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Overnight extubations associated with worse outcomes

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Clinical question: Are overnight extubations in intensive care units associated with higher mortality rate?

Background: Little is known about the frequency, safety, and effectiveness of overnight extubations in the ICU.

Study design: Retrospective cohort study.

Setting: One-hundred sixty-five ICUs in the United States.

Synopsis: Using the Project IMPACT database, 97,844 adults undergoing mechanical ventilation (MV) admitted to ICUs were studied. Overnight extubation was defined as occurring between 7 p.m. and 6:59 a.m. Primary outcome was reintubation; secondary outcomes were ICU and hospital mortality and ICU and hospital length of stay.

Only one-fifth of patients with MV underwent overnight extubations. For MV duration of at least 12 hours, rates of reintubation were higher for patients undergoing overnight extubation (14.6% vs. 12.4%; P less than .001). Mortality was significantly higher for patients undergoing overnight versus daytime extubation in the ICU (11.2% vs. 6.1%; P less than.001) and in the hospital (16.0% vs. 11.1%; P less than .001). Length of ICU and hospital stays did not differ.

Bottom line: Overnight extubations occur in one of five patients in U.S. ICUs and are associated with worse outcomes, compared with daytime extubations.

Citation: Gershengorn HB, Scales DC, Kramer A, Wunsch H. Association between overnight extubations and outcomes in the intensive care unit. JAMA Intern Med. 2016;176(11):1651-1660.

 

Dr. Mosetti is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at University of Miami Hospital and Jackson Memorial Hospital.

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Clinical question: Are overnight extubations in intensive care units associated with higher mortality rate?

Background: Little is known about the frequency, safety, and effectiveness of overnight extubations in the ICU.

Study design: Retrospective cohort study.

Setting: One-hundred sixty-five ICUs in the United States.

Synopsis: Using the Project IMPACT database, 97,844 adults undergoing mechanical ventilation (MV) admitted to ICUs were studied. Overnight extubation was defined as occurring between 7 p.m. and 6:59 a.m. Primary outcome was reintubation; secondary outcomes were ICU and hospital mortality and ICU and hospital length of stay.

Only one-fifth of patients with MV underwent overnight extubations. For MV duration of at least 12 hours, rates of reintubation were higher for patients undergoing overnight extubation (14.6% vs. 12.4%; P less than .001). Mortality was significantly higher for patients undergoing overnight versus daytime extubation in the ICU (11.2% vs. 6.1%; P less than.001) and in the hospital (16.0% vs. 11.1%; P less than .001). Length of ICU and hospital stays did not differ.

Bottom line: Overnight extubations occur in one of five patients in U.S. ICUs and are associated with worse outcomes, compared with daytime extubations.

Citation: Gershengorn HB, Scales DC, Kramer A, Wunsch H. Association between overnight extubations and outcomes in the intensive care unit. JAMA Intern Med. 2016;176(11):1651-1660.

 

Dr. Mosetti is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at University of Miami Hospital and Jackson Memorial Hospital.

Clinical question: Are overnight extubations in intensive care units associated with higher mortality rate?

Background: Little is known about the frequency, safety, and effectiveness of overnight extubations in the ICU.

Study design: Retrospective cohort study.

Setting: One-hundred sixty-five ICUs in the United States.

Synopsis: Using the Project IMPACT database, 97,844 adults undergoing mechanical ventilation (MV) admitted to ICUs were studied. Overnight extubation was defined as occurring between 7 p.m. and 6:59 a.m. Primary outcome was reintubation; secondary outcomes were ICU and hospital mortality and ICU and hospital length of stay.

Only one-fifth of patients with MV underwent overnight extubations. For MV duration of at least 12 hours, rates of reintubation were higher for patients undergoing overnight extubation (14.6% vs. 12.4%; P less than .001). Mortality was significantly higher for patients undergoing overnight versus daytime extubation in the ICU (11.2% vs. 6.1%; P less than.001) and in the hospital (16.0% vs. 11.1%; P less than .001). Length of ICU and hospital stays did not differ.

Bottom line: Overnight extubations occur in one of five patients in U.S. ICUs and are associated with worse outcomes, compared with daytime extubations.

Citation: Gershengorn HB, Scales DC, Kramer A, Wunsch H. Association between overnight extubations and outcomes in the intensive care unit. JAMA Intern Med. 2016;176(11):1651-1660.

 

Dr. Mosetti is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at University of Miami Hospital and Jackson Memorial Hospital.

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Fecal transplant efficacy for Clostridium difficile infections

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Fecal transplant efficacy for Clostridium difficile infections

Clinical question: Is fecal microbiota transplantation (FMT) an efficacious and safe treatment approach for patients with recurrent Clostridium difficile infection (CDI)?

Background: FMT restores the normal composition of gut microbiota and is recommended when antibiotics fail to clear CDI. To date, only case series and open-labeled clinical trials support the use of FMT.

Study design: Randomized, controlled, double-blinded clinical trial.


Setting: Academic medical centers.

Synopsis: This study included 46 patients with three or more recurrences of CDI who received a course of vancomycin for their most recent acute episode. FMTs with donor stool or patient’s stool (autologous) were administered by colonoscopy.

The primary endpoint was resolution of diarrhea without anti-CDI therapy after 8 weeks of follow-up. In the donor FMT group, 90.9% achieved clinical cure, compared with 62.5% in the autologous group. Patients who developed recurrent CDI were free of further disease after subsequent donor FMT.

The study included only patients who experienced three or more recurrences but excluded immunocompromised and older patients (older than 75 years of age).

Bottom line: Donor stool administered via colonoscopy was more effective than autologous FMT in preventing further CDI episodes.

Citation: Kelly CR, Khoruts A, Staley C, et al. Effect of fecal microbiota transplantation on recurrence in multiply recurrent Clostridium difficile infection: a randomized trial. Ann Intern Med. 2016;165(9):609-616.

Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.

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Clinical question: Is fecal microbiota transplantation (FMT) an efficacious and safe treatment approach for patients with recurrent Clostridium difficile infection (CDI)?

Background: FMT restores the normal composition of gut microbiota and is recommended when antibiotics fail to clear CDI. To date, only case series and open-labeled clinical trials support the use of FMT.

Study design: Randomized, controlled, double-blinded clinical trial.


Setting: Academic medical centers.

Synopsis: This study included 46 patients with three or more recurrences of CDI who received a course of vancomycin for their most recent acute episode. FMTs with donor stool or patient’s stool (autologous) were administered by colonoscopy.

The primary endpoint was resolution of diarrhea without anti-CDI therapy after 8 weeks of follow-up. In the donor FMT group, 90.9% achieved clinical cure, compared with 62.5% in the autologous group. Patients who developed recurrent CDI were free of further disease after subsequent donor FMT.

The study included only patients who experienced three or more recurrences but excluded immunocompromised and older patients (older than 75 years of age).

Bottom line: Donor stool administered via colonoscopy was more effective than autologous FMT in preventing further CDI episodes.

Citation: Kelly CR, Khoruts A, Staley C, et al. Effect of fecal microbiota transplantation on recurrence in multiply recurrent Clostridium difficile infection: a randomized trial. Ann Intern Med. 2016;165(9):609-616.

Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.

Clinical question: Is fecal microbiota transplantation (FMT) an efficacious and safe treatment approach for patients with recurrent Clostridium difficile infection (CDI)?

Background: FMT restores the normal composition of gut microbiota and is recommended when antibiotics fail to clear CDI. To date, only case series and open-labeled clinical trials support the use of FMT.

Study design: Randomized, controlled, double-blinded clinical trial.


Setting: Academic medical centers.

Synopsis: This study included 46 patients with three or more recurrences of CDI who received a course of vancomycin for their most recent acute episode. FMTs with donor stool or patient’s stool (autologous) were administered by colonoscopy.

The primary endpoint was resolution of diarrhea without anti-CDI therapy after 8 weeks of follow-up. In the donor FMT group, 90.9% achieved clinical cure, compared with 62.5% in the autologous group. Patients who developed recurrent CDI were free of further disease after subsequent donor FMT.

The study included only patients who experienced three or more recurrences but excluded immunocompromised and older patients (older than 75 years of age).

Bottom line: Donor stool administered via colonoscopy was more effective than autologous FMT in preventing further CDI episodes.

Citation: Kelly CR, Khoruts A, Staley C, et al. Effect of fecal microbiota transplantation on recurrence in multiply recurrent Clostridium difficile infection: a randomized trial. Ann Intern Med. 2016;165(9):609-616.

Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.

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Fecal transplant efficacy for Clostridium difficile infections
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Non–vitamin K antagonist oral anticoagulants for planned atrial fibrillation cardioversions

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Clinical question: How does edoxaban compare with enoxaparin-warfarin in patients with nonvalvular atrial fibrillation undergoing cardioversion?

Background: Studies on non–vitamin K antagonist oral anticoagulants (NOACs) for patients with nonvalvular atrial fibrillation undergoing cardioversion are limited.

Study design: Multicenter, prospective, randomized trial.

Setting: Nineteen countries at 239 study sites.

Synopsis: This trial compared edoxaban with enoxaparin-warfarin. The study was stratified by cardioversion approach, anticoagulant experience, selected edoxaban dose, and region. There were 2,199 patients, mean age was 64, mean CHA2DS2-VASc score was 2.6, and mean therapeutic time on warfarin was 70.8%.

The primary efficacy endpoint was a composite of stroke, systemic emboli, myocardial infarction, and cardiovascular mortality, which occurred in 5 (1%) patients in the edoxaban group versus 11 (1%) in the enoxaparin-warfarin group (odds ratio, 0.46; 95% CI, 0.12-1.43).

The primary safety endpoint was major and clinically relevant nonmajor bleeding for patients receiving at least one dose of the study drug, occurring in 16 (1%) of 1,067 patients given edoxaban versus 11 (1%) of 1,082 patients given enoxaparin-warfarin (OR, 1.48; 95% CI, 0.64-3.55).

Bottom line: In patients with nonvalvular atrial fibrillation undergoing cardioversion, edoxaban had low rates of major bleeding and thromboembolism similar to enoxaparin-warfarin therapy.

Citation: Goette A, Merino JL, Ezekowitz MD, et al. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial. Lancet. 2016;388(10055):1995-2003.

Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.

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Clinical question: How does edoxaban compare with enoxaparin-warfarin in patients with nonvalvular atrial fibrillation undergoing cardioversion?

Background: Studies on non–vitamin K antagonist oral anticoagulants (NOACs) for patients with nonvalvular atrial fibrillation undergoing cardioversion are limited.

Study design: Multicenter, prospective, randomized trial.

Setting: Nineteen countries at 239 study sites.

Synopsis: This trial compared edoxaban with enoxaparin-warfarin. The study was stratified by cardioversion approach, anticoagulant experience, selected edoxaban dose, and region. There were 2,199 patients, mean age was 64, mean CHA2DS2-VASc score was 2.6, and mean therapeutic time on warfarin was 70.8%.

The primary efficacy endpoint was a composite of stroke, systemic emboli, myocardial infarction, and cardiovascular mortality, which occurred in 5 (1%) patients in the edoxaban group versus 11 (1%) in the enoxaparin-warfarin group (odds ratio, 0.46; 95% CI, 0.12-1.43).

The primary safety endpoint was major and clinically relevant nonmajor bleeding for patients receiving at least one dose of the study drug, occurring in 16 (1%) of 1,067 patients given edoxaban versus 11 (1%) of 1,082 patients given enoxaparin-warfarin (OR, 1.48; 95% CI, 0.64-3.55).

Bottom line: In patients with nonvalvular atrial fibrillation undergoing cardioversion, edoxaban had low rates of major bleeding and thromboembolism similar to enoxaparin-warfarin therapy.

Citation: Goette A, Merino JL, Ezekowitz MD, et al. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial. Lancet. 2016;388(10055):1995-2003.

Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.

Clinical question: How does edoxaban compare with enoxaparin-warfarin in patients with nonvalvular atrial fibrillation undergoing cardioversion?

Background: Studies on non–vitamin K antagonist oral anticoagulants (NOACs) for patients with nonvalvular atrial fibrillation undergoing cardioversion are limited.

Study design: Multicenter, prospective, randomized trial.

Setting: Nineteen countries at 239 study sites.

Synopsis: This trial compared edoxaban with enoxaparin-warfarin. The study was stratified by cardioversion approach, anticoagulant experience, selected edoxaban dose, and region. There were 2,199 patients, mean age was 64, mean CHA2DS2-VASc score was 2.6, and mean therapeutic time on warfarin was 70.8%.

The primary efficacy endpoint was a composite of stroke, systemic emboli, myocardial infarction, and cardiovascular mortality, which occurred in 5 (1%) patients in the edoxaban group versus 11 (1%) in the enoxaparin-warfarin group (odds ratio, 0.46; 95% CI, 0.12-1.43).

The primary safety endpoint was major and clinically relevant nonmajor bleeding for patients receiving at least one dose of the study drug, occurring in 16 (1%) of 1,067 patients given edoxaban versus 11 (1%) of 1,082 patients given enoxaparin-warfarin (OR, 1.48; 95% CI, 0.64-3.55).

Bottom line: In patients with nonvalvular atrial fibrillation undergoing cardioversion, edoxaban had low rates of major bleeding and thromboembolism similar to enoxaparin-warfarin therapy.

Citation: Goette A, Merino JL, Ezekowitz MD, et al. Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial. Lancet. 2016;388(10055):1995-2003.

Dr. Fernandez de la Vara is an instructor at the University of Miami Miller School of Medicine and chief medical resident at the University of Miami Hospital.

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Home treatment of PE remains rare

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Clinical question: What is the prevalence of outpatient treatment of acute pulmonary embolism (PE)?

Background: PE traditionally is perceived as a serious condition requiring hospitalization. Many studies, however, have shown that outpatient treatment of PE in low-risk, compliant patients is safe. Several scoring systems have been derived to identify patients with PE who are at low risk of adverse events and may be candidates for home treatment.

Study design: Retrospective cohort study.

Setting: Five U.S. EDs.

Synopsis: Among 983 patients diagnosed with acute PE, 237 (24.1%) were unstable and hypoxic. Only a small proportion of patients (1.7%) were eligible for outpatient therapy, and an additional 16.2% of hospitalized patients were discharged early (2 days or less). Novel oral anticoagulants were administered to fewer than one-third of patients.

Bottom line: In the era of novel anticoagulants, the majority of patients with acute PE were hospitalized, and home treatment was infrequently selected for stable low-risk patients.

Citation: Stein PD, Matta F, Hughes PG, et al. Home treatment of pulmonary embolism in the era of novel oral anticoagulants. Am J Med. 2016;129(9):974-977.


Dr. Gummalla is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at University of Miami Hospital and Jackson Memorial Hospital.

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Clinical question: What is the prevalence of outpatient treatment of acute pulmonary embolism (PE)?

Background: PE traditionally is perceived as a serious condition requiring hospitalization. Many studies, however, have shown that outpatient treatment of PE in low-risk, compliant patients is safe. Several scoring systems have been derived to identify patients with PE who are at low risk of adverse events and may be candidates for home treatment.

Study design: Retrospective cohort study.

Setting: Five U.S. EDs.

Synopsis: Among 983 patients diagnosed with acute PE, 237 (24.1%) were unstable and hypoxic. Only a small proportion of patients (1.7%) were eligible for outpatient therapy, and an additional 16.2% of hospitalized patients were discharged early (2 days or less). Novel oral anticoagulants were administered to fewer than one-third of patients.

Bottom line: In the era of novel anticoagulants, the majority of patients with acute PE were hospitalized, and home treatment was infrequently selected for stable low-risk patients.

Citation: Stein PD, Matta F, Hughes PG, et al. Home treatment of pulmonary embolism in the era of novel oral anticoagulants. Am J Med. 2016;129(9):974-977.


Dr. Gummalla is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at University of Miami Hospital and Jackson Memorial Hospital.

Clinical question: What is the prevalence of outpatient treatment of acute pulmonary embolism (PE)?

Background: PE traditionally is perceived as a serious condition requiring hospitalization. Many studies, however, have shown that outpatient treatment of PE in low-risk, compliant patients is safe. Several scoring systems have been derived to identify patients with PE who are at low risk of adverse events and may be candidates for home treatment.

Study design: Retrospective cohort study.

Setting: Five U.S. EDs.

Synopsis: Among 983 patients diagnosed with acute PE, 237 (24.1%) were unstable and hypoxic. Only a small proportion of patients (1.7%) were eligible for outpatient therapy, and an additional 16.2% of hospitalized patients were discharged early (2 days or less). Novel oral anticoagulants were administered to fewer than one-third of patients.

Bottom line: In the era of novel anticoagulants, the majority of patients with acute PE were hospitalized, and home treatment was infrequently selected for stable low-risk patients.

Citation: Stein PD, Matta F, Hughes PG, et al. Home treatment of pulmonary embolism in the era of novel oral anticoagulants. Am J Med. 2016;129(9):974-977.


Dr. Gummalla is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at University of Miami Hospital and Jackson Memorial Hospital.

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Updated recommendations for managing gout

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Clinical question: What are the new treatment options for gout?

Background: The 2006 European League Against Rheumatism (EULAR) guidelines recommend that acute flares of gout be treated as early as possible with either oral colchicine, oral corticosteroids, or intra-articular corticosteroids. Experts recommend starting urate-lowering therapy (ULT) only when certain severe clinical features occur, such as recurrent acute attacks and tophi.

Study design: Systematic review.

Setting: EULAR task force members from 12 European countries.

Synopsis: Since the last guidelines, interleukin-1 blockers (IL-1) were found to play a crucial role in crystal-induced inflammation. IL-1, NSAIDs, and corticosteroids should be considered in patients with frequent flares and contraindications to colchicine.

Unlike in the previous guidelines, ULT should be considered from first presentation of gout; for severe disease, serum uric acid (SUA) levels should be maintained at less than 6 mg/dL and less than 5 mg/dL.

Allopurinol is recommended for first-line ULT, and if the SUA target cannot be reached, it should be switched to another xanthine oxidase inhibitor (febuxostat) or a uricosuric or combined with a uricosuric.

Pegloticase is recommended for refractory gout.

Bottom line: The updated 2016 EULAR guidelines recommend new treatment options for gout and updated indications for ULT.

Citation: Richette P, Doherty M, Pascual E, et al. 2016 updated EULAR evidence-based recommendations for the management of gout [published online ahead of print July 25, 2016]. Ann Rheum Dis. doi: 10.1136/annrheumdis-2016-209707.


Dr. Gummalla is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at University of Miami Hospital and Jackson Memorial Hospital.

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Clinical question: What are the new treatment options for gout?

Background: The 2006 European League Against Rheumatism (EULAR) guidelines recommend that acute flares of gout be treated as early as possible with either oral colchicine, oral corticosteroids, or intra-articular corticosteroids. Experts recommend starting urate-lowering therapy (ULT) only when certain severe clinical features occur, such as recurrent acute attacks and tophi.

Study design: Systematic review.

Setting: EULAR task force members from 12 European countries.

Synopsis: Since the last guidelines, interleukin-1 blockers (IL-1) were found to play a crucial role in crystal-induced inflammation. IL-1, NSAIDs, and corticosteroids should be considered in patients with frequent flares and contraindications to colchicine.

Unlike in the previous guidelines, ULT should be considered from first presentation of gout; for severe disease, serum uric acid (SUA) levels should be maintained at less than 6 mg/dL and less than 5 mg/dL.

Allopurinol is recommended for first-line ULT, and if the SUA target cannot be reached, it should be switched to another xanthine oxidase inhibitor (febuxostat) or a uricosuric or combined with a uricosuric.

Pegloticase is recommended for refractory gout.

Bottom line: The updated 2016 EULAR guidelines recommend new treatment options for gout and updated indications for ULT.

Citation: Richette P, Doherty M, Pascual E, et al. 2016 updated EULAR evidence-based recommendations for the management of gout [published online ahead of print July 25, 2016]. Ann Rheum Dis. doi: 10.1136/annrheumdis-2016-209707.


Dr. Gummalla is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at University of Miami Hospital and Jackson Memorial Hospital.

Clinical question: What are the new treatment options for gout?

Background: The 2006 European League Against Rheumatism (EULAR) guidelines recommend that acute flares of gout be treated as early as possible with either oral colchicine, oral corticosteroids, or intra-articular corticosteroids. Experts recommend starting urate-lowering therapy (ULT) only when certain severe clinical features occur, such as recurrent acute attacks and tophi.

Study design: Systematic review.

Setting: EULAR task force members from 12 European countries.

Synopsis: Since the last guidelines, interleukin-1 blockers (IL-1) were found to play a crucial role in crystal-induced inflammation. IL-1, NSAIDs, and corticosteroids should be considered in patients with frequent flares and contraindications to colchicine.

Unlike in the previous guidelines, ULT should be considered from first presentation of gout; for severe disease, serum uric acid (SUA) levels should be maintained at less than 6 mg/dL and less than 5 mg/dL.

Allopurinol is recommended for first-line ULT, and if the SUA target cannot be reached, it should be switched to another xanthine oxidase inhibitor (febuxostat) or a uricosuric or combined with a uricosuric.

Pegloticase is recommended for refractory gout.

Bottom line: The updated 2016 EULAR guidelines recommend new treatment options for gout and updated indications for ULT.

Citation: Richette P, Doherty M, Pascual E, et al. 2016 updated EULAR evidence-based recommendations for the management of gout [published online ahead of print July 25, 2016]. Ann Rheum Dis. doi: 10.1136/annrheumdis-2016-209707.


Dr. Gummalla is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at University of Miami Hospital and Jackson Memorial Hospital.

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Instability of INRs

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Thu, 12/15/2022 - 15:57

Clinical question: Does an initial stable international normalized ratio (INR) predict long-term stability?

Background: Warfarin decreases stroke risk among patients with atrial fibrillation; however, it interacts with food and drugs and requires monitoring to achieve a therapeutic INR. It is unclear if patients on warfarin with an initial stable INR value remain stable over time. Additionally, it is controversial whether patients on warfarin with previously stable INRs should benefit from switching to a non–vitamin K oral anticoagulant.

Study design: Retrospective study.

Setting: Outpatient clinics.


Synopsis: Data were collected from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation. Included in the study were patients taking warfarin at baseline with three or more INR values in the first 6 months and six or more INR values in the subsequent year. Stability was defined as 80% or more INRs in therapeutic range (2.0-3.0).

Only 26% of patients taking warfarin had a stable INR during the first 6 months, and only 34% continued to have a stable INR in the subsequent year.

Bottom line: Initial stable INR within the first 6 months among patients taking warfarin does not predict long-term INR stability in the subsequent year.

Citation: Pokorney SD, Simon DN, Thomas L, et al. Stability of international normalized ratios in patients taking long-term warfarin therapy. JAMA.2016;316(6):661-663

Dr. Florindez is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at University of Miami Hospital and Jackson Memorial Hospital.

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Clinical question: Does an initial stable international normalized ratio (INR) predict long-term stability?

Background: Warfarin decreases stroke risk among patients with atrial fibrillation; however, it interacts with food and drugs and requires monitoring to achieve a therapeutic INR. It is unclear if patients on warfarin with an initial stable INR value remain stable over time. Additionally, it is controversial whether patients on warfarin with previously stable INRs should benefit from switching to a non–vitamin K oral anticoagulant.

Study design: Retrospective study.

Setting: Outpatient clinics.


Synopsis: Data were collected from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation. Included in the study were patients taking warfarin at baseline with three or more INR values in the first 6 months and six or more INR values in the subsequent year. Stability was defined as 80% or more INRs in therapeutic range (2.0-3.0).

Only 26% of patients taking warfarin had a stable INR during the first 6 months, and only 34% continued to have a stable INR in the subsequent year.

Bottom line: Initial stable INR within the first 6 months among patients taking warfarin does not predict long-term INR stability in the subsequent year.

Citation: Pokorney SD, Simon DN, Thomas L, et al. Stability of international normalized ratios in patients taking long-term warfarin therapy. JAMA.2016;316(6):661-663

Dr. Florindez is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at University of Miami Hospital and Jackson Memorial Hospital.

Clinical question: Does an initial stable international normalized ratio (INR) predict long-term stability?

Background: Warfarin decreases stroke risk among patients with atrial fibrillation; however, it interacts with food and drugs and requires monitoring to achieve a therapeutic INR. It is unclear if patients on warfarin with an initial stable INR value remain stable over time. Additionally, it is controversial whether patients on warfarin with previously stable INRs should benefit from switching to a non–vitamin K oral anticoagulant.

Study design: Retrospective study.

Setting: Outpatient clinics.


Synopsis: Data were collected from the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation. Included in the study were patients taking warfarin at baseline with three or more INR values in the first 6 months and six or more INR values in the subsequent year. Stability was defined as 80% or more INRs in therapeutic range (2.0-3.0).

Only 26% of patients taking warfarin had a stable INR during the first 6 months, and only 34% continued to have a stable INR in the subsequent year.

Bottom line: Initial stable INR within the first 6 months among patients taking warfarin does not predict long-term INR stability in the subsequent year.

Citation: Pokorney SD, Simon DN, Thomas L, et al. Stability of international normalized ratios in patients taking long-term warfarin therapy. JAMA.2016;316(6):661-663

Dr. Florindez is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at University of Miami Hospital and Jackson Memorial Hospital.

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Inpatient antibiotic use has not declined

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Clinical question: How has inpatient antibiotic use changed in the United States in recent years?

Background: Antibiotic resistance is a result of inappropriate antibiotic use. Understanding antibiotic trends will help improve antibiotic stewardship efforts.

Study design: Retrospective analysis.

Setting: Adult and pediatric data from 300 acute-care hospitals, 2006-2012.

Synopsis: Weighted extrapolation of data from a database was used to estimate national antibiotic use. Overall, 55.1% of discharged patients received antibiotics. The rate of antibiotic use was 755/1,000 patient-days over the study period. The small increase in antibiotic use over the years (5.6 days of therapy/1,000 patient-days increase; 95% CI, –18.9 to 30.1; P = .65) was not statistically significant. There was a significant decrease in the use of aminoglycosides, first- and second-generation cephalosporins, fluoroquinolones, sulfonamide, metronidazole, and penicillins. The use of third- and fourth-generation cephalosporins, macrolides, glycopeptides, beta-lactam/beta-lactamase inhibitor, carbapenems, and tetracyclines has increased significantly.

Limitations of the study include underrepresentation of pediatric hospitals and certain geographic regions.

Bottom line: Antibiotic-use rates have not changed during 2006-2012. However, broad-spectrum antibiotic use has increased significantly.

Citation: Baggs J, Fridkin SK, Pollack LA, Srinivasan A, Jernigan JA. Estimating national trends in inpatient antibiotic use among US hospitals from 2006 to 2012. JAMA Intern Med. 2016;176(11):1639-1648.

Dr. Menon is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at University of Miami Hospital and Jackson Memorial Hospital.

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Clinical question: How has inpatient antibiotic use changed in the United States in recent years?

Background: Antibiotic resistance is a result of inappropriate antibiotic use. Understanding antibiotic trends will help improve antibiotic stewardship efforts.

Study design: Retrospective analysis.

Setting: Adult and pediatric data from 300 acute-care hospitals, 2006-2012.

Synopsis: Weighted extrapolation of data from a database was used to estimate national antibiotic use. Overall, 55.1% of discharged patients received antibiotics. The rate of antibiotic use was 755/1,000 patient-days over the study period. The small increase in antibiotic use over the years (5.6 days of therapy/1,000 patient-days increase; 95% CI, –18.9 to 30.1; P = .65) was not statistically significant. There was a significant decrease in the use of aminoglycosides, first- and second-generation cephalosporins, fluoroquinolones, sulfonamide, metronidazole, and penicillins. The use of third- and fourth-generation cephalosporins, macrolides, glycopeptides, beta-lactam/beta-lactamase inhibitor, carbapenems, and tetracyclines has increased significantly.

Limitations of the study include underrepresentation of pediatric hospitals and certain geographic regions.

Bottom line: Antibiotic-use rates have not changed during 2006-2012. However, broad-spectrum antibiotic use has increased significantly.

Citation: Baggs J, Fridkin SK, Pollack LA, Srinivasan A, Jernigan JA. Estimating national trends in inpatient antibiotic use among US hospitals from 2006 to 2012. JAMA Intern Med. 2016;176(11):1639-1648.

Dr. Menon is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at University of Miami Hospital and Jackson Memorial Hospital.

Clinical question: How has inpatient antibiotic use changed in the United States in recent years?

Background: Antibiotic resistance is a result of inappropriate antibiotic use. Understanding antibiotic trends will help improve antibiotic stewardship efforts.

Study design: Retrospective analysis.

Setting: Adult and pediatric data from 300 acute-care hospitals, 2006-2012.

Synopsis: Weighted extrapolation of data from a database was used to estimate national antibiotic use. Overall, 55.1% of discharged patients received antibiotics. The rate of antibiotic use was 755/1,000 patient-days over the study period. The small increase in antibiotic use over the years (5.6 days of therapy/1,000 patient-days increase; 95% CI, –18.9 to 30.1; P = .65) was not statistically significant. There was a significant decrease in the use of aminoglycosides, first- and second-generation cephalosporins, fluoroquinolones, sulfonamide, metronidazole, and penicillins. The use of third- and fourth-generation cephalosporins, macrolides, glycopeptides, beta-lactam/beta-lactamase inhibitor, carbapenems, and tetracyclines has increased significantly.

Limitations of the study include underrepresentation of pediatric hospitals and certain geographic regions.

Bottom line: Antibiotic-use rates have not changed during 2006-2012. However, broad-spectrum antibiotic use has increased significantly.

Citation: Baggs J, Fridkin SK, Pollack LA, Srinivasan A, Jernigan JA. Estimating national trends in inpatient antibiotic use among US hospitals from 2006 to 2012. JAMA Intern Med. 2016;176(11):1639-1648.

Dr. Menon is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at University of Miami Hospital and Jackson Memorial Hospital.

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Evaluating the qSOF

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Clinical question: How does the quick Sepsis-Related Organ Failure Assessment (qSOFA) compare with other sepsis scoring tools?

Background: The qSOFA score has been shown to be superior to the Sepsis-Related Organ Failure Assessment (SOFA) with respect to predicting in-hospital mortality outside of the ICU. It has not been compared to other scoring systems or tested among ED patients.

Study design: Single-center, retrospective analysis.

Setting: Hospital ED in China.

Synopsis: A total of 516 adult ED patients with clinically diagnosed infections were followed for 28 days. Calculated scores for qSOFA, SOFA, Mortality in ED Sepsis (MEDS), and Acute Physiology and Chronic Health Evaluation (APACHE) II were compared using ROC curves.

qSOFA was similar to the other scoring systems to predict ICU admission.

The area under the curve for qSOFA to predict 28-day mortality was lower than all other scoring systems but was statistically significant only when compared to MEDS. A qSOFA score of 2 had a positive likelihood ratio of 2.47 to predict mortality (95% CI, 2.3-5.4) and a positive likelihood ratio of 2.08 (95% CI, 1.7-4.1) to predict ICU admission.

Bottom line: qSOFA was similar to other scoring systems to predict 28-day mortality and ICU admission but slightly inferior than MEDS to predict mortality.

Citation: Wang JY, Chen YX, Guo SB, Mei X, Yang P. Predictive performance of quick sepsis-related organ failure assessment for mortality and ICU admission in patients with infection at the ED. Am J Em Med. 2016;34(9):1788-1793

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Clinical question: How does the quick Sepsis-Related Organ Failure Assessment (qSOFA) compare with other sepsis scoring tools?

Background: The qSOFA score has been shown to be superior to the Sepsis-Related Organ Failure Assessment (SOFA) with respect to predicting in-hospital mortality outside of the ICU. It has not been compared to other scoring systems or tested among ED patients.

Study design: Single-center, retrospective analysis.

Setting: Hospital ED in China.

Synopsis: A total of 516 adult ED patients with clinically diagnosed infections were followed for 28 days. Calculated scores for qSOFA, SOFA, Mortality in ED Sepsis (MEDS), and Acute Physiology and Chronic Health Evaluation (APACHE) II were compared using ROC curves.

qSOFA was similar to the other scoring systems to predict ICU admission.

The area under the curve for qSOFA to predict 28-day mortality was lower than all other scoring systems but was statistically significant only when compared to MEDS. A qSOFA score of 2 had a positive likelihood ratio of 2.47 to predict mortality (95% CI, 2.3-5.4) and a positive likelihood ratio of 2.08 (95% CI, 1.7-4.1) to predict ICU admission.

Bottom line: qSOFA was similar to other scoring systems to predict 28-day mortality and ICU admission but slightly inferior than MEDS to predict mortality.

Citation: Wang JY, Chen YX, Guo SB, Mei X, Yang P. Predictive performance of quick sepsis-related organ failure assessment for mortality and ICU admission in patients with infection at the ED. Am J Em Med. 2016;34(9):1788-1793

Clinical question: How does the quick Sepsis-Related Organ Failure Assessment (qSOFA) compare with other sepsis scoring tools?

Background: The qSOFA score has been shown to be superior to the Sepsis-Related Organ Failure Assessment (SOFA) with respect to predicting in-hospital mortality outside of the ICU. It has not been compared to other scoring systems or tested among ED patients.

Study design: Single-center, retrospective analysis.

Setting: Hospital ED in China.

Synopsis: A total of 516 adult ED patients with clinically diagnosed infections were followed for 28 days. Calculated scores for qSOFA, SOFA, Mortality in ED Sepsis (MEDS), and Acute Physiology and Chronic Health Evaluation (APACHE) II were compared using ROC curves.

qSOFA was similar to the other scoring systems to predict ICU admission.

The area under the curve for qSOFA to predict 28-day mortality was lower than all other scoring systems but was statistically significant only when compared to MEDS. A qSOFA score of 2 had a positive likelihood ratio of 2.47 to predict mortality (95% CI, 2.3-5.4) and a positive likelihood ratio of 2.08 (95% CI, 1.7-4.1) to predict ICU admission.

Bottom line: qSOFA was similar to other scoring systems to predict 28-day mortality and ICU admission but slightly inferior than MEDS to predict mortality.

Citation: Wang JY, Chen YX, Guo SB, Mei X, Yang P. Predictive performance of quick sepsis-related organ failure assessment for mortality and ICU admission in patients with infection at the ED. Am J Em Med. 2016;34(9):1788-1793

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Pulmonary embolism in COPD exacerbations

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Clinical question: How frequent is pulmonary embolism (PE) in patients with unexplained acute chronic obstructive pulmonary disease (COPD) exacerbation?

Background: Acute COPD exacerbations are highly inflammatory states, and since there is a well-known interaction between inflammatory pathways and thrombosis, PE occurs with increased prevalence, ranging from 18% to 25%. In approximately 30% of cases of acute exacerbations of COPD, no clear etiology is found.

Study design: Systematic review.

Setting: U.S. hospitals and EDs.

Synopsis: PE prevalence was 16.1% (95% CI, 8.3%-25.8%) in patients with unexplained COPD exacerbations. Thirty-two percent were subsegmental, 35% affected one of the main pulmonary arteries, and 32% were located in the lobar and interlobar arteries. Heterogeneity between the included studies was high. In-hospital and 1-year mortality were increased in patients with PE and COPD exacerbations in one study but not in another.

Signs of cardiac failure, hypotension, and syncope were more frequently found in patients with COPD exacerbation and PE, compared with patients with COPD exacerbation without PE.

Bottom line: PE is a common occurrence in patients with unexplained COPD exacerbations; two-thirds of those emboli involved segmental circulation and therefore were clinically relevant.

Citation: Aleva FE, Voets LW, Simons SO, de Mast Q, van der Ven A, Heijdra YF. Prevalence and localization of pulmonary embolism in unexplained acute exacerbations of COPD: a systematic review and meta-analysis [published online ahead of print Aug. 11, 2016]. Chest. doi: 10.1016/j.chest.2016.07.034.

Dr. Giese is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at the University of Miami Hospital and Jackson Memorial Hospital.
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Clinical question: How frequent is pulmonary embolism (PE) in patients with unexplained acute chronic obstructive pulmonary disease (COPD) exacerbation?

Background: Acute COPD exacerbations are highly inflammatory states, and since there is a well-known interaction between inflammatory pathways and thrombosis, PE occurs with increased prevalence, ranging from 18% to 25%. In approximately 30% of cases of acute exacerbations of COPD, no clear etiology is found.

Study design: Systematic review.

Setting: U.S. hospitals and EDs.

Synopsis: PE prevalence was 16.1% (95% CI, 8.3%-25.8%) in patients with unexplained COPD exacerbations. Thirty-two percent were subsegmental, 35% affected one of the main pulmonary arteries, and 32% were located in the lobar and interlobar arteries. Heterogeneity between the included studies was high. In-hospital and 1-year mortality were increased in patients with PE and COPD exacerbations in one study but not in another.

Signs of cardiac failure, hypotension, and syncope were more frequently found in patients with COPD exacerbation and PE, compared with patients with COPD exacerbation without PE.

Bottom line: PE is a common occurrence in patients with unexplained COPD exacerbations; two-thirds of those emboli involved segmental circulation and therefore were clinically relevant.

Citation: Aleva FE, Voets LW, Simons SO, de Mast Q, van der Ven A, Heijdra YF. Prevalence and localization of pulmonary embolism in unexplained acute exacerbations of COPD: a systematic review and meta-analysis [published online ahead of print Aug. 11, 2016]. Chest. doi: 10.1016/j.chest.2016.07.034.

Dr. Giese is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at the University of Miami Hospital and Jackson Memorial Hospital.

 

Clinical question: How frequent is pulmonary embolism (PE) in patients with unexplained acute chronic obstructive pulmonary disease (COPD) exacerbation?

Background: Acute COPD exacerbations are highly inflammatory states, and since there is a well-known interaction between inflammatory pathways and thrombosis, PE occurs with increased prevalence, ranging from 18% to 25%. In approximately 30% of cases of acute exacerbations of COPD, no clear etiology is found.

Study design: Systematic review.

Setting: U.S. hospitals and EDs.

Synopsis: PE prevalence was 16.1% (95% CI, 8.3%-25.8%) in patients with unexplained COPD exacerbations. Thirty-two percent were subsegmental, 35% affected one of the main pulmonary arteries, and 32% were located in the lobar and interlobar arteries. Heterogeneity between the included studies was high. In-hospital and 1-year mortality were increased in patients with PE and COPD exacerbations in one study but not in another.

Signs of cardiac failure, hypotension, and syncope were more frequently found in patients with COPD exacerbation and PE, compared with patients with COPD exacerbation without PE.

Bottom line: PE is a common occurrence in patients with unexplained COPD exacerbations; two-thirds of those emboli involved segmental circulation and therefore were clinically relevant.

Citation: Aleva FE, Voets LW, Simons SO, de Mast Q, van der Ven A, Heijdra YF. Prevalence and localization of pulmonary embolism in unexplained acute exacerbations of COPD: a systematic review and meta-analysis [published online ahead of print Aug. 11, 2016]. Chest. doi: 10.1016/j.chest.2016.07.034.

Dr. Giese is an assistant professor at the University of Miami Miller School of Medicine and a hospitalist at the University of Miami Hospital and Jackson Memorial Hospital.
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Nonischemic cardiomyopathy does not benefit from prophylactic ICDs

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Clinical question: Do prophylactic implantable cardioverter defibrillators (ICDs) reduce long-term mortality in patients with symptomatic nonischemic systolic heart failure (NISHF)?

Background: ICDs are associated with significant reductions in the rate of sudden cardiac death and mortality in NISHF patients. However, no trials of NISHF patients have shown an effect on total mortality.

Study design: Multicenter, nonblinded, randomized controlled prospective trial.

Setting: Danish ICD centers.

Synopsis: A total of 1,116 patients with symptomatic NISHF (left ventricular ejection fraction of less than 35%) were randomized to either receive an ICD or usual clinical care. The primary outcome, death from any cause, occurred in 120 patients (21.6%) in the ICD group (4.4 events/100 person-years) and in 131 patients (23.4%) in the control group. The hazard ratio for death from any cause in the ICD group, as compared with the control group, was 0.87 (95% CI , 0.68-1.12; P = .28). The HR for death from any cause in the ICD group, as compared with the control group, was 0.87 (95% CI, 0.68-1.12; P = .28)

Bottom line: Prophylactic ICD implantation in patients with symptomatic NISHF does not reduce long-term mortality.

Citation: Kober L, Thune JJ, Nielsen JC, et al. Defibrillator implantation in patients with nonischemic systolic heart failure. N Engl J Med. 2016;375:1221-1230.

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Clinical question: Do prophylactic implantable cardioverter defibrillators (ICDs) reduce long-term mortality in patients with symptomatic nonischemic systolic heart failure (NISHF)?

Background: ICDs are associated with significant reductions in the rate of sudden cardiac death and mortality in NISHF patients. However, no trials of NISHF patients have shown an effect on total mortality.

Study design: Multicenter, nonblinded, randomized controlled prospective trial.

Setting: Danish ICD centers.

Synopsis: A total of 1,116 patients with symptomatic NISHF (left ventricular ejection fraction of less than 35%) were randomized to either receive an ICD or usual clinical care. The primary outcome, death from any cause, occurred in 120 patients (21.6%) in the ICD group (4.4 events/100 person-years) and in 131 patients (23.4%) in the control group. The hazard ratio for death from any cause in the ICD group, as compared with the control group, was 0.87 (95% CI , 0.68-1.12; P = .28). The HR for death from any cause in the ICD group, as compared with the control group, was 0.87 (95% CI, 0.68-1.12; P = .28)

Bottom line: Prophylactic ICD implantation in patients with symptomatic NISHF does not reduce long-term mortality.

Citation: Kober L, Thune JJ, Nielsen JC, et al. Defibrillator implantation in patients with nonischemic systolic heart failure. N Engl J Med. 2016;375:1221-1230.

Clinical question: Do prophylactic implantable cardioverter defibrillators (ICDs) reduce long-term mortality in patients with symptomatic nonischemic systolic heart failure (NISHF)?

Background: ICDs are associated with significant reductions in the rate of sudden cardiac death and mortality in NISHF patients. However, no trials of NISHF patients have shown an effect on total mortality.

Study design: Multicenter, nonblinded, randomized controlled prospective trial.

Setting: Danish ICD centers.

Synopsis: A total of 1,116 patients with symptomatic NISHF (left ventricular ejection fraction of less than 35%) were randomized to either receive an ICD or usual clinical care. The primary outcome, death from any cause, occurred in 120 patients (21.6%) in the ICD group (4.4 events/100 person-years) and in 131 patients (23.4%) in the control group. The hazard ratio for death from any cause in the ICD group, as compared with the control group, was 0.87 (95% CI , 0.68-1.12; P = .28). The HR for death from any cause in the ICD group, as compared with the control group, was 0.87 (95% CI, 0.68-1.12; P = .28)

Bottom line: Prophylactic ICD implantation in patients with symptomatic NISHF does not reduce long-term mortality.

Citation: Kober L, Thune JJ, Nielsen JC, et al. Defibrillator implantation in patients with nonischemic systolic heart failure. N Engl J Med. 2016;375:1221-1230.

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