL CHILL was an investigator-initiated study and funding was provided by the University of Ottawa Heart Institute Cardiac Arrest Program. Dr. Le May has disclosed no relevant financial relationships.

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

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For comatose survivors of out-of-hospital cardiac arrest (OHCA), moderate hypothermia to a target body temperature of 31°C did not improve outcomes, compared with guideline-recommended mild hypothermia (target temp 34°C) in the CAPITAL CHILL study.

The results “do not support the use of moderate therapeutic hypothermia to improve neurologic outcomes in comatose survivors of out-of-hospital cardiac arrest,” write the investigators led by Michel Le May, MD, from the University of Ottawa Heart Institute, Ontario, Canada.

The CAPITAL CHILL results were first presented at the American College of Cardiology (ACC) 2021 Scientific Sessions in May.   

They have now been published online, October 19, in JAMA. 
 

High rates of brain injury and death

Comatose survivors of OHCA have high rates of severe brain injury and death. Current guidelines recommend targeted temperature management at 32°C to 36°C for 24 hours. However, small studies have suggested a potential benefit of targeting lower body temperatures.

In the CAPITAL CHILL study of 367 OHCA patients who were comatose on admission, there were no statistically significant differences in the primary composite outcome of all-cause mortality or poor neurologic outcome at 180 days with mild-versus-moderate hypothermia.

The primary composite outcome occurred in 89 of 184 (48.4%) patients in the moderate hypothermia group and 83 of 183 (45.4%) patients in the mild hypothermia group — a risk difference of 3.0% (95% confidence interval [CI], 7.2% - 13.2%) and relative risk of 1.07 (95% CI, 0.86 - 1.33; P = .56).

There was also no significant difference when looking at the individual components of mortality (43.5% vs 41.0%) and poor neurologic outcome (Disability Rating Scale score >5: 4.9% vs 4.4%).

The baseline characteristics of patients were similar in the moderate and mild hypothermia groups. The lack of a significant difference in the primary outcome was consistent after adjusting for baseline covariates as well as across all subgroups.

The rates of secondary outcomes were also similar between the two groups, except for a longer length of stay in the intensive care unit in the moderate hypothermia group compared with the mild hypothermia group, which would likely add to overall costs.

The researchers note that the Targeted Hypothermia vs Targeted Normothermia After Out-of-Hospital Cardiac Arrest (TTM2) trial recently reported that targeted hypothermia at 33°C did not improve survival at 180 days compared with targeted normothermia at 37.5°C or less.

The CAPITAL CHILL study “adds to the spectrum of target temperature management, as it did not find any benefit of even further lowering temperatures to 31°C,” the study team says.

They caution that most patients in the trial had cardiac arrest secondary to a primary cardiac etiology and therefore the findings may not be applicable to cardiac arrest of all etiologies.

It’s also possible that the trial was underpowered to detect clinically important differences between moderate and mild hypothermia. Also, the number of patients presenting with a nonshockable rhythm was relatively small, and further study may be worthwhile in this subgroup, they say.

For now, however, the CAPITAL CHILL results provide no support for a lower target temperature of 31°C to improve outcomes in OHCA patients, Dr. Le May and colleagues conclude.

CAPITAL CHILL was an investigator-initiated study and funding was provided by the University of Ottawa Heart Institute Cardiac Arrest Program. Dr. Le May has disclosed no relevant financial relationships.

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

For comatose survivors of out-of-hospital cardiac arrest (OHCA), moderate hypothermia to a target body temperature of 31°C did not improve outcomes, compared with guideline-recommended mild hypothermia (target temp 34°C) in the CAPITAL CHILL study.

The results “do not support the use of moderate therapeutic hypothermia to improve neurologic outcomes in comatose survivors of out-of-hospital cardiac arrest,” write the investigators led by Michel Le May, MD, from the University of Ottawa Heart Institute, Ontario, Canada.

The CAPITAL CHILL results were first presented at the American College of Cardiology (ACC) 2021 Scientific Sessions in May.   

They have now been published online, October 19, in JAMA. 
 

High rates of brain injury and death

Comatose survivors of OHCA have high rates of severe brain injury and death. Current guidelines recommend targeted temperature management at 32°C to 36°C for 24 hours. However, small studies have suggested a potential benefit of targeting lower body temperatures.

In the CAPITAL CHILL study of 367 OHCA patients who were comatose on admission, there were no statistically significant differences in the primary composite outcome of all-cause mortality or poor neurologic outcome at 180 days with mild-versus-moderate hypothermia.

The primary composite outcome occurred in 89 of 184 (48.4%) patients in the moderate hypothermia group and 83 of 183 (45.4%) patients in the mild hypothermia group — a risk difference of 3.0% (95% confidence interval [CI], 7.2% - 13.2%) and relative risk of 1.07 (95% CI, 0.86 - 1.33; P = .56).

There was also no significant difference when looking at the individual components of mortality (43.5% vs 41.0%) and poor neurologic outcome (Disability Rating Scale score >5: 4.9% vs 4.4%).

The baseline characteristics of patients were similar in the moderate and mild hypothermia groups. The lack of a significant difference in the primary outcome was consistent after adjusting for baseline covariates as well as across all subgroups.

The rates of secondary outcomes were also similar between the two groups, except for a longer length of stay in the intensive care unit in the moderate hypothermia group compared with the mild hypothermia group, which would likely add to overall costs.

The researchers note that the Targeted Hypothermia vs Targeted Normothermia After Out-of-Hospital Cardiac Arrest (TTM2) trial recently reported that targeted hypothermia at 33°C did not improve survival at 180 days compared with targeted normothermia at 37.5°C or less.

The CAPITAL CHILL study “adds to the spectrum of target temperature management, as it did not find any benefit of even further lowering temperatures to 31°C,” the study team says.

They caution that most patients in the trial had cardiac arrest secondary to a primary cardiac etiology and therefore the findings may not be applicable to cardiac arrest of all etiologies.

It’s also possible that the trial was underpowered to detect clinically important differences between moderate and mild hypothermia. Also, the number of patients presenting with a nonshockable rhythm was relatively small, and further study may be worthwhile in this subgroup, they say.

For now, however, the CAPITAL CHILL results provide no support for a lower target temperature of 31°C to improve outcomes in OHCA patients, Dr. Le May and colleagues conclude.

CAPITAL CHILL was an investigator-initiated study and funding was provided by the University of Ottawa Heart Institute Cardiac Arrest Program. Dr. Le May has disclosed no relevant financial relationships.

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

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FDA approves combo pill for severe, acute pain

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Thu, 10/21/2021 - 08:02

The U.S. Food and Drug Administration (FDA) has approved a combination pill containing celecoxib and tramadol (Seglentis) for the treatment of adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief.

Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid agonist. Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.

“The unique co-crystal formulation of Seglentis provides effective pain relief via a multimodal approach,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in a news release.

Esteve Pharmaceuticals has entered into an agreement with Kowa Pharmaceuticals America to commercialize the pain medicine in the United States, with a launch planned for early 2022.

“Seglentis uses four different and complementary mechanisms of analgesia and offers healthcare providers an important option to treat acute pain in adults that is severe enough to require opioid treatment and for which alternative treatments are inadequate,” Dr. Sponseller said.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis.

The label states that the drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals.

Patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.

Prescribers should discuss naloxone (Narcan) with patients and consider prescribing the opioid antagonist naloxone based on the patient’s risk factors for overdose.

Full prescribing information is available online.

A version of this article was first published on Medscape.com.

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The U.S. Food and Drug Administration (FDA) has approved a combination pill containing celecoxib and tramadol (Seglentis) for the treatment of adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief.

Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid agonist. Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.

“The unique co-crystal formulation of Seglentis provides effective pain relief via a multimodal approach,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in a news release.

Esteve Pharmaceuticals has entered into an agreement with Kowa Pharmaceuticals America to commercialize the pain medicine in the United States, with a launch planned for early 2022.

“Seglentis uses four different and complementary mechanisms of analgesia and offers healthcare providers an important option to treat acute pain in adults that is severe enough to require opioid treatment and for which alternative treatments are inadequate,” Dr. Sponseller said.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis.

The label states that the drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals.

Patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.

Prescribers should discuss naloxone (Narcan) with patients and consider prescribing the opioid antagonist naloxone based on the patient’s risk factors for overdose.

Full prescribing information is available online.

A version of this article was first published on Medscape.com.

The U.S. Food and Drug Administration (FDA) has approved a combination pill containing celecoxib and tramadol (Seglentis) for the treatment of adults with acute pain severe enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief.

Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid agonist. Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.

“The unique co-crystal formulation of Seglentis provides effective pain relief via a multimodal approach,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in a news release.

Esteve Pharmaceuticals has entered into an agreement with Kowa Pharmaceuticals America to commercialize the pain medicine in the United States, with a launch planned for early 2022.

“Seglentis uses four different and complementary mechanisms of analgesia and offers healthcare providers an important option to treat acute pain in adults that is severe enough to require opioid treatment and for which alternative treatments are inadequate,” Dr. Sponseller said.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis.

The label states that the drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals.

Patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.

Prescribers should discuss naloxone (Narcan) with patients and consider prescribing the opioid antagonist naloxone based on the patient’s risk factors for overdose.

Full prescribing information is available online.

A version of this article was first published on Medscape.com.

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