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Clinical question: Does long-term inhaled corticosteroid therapy, with and without long-acting beta-agonists, decrease airway inflammation and improve lung function in patients with moderate to severe chronic obstructive pulmonary disease (COPD)?

Background: Guideline-recommended treatment of COPD with inhaled corticosteroids and long-acting beta-agonists improves symptoms and exacerbation rates; little is known about the impact of these therapies on inflammation and long-term lung function.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Two university medical centers in the Netherlands.

Synopsis: One hundred one steroid-naïve patients, ages 45 to 75 who were current or former smokers with moderate to severe COPD, were randomized to one of four regimens: 1) fluticasone for six months, then placebo for 24 months; 2) fluticasone for 30 months; 3) fluticasone and salmeterol for 30 months; or 4) placebo for 30 months. The primary outcome was inflammatory cell counts in bronchial biopsies/induced sputum. Secondary outcomes included postbronchodilator spirometry, methacholine hyperresponsiveness, and self-reported symptoms and health status. Patients with asthma were excluded.

Short-term fluticasone therapy decreased inflammation and improved forced expiratory volume in one second (FEV1). Long-term therapy also decreased the rate of FEV1 decline, reduced dyspnea, and improved health status. Discontinuation of therapy at six months led to inflammation relapse with worsened symptoms and increased rate of FEV1 decline. The addition of long-acting beta-agonists did not provide additional anti-inflammatory benefits, but it did improve FEV1 and dyspnea at six months.

Additional studies are needed to further define clinical outcomes and assess the cost benefit of these therapies.

Bottom line: Inhaled corticosteroids decrease inflammation in steroid-naïve patients with moderate to severe COPD and might decrease the rate of lung function decline. Long-acting beta-agonists do not offer additional anti-inflammatory benefit.

Citation: Lapperre TS, Snoeck-Stroband JB, Gosman MM, et al. Effect of fluticasone with and without salmeterol on pulmonary outcomes in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2009;151(8):517-527.

Clinical question: Does long-term inhaled corticosteroid therapy, with and without long-acting beta-agonists, decrease airway inflammation and improve lung function in patients with moderate to severe chronic obstructive pulmonary disease (COPD)?

Background: Guideline-recommended treatment of COPD with inhaled corticosteroids and long-acting beta-agonists improves symptoms and exacerbation rates; little is known about the impact of these therapies on inflammation and long-term lung function.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Two university medical centers in the Netherlands.

Synopsis: One hundred one steroid-naïve patients, ages 45 to 75 who were current or former smokers with moderate to severe COPD, were randomized to one of four regimens: 1) fluticasone for six months, then placebo for 24 months; 2) fluticasone for 30 months; 3) fluticasone and salmeterol for 30 months; or 4) placebo for 30 months. The primary outcome was inflammatory cell counts in bronchial biopsies/induced sputum. Secondary outcomes included postbronchodilator spirometry, methacholine hyperresponsiveness, and self-reported symptoms and health status. Patients with asthma were excluded.

Short-term fluticasone therapy decreased inflammation and improved forced expiratory volume in one second (FEV1). Long-term therapy also decreased the rate of FEV1 decline, reduced dyspnea, and improved health status. Discontinuation of therapy at six months led to inflammation relapse with worsened symptoms and increased rate of FEV1 decline. The addition of long-acting beta-agonists did not provide additional anti-inflammatory benefits, but it did improve FEV1 and dyspnea at six months.

Additional studies are needed to further define clinical outcomes and assess the cost benefit of these therapies.

Bottom line: Inhaled corticosteroids decrease inflammation in steroid-naïve patients with moderate to severe COPD and might decrease the rate of lung function decline. Long-acting beta-agonists do not offer additional anti-inflammatory benefit.

Citation: Lapperre TS, Snoeck-Stroband JB, Gosman MM, et al. Effect of fluticasone with and without salmeterol on pulmonary outcomes in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2009;151(8):517-527.

Clinical question: Does long-term inhaled corticosteroid therapy, with and without long-acting beta-agonists, decrease airway inflammation and improve lung function in patients with moderate to severe chronic obstructive pulmonary disease (COPD)?

Background: Guideline-recommended treatment of COPD with inhaled corticosteroids and long-acting beta-agonists improves symptoms and exacerbation rates; little is known about the impact of these therapies on inflammation and long-term lung function.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Two university medical centers in the Netherlands.

Synopsis: One hundred one steroid-naïve patients, ages 45 to 75 who were current or former smokers with moderate to severe COPD, were randomized to one of four regimens: 1) fluticasone for six months, then placebo for 24 months; 2) fluticasone for 30 months; 3) fluticasone and salmeterol for 30 months; or 4) placebo for 30 months. The primary outcome was inflammatory cell counts in bronchial biopsies/induced sputum. Secondary outcomes included postbronchodilator spirometry, methacholine hyperresponsiveness, and self-reported symptoms and health status. Patients with asthma were excluded.

Short-term fluticasone therapy decreased inflammation and improved forced expiratory volume in one second (FEV1). Long-term therapy also decreased the rate of FEV1 decline, reduced dyspnea, and improved health status. Discontinuation of therapy at six months led to inflammation relapse with worsened symptoms and increased rate of FEV1 decline. The addition of long-acting beta-agonists did not provide additional anti-inflammatory benefits, but it did improve FEV1 and dyspnea at six months.

Additional studies are needed to further define clinical outcomes and assess the cost benefit of these therapies.

Bottom line: Inhaled corticosteroids decrease inflammation in steroid-naïve patients with moderate to severe COPD and might decrease the rate of lung function decline. Long-acting beta-agonists do not offer additional anti-inflammatory benefit.

Citation: Lapperre TS, Snoeck-Stroband JB, Gosman MM, et al. Effect of fluticasone with and without salmeterol on pulmonary outcomes in chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med. 2009;151(8):517-527.

Clinical question: Do resident fatigue and distress contribute to medical errors?

Background: In recent years, such measures as work-hour limitations have been implemented to decrease resident fatigue and, it is presumed, medical errors. However, few studies address the relationship between residents’ well-being and self-reported medical errors.

Study design: Prospective six-year longitudinal cohort study.

Setting: Single academic medical center.

Synopsis: The authors had 380 internal-medicine residents complete quarterly surveys to assess fatigue, quality of life, burnout, symptoms of depression, and frequency of perceived medical errors. In a univariate analysis, fatigue/sleepiness, burnout, depression, and overall quality of life measures correlated significantly with self-reported major medical errors. Fatigue/sleepiness and measures of distress additively increased the risk of self-reported errors. Increases in one or both domains were estimated to increase the risk of self-reported errors by as much as 15% to 28%.

The authors studied only self-reported medical errors. It is difficult to know whether these errors directly affected patient outcomes. Additionally, results of this single-site study might not be able to be generalized.

Bottom line: Fatigue and distress contribute to self-perceived medical errors among residents.

Citation: West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009;302(12):1294-1300.

Clinical question: Do resident fatigue and distress contribute to medical errors?

Background: In recent years, such measures as work-hour limitations have been implemented to decrease resident fatigue and, it is presumed, medical errors. However, few studies address the relationship between residents’ well-being and self-reported medical errors.

Study design: Prospective six-year longitudinal cohort study.

Setting: Single academic medical center.

Synopsis: The authors had 380 internal-medicine residents complete quarterly surveys to assess fatigue, quality of life, burnout, symptoms of depression, and frequency of perceived medical errors. In a univariate analysis, fatigue/sleepiness, burnout, depression, and overall quality of life measures correlated significantly with self-reported major medical errors. Fatigue/sleepiness and measures of distress additively increased the risk of self-reported errors. Increases in one or both domains were estimated to increase the risk of self-reported errors by as much as 15% to 28%.

The authors studied only self-reported medical errors. It is difficult to know whether these errors directly affected patient outcomes. Additionally, results of this single-site study might not be able to be generalized.

Bottom line: Fatigue and distress contribute to self-perceived medical errors among residents.

Citation: West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009;302(12):1294-1300.

Clinical question: Do resident fatigue and distress contribute to medical errors?

Background: In recent years, such measures as work-hour limitations have been implemented to decrease resident fatigue and, it is presumed, medical errors. However, few studies address the relationship between residents’ well-being and self-reported medical errors.

Study design: Prospective six-year longitudinal cohort study.

Setting: Single academic medical center.

Synopsis: The authors had 380 internal-medicine residents complete quarterly surveys to assess fatigue, quality of life, burnout, symptoms of depression, and frequency of perceived medical errors. In a univariate analysis, fatigue/sleepiness, burnout, depression, and overall quality of life measures correlated significantly with self-reported major medical errors. Fatigue/sleepiness and measures of distress additively increased the risk of self-reported errors. Increases in one or both domains were estimated to increase the risk of self-reported errors by as much as 15% to 28%.

The authors studied only self-reported medical errors. It is difficult to know whether these errors directly affected patient outcomes. Additionally, results of this single-site study might not be able to be generalized.

Bottom line: Fatigue and distress contribute to self-perceived medical errors among residents.

Citation: West CP, Tan AD, Habermann TM, Sloan JA, Shanafelt TD. Association of resident fatigue and distress with perceived medical errors. JAMA. 2009;302(12):1294-1300.

Clinical question: Is dabigatran, an oral thrombin inhibitor, an effective and safe alternative to warfarin in patients with atrial fibrillation?

Background: Warfarin reduces the risk of stroke among patients with atrial fibrillation (AF) but requires frequent laboratory monitoring. Dabigatran is an oral direct thrombin inhibitor given in fixed dosages without laboratory monitoring.

Study design: Randomized, multicenter, open-label, noninferiority trial.

Setting: 951 clinical centers in 44 countries.

Synopsis: More than 18,000 patients 65 and older with AF and at least one stroke risk factor were enrolled. The average CHADS2 score was 2.1. Patients were randomized to receive fixed doses of dabigatran (110 mg or 150 mg, twice daily) or warfarin adjusted to an INR of 2.0-3.0. The primary outcomes were a) stroke or systemic embolism and b) major hemorrhage. Median followup was two years.

The annual rates of stroke or systemic embolism for both doses of dabigatran were noninferior to warfarin (P<0.001); higher-dose dabigatran was statistically superior to warfarin (relative risk (RR)=0.66, P<0.001). The annual rate of major hemorrhage was lowest in the lower-dose dabigatran group (RR=0.80, P=0.003 compared with warfarin); the higher-dose dabigatran and warfarin groups had equivalent rates of major bleeding. No increased risk of liver function abnormalities was noted.

Bottom line: Dabigatran appears to be an effective and safe alternative to warfarin in AF patients. If the drug were to be FDA-approved, appropriate patient selection and cost will need to be established.

Citation: Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-1151.

Clinical question: Is dabigatran, an oral thrombin inhibitor, an effective and safe alternative to warfarin in patients with atrial fibrillation?

Background: Warfarin reduces the risk of stroke among patients with atrial fibrillation (AF) but requires frequent laboratory monitoring. Dabigatran is an oral direct thrombin inhibitor given in fixed dosages without laboratory monitoring.

Study design: Randomized, multicenter, open-label, noninferiority trial.

Setting: 951 clinical centers in 44 countries.

Synopsis: More than 18,000 patients 65 and older with AF and at least one stroke risk factor were enrolled. The average CHADS2 score was 2.1. Patients were randomized to receive fixed doses of dabigatran (110 mg or 150 mg, twice daily) or warfarin adjusted to an INR of 2.0-3.0. The primary outcomes were a) stroke or systemic embolism and b) major hemorrhage. Median followup was two years.

The annual rates of stroke or systemic embolism for both doses of dabigatran were noninferior to warfarin (P<0.001); higher-dose dabigatran was statistically superior to warfarin (relative risk (RR)=0.66, P<0.001). The annual rate of major hemorrhage was lowest in the lower-dose dabigatran group (RR=0.80, P=0.003 compared with warfarin); the higher-dose dabigatran and warfarin groups had equivalent rates of major bleeding. No increased risk of liver function abnormalities was noted.

Bottom line: Dabigatran appears to be an effective and safe alternative to warfarin in AF patients. If the drug were to be FDA-approved, appropriate patient selection and cost will need to be established.

Citation: Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-1151.

Clinical question: Is dabigatran, an oral thrombin inhibitor, an effective and safe alternative to warfarin in patients with atrial fibrillation?

Background: Warfarin reduces the risk of stroke among patients with atrial fibrillation (AF) but requires frequent laboratory monitoring. Dabigatran is an oral direct thrombin inhibitor given in fixed dosages without laboratory monitoring.

Study design: Randomized, multicenter, open-label, noninferiority trial.

Setting: 951 clinical centers in 44 countries.

Synopsis: More than 18,000 patients 65 and older with AF and at least one stroke risk factor were enrolled. The average CHADS2 score was 2.1. Patients were randomized to receive fixed doses of dabigatran (110 mg or 150 mg, twice daily) or warfarin adjusted to an INR of 2.0-3.0. The primary outcomes were a) stroke or systemic embolism and b) major hemorrhage. Median followup was two years.

The annual rates of stroke or systemic embolism for both doses of dabigatran were noninferior to warfarin (P<0.001); higher-dose dabigatran was statistically superior to warfarin (relative risk (RR)=0.66, P<0.001). The annual rate of major hemorrhage was lowest in the lower-dose dabigatran group (RR=0.80, P=0.003 compared with warfarin); the higher-dose dabigatran and warfarin groups had equivalent rates of major bleeding. No increased risk of liver function abnormalities was noted.

Bottom line: Dabigatran appears to be an effective and safe alternative to warfarin in AF patients. If the drug were to be FDA-approved, appropriate patient selection and cost will need to be established.

Citation: Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-1151.

Clinical question: Does cardiac resynchronization therapy (CRT) with biventricular pacing decrease cardiac events in patients with reduced ejection fraction (EF) and wide QRS complex but only mild cardiac symptoms?

Background: In patients with severely reduced EF, implantable cardioverter defibrillators (ICDs) have been shown to improve survival. Meanwhile, CRT decreases heart-failure-related hospitalizations for patients with advanced heart-failure symptoms, EF less than 35%, and intraventricular conduction delay. It is not as clear whether patients with less-severe symptoms benefit from CRT.

Study design: Randomized, controlled trial.

Setting: 110 medical centers in the U.S., Canada, and Europe.

Synopsis: This Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study randomly assigned 1,820 adults with EF less than 30%, New York Health Association Class I or II congestive heart failure, and in sinus rhythm with QRS greater than 130 msec to receive ICD with CRT or ICD alone. The primary endpoint was all-cause mortality or nonfatal heart-failure events. Average followup was 2.4 years.

A 34% reduction in the primary endpoint was found in the ICD-CRT group when compared with the ICD-only group, primarily due to a 41% reduction in heart-failure events. In a subgroup analysis, women and patients with QRS greater than 150 msec experienced particular benefit. Echocardiography one year after device implantation demonstrated significant reductions in left ventricular end-systolic and end-diastolic volume, and a significant increase in EF with ICD-CRT versus ICD-only (P<0.001).

Bottom line: Compared with ICD alone, CRT in combination with ICD prevented heart-failure events in relatively asymptomatic heart-failure patients with low EF and prolonged QRS.

Citation: Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009;361(14):1329-1338.

Clinical question: Does cardiac resynchronization therapy (CRT) with biventricular pacing decrease cardiac events in patients with reduced ejection fraction (EF) and wide QRS complex but only mild cardiac symptoms?

Background: In patients with severely reduced EF, implantable cardioverter defibrillators (ICDs) have been shown to improve survival. Meanwhile, CRT decreases heart-failure-related hospitalizations for patients with advanced heart-failure symptoms, EF less than 35%, and intraventricular conduction delay. It is not as clear whether patients with less-severe symptoms benefit from CRT.

Study design: Randomized, controlled trial.

Setting: 110 medical centers in the U.S., Canada, and Europe.

Synopsis: This Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study randomly assigned 1,820 adults with EF less than 30%, New York Health Association Class I or II congestive heart failure, and in sinus rhythm with QRS greater than 130 msec to receive ICD with CRT or ICD alone. The primary endpoint was all-cause mortality or nonfatal heart-failure events. Average followup was 2.4 years.

A 34% reduction in the primary endpoint was found in the ICD-CRT group when compared with the ICD-only group, primarily due to a 41% reduction in heart-failure events. In a subgroup analysis, women and patients with QRS greater than 150 msec experienced particular benefit. Echocardiography one year after device implantation demonstrated significant reductions in left ventricular end-systolic and end-diastolic volume, and a significant increase in EF with ICD-CRT versus ICD-only (P<0.001).

Bottom line: Compared with ICD alone, CRT in combination with ICD prevented heart-failure events in relatively asymptomatic heart-failure patients with low EF and prolonged QRS.

Citation: Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009;361(14):1329-1338.

Clinical question: Does cardiac resynchronization therapy (CRT) with biventricular pacing decrease cardiac events in patients with reduced ejection fraction (EF) and wide QRS complex but only mild cardiac symptoms?

Background: In patients with severely reduced EF, implantable cardioverter defibrillators (ICDs) have been shown to improve survival. Meanwhile, CRT decreases heart-failure-related hospitalizations for patients with advanced heart-failure symptoms, EF less than 35%, and intraventricular conduction delay. It is not as clear whether patients with less-severe symptoms benefit from CRT.

Study design: Randomized, controlled trial.

Setting: 110 medical centers in the U.S., Canada, and Europe.

Synopsis: This Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) study randomly assigned 1,820 adults with EF less than 30%, New York Health Association Class I or II congestive heart failure, and in sinus rhythm with QRS greater than 130 msec to receive ICD with CRT or ICD alone. The primary endpoint was all-cause mortality or nonfatal heart-failure events. Average followup was 2.4 years.

A 34% reduction in the primary endpoint was found in the ICD-CRT group when compared with the ICD-only group, primarily due to a 41% reduction in heart-failure events. In a subgroup analysis, women and patients with QRS greater than 150 msec experienced particular benefit. Echocardiography one year after device implantation demonstrated significant reductions in left ventricular end-systolic and end-diastolic volume, and a significant increase in EF with ICD-CRT versus ICD-only (P<0.001).

Bottom line: Compared with ICD alone, CRT in combination with ICD prevented heart-failure events in relatively asymptomatic heart-failure patients with low EF and prolonged QRS.

Citation: Moss AJ, Hall WJ, Cannom DS, et al. Cardiac-resynchronization therapy for the prevention of heart-failure events. N Engl J Med. 2009;361(14):1329-1338.

Clinical question: Does perioperative fluvastatin decrease adverse cardiac events after vascular surgery?

Background: Patients with atherosclerotic vascular disease who undergo vascular surgery are at high risk for postoperative cardiac events. Studies in nonsurgical populations have shown the beneficial effects of statin therapy on cardiac outcomes. However, no placebo-controlled trials have addressed the effect of statins on postoperative cardiac outcomes.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Single large academic medical center in the Netherlands.

Synopsis: The study looked at 497 statin-naïve patients 40 years or older undergoing non-cardiac vascular surgery. The patients were randomized to 80 mg of extended-release fluvastatin versus placebo; all patients received a beta-blocker. Therapy began preoperatively (median of 37 days) and continued for at least 30 days after surgery. Outcomes were assessed at 30 days post-surgery.

Postoperative myocardial infarction (MI) was significantly less common in the fluvastatin group than with placebo (10.8% vs. 19%, hazard ratio (HR) 0.55, P=0.01). In addition, the treatment group had a lower frequency of death from cardiovascular causes (4.8% vs. 10.1%, HR 0.47, P=0.03). Statin therapy was not associated with an increased rate of adverse events.

Notably, all of the patients enrolled in this study were high-risk patients undergoing high-risk (vascular) surgery. Patients already on statins were excluded.

Further studies are needed to determine whether the findings can be extrapolated to other populations, including nonvascular surgery patients.

Bottom line: Perioperative statin therapy resulted in a significant decrease in postoperative MI and death within 30 days of vascular surgery.

Citation: Schouten O, Boersma E, Hoeks SE, et al. Fluvastatin and perioperative events in patients undergoing vascular surgery. N Engl J Med. 2009;361(10):980-989.

Clinical question: Does perioperative fluvastatin decrease adverse cardiac events after vascular surgery?

Background: Patients with atherosclerotic vascular disease who undergo vascular surgery are at high risk for postoperative cardiac events. Studies in nonsurgical populations have shown the beneficial effects of statin therapy on cardiac outcomes. However, no placebo-controlled trials have addressed the effect of statins on postoperative cardiac outcomes.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Single large academic medical center in the Netherlands.

Synopsis: The study looked at 497 statin-naïve patients 40 years or older undergoing non-cardiac vascular surgery. The patients were randomized to 80 mg of extended-release fluvastatin versus placebo; all patients received a beta-blocker. Therapy began preoperatively (median of 37 days) and continued for at least 30 days after surgery. Outcomes were assessed at 30 days post-surgery.

Postoperative myocardial infarction (MI) was significantly less common in the fluvastatin group than with placebo (10.8% vs. 19%, hazard ratio (HR) 0.55, P=0.01). In addition, the treatment group had a lower frequency of death from cardiovascular causes (4.8% vs. 10.1%, HR 0.47, P=0.03). Statin therapy was not associated with an increased rate of adverse events.

Notably, all of the patients enrolled in this study were high-risk patients undergoing high-risk (vascular) surgery. Patients already on statins were excluded.

Further studies are needed to determine whether the findings can be extrapolated to other populations, including nonvascular surgery patients.

Bottom line: Perioperative statin therapy resulted in a significant decrease in postoperative MI and death within 30 days of vascular surgery.

Citation: Schouten O, Boersma E, Hoeks SE, et al. Fluvastatin and perioperative events in patients undergoing vascular surgery. N Engl J Med. 2009;361(10):980-989.

Clinical question: Does perioperative fluvastatin decrease adverse cardiac events after vascular surgery?

Background: Patients with atherosclerotic vascular disease who undergo vascular surgery are at high risk for postoperative cardiac events. Studies in nonsurgical populations have shown the beneficial effects of statin therapy on cardiac outcomes. However, no placebo-controlled trials have addressed the effect of statins on postoperative cardiac outcomes.

Study design: Randomized, double-blind, placebo-controlled trial.

Setting: Single large academic medical center in the Netherlands.

Synopsis: The study looked at 497 statin-naïve patients 40 years or older undergoing non-cardiac vascular surgery. The patients were randomized to 80 mg of extended-release fluvastatin versus placebo; all patients received a beta-blocker. Therapy began preoperatively (median of 37 days) and continued for at least 30 days after surgery. Outcomes were assessed at 30 days post-surgery.

Postoperative myocardial infarction (MI) was significantly less common in the fluvastatin group than with placebo (10.8% vs. 19%, hazard ratio (HR) 0.55, P=0.01). In addition, the treatment group had a lower frequency of death from cardiovascular causes (4.8% vs. 10.1%, HR 0.47, P=0.03). Statin therapy was not associated with an increased rate of adverse events.

Notably, all of the patients enrolled in this study were high-risk patients undergoing high-risk (vascular) surgery. Patients already on statins were excluded.

Further studies are needed to determine whether the findings can be extrapolated to other populations, including nonvascular surgery patients.

Bottom line: Perioperative statin therapy resulted in a significant decrease in postoperative MI and death within 30 days of vascular surgery.

Citation: Schouten O, Boersma E, Hoeks SE, et al. Fluvastatin and perioperative events in patients undergoing vascular surgery. N Engl J Med. 2009;361(10):980-989.

Clinical question: When hallway boarding is required, do patients prefer inpatient units over the ED?

Background: ED crowding is associated with patient dissatisfaction, ambulance diversion, delays in care, medical errors, and higher mortality rates. Strategies to alleviate the problem of boarding admitted patients in the ED can include relocation to inpatient hallways while awaiting a regular hospital bed. Traditional objections to inpatient hallway boarding include concerns regarding patient satisfaction and safety.

Study design: Structured telephone survey.

Setting: Suburban, university-based, teaching hospital.

Synopsis: Patients who required boarding in the ED hallway after hospital admission were eligible for inpatient hallway boarding according to the institutional protocol, which screens for those with only mild to moderate comorbidities. Of 110 consecutive patients contacted who experienced both ED and inpatient hallway boarding, 105 consented to participate in a tested telephone survey instrument.

The overall preferred location was inpatient hallways for 85% (95% CI 75-90) of respondents. Comparing ED boarding to inpatient hallway boarding, respondents preferred inpatient boarding with regard to staff availability (84%), safety (83%), confidentiality (82%), and comfort (79%).

Study results were subject to non-response bias, because working telephone numbers were required for study inclusion, as well as recall bias, because the survey was conducted within several months after discharge. This study’s results are based on actual patient experiences, whereas prior literature relied on patients to hypothesize the preferred environment after experiencing only ED hallway boarding to predict satisfaction.

Bottom line: Boarding in inpatient hallways was associated with higher patient satisfaction compared with ED hallway boarding.

Citation: Viccellio P, Zito JA, Sayage V, et al. Patients overwhelmingly prefer inpatient boarding to emergency department boarding [published online ahead of print September 21, 2013].

Clinical question: When hallway boarding is required, do patients prefer inpatient units over the ED?

Background: ED crowding is associated with patient dissatisfaction, ambulance diversion, delays in care, medical errors, and higher mortality rates. Strategies to alleviate the problem of boarding admitted patients in the ED can include relocation to inpatient hallways while awaiting a regular hospital bed. Traditional objections to inpatient hallway boarding include concerns regarding patient satisfaction and safety.

Study design: Structured telephone survey.

Setting: Suburban, university-based, teaching hospital.

Synopsis: Patients who required boarding in the ED hallway after hospital admission were eligible for inpatient hallway boarding according to the institutional protocol, which screens for those with only mild to moderate comorbidities. Of 110 consecutive patients contacted who experienced both ED and inpatient hallway boarding, 105 consented to participate in a tested telephone survey instrument.

The overall preferred location was inpatient hallways for 85% (95% CI 75-90) of respondents. Comparing ED boarding to inpatient hallway boarding, respondents preferred inpatient boarding with regard to staff availability (84%), safety (83%), confidentiality (82%), and comfort (79%).

Study results were subject to non-response bias, because working telephone numbers were required for study inclusion, as well as recall bias, because the survey was conducted within several months after discharge. This study’s results are based on actual patient experiences, whereas prior literature relied on patients to hypothesize the preferred environment after experiencing only ED hallway boarding to predict satisfaction.

Bottom line: Boarding in inpatient hallways was associated with higher patient satisfaction compared with ED hallway boarding.

Citation: Viccellio P, Zito JA, Sayage V, et al. Patients overwhelmingly prefer inpatient boarding to emergency department boarding [published online ahead of print September 21, 2013].

Clinical question: When hallway boarding is required, do patients prefer inpatient units over the ED?

Background: ED crowding is associated with patient dissatisfaction, ambulance diversion, delays in care, medical errors, and higher mortality rates. Strategies to alleviate the problem of boarding admitted patients in the ED can include relocation to inpatient hallways while awaiting a regular hospital bed. Traditional objections to inpatient hallway boarding include concerns regarding patient satisfaction and safety.

Study design: Structured telephone survey.

Setting: Suburban, university-based, teaching hospital.

Synopsis: Patients who required boarding in the ED hallway after hospital admission were eligible for inpatient hallway boarding according to the institutional protocol, which screens for those with only mild to moderate comorbidities. Of 110 consecutive patients contacted who experienced both ED and inpatient hallway boarding, 105 consented to participate in a tested telephone survey instrument.

The overall preferred location was inpatient hallways for 85% (95% CI 75-90) of respondents. Comparing ED boarding to inpatient hallway boarding, respondents preferred inpatient boarding with regard to staff availability (84%), safety (83%), confidentiality (82%), and comfort (79%).

Study results were subject to non-response bias, because working telephone numbers were required for study inclusion, as well as recall bias, because the survey was conducted within several months after discharge. This study’s results are based on actual patient experiences, whereas prior literature relied on patients to hypothesize the preferred environment after experiencing only ED hallway boarding to predict satisfaction.

Bottom line: Boarding in inpatient hallways was associated with higher patient satisfaction compared with ED hallway boarding.

Citation: Viccellio P, Zito JA, Sayage V, et al. Patients overwhelmingly prefer inpatient boarding to emergency department boarding [published online ahead of print September 21, 2013].

Clinical question: What factors determine rates of readmission after major surgery?

Background: Reducing hospital readmission rates has become a national priority. The U.S. patterns for surgical readmissions are unknown, as are the specific structural and quality characteristics of hospitals associated with lower surgical readmission rates.

Study design: Retrospective study of national Medicare data was used to calculate 30-day readmission rates for six major surgical procedures.

Setting: U.S. Hospitals, 2009-2010.

Synopsis: Six major surgical procedures were tracked by Medicare data, with 479,471 discharges from 3,004 hospitals. Structural characteristics included hospital size, teaching status, region, ownership, and proportion of patients living below the federal poverty line. Three well-established measures of surgical quality were used: the HQA surgical score, procedure volume, and 30-day mortality.

Hospitals in the highest quartile for surgical volume had a significantly lower readmission rate. Additionally, hospitals with the lowest surgical mortality rates had significantly lower readmission rates. Interestingly, high adherence to reported surgical process measures was only marginally associated with reduced admission rates. Prior studies have also shown inconsistent relationship between HQA surgical score and mortality.

Limitations to this study include inability to account for factors not captured by billing codes and the focus on a Medicare population.

Bottom line: Surgical readmission rates are associated with measures of surgical quality, specifically procedural volume and mortality.

Citation: Tsai TC, Joynt KE, Orav EJ, Gawande AA, Jha AK. Variation in surgical-readmission rates and quality of hospital care. 2013;369(12):1134-1142.

Clinical question: What factors determine rates of readmission after major surgery?

Background: Reducing hospital readmission rates has become a national priority. The U.S. patterns for surgical readmissions are unknown, as are the specific structural and quality characteristics of hospitals associated with lower surgical readmission rates.

Study design: Retrospective study of national Medicare data was used to calculate 30-day readmission rates for six major surgical procedures.

Setting: U.S. Hospitals, 2009-2010.

Synopsis: Six major surgical procedures were tracked by Medicare data, with 479,471 discharges from 3,004 hospitals. Structural characteristics included hospital size, teaching status, region, ownership, and proportion of patients living below the federal poverty line. Three well-established measures of surgical quality were used: the HQA surgical score, procedure volume, and 30-day mortality.

Hospitals in the highest quartile for surgical volume had a significantly lower readmission rate. Additionally, hospitals with the lowest surgical mortality rates had significantly lower readmission rates. Interestingly, high adherence to reported surgical process measures was only marginally associated with reduced admission rates. Prior studies have also shown inconsistent relationship between HQA surgical score and mortality.

Limitations to this study include inability to account for factors not captured by billing codes and the focus on a Medicare population.

Bottom line: Surgical readmission rates are associated with measures of surgical quality, specifically procedural volume and mortality.

Citation: Tsai TC, Joynt KE, Orav EJ, Gawande AA, Jha AK. Variation in surgical-readmission rates and quality of hospital care. 2013;369(12):1134-1142.

Clinical question: What factors determine rates of readmission after major surgery?

Background: Reducing hospital readmission rates has become a national priority. The U.S. patterns for surgical readmissions are unknown, as are the specific structural and quality characteristics of hospitals associated with lower surgical readmission rates.

Study design: Retrospective study of national Medicare data was used to calculate 30-day readmission rates for six major surgical procedures.

Setting: U.S. Hospitals, 2009-2010.

Synopsis: Six major surgical procedures were tracked by Medicare data, with 479,471 discharges from 3,004 hospitals. Structural characteristics included hospital size, teaching status, region, ownership, and proportion of patients living below the federal poverty line. Three well-established measures of surgical quality were used: the HQA surgical score, procedure volume, and 30-day mortality.

Hospitals in the highest quartile for surgical volume had a significantly lower readmission rate. Additionally, hospitals with the lowest surgical mortality rates had significantly lower readmission rates. Interestingly, high adherence to reported surgical process measures was only marginally associated with reduced admission rates. Prior studies have also shown inconsistent relationship between HQA surgical score and mortality.

Limitations to this study include inability to account for factors not captured by billing codes and the focus on a Medicare population.

Bottom line: Surgical readmission rates are associated with measures of surgical quality, specifically procedural volume and mortality.

Citation: Tsai TC, Joynt KE, Orav EJ, Gawande AA, Jha AK. Variation in surgical-readmission rates and quality of hospital care. 2013;369(12):1134-1142.

Clinical question: Is continuity of care related to preventable hospitalizations among older adults?

Background: Preventable hospitalizations cost approximately $25 billion annually in the U.S. The relationship between continuity of care and the risk of preventable hospitalization is unknown.

Study design: Retrospective cohort study.

Setting: Random sample of fee-for-service Medicare beneficiaries, for ambulatory visits and hospital admissions.

Synopsis: This study examined 3.2 million Medicare beneficiaries using 2008-2010 claims data to measure continuity and the first preventable hospitalization. The Prevention Quality Indicators definitions and technical specifications from the Agency for Healthcare Research and Quality were used to identify preventable hospitalizations. Both the continuity of care score and usual provider continuity score were used to calculate continuity metrics. Baseline risk of preventable hospitalization included age, sex, race, Medicaid dual-eligible status, and residential zip code.

During a two-year period, 12.6% of patients had a preventable hospitalization. After adjusting for variables, a 0.1 increase in continuity of care was associated with about a 2% lower rate of preventable hospitalization. Interestingly, continuity of care was not related to mortality rates.

This study extends prior research associating continuity of care with reduced rate of hospitalization; however, the associations found cannot assert a causal relationship. This study used coding practices that vary throughout the country, included only older fee-for-service Medicare beneficiaries, and could not verify why some patients had higher continuity of care. The authors suggest that efforts to strengthen physician-patient relationships through high-quality primary care will deter some hospital admissions.

Bottom line: Higher continuity of ambulatory care is associated with lower preventable hospitalizations in Medicare beneficiaries.

Citation: Nyweide DJ, Anthony DL, Bynum JP, et al. Continuity of care and the risk of preventable hospitalization in older adults. 2013;173(20):1879-1885.

Clinical question: Is continuity of care related to preventable hospitalizations among older adults?

Background: Preventable hospitalizations cost approximately $25 billion annually in the U.S. The relationship between continuity of care and the risk of preventable hospitalization is unknown.

Study design: Retrospective cohort study.

Setting: Random sample of fee-for-service Medicare beneficiaries, for ambulatory visits and hospital admissions.

Synopsis: This study examined 3.2 million Medicare beneficiaries using 2008-2010 claims data to measure continuity and the first preventable hospitalization. The Prevention Quality Indicators definitions and technical specifications from the Agency for Healthcare Research and Quality were used to identify preventable hospitalizations. Both the continuity of care score and usual provider continuity score were used to calculate continuity metrics. Baseline risk of preventable hospitalization included age, sex, race, Medicaid dual-eligible status, and residential zip code.

During a two-year period, 12.6% of patients had a preventable hospitalization. After adjusting for variables, a 0.1 increase in continuity of care was associated with about a 2% lower rate of preventable hospitalization. Interestingly, continuity of care was not related to mortality rates.

This study extends prior research associating continuity of care with reduced rate of hospitalization; however, the associations found cannot assert a causal relationship. This study used coding practices that vary throughout the country, included only older fee-for-service Medicare beneficiaries, and could not verify why some patients had higher continuity of care. The authors suggest that efforts to strengthen physician-patient relationships through high-quality primary care will deter some hospital admissions.

Bottom line: Higher continuity of ambulatory care is associated with lower preventable hospitalizations in Medicare beneficiaries.

Citation: Nyweide DJ, Anthony DL, Bynum JP, et al. Continuity of care and the risk of preventable hospitalization in older adults. 2013;173(20):1879-1885.

Clinical question: Is continuity of care related to preventable hospitalizations among older adults?

Background: Preventable hospitalizations cost approximately $25 billion annually in the U.S. The relationship between continuity of care and the risk of preventable hospitalization is unknown.

Study design: Retrospective cohort study.

Setting: Random sample of fee-for-service Medicare beneficiaries, for ambulatory visits and hospital admissions.

Synopsis: This study examined 3.2 million Medicare beneficiaries using 2008-2010 claims data to measure continuity and the first preventable hospitalization. The Prevention Quality Indicators definitions and technical specifications from the Agency for Healthcare Research and Quality were used to identify preventable hospitalizations. Both the continuity of care score and usual provider continuity score were used to calculate continuity metrics. Baseline risk of preventable hospitalization included age, sex, race, Medicaid dual-eligible status, and residential zip code.

During a two-year period, 12.6% of patients had a preventable hospitalization. After adjusting for variables, a 0.1 increase in continuity of care was associated with about a 2% lower rate of preventable hospitalization. Interestingly, continuity of care was not related to mortality rates.

This study extends prior research associating continuity of care with reduced rate of hospitalization; however, the associations found cannot assert a causal relationship. This study used coding practices that vary throughout the country, included only older fee-for-service Medicare beneficiaries, and could not verify why some patients had higher continuity of care. The authors suggest that efforts to strengthen physician-patient relationships through high-quality primary care will deter some hospital admissions.

Bottom line: Higher continuity of ambulatory care is associated with lower preventable hospitalizations in Medicare beneficiaries.

Citation: Nyweide DJ, Anthony DL, Bynum JP, et al. Continuity of care and the risk of preventable hospitalization in older adults. 2013;173(20):1879-1885.

Clinical question: What effect does a hospitalist-staffed, post-discharge clinic have on time to first post-hospitalization visit?

Background: Hospital discharge is a well-recognized care transition that can leave patients vulnerable to morbidity and re-hospitalization. Limited primary care access can hamper complex post-hospital follow-up. Discharge clinic models staffed by hospitalists have been developed to mitigate access issues, but research is lacking to describe their characteristics and benefits.

Study design: Single-center, prospective, observational database review.

Setting: Large, academic primary care practice affiliated with an academic medical center.

Synopsis: Between 2009 and 2011, this hospitalist-staffed, post-discharge clinic saw 596 patients, while the affiliated, large primary care practice saw 10,839 patients. Patients utilizing the hospitalist discharge clinic were more likely to be black (39% vs. 29%, <0.001) and to receive primary care from resident clinics (40% vs. 21%, <0.001). The median duration from hospital discharge to the first clinic visit was shorter for the post-discharge clinic (8.45 ± 0.43 days, <0.001).

The number of radiology and laboratory tests performed at the first post-discharge clinic visit showed similar patterns between the hospitalist discharge clinic and the primary care practice. Study design and size did not permit comparisons of readmission rates or mortality from time of discharge and also precluded evaluation of interventions on discharge-related medication errors or response time to outstanding test results.

Bottom line: A hospitalist-staffed, post-discharge clinic was associated with shorter time to first post-discharge visit, especially for patients who are black and receive primary care from resident clinics.

Citation: Doctoroff L, Nijhawan A, McNally D, Vanka A, Yu R, Mukamal KJ. The characteristics and impact of a hospitalist-staffed post-discharge clinic. 2013;126(11):1016.e9-1016.e15.

Clinical question: What effect does a hospitalist-staffed, post-discharge clinic have on time to first post-hospitalization visit?

Background: Hospital discharge is a well-recognized care transition that can leave patients vulnerable to morbidity and re-hospitalization. Limited primary care access can hamper complex post-hospital follow-up. Discharge clinic models staffed by hospitalists have been developed to mitigate access issues, but research is lacking to describe their characteristics and benefits.

Study design: Single-center, prospective, observational database review.

Setting: Large, academic primary care practice affiliated with an academic medical center.

Synopsis: Between 2009 and 2011, this hospitalist-staffed, post-discharge clinic saw 596 patients, while the affiliated, large primary care practice saw 10,839 patients. Patients utilizing the hospitalist discharge clinic were more likely to be black (39% vs. 29%, <0.001) and to receive primary care from resident clinics (40% vs. 21%, <0.001). The median duration from hospital discharge to the first clinic visit was shorter for the post-discharge clinic (8.45 ± 0.43 days, <0.001).

The number of radiology and laboratory tests performed at the first post-discharge clinic visit showed similar patterns between the hospitalist discharge clinic and the primary care practice. Study design and size did not permit comparisons of readmission rates or mortality from time of discharge and also precluded evaluation of interventions on discharge-related medication errors or response time to outstanding test results.

Bottom line: A hospitalist-staffed, post-discharge clinic was associated with shorter time to first post-discharge visit, especially for patients who are black and receive primary care from resident clinics.

Citation: Doctoroff L, Nijhawan A, McNally D, Vanka A, Yu R, Mukamal KJ. The characteristics and impact of a hospitalist-staffed post-discharge clinic. 2013;126(11):1016.e9-1016.e15.

Clinical question: What effect does a hospitalist-staffed, post-discharge clinic have on time to first post-hospitalization visit?

Background: Hospital discharge is a well-recognized care transition that can leave patients vulnerable to morbidity and re-hospitalization. Limited primary care access can hamper complex post-hospital follow-up. Discharge clinic models staffed by hospitalists have been developed to mitigate access issues, but research is lacking to describe their characteristics and benefits.

Study design: Single-center, prospective, observational database review.

Setting: Large, academic primary care practice affiliated with an academic medical center.

Synopsis: Between 2009 and 2011, this hospitalist-staffed, post-discharge clinic saw 596 patients, while the affiliated, large primary care practice saw 10,839 patients. Patients utilizing the hospitalist discharge clinic were more likely to be black (39% vs. 29%, <0.001) and to receive primary care from resident clinics (40% vs. 21%, <0.001). The median duration from hospital discharge to the first clinic visit was shorter for the post-discharge clinic (8.45 ± 0.43 days, <0.001).

The number of radiology and laboratory tests performed at the first post-discharge clinic visit showed similar patterns between the hospitalist discharge clinic and the primary care practice. Study design and size did not permit comparisons of readmission rates or mortality from time of discharge and also precluded evaluation of interventions on discharge-related medication errors or response time to outstanding test results.

Bottom line: A hospitalist-staffed, post-discharge clinic was associated with shorter time to first post-discharge visit, especially for patients who are black and receive primary care from resident clinics.

Citation: Doctoroff L, Nijhawan A, McNally D, Vanka A, Yu R, Mukamal KJ. The characteristics and impact of a hospitalist-staffed post-discharge clinic. 2013;126(11):1016.e9-1016.e15.

Clinical question: Does the addition of pentoxifylline to prednisolone improve six-month mortality compared to prednisolone alone in patients with severe alcoholic hepatitis?

Background: Prednisolone improves liver function and reduces inflammation in patients with alcoholic hepatitis. Pentoxifylline appears to have a protective effect against hepatorenal syndrome in patients with severe alcoholic hepatitis. The medications have different mechanisms of action; therefore, the researchers hypothesized that the combination of medication would improve outcomes.

Study design: Multi-center, randomized, double-blinded clinical trial.

Setting: One Belgian and 23 French hospitals, from December 2007 to October 2010.

Synopsis: This study randomized 270 patients to receive either prednisolone and pentoxifylline or prednisolone and placebo for 28 days. Acute alcoholic hepatitis was defined by a positive biopsy, onset of jaundice three months prior to the study, and a Maddrey’s discriminant function score of >32. All patients were assessed for response to treatment using the Lille model at seven days of treatment, occurrence of hepatorenal syndrome, and survival at six months.

Results showed no significant difference in treatment response, alcohol relapse, death, time to death, or occurrence of hepatorenal syndrome between the two treatment groups; however, there were fewer episodes of hepatorenal syndrome in the pentoxifylline group.

Patients considered responders by the Lille model and those with lower Model for End-Stage Liver Disease scores had improved mortality. Patients treated with pentoxifylline had lower rates of hepatorenal syndrome at one month but no difference by six months. Patients with a lower Lille score had significantly less incidence of hepatorenal syndrome. The study may be underpowered to accurately determine outcomes other than six-month survival.

Bottom line: Adding pentoxifylline to prednisolone does not improve six-month survival in severe alcoholic hepatitis compared to prednisolone alone.

Citation: Mathurin P, Louvet A, Duhamel A, et al. Prednisolone with vs without pentoxifylline and survival of patients with severe alcoholic hepatitis: a randomized clinical trial. 2013;310(10):1033-1041.

Clinical question: Does the addition of pentoxifylline to prednisolone improve six-month mortality compared to prednisolone alone in patients with severe alcoholic hepatitis?

Background: Prednisolone improves liver function and reduces inflammation in patients with alcoholic hepatitis. Pentoxifylline appears to have a protective effect against hepatorenal syndrome in patients with severe alcoholic hepatitis. The medications have different mechanisms of action; therefore, the researchers hypothesized that the combination of medication would improve outcomes.

Study design: Multi-center, randomized, double-blinded clinical trial.

Setting: One Belgian and 23 French hospitals, from December 2007 to October 2010.

Synopsis: This study randomized 270 patients to receive either prednisolone and pentoxifylline or prednisolone and placebo for 28 days. Acute alcoholic hepatitis was defined by a positive biopsy, onset of jaundice three months prior to the study, and a Maddrey’s discriminant function score of >32. All patients were assessed for response to treatment using the Lille model at seven days of treatment, occurrence of hepatorenal syndrome, and survival at six months.

Results showed no significant difference in treatment response, alcohol relapse, death, time to death, or occurrence of hepatorenal syndrome between the two treatment groups; however, there were fewer episodes of hepatorenal syndrome in the pentoxifylline group.

Patients considered responders by the Lille model and those with lower Model for End-Stage Liver Disease scores had improved mortality. Patients treated with pentoxifylline had lower rates of hepatorenal syndrome at one month but no difference by six months. Patients with a lower Lille score had significantly less incidence of hepatorenal syndrome. The study may be underpowered to accurately determine outcomes other than six-month survival.

Bottom line: Adding pentoxifylline to prednisolone does not improve six-month survival in severe alcoholic hepatitis compared to prednisolone alone.

Citation: Mathurin P, Louvet A, Duhamel A, et al. Prednisolone with vs without pentoxifylline and survival of patients with severe alcoholic hepatitis: a randomized clinical trial. 2013;310(10):1033-1041.

Clinical question: Does the addition of pentoxifylline to prednisolone improve six-month mortality compared to prednisolone alone in patients with severe alcoholic hepatitis?

Background: Prednisolone improves liver function and reduces inflammation in patients with alcoholic hepatitis. Pentoxifylline appears to have a protective effect against hepatorenal syndrome in patients with severe alcoholic hepatitis. The medications have different mechanisms of action; therefore, the researchers hypothesized that the combination of medication would improve outcomes.

Study design: Multi-center, randomized, double-blinded clinical trial.

Setting: One Belgian and 23 French hospitals, from December 2007 to October 2010.

Synopsis: This study randomized 270 patients to receive either prednisolone and pentoxifylline or prednisolone and placebo for 28 days. Acute alcoholic hepatitis was defined by a positive biopsy, onset of jaundice three months prior to the study, and a Maddrey’s discriminant function score of >32. All patients were assessed for response to treatment using the Lille model at seven days of treatment, occurrence of hepatorenal syndrome, and survival at six months.

Results showed no significant difference in treatment response, alcohol relapse, death, time to death, or occurrence of hepatorenal syndrome between the two treatment groups; however, there were fewer episodes of hepatorenal syndrome in the pentoxifylline group.

Patients considered responders by the Lille model and those with lower Model for End-Stage Liver Disease scores had improved mortality. Patients treated with pentoxifylline had lower rates of hepatorenal syndrome at one month but no difference by six months. Patients with a lower Lille score had significantly less incidence of hepatorenal syndrome. The study may be underpowered to accurately determine outcomes other than six-month survival.

Bottom line: Adding pentoxifylline to prednisolone does not improve six-month survival in severe alcoholic hepatitis compared to prednisolone alone.

Citation: Mathurin P, Louvet A, Duhamel A, et al. Prednisolone with vs without pentoxifylline and survival of patients with severe alcoholic hepatitis: a randomized clinical trial. 2013;310(10):1033-1041.