Literature Review

Clinical question: What is the efficacy of dexamethasone in mechanically ventilated children younger than two years of age with respiratory syncytial virus (RSV) lower respiratory tract infections?

Background: Although RSV typically causes self-limited respiratory tract disease with stable and low mortality rates, a small proportion of infants will have severe lower respiratory tract disease requiring mechanical ventilation. The authors previously found no evidence of a benefit of corticosteroids in these infants, but post-hoc analysis suggested a benefit in infants with mild oxygenation abnormalities.

Study design: International, multicenter, randomized, double-blind, placebo-controlled trial.

Setting: Twelve ICUs in Europe.

Synopsis: All patients <2 years of age with RSV-positive bronchiolitis requiring mechanical ventilation were eligible if they had not received corticosteroids in the previous two weeks. Patients were categorized as having either mild or severe oxygenation abnormalities based on their arterial partial pressure of oxygen/fractional inspired oxygen concentration and/or mean airway pressure. The primary outcome measure was duration of mechanical ventilation, and the trial was stopped after interim analysis of 89 patients in the mild oxygenation abnormalities arm revealed insufficient power to detect a >20% difference between the groups if the planned number of 128 patients were ultimately enrolled.

Fifty-six patients were enrolled in the severe oxygenation abnormalities arm. For both groups, there were no differences in either the duration of mechanical ventilation or secondary outcomes, such as length of stay or duration of supplemental oxygen, between intervention and control patients.

This well-designed study adds to an established body of literature painting a clear picture of the inefficacy of corticosteroids in infants with bronchiolitis, with or without severe disease. Although enrollment was slow and ultimately the trial was prematurely terminated, the randomization resulted in almost perfectly matched groups, which likely strengthens the findings despite the small sample size.

Bottom line: Corticosteroids should not be administered to critically ill children with bronchiolitis.

Citation: Van Woensel JB, Vyas H, et al. Dexamethasone in children mechanically ventilated for lower respiratory tract infection caused by respiratory syncytial virus: a randomized controlled trial. Crit Care Med. 2011;39(7):1779-1783.

Reviewed by Pediatric Editor Mark Shen, MD, FHM, medical director of hospital medicine at Dell Children’s Medical Center, Austin, Texas.

Clinical question: What is the efficacy of dexamethasone in mechanically ventilated children younger than two years of age with respiratory syncytial virus (RSV) lower respiratory tract infections?

Background: Although RSV typically causes self-limited respiratory tract disease with stable and low mortality rates, a small proportion of infants will have severe lower respiratory tract disease requiring mechanical ventilation. The authors previously found no evidence of a benefit of corticosteroids in these infants, but post-hoc analysis suggested a benefit in infants with mild oxygenation abnormalities.

Study design: International, multicenter, randomized, double-blind, placebo-controlled trial.

Setting: Twelve ICUs in Europe.

Synopsis: All patients <2 years of age with RSV-positive bronchiolitis requiring mechanical ventilation were eligible if they had not received corticosteroids in the previous two weeks. Patients were categorized as having either mild or severe oxygenation abnormalities based on their arterial partial pressure of oxygen/fractional inspired oxygen concentration and/or mean airway pressure. The primary outcome measure was duration of mechanical ventilation, and the trial was stopped after interim analysis of 89 patients in the mild oxygenation abnormalities arm revealed insufficient power to detect a >20% difference between the groups if the planned number of 128 patients were ultimately enrolled.

Fifty-six patients were enrolled in the severe oxygenation abnormalities arm. For both groups, there were no differences in either the duration of mechanical ventilation or secondary outcomes, such as length of stay or duration of supplemental oxygen, between intervention and control patients.

This well-designed study adds to an established body of literature painting a clear picture of the inefficacy of corticosteroids in infants with bronchiolitis, with or without severe disease. Although enrollment was slow and ultimately the trial was prematurely terminated, the randomization resulted in almost perfectly matched groups, which likely strengthens the findings despite the small sample size.

Bottom line: Corticosteroids should not be administered to critically ill children with bronchiolitis.

Citation: Van Woensel JB, Vyas H, et al. Dexamethasone in children mechanically ventilated for lower respiratory tract infection caused by respiratory syncytial virus: a randomized controlled trial. Crit Care Med. 2011;39(7):1779-1783.

Reviewed by Pediatric Editor Mark Shen, MD, FHM, medical director of hospital medicine at Dell Children’s Medical Center, Austin, Texas.

Clinical question: What is the efficacy of dexamethasone in mechanically ventilated children younger than two years of age with respiratory syncytial virus (RSV) lower respiratory tract infections?

Background: Although RSV typically causes self-limited respiratory tract disease with stable and low mortality rates, a small proportion of infants will have severe lower respiratory tract disease requiring mechanical ventilation. The authors previously found no evidence of a benefit of corticosteroids in these infants, but post-hoc analysis suggested a benefit in infants with mild oxygenation abnormalities.

Study design: International, multicenter, randomized, double-blind, placebo-controlled trial.

Setting: Twelve ICUs in Europe.

Synopsis: All patients <2 years of age with RSV-positive bronchiolitis requiring mechanical ventilation were eligible if they had not received corticosteroids in the previous two weeks. Patients were categorized as having either mild or severe oxygenation abnormalities based on their arterial partial pressure of oxygen/fractional inspired oxygen concentration and/or mean airway pressure. The primary outcome measure was duration of mechanical ventilation, and the trial was stopped after interim analysis of 89 patients in the mild oxygenation abnormalities arm revealed insufficient power to detect a >20% difference between the groups if the planned number of 128 patients were ultimately enrolled.

Fifty-six patients were enrolled in the severe oxygenation abnormalities arm. For both groups, there were no differences in either the duration of mechanical ventilation or secondary outcomes, such as length of stay or duration of supplemental oxygen, between intervention and control patients.

This well-designed study adds to an established body of literature painting a clear picture of the inefficacy of corticosteroids in infants with bronchiolitis, with or without severe disease. Although enrollment was slow and ultimately the trial was prematurely terminated, the randomization resulted in almost perfectly matched groups, which likely strengthens the findings despite the small sample size.

Bottom line: Corticosteroids should not be administered to critically ill children with bronchiolitis.

Citation: Van Woensel JB, Vyas H, et al. Dexamethasone in children mechanically ventilated for lower respiratory tract infection caused by respiratory syncytial virus: a randomized controlled trial. Crit Care Med. 2011;39(7):1779-1783.

Reviewed by Pediatric Editor Mark Shen, MD, FHM, medical director of hospital medicine at Dell Children’s Medical Center, Austin, Texas.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Use of a Care-Transitions Intervention Reduces 30-Day Hospital Readmissions
2. Routine Chest Radiographs after Pneumonia to Rule Out Lung Cancer Have Low Diagnostic Yield
3. Hospitalist Care Shifts Costs to the Outpatient Environment
4. Stopping Smoking at Any Time before Surgery Is Safe
5. Hospitalization for Infection Increases Risk of Stroke
6. Longer Duration of Perioperative Antibiotics May Be Beneficial after Cardiac Surgery
7. Stroke Unit Care Combined with Early Supported Discharge Improves Outcomes
8. Criteria May Help Identify Patients at Risk for Infective Endocarditis

Use of a Care-Transitions Intervention Reduces 30-Day Hospital Readmissions

Clinical question: Does use of a specific care-transitions intervention (CTI) reduce 30-day hospital readmissions in a nonintegrated healthcare system?

Background: Previous interventions addressing improved communication between members of the healthcare team, patients, and families at time of discharge show promise for reducing hospital readmissions. Although these interventions revealed positive results, no research has been completed within a system where healthcare is integrated across settings.

Study design: Quasi-experimental prospective cohort study.

Setting: Six Rhode Island acute-care hospitals, including two community hospitals, three teaching hospitals, and a tertiary-care center and teaching hospital. Facilities ranged from 129 beds to 719 beds.

Synopsis: The CTI is a patient-centered intervention occurring across 30 days. The intervention includes a home visit by a coach within three days of hospital discharge, a telephone call within seven to 10 days of discharge, and a final telephone call no later than 30 days after admission. During these contacts, coaches encourage patient and family participation in care, and active communication with their primary-care provider regarding their disease state. A convenience sample of fee-for-service Medicare beneficiaries was identified by admission diagnoses of acute myocardial infarction, congestive heart failure, or specific pulmonary conditions. Overall, 74% participants completed the entire intervention. The odds of a hospital readmission were significantly lower in the intervention population compared with those who did not receive the intervention (OR 0.61; 95% CI, 0.42-0.88).

Study design: Study design was limited by ability to provide coaching (only 8% of total population was approached), and therefore may not be representative of a typical integrated healthcare setting. In addition, the sample consisted of a convenience sample, which may limit generalizability.

Bottom line: The CTI appears to decrease the rate of 30-day hospital readmissions in Medicare patients with certain cardiac and pulmonary diagnoses.

Citation: Voss R, Gardner R, Baier R, Butterfield K, Lehrman S, Gravenstein S. The care transitions intervention: translating from efficacy to effectiveness. Arch Intern Med. 2011;171:1232-1237.

Routine Chest Radiographs after Pneumonia to Rule Out Lung Cancer Have Low Diagnostic Yield

Clinical question: What is the incidence of new lung cancer detected on routine post-pneumonia chest radiographs?

Background: Routine chest radiographs have been recommended four to eight weeks after resolution of pneumonia to exclude underlying lung cancer. The diagnostic yield of this practice is uncertain.

Study design: Population-based cohort.

Setting: Seven emergency departments and six hospitals in Edmonton, Alberta, Canada.

Synopsis: Authors enrolled 3,398 patients with clinical and radiographic evidence of pneumonia. Of these, 59% were aged 50 and older, 52% were male, 17% were current smokers, 18% had COPD, and 49% were treated as inpatients. At 90-day follow-up, 1.1% of patients received a new diagnosis of lung cancer, with incidence steadily increasing to 2.2% at three-year follow-up. In multivariate analysis, age 50 and older, male sex, and current smoking were independent predictors of post-pneumonia new lung cancer diagnosis. Limiting follow-up chest radiographs to patients aged 50 and older would have detected 98% of new lung cancers and improved diagnostic yield to 2.8%.

 

Bottom line: Routine post-pneumonia chest radiographs for lung cancer screening have low diagnostic yield that is only marginally improved by selecting high-risk populations.

Citation: Tang KL, Eurich DT, Minhas-Sandhu JK, Marrie TJ, Majumdar SR. Incidence, correlates, and chest radiographic yield of new lung cancer diagnosis in 3398 patients with pneumonia. Arch Intern Med. 2011;171:1193-1198.

Hospitalist Care Shifts Costs to the Outpatient Environment

Clinical question: How does hospitalist care affect medical utilization costs after hospital discharge?

Background: The number of patients cared for by hospitalists is growing rapidly. Some studies have shown hospitalists to decrease length of stay and inpatient costs. The impact of shorter hospitalization on outpatient medical utilization and costs is not known.

Study design: Population-based national cohort.

Setting: Hospitalized Medicare patients.

Synopsis: In this study of 58,125 Medicare admissions at 454 hospitals, hospitalist care was associated with a 0.64-day shorter adjusted length of stay and $282 lower hospital charges compared with patients cared for by their primary-care physicians (PCPs). This was offset by $332 higher Medicare spending in the 30 days following hospitalization. Patients cared for by hospitalists were less likely to be discharged home (OR 0.82, 95% CI, 0.78-0.86), and were more likely to require emergency department visits (OR 1.18, 95% CI, 1.12-1.24) and readmissions (OR 1.08, 95% CI, 1.02-1.14). The authors postulate that shorter length of stay associated with hospitalist care is achieved at the expense of shifting costs to the outpatient environment. The discharged patients are sicker and, as a result, require more skilled care and repeat hospital visits.

Bottom line: Hospitalist care may be associated with higher overall costs and more medical utilization.

Citation: Kuo YF, Goodwin JS. Association of hospitalist care with medical utilization after discharge: evidence of cost shift from a cohort study. Ann Intern Med. 2011;155:152-159.

Stopping Smoking at Any Time before Surgery Is Safe

Clinical question: Is smoking cessation within eight weeks of surgery safe?

Background: Smoking cessation before surgery can decrease the risk of surgical complications. However, several studies found increased risk for perioperative complications when smoking was stopped within eight weeks of surgery. These findings created uncertainty about general safety of tobacco cessation counseling before surgery.

Study design: Systematic review and meta-analysis.

Setting: Smokers undergoing any type of surgery.

Synopsis: The authors identified nine studies involving 889 patients that compared smokers who quit within eight weeks of surgery with those who continued to smoke. There was considerable heterogeneity in the studies but no overall difference in perioperative complications between those who quit smoking and those who continued to smoke (OR 0.78, 95% CI, 0.57-1.07). The subset of studies examining pulmonary complications also found no difference (OR 1.18, 95% CI, 0.95-1.46).

Bottom line: Smoking cessation at any time before surgery appears to be safe.

Citation: Myers K, Hajek P, Hinds C, McRobbie H. Stopping smoking shortly before surgery and postoperative complications: a systematic review and meta-analysis. Arch Intern Med. 2011;171:983-989.

Hospitalization for Infection Increases Risk of Stroke

Clinical question: Can infection act as a precipitant for acute ischemic stroke?

Background: Little is known about precipitants of acute ischemic stroke. Severe infections have been shown to promote hypercoagulability and platelet activation, and to induce endothelial dysfunction. Authors postulated that infections severe enough to warrant hospitalization might transiently increase the risk for stroke.

Study design: Case-crossover analysis of data from a multicenter prospective cohort (Cardiovascular Health Study).

 

Setting: Medicare patients in four communities.

Synopsis: During a median follow-up of 12.2 years, 669 strokes occurred in 5,639 study participants. Hospitalization for infection within 14 days was associated with increased risk of stroke (OR 8.0, 95% CI, 1.6-77.3), and the risk remained elevated for hospitalizations within 90 days (OR 3.4, 95% CI, 1.8-6.5). The findings remained significant after adjusting for comorbidities, including age, sex, race, smoking, and diabetes. The number of patients hospitalized for infection before stroke was small—eight within 14 days, and 29 within 90 days.

Bottom line: Infection severe enough to require hospitalization may act as a trigger for acute ischemic stroke.

Citation: Elkind MS, Carty CL, O’Meara ES, et al. Hospitalization for infection and risk of acute ischemic stroke: the Cardiovascular Health Study. Stroke. 2011;42:1851-1856.

Longer Duration of Perioperative Antibiotics May Be Beneficial after Cardiac Surgery

Clinical question: Is antibiotic prophylaxis for 24 or more hours better than shorter duration of treatment after cardiac surgery?

Background: Sternal surgical site infections are a serious complication of cardiac surgery. The optimal duration of perioperative antibiotic prophylaxis is not known, with recommendations ranging from a single dose to 72 hours. The Society of Thoracic Surgeons’ recommendation for 24 to 72 hours of prophylaxis is not based on a systematic review and meta-analysis.

Study design: Systematic review and meta-analysis.

Setting: Adult patients undergoing open-heart surgery who received perioperative antibiotic prophylaxis.

Synopsis: Authors identified 12 trials encompassing 7,893 patients. Compared with prophylaxis of ≥24 hours, prophylaxis of <24 hours was associated with a higher risk of sternal surgical site infections (RR 1.38, 95% CI, 1.13-1.69) and deep infections (RR 1.68, 95% CI, 1.12-2.53). There was no difference in mortality, other infections, or adverse events. Most studies had methodological limitations with a high risk for bias.

Bottom line: Perioperative antibiotic prophylaxis of ≥24 hours reduces sternal surgical infections.

Citation: Mertz D, Johnstone J, Loeb M. Does duration of perioperative antibiotic prophylaxis matter in cardiac surgery? A systematic review and meta-analysis. Ann Surg. 2011;254:48-54.

Stroke Unit Care Combined with Early Supported Discharge Improves Outcomes

Clinical question: Does early supported discharge (ESD) improve outcomes more than conventional follow-up in stroke patients?

Background: ESD is a mobile team that coordinates follow-up and rehabilitation. Previous studies have shown it to be beneficial in patients with mild to moderate disability at one year, but long-term effects of ESD are not known.

Study design: Randomized controlled trial.

Setting: Single center in Norway.

Synopsis: Stroke-unit patients were recruited and received standard care or ESD after discharge. All 320 patients received standard acute care. The proportion of patients with modified Rankin Score (mRS) of ≤2 was not significantly different in the two groups but identified a trend toward improvement in the intervention group (38% vs. 30%, P=0.106). More patients receiving conventional follow-up died or were institutionalized (P=0.032) but mortality rates at five years were similar (ESD 46% vs. 51%). Secondary outcomes (Scandinavian Stroke Scale, Barthel Index, Frenchay Activity Index, and Mini Mental Status Examination) were not statistically different. Predictors of good outcome in the ESD group included young age, low mRS, and living with others.

This study recruited patients from 1995 to 1997 and followed the patients for five years. Limitations to the applicability include advances in stroke rehabilitation in the last 10 years. The cost of a mobile multidisciplinary team consisting of a physiotherapist, occupational therapist, nurse, and part-time physician was not discussed and may limit the availability to many patients.

 

Bottom line: Early supported discharge may increase the proportion of patients living at home five years after stroke.

Citation: Fjaertoft H, Rohweder G, Indredavik B. Stroke unit care combined with early supported discharge improves 5-year outcome: a randomized controlled trial. Stroke. 2011;42:1707-1711.

Criteria May Help Identify Patients at Risk for Infective Endocarditis

Clinical question: Which patients with Staphylococcus aureus bacteremia benefit the most from transesophageal echocardiography?

Background: Infective endocarditis is a serious complication of S. aureus bacteremia (SAB), occurring in 5% to 17% of patients with documented SAB. It has been recommended to perform transesophageal echocardiography (TEE) in all patients with SAB. Large variation exists in rates of TEE, and identifying patients at low risk for endocarditis may help with more appropriate utilization of this test.

Study design: Retrospective cohort analysis.

Setting: Two university-based German tertiary hospitals (INSTINCT cohort) and one North American university-based hospital from October 1994 to December 2009 (SABG cohort).

Synopsis: A total of 736 cases of nosocomial SAB were analyzed. Age, source of infection, and 30-day and 90-day case fatality rates were similar between the two cohorts. Patients were followed during the index hospitalization and for three months after discharge.

Patients with infective endocarditis were more likely to have prolonged bacteremia; a permanent intracardiac device, such as a pacemaker or a heart valve; be recipients of hemodialysis; and have osteomyelitis. Of the 83 patients who did not fulfill any of the prediction criteria, no cases of infective endocarditis were found.

Bottom line: A set of simple criteria may help identify patients with nosocomial SAB who are at risk for infective endocarditis. The subset of patients who do not meet any of these criteria may not need diagnostic evaluation with TEE.

Citation: Kaasch, AJ, Fowler VG Jr., Rieg S, et al. Use of a simple criteria set for guiding echocardiography in nosocomial Staphylococcus aureus bacteremia. Clin Infect Dis. 2011;53:1-9.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Use of a Care-Transitions Intervention Reduces 30-Day Hospital Readmissions
2. Routine Chest Radiographs after Pneumonia to Rule Out Lung Cancer Have Low Diagnostic Yield
3. Hospitalist Care Shifts Costs to the Outpatient Environment
4. Stopping Smoking at Any Time before Surgery Is Safe
5. Hospitalization for Infection Increases Risk of Stroke
6. Longer Duration of Perioperative Antibiotics May Be Beneficial after Cardiac Surgery
7. Stroke Unit Care Combined with Early Supported Discharge Improves Outcomes
8. Criteria May Help Identify Patients at Risk for Infective Endocarditis

Use of a Care-Transitions Intervention Reduces 30-Day Hospital Readmissions

Clinical question: Does use of a specific care-transitions intervention (CTI) reduce 30-day hospital readmissions in a nonintegrated healthcare system?

Background: Previous interventions addressing improved communication between members of the healthcare team, patients, and families at time of discharge show promise for reducing hospital readmissions. Although these interventions revealed positive results, no research has been completed within a system where healthcare is integrated across settings.

Study design: Quasi-experimental prospective cohort study.

Setting: Six Rhode Island acute-care hospitals, including two community hospitals, three teaching hospitals, and a tertiary-care center and teaching hospital. Facilities ranged from 129 beds to 719 beds.

Synopsis: The CTI is a patient-centered intervention occurring across 30 days. The intervention includes a home visit by a coach within three days of hospital discharge, a telephone call within seven to 10 days of discharge, and a final telephone call no later than 30 days after admission. During these contacts, coaches encourage patient and family participation in care, and active communication with their primary-care provider regarding their disease state. A convenience sample of fee-for-service Medicare beneficiaries was identified by admission diagnoses of acute myocardial infarction, congestive heart failure, or specific pulmonary conditions. Overall, 74% participants completed the entire intervention. The odds of a hospital readmission were significantly lower in the intervention population compared with those who did not receive the intervention (OR 0.61; 95% CI, 0.42-0.88).

Study design: Study design was limited by ability to provide coaching (only 8% of total population was approached), and therefore may not be representative of a typical integrated healthcare setting. In addition, the sample consisted of a convenience sample, which may limit generalizability.

Bottom line: The CTI appears to decrease the rate of 30-day hospital readmissions in Medicare patients with certain cardiac and pulmonary diagnoses.

Citation: Voss R, Gardner R, Baier R, Butterfield K, Lehrman S, Gravenstein S. The care transitions intervention: translating from efficacy to effectiveness. Arch Intern Med. 2011;171:1232-1237.

Routine Chest Radiographs after Pneumonia to Rule Out Lung Cancer Have Low Diagnostic Yield

Clinical question: What is the incidence of new lung cancer detected on routine post-pneumonia chest radiographs?

Background: Routine chest radiographs have been recommended four to eight weeks after resolution of pneumonia to exclude underlying lung cancer. The diagnostic yield of this practice is uncertain.

Study design: Population-based cohort.

Setting: Seven emergency departments and six hospitals in Edmonton, Alberta, Canada.

Synopsis: Authors enrolled 3,398 patients with clinical and radiographic evidence of pneumonia. Of these, 59% were aged 50 and older, 52% were male, 17% were current smokers, 18% had COPD, and 49% were treated as inpatients. At 90-day follow-up, 1.1% of patients received a new diagnosis of lung cancer, with incidence steadily increasing to 2.2% at three-year follow-up. In multivariate analysis, age 50 and older, male sex, and current smoking were independent predictors of post-pneumonia new lung cancer diagnosis. Limiting follow-up chest radiographs to patients aged 50 and older would have detected 98% of new lung cancers and improved diagnostic yield to 2.8%.

 

Bottom line: Routine post-pneumonia chest radiographs for lung cancer screening have low diagnostic yield that is only marginally improved by selecting high-risk populations.

Citation: Tang KL, Eurich DT, Minhas-Sandhu JK, Marrie TJ, Majumdar SR. Incidence, correlates, and chest radiographic yield of new lung cancer diagnosis in 3398 patients with pneumonia. Arch Intern Med. 2011;171:1193-1198.

Hospitalist Care Shifts Costs to the Outpatient Environment

Clinical question: How does hospitalist care affect medical utilization costs after hospital discharge?

Background: The number of patients cared for by hospitalists is growing rapidly. Some studies have shown hospitalists to decrease length of stay and inpatient costs. The impact of shorter hospitalization on outpatient medical utilization and costs is not known.

Study design: Population-based national cohort.

Setting: Hospitalized Medicare patients.

Synopsis: In this study of 58,125 Medicare admissions at 454 hospitals, hospitalist care was associated with a 0.64-day shorter adjusted length of stay and $282 lower hospital charges compared with patients cared for by their primary-care physicians (PCPs). This was offset by $332 higher Medicare spending in the 30 days following hospitalization. Patients cared for by hospitalists were less likely to be discharged home (OR 0.82, 95% CI, 0.78-0.86), and were more likely to require emergency department visits (OR 1.18, 95% CI, 1.12-1.24) and readmissions (OR 1.08, 95% CI, 1.02-1.14). The authors postulate that shorter length of stay associated with hospitalist care is achieved at the expense of shifting costs to the outpatient environment. The discharged patients are sicker and, as a result, require more skilled care and repeat hospital visits.

Bottom line: Hospitalist care may be associated with higher overall costs and more medical utilization.

Citation: Kuo YF, Goodwin JS. Association of hospitalist care with medical utilization after discharge: evidence of cost shift from a cohort study. Ann Intern Med. 2011;155:152-159.

Stopping Smoking at Any Time before Surgery Is Safe

Clinical question: Is smoking cessation within eight weeks of surgery safe?

Background: Smoking cessation before surgery can decrease the risk of surgical complications. However, several studies found increased risk for perioperative complications when smoking was stopped within eight weeks of surgery. These findings created uncertainty about general safety of tobacco cessation counseling before surgery.

Study design: Systematic review and meta-analysis.

Setting: Smokers undergoing any type of surgery.

Synopsis: The authors identified nine studies involving 889 patients that compared smokers who quit within eight weeks of surgery with those who continued to smoke. There was considerable heterogeneity in the studies but no overall difference in perioperative complications between those who quit smoking and those who continued to smoke (OR 0.78, 95% CI, 0.57-1.07). The subset of studies examining pulmonary complications also found no difference (OR 1.18, 95% CI, 0.95-1.46).

Bottom line: Smoking cessation at any time before surgery appears to be safe.

Citation: Myers K, Hajek P, Hinds C, McRobbie H. Stopping smoking shortly before surgery and postoperative complications: a systematic review and meta-analysis. Arch Intern Med. 2011;171:983-989.

Hospitalization for Infection Increases Risk of Stroke

Clinical question: Can infection act as a precipitant for acute ischemic stroke?

Background: Little is known about precipitants of acute ischemic stroke. Severe infections have been shown to promote hypercoagulability and platelet activation, and to induce endothelial dysfunction. Authors postulated that infections severe enough to warrant hospitalization might transiently increase the risk for stroke.

Study design: Case-crossover analysis of data from a multicenter prospective cohort (Cardiovascular Health Study).

 

Setting: Medicare patients in four communities.

Synopsis: During a median follow-up of 12.2 years, 669 strokes occurred in 5,639 study participants. Hospitalization for infection within 14 days was associated with increased risk of stroke (OR 8.0, 95% CI, 1.6-77.3), and the risk remained elevated for hospitalizations within 90 days (OR 3.4, 95% CI, 1.8-6.5). The findings remained significant after adjusting for comorbidities, including age, sex, race, smoking, and diabetes. The number of patients hospitalized for infection before stroke was small—eight within 14 days, and 29 within 90 days.

Bottom line: Infection severe enough to require hospitalization may act as a trigger for acute ischemic stroke.

Citation: Elkind MS, Carty CL, O’Meara ES, et al. Hospitalization for infection and risk of acute ischemic stroke: the Cardiovascular Health Study. Stroke. 2011;42:1851-1856.

Longer Duration of Perioperative Antibiotics May Be Beneficial after Cardiac Surgery

Clinical question: Is antibiotic prophylaxis for 24 or more hours better than shorter duration of treatment after cardiac surgery?

Background: Sternal surgical site infections are a serious complication of cardiac surgery. The optimal duration of perioperative antibiotic prophylaxis is not known, with recommendations ranging from a single dose to 72 hours. The Society of Thoracic Surgeons’ recommendation for 24 to 72 hours of prophylaxis is not based on a systematic review and meta-analysis.

Study design: Systematic review and meta-analysis.

Setting: Adult patients undergoing open-heart surgery who received perioperative antibiotic prophylaxis.

Synopsis: Authors identified 12 trials encompassing 7,893 patients. Compared with prophylaxis of ≥24 hours, prophylaxis of <24 hours was associated with a higher risk of sternal surgical site infections (RR 1.38, 95% CI, 1.13-1.69) and deep infections (RR 1.68, 95% CI, 1.12-2.53). There was no difference in mortality, other infections, or adverse events. Most studies had methodological limitations with a high risk for bias.

Bottom line: Perioperative antibiotic prophylaxis of ≥24 hours reduces sternal surgical infections.

Citation: Mertz D, Johnstone J, Loeb M. Does duration of perioperative antibiotic prophylaxis matter in cardiac surgery? A systematic review and meta-analysis. Ann Surg. 2011;254:48-54.

Stroke Unit Care Combined with Early Supported Discharge Improves Outcomes

Clinical question: Does early supported discharge (ESD) improve outcomes more than conventional follow-up in stroke patients?

Background: ESD is a mobile team that coordinates follow-up and rehabilitation. Previous studies have shown it to be beneficial in patients with mild to moderate disability at one year, but long-term effects of ESD are not known.

Study design: Randomized controlled trial.

Setting: Single center in Norway.

Synopsis: Stroke-unit patients were recruited and received standard care or ESD after discharge. All 320 patients received standard acute care. The proportion of patients with modified Rankin Score (mRS) of ≤2 was not significantly different in the two groups but identified a trend toward improvement in the intervention group (38% vs. 30%, P=0.106). More patients receiving conventional follow-up died or were institutionalized (P=0.032) but mortality rates at five years were similar (ESD 46% vs. 51%). Secondary outcomes (Scandinavian Stroke Scale, Barthel Index, Frenchay Activity Index, and Mini Mental Status Examination) were not statistically different. Predictors of good outcome in the ESD group included young age, low mRS, and living with others.

This study recruited patients from 1995 to 1997 and followed the patients for five years. Limitations to the applicability include advances in stroke rehabilitation in the last 10 years. The cost of a mobile multidisciplinary team consisting of a physiotherapist, occupational therapist, nurse, and part-time physician was not discussed and may limit the availability to many patients.

 

Bottom line: Early supported discharge may increase the proportion of patients living at home five years after stroke.

Citation: Fjaertoft H, Rohweder G, Indredavik B. Stroke unit care combined with early supported discharge improves 5-year outcome: a randomized controlled trial. Stroke. 2011;42:1707-1711.

Criteria May Help Identify Patients at Risk for Infective Endocarditis

Clinical question: Which patients with Staphylococcus aureus bacteremia benefit the most from transesophageal echocardiography?

Background: Infective endocarditis is a serious complication of S. aureus bacteremia (SAB), occurring in 5% to 17% of patients with documented SAB. It has been recommended to perform transesophageal echocardiography (TEE) in all patients with SAB. Large variation exists in rates of TEE, and identifying patients at low risk for endocarditis may help with more appropriate utilization of this test.

Study design: Retrospective cohort analysis.

Setting: Two university-based German tertiary hospitals (INSTINCT cohort) and one North American university-based hospital from October 1994 to December 2009 (SABG cohort).

Synopsis: A total of 736 cases of nosocomial SAB were analyzed. Age, source of infection, and 30-day and 90-day case fatality rates were similar between the two cohorts. Patients were followed during the index hospitalization and for three months after discharge.

Patients with infective endocarditis were more likely to have prolonged bacteremia; a permanent intracardiac device, such as a pacemaker or a heart valve; be recipients of hemodialysis; and have osteomyelitis. Of the 83 patients who did not fulfill any of the prediction criteria, no cases of infective endocarditis were found.

Bottom line: A set of simple criteria may help identify patients with nosocomial SAB who are at risk for infective endocarditis. The subset of patients who do not meet any of these criteria may not need diagnostic evaluation with TEE.

Citation: Kaasch, AJ, Fowler VG Jr., Rieg S, et al. Use of a simple criteria set for guiding echocardiography in nosocomial Staphylococcus aureus bacteremia. Clin Infect Dis. 2011;53:1-9.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Use of a Care-Transitions Intervention Reduces 30-Day Hospital Readmissions
2. Routine Chest Radiographs after Pneumonia to Rule Out Lung Cancer Have Low Diagnostic Yield
3. Hospitalist Care Shifts Costs to the Outpatient Environment
4. Stopping Smoking at Any Time before Surgery Is Safe
5. Hospitalization for Infection Increases Risk of Stroke
6. Longer Duration of Perioperative Antibiotics May Be Beneficial after Cardiac Surgery
7. Stroke Unit Care Combined with Early Supported Discharge Improves Outcomes
8. Criteria May Help Identify Patients at Risk for Infective Endocarditis

Use of a Care-Transitions Intervention Reduces 30-Day Hospital Readmissions

Clinical question: Does use of a specific care-transitions intervention (CTI) reduce 30-day hospital readmissions in a nonintegrated healthcare system?

Background: Previous interventions addressing improved communication between members of the healthcare team, patients, and families at time of discharge show promise for reducing hospital readmissions. Although these interventions revealed positive results, no research has been completed within a system where healthcare is integrated across settings.

Study design: Quasi-experimental prospective cohort study.

Setting: Six Rhode Island acute-care hospitals, including two community hospitals, three teaching hospitals, and a tertiary-care center and teaching hospital. Facilities ranged from 129 beds to 719 beds.

Synopsis: The CTI is a patient-centered intervention occurring across 30 days. The intervention includes a home visit by a coach within three days of hospital discharge, a telephone call within seven to 10 days of discharge, and a final telephone call no later than 30 days after admission. During these contacts, coaches encourage patient and family participation in care, and active communication with their primary-care provider regarding their disease state. A convenience sample of fee-for-service Medicare beneficiaries was identified by admission diagnoses of acute myocardial infarction, congestive heart failure, or specific pulmonary conditions. Overall, 74% participants completed the entire intervention. The odds of a hospital readmission were significantly lower in the intervention population compared with those who did not receive the intervention (OR 0.61; 95% CI, 0.42-0.88).

Study design: Study design was limited by ability to provide coaching (only 8% of total population was approached), and therefore may not be representative of a typical integrated healthcare setting. In addition, the sample consisted of a convenience sample, which may limit generalizability.

Bottom line: The CTI appears to decrease the rate of 30-day hospital readmissions in Medicare patients with certain cardiac and pulmonary diagnoses.

Citation: Voss R, Gardner R, Baier R, Butterfield K, Lehrman S, Gravenstein S. The care transitions intervention: translating from efficacy to effectiveness. Arch Intern Med. 2011;171:1232-1237.

Routine Chest Radiographs after Pneumonia to Rule Out Lung Cancer Have Low Diagnostic Yield

Clinical question: What is the incidence of new lung cancer detected on routine post-pneumonia chest radiographs?

Background: Routine chest radiographs have been recommended four to eight weeks after resolution of pneumonia to exclude underlying lung cancer. The diagnostic yield of this practice is uncertain.

Study design: Population-based cohort.

Setting: Seven emergency departments and six hospitals in Edmonton, Alberta, Canada.

Synopsis: Authors enrolled 3,398 patients with clinical and radiographic evidence of pneumonia. Of these, 59% were aged 50 and older, 52% were male, 17% were current smokers, 18% had COPD, and 49% were treated as inpatients. At 90-day follow-up, 1.1% of patients received a new diagnosis of lung cancer, with incidence steadily increasing to 2.2% at three-year follow-up. In multivariate analysis, age 50 and older, male sex, and current smoking were independent predictors of post-pneumonia new lung cancer diagnosis. Limiting follow-up chest radiographs to patients aged 50 and older would have detected 98% of new lung cancers and improved diagnostic yield to 2.8%.

 

Bottom line: Routine post-pneumonia chest radiographs for lung cancer screening have low diagnostic yield that is only marginally improved by selecting high-risk populations.

Citation: Tang KL, Eurich DT, Minhas-Sandhu JK, Marrie TJ, Majumdar SR. Incidence, correlates, and chest radiographic yield of new lung cancer diagnosis in 3398 patients with pneumonia. Arch Intern Med. 2011;171:1193-1198.

Hospitalist Care Shifts Costs to the Outpatient Environment

Clinical question: How does hospitalist care affect medical utilization costs after hospital discharge?

Background: The number of patients cared for by hospitalists is growing rapidly. Some studies have shown hospitalists to decrease length of stay and inpatient costs. The impact of shorter hospitalization on outpatient medical utilization and costs is not known.

Study design: Population-based national cohort.

Setting: Hospitalized Medicare patients.

Synopsis: In this study of 58,125 Medicare admissions at 454 hospitals, hospitalist care was associated with a 0.64-day shorter adjusted length of stay and $282 lower hospital charges compared with patients cared for by their primary-care physicians (PCPs). This was offset by $332 higher Medicare spending in the 30 days following hospitalization. Patients cared for by hospitalists were less likely to be discharged home (OR 0.82, 95% CI, 0.78-0.86), and were more likely to require emergency department visits (OR 1.18, 95% CI, 1.12-1.24) and readmissions (OR 1.08, 95% CI, 1.02-1.14). The authors postulate that shorter length of stay associated with hospitalist care is achieved at the expense of shifting costs to the outpatient environment. The discharged patients are sicker and, as a result, require more skilled care and repeat hospital visits.

Bottom line: Hospitalist care may be associated with higher overall costs and more medical utilization.

Citation: Kuo YF, Goodwin JS. Association of hospitalist care with medical utilization after discharge: evidence of cost shift from a cohort study. Ann Intern Med. 2011;155:152-159.

Stopping Smoking at Any Time before Surgery Is Safe

Clinical question: Is smoking cessation within eight weeks of surgery safe?

Background: Smoking cessation before surgery can decrease the risk of surgical complications. However, several studies found increased risk for perioperative complications when smoking was stopped within eight weeks of surgery. These findings created uncertainty about general safety of tobacco cessation counseling before surgery.

Study design: Systematic review and meta-analysis.

Setting: Smokers undergoing any type of surgery.

Synopsis: The authors identified nine studies involving 889 patients that compared smokers who quit within eight weeks of surgery with those who continued to smoke. There was considerable heterogeneity in the studies but no overall difference in perioperative complications between those who quit smoking and those who continued to smoke (OR 0.78, 95% CI, 0.57-1.07). The subset of studies examining pulmonary complications also found no difference (OR 1.18, 95% CI, 0.95-1.46).

Bottom line: Smoking cessation at any time before surgery appears to be safe.

Citation: Myers K, Hajek P, Hinds C, McRobbie H. Stopping smoking shortly before surgery and postoperative complications: a systematic review and meta-analysis. Arch Intern Med. 2011;171:983-989.

Hospitalization for Infection Increases Risk of Stroke

Clinical question: Can infection act as a precipitant for acute ischemic stroke?

Background: Little is known about precipitants of acute ischemic stroke. Severe infections have been shown to promote hypercoagulability and platelet activation, and to induce endothelial dysfunction. Authors postulated that infections severe enough to warrant hospitalization might transiently increase the risk for stroke.

Study design: Case-crossover analysis of data from a multicenter prospective cohort (Cardiovascular Health Study).

 

Setting: Medicare patients in four communities.

Synopsis: During a median follow-up of 12.2 years, 669 strokes occurred in 5,639 study participants. Hospitalization for infection within 14 days was associated with increased risk of stroke (OR 8.0, 95% CI, 1.6-77.3), and the risk remained elevated for hospitalizations within 90 days (OR 3.4, 95% CI, 1.8-6.5). The findings remained significant after adjusting for comorbidities, including age, sex, race, smoking, and diabetes. The number of patients hospitalized for infection before stroke was small—eight within 14 days, and 29 within 90 days.

Bottom line: Infection severe enough to require hospitalization may act as a trigger for acute ischemic stroke.

Citation: Elkind MS, Carty CL, O’Meara ES, et al. Hospitalization for infection and risk of acute ischemic stroke: the Cardiovascular Health Study. Stroke. 2011;42:1851-1856.

Longer Duration of Perioperative Antibiotics May Be Beneficial after Cardiac Surgery

Clinical question: Is antibiotic prophylaxis for 24 or more hours better than shorter duration of treatment after cardiac surgery?

Background: Sternal surgical site infections are a serious complication of cardiac surgery. The optimal duration of perioperative antibiotic prophylaxis is not known, with recommendations ranging from a single dose to 72 hours. The Society of Thoracic Surgeons’ recommendation for 24 to 72 hours of prophylaxis is not based on a systematic review and meta-analysis.

Study design: Systematic review and meta-analysis.

Setting: Adult patients undergoing open-heart surgery who received perioperative antibiotic prophylaxis.

Synopsis: Authors identified 12 trials encompassing 7,893 patients. Compared with prophylaxis of ≥24 hours, prophylaxis of <24 hours was associated with a higher risk of sternal surgical site infections (RR 1.38, 95% CI, 1.13-1.69) and deep infections (RR 1.68, 95% CI, 1.12-2.53). There was no difference in mortality, other infections, or adverse events. Most studies had methodological limitations with a high risk for bias.

Bottom line: Perioperative antibiotic prophylaxis of ≥24 hours reduces sternal surgical infections.

Citation: Mertz D, Johnstone J, Loeb M. Does duration of perioperative antibiotic prophylaxis matter in cardiac surgery? A systematic review and meta-analysis. Ann Surg. 2011;254:48-54.

Stroke Unit Care Combined with Early Supported Discharge Improves Outcomes

Clinical question: Does early supported discharge (ESD) improve outcomes more than conventional follow-up in stroke patients?

Background: ESD is a mobile team that coordinates follow-up and rehabilitation. Previous studies have shown it to be beneficial in patients with mild to moderate disability at one year, but long-term effects of ESD are not known.

Study design: Randomized controlled trial.

Setting: Single center in Norway.

Synopsis: Stroke-unit patients were recruited and received standard care or ESD after discharge. All 320 patients received standard acute care. The proportion of patients with modified Rankin Score (mRS) of ≤2 was not significantly different in the two groups but identified a trend toward improvement in the intervention group (38% vs. 30%, P=0.106). More patients receiving conventional follow-up died or were institutionalized (P=0.032) but mortality rates at five years were similar (ESD 46% vs. 51%). Secondary outcomes (Scandinavian Stroke Scale, Barthel Index, Frenchay Activity Index, and Mini Mental Status Examination) were not statistically different. Predictors of good outcome in the ESD group included young age, low mRS, and living with others.

This study recruited patients from 1995 to 1997 and followed the patients for five years. Limitations to the applicability include advances in stroke rehabilitation in the last 10 years. The cost of a mobile multidisciplinary team consisting of a physiotherapist, occupational therapist, nurse, and part-time physician was not discussed and may limit the availability to many patients.

 

Bottom line: Early supported discharge may increase the proportion of patients living at home five years after stroke.

Citation: Fjaertoft H, Rohweder G, Indredavik B. Stroke unit care combined with early supported discharge improves 5-year outcome: a randomized controlled trial. Stroke. 2011;42:1707-1711.

Criteria May Help Identify Patients at Risk for Infective Endocarditis

Clinical question: Which patients with Staphylococcus aureus bacteremia benefit the most from transesophageal echocardiography?

Background: Infective endocarditis is a serious complication of S. aureus bacteremia (SAB), occurring in 5% to 17% of patients with documented SAB. It has been recommended to perform transesophageal echocardiography (TEE) in all patients with SAB. Large variation exists in rates of TEE, and identifying patients at low risk for endocarditis may help with more appropriate utilization of this test.

Study design: Retrospective cohort analysis.

Setting: Two university-based German tertiary hospitals (INSTINCT cohort) and one North American university-based hospital from October 1994 to December 2009 (SABG cohort).

Synopsis: A total of 736 cases of nosocomial SAB were analyzed. Age, source of infection, and 30-day and 90-day case fatality rates were similar between the two cohorts. Patients were followed during the index hospitalization and for three months after discharge.

Patients with infective endocarditis were more likely to have prolonged bacteremia; a permanent intracardiac device, such as a pacemaker or a heart valve; be recipients of hemodialysis; and have osteomyelitis. Of the 83 patients who did not fulfill any of the prediction criteria, no cases of infective endocarditis were found.

Bottom line: A set of simple criteria may help identify patients with nosocomial SAB who are at risk for infective endocarditis. The subset of patients who do not meet any of these criteria may not need diagnostic evaluation with TEE.

Citation: Kaasch, AJ, Fowler VG Jr., Rieg S, et al. Use of a simple criteria set for guiding echocardiography in nosocomial Staphylococcus aureus bacteremia. Clin Infect Dis. 2011;53:1-9.

Clinical question: What is the incidence of kernicterus over the past few decades?

Background: Recent guidelines for hyperbilirubinemia have recommended a systematic approach to management in order to prevent the occurrence of severe hyperbilirubinemia and, potentially, kernicterus. There has been concern that rates of kernicterus might have increased in the 1990s, when a “kindler, gentler” approach to hyperbilirubinemia was advocated by earlier guidelines.

Study design: Retrospective observational study.

Setting: California registry of developmental services enrollees.

Synopsis: Of 64,346 children born from 1988 to 1997 who received services from the California Department of Developmental Services (DDS) from 1988 to 2002, 25 met a strict definition of kernicterus. The time trend of incidence remained stable during the study years at 0.44 (95% confidence interval [CI]: 0.28-0.65) per 100,000 live births. There were no significant differences in rates before and after 1994.

Data from a national database of death certificates revealed a similar stable trend in deaths attributed to kernicterus.

A primary limitation of this study is the lack of clarity surrounding enrollment in California’s DDS by children with kernicterus. Although all children with developmental disabilities are eligible, the exact enrollment rate likely is unknown. However, this is one of the first studies to put a denominator on kernicterus in this country.

Updated guidelines on the management of hyperbilirubinemia in 2004 advocated a safer, more systematic approach to management, in part because of concerns that there had been a resurgence of kernicterus. This now seems less likely and this article adds to a body of literature that raises questions about whether a large population of patients with hyperbilirubinemia who are at extremely low risk for kernicterus are being overtreated.

Bottom line: Kernicterus rates remained unchanged in the 1990s.

Citation: Brooks JC, Fisher-Owens SA, Wu YW, Strauss DJ, Newman TB. Evidence suggests there was not a “resurgence” of kernicterus in the 1990s. Pediatrics. 2011;127:672-679.

Reviewed by Pediatric Editor Mark Shen, MD, FHM, medical director of hospital medicine at Dell Children’s Medical Center, Austin, Texas.

Clinical question: What is the incidence of kernicterus over the past few decades?

Background: Recent guidelines for hyperbilirubinemia have recommended a systematic approach to management in order to prevent the occurrence of severe hyperbilirubinemia and, potentially, kernicterus. There has been concern that rates of kernicterus might have increased in the 1990s, when a “kindler, gentler” approach to hyperbilirubinemia was advocated by earlier guidelines.

Study design: Retrospective observational study.

Setting: California registry of developmental services enrollees.

Synopsis: Of 64,346 children born from 1988 to 1997 who received services from the California Department of Developmental Services (DDS) from 1988 to 2002, 25 met a strict definition of kernicterus. The time trend of incidence remained stable during the study years at 0.44 (95% confidence interval [CI]: 0.28-0.65) per 100,000 live births. There were no significant differences in rates before and after 1994.

Data from a national database of death certificates revealed a similar stable trend in deaths attributed to kernicterus.

A primary limitation of this study is the lack of clarity surrounding enrollment in California’s DDS by children with kernicterus. Although all children with developmental disabilities are eligible, the exact enrollment rate likely is unknown. However, this is one of the first studies to put a denominator on kernicterus in this country.

Updated guidelines on the management of hyperbilirubinemia in 2004 advocated a safer, more systematic approach to management, in part because of concerns that there had been a resurgence of kernicterus. This now seems less likely and this article adds to a body of literature that raises questions about whether a large population of patients with hyperbilirubinemia who are at extremely low risk for kernicterus are being overtreated.

Bottom line: Kernicterus rates remained unchanged in the 1990s.

Citation: Brooks JC, Fisher-Owens SA, Wu YW, Strauss DJ, Newman TB. Evidence suggests there was not a “resurgence” of kernicterus in the 1990s. Pediatrics. 2011;127:672-679.

Reviewed by Pediatric Editor Mark Shen, MD, FHM, medical director of hospital medicine at Dell Children’s Medical Center, Austin, Texas.

Clinical question: What is the incidence of kernicterus over the past few decades?

Background: Recent guidelines for hyperbilirubinemia have recommended a systematic approach to management in order to prevent the occurrence of severe hyperbilirubinemia and, potentially, kernicterus. There has been concern that rates of kernicterus might have increased in the 1990s, when a “kindler, gentler” approach to hyperbilirubinemia was advocated by earlier guidelines.

Study design: Retrospective observational study.

Setting: California registry of developmental services enrollees.

Synopsis: Of 64,346 children born from 1988 to 1997 who received services from the California Department of Developmental Services (DDS) from 1988 to 2002, 25 met a strict definition of kernicterus. The time trend of incidence remained stable during the study years at 0.44 (95% confidence interval [CI]: 0.28-0.65) per 100,000 live births. There were no significant differences in rates before and after 1994.

Data from a national database of death certificates revealed a similar stable trend in deaths attributed to kernicterus.

A primary limitation of this study is the lack of clarity surrounding enrollment in California’s DDS by children with kernicterus. Although all children with developmental disabilities are eligible, the exact enrollment rate likely is unknown. However, this is one of the first studies to put a denominator on kernicterus in this country.

Updated guidelines on the management of hyperbilirubinemia in 2004 advocated a safer, more systematic approach to management, in part because of concerns that there had been a resurgence of kernicterus. This now seems less likely and this article adds to a body of literature that raises questions about whether a large population of patients with hyperbilirubinemia who are at extremely low risk for kernicterus are being overtreated.

Bottom line: Kernicterus rates remained unchanged in the 1990s.

Citation: Brooks JC, Fisher-Owens SA, Wu YW, Strauss DJ, Newman TB. Evidence suggests there was not a “resurgence” of kernicterus in the 1990s. Pediatrics. 2011;127:672-679.

Reviewed by Pediatric Editor Mark Shen, MD, FHM, medical director of hospital medicine at Dell Children’s Medical Center, Austin, Texas.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. PCI Not Inferior to CABG in Left Main Coronary Artery Stenosis at One Year, But Requires Further Study
2. CABG Did Not Decrease Mortality in Patients with CAD and Left Ventricular Dysfunction
3. Linezolid Not Superior to Glycopeptide Antibiotics in Treatment of Nosocomial Pneumonia
4. CRP and Procalcitonin Independently Differentiated Pneumonia from Asthma or COPD Exacerbation
5. Survival Benefit Demonstrated with FOLFIRINOX in Select Patients with Metastatic Pancreatic Cancer
6. MRSA Bundle Implementation at VA Hospitals Reduced Healthcare-Associated MRSA Infections
7. New Left Bundle Branch Block Does Not Predict MI
8. Acute Beta-Blocker Therapy for MI Increased Risk of Shock

PCI Not Inferior to CABG in Left Main Coronary Artery Stenosis at One Year, But Requires Further Study

Clinical question: Is percutaneous coronary intervention (PCI) an acceptable alternative to coronary artery bypass grafting (CABG) in unprotected left main coronary artery disease (CAD)?

Background: The current standard of care for unprotected left main CAD is CABG. A sub-study from a large randomized trial suggests that PCI might be an alternative to CABG for patients with left main CAD. Outcomes after the two treatments have not been directly compared in an appropriately powered trial.

Study design: Prospective, open-label, randomized trial powered for noninferiority.

Setting: Thirteen sites in South Korea.

Synopsis: Six hundred patients with newly diagnosed left main disease with >50% stenosis were randomized to PCI with a sirolimus-eluting stent versus CABG. The primary endpoint of major adverse cardiac or cerebrovascular events occurred in 8.7% in the PCI group and 6.7% in the CABG group at one year (absolute risk difference 2 percentage points, 95% CI, -1.6 to 5.6; P=0.01), which was considered noninferior.

However, ischemia-driven target-vessel revascularization occurred in significantly more patients in the PCI group than in the CABG group. The wide noninferiority margin was due to an unexpectedly low rate of events, thus underpowering the study. Also, study duration was only two years.

Bottom line: PCI with a sirolimus-eluting stent was noninferior to CABG for unprotected left main CAD in this study, but the wide noninferiority margin and limited follow-up duration limit clinical application.

Reference: Park SJ, Kim YH, Park DW, et al. Randomized trial of stents versus bypass surgery for left main coronary artery disease. N Engl J Med. 2011;364(18):1718-1727.

CABG Did Not Decrease Mortality in Patients with CAD and Left Ventricular Dysfunction

Clinical question: What role does coronary-artery bypass grafting (CABG) have in the treatment of patients with both coronary artery disease (CAD) and heart failure?

Background: Although CAD is the most common cause of heart failure, early trials that evaluated the use of CABG in relieving angina excluded patients who had left ventricular (LV) dysfunction with ejection fraction <35%. It is unknown whether CABG adds mortality benefit to intensive medical treatment in patients with CAD and LV dysfunction.

Study design: Multicenter, nonblinded, randomized trial.

Setting: One hundred twenty-seven sites in 26 countries.

Synopsis: From July 2002 to May 2007, 1,212 patients with known CAD amenable to CABG and LV ejection fraction <35% were randomized to medical therapy alone versus CABG plus medical therapy with an average follow-up of five years. The primary outcome of death from any cause occurred in 41% of the medical-therapy-alone group and 36% of the CABG-plus-medical-therapy group (hazard ratio with CABG 0.86; 95% CI 0.72 to 1.04; P=0.12).

Despite subgroup analysis suggesting decreased death rates from cardiovascular causes in the latter group, there was no significant difference in the primary endpoint of death from any cause.

Bottom line: The addition of CABG to medical therapy for patients with CAD and left ventricular dysfunction does not decrease mortality.

 

Reference: Velazquez EJ, Lee KL, Deja MA, et al. Coronary-artery bypass surgery in patients with left ventricular dysfunction. N Engl J Med. 2011;364(17):1607-1616.

Linezolid Not Superior to Glycopeptide Antibiotics in Treatment of Nosocomial Pneumonia

Clinical question: Is linezolid superior to glycopeptide antibiotics in the treatment of nosocomial pneumonia?

Background: Current ATS/IDSA guidelines suggest that linezolid might be preferred over glycopeptide antibiotics (i.e. vancomycin and teicoplanin) for methicillin-resistant Staphylococcus aureus (MRSA) pneumonia, although this recommendation is based on a retrospective subgroup analysis of one randomized trial. No systematic reviews have looked at the comparative efficacy and safety of linezolid and glycopeptide antibiotics for nosocomial pneumonia.

Study design: Meta-analysis using a highly sensitive search method.

Setting: Eight multicenter, randomized controlled trials (RCTs).

Synopsis: The study authors retrieved 762 articles with a highly sensitive search strategy, from which eight RCTs were identified that met study criteria for a total of 1,641 patients. Primary outcome of clinical success at test-of-cure was not different between the two classes of antibiotics (pooled RR 1.04, 95% CI 0.97-1.11, P=0.28). Other endpoints, including mortality and microbiologic eradication, were similar between the two groups.

Clinical success in the subgroup of patients with culture-confirmed MRSA pneumonia was not different than those without culture-proven MRSA, although the study was not powered for subgroup analysis. Risk of thrombocytopenia and renal impairment were not statistically different in the limited subgroup of trials reporting this data.

The results should not be generalized to community-acquired MRSA or MRSA pneumonia with characteristics of PVL toxin-producing strain.

Bottom line: For the treatment of nosocomial pneumonia, there was no significant difference in clinical success or mortality between linezolid and glycopeptide antibiotics.

Citation: Walkey AJ, O’Donnell MR, Weiner RS. Linezolid vs. glycopeptide antibiotics for the treatment of suspected methicillin-resistant Staphylococcus aureus nosocomial pneumonia. Chest. 2011;139: 1148-1155.

CRP and Procalcitonin Independently Differentiated Pneumonia from Asthma or COPD Exacerbation

Clinical question: Are biomarkers such as CRP or procalcitonin useful in differentiating pneumonia from asthma or COPD exacerbation in hospitalized patients?

Background: Antibiotic overuse is associated with the emergence of drug resistance. One potential strategy to decrease antibiotic overuse is biomarker-guided therapy. Several randomized controlled trials (RCT) with procalcitonin-guided therapy have resulted in reduced antibiotic use for symptoms of acute respiratory tract infections (RTI). The use of CRP as a biomarker in acute RTI is not as well-described.

Study design: Prospective, observational, diagnostic accuracy study.

Setting: Winter months, 2006 to 2008, in two hospitals in England.

Synopsis: The study examined 319 patients: 62 with pneumonia, 96 with asthma exacerbation, and 161 with COPD exacerbation. Patients with pneumonia had significantly higher procalcitonin and CRP levels than those with COPD (P<0.0001) or asthma (P<0.0001). The area under receiver operator characteristic curve for distinguishing between pneumonia (requiring antibiotics) and asthma exacerbation (not requiring antibiotics) was 0.93 (0.88-0.98) for procalcitonin and 0.96 (0.93-1.00) for CRP. A CRP value >48 mg/L had a sensitivity of 91% (95% CI 80%-97%) and specificity of 93% (95% CI 86-98).

Using this CRP threshold, antibiotic use would have been reduced by 88% in asthma exacerbation, 76% in COPD exacerbation, and 9% in pneumonia cases.

This strategy was developed in a single-center study and requires further validation in a multicenter RCT.

Bottom line: Procalcitonin and CRP were elevated in patients with pneumonia compared to patients with asthma or COPD exacerbation and might be useful in guiding antibiotic usage.

Citation: Bafadhel, M, Clark TW, Reid, C, et al. Procalcitonin and C-reactive protein in hospitalized adult patients with community-acquired pneumonia or exacerbation of asthma or COPD. Chest. 2011;139:1410-1418.

 

Survival Benefit Demonstrated with FOLFIRINOX in Select Patients with Metastatic Pancreatic Cancer

Clinical question: How does FOLFIRINOX compare to gemcitabine as first-line treatment of metastatic pancreatic cancer?

Background: Single-agent gemcitabine is the standard first-line treatment for metastatic pancreatic cancer. Preclinical studies followed by Phase 1 and Phase 2 studies have demonstrated response to the oxaliplatin, irinotecan, leucovorin, and fluorouracil regimen (FOLFIRINOX).

Study design: Multicenter, randomized, controlled Phase 2-3 trial.

Setting: Fifteen centers in France during Phase 2, which then expanded to 48 centers for Phase 3.

Synopsis: Three hundred forty-two patients with good performance status (ECOG 0 or 1) and age <76 were randomized to receive FOLFIRINOX or gemcitabine. Median survival in the FOLFIRINOX group was significantly increased, at 11.1 months, compared with 6.8 months in the gemcitabine group (HR 0.57, CI 95%, 0.45-0.73, P<000.1).

Median progression-free survival, objective response rate, and quality of life score at six months were significantly increased in the FOLFIRINOX group. Significantly more grade 3 or grade 4 toxicity was reported in the FOLFIRINOX group.

Patients with elevated bilirubin were excluded due to increased risk of irinotecan-induced toxicity, resulting in only 38% of study patients with carcinoma of the pancreatic head and low proportion of enrolled patients (14.3%) with biliary stents.

Bottom line: FOLFIRONOX was associated with a significant survival advantage compared with single-agent gemcitabine in carefully selected patients with advanced pancreatic cancer, although it was associated with increased toxicity.

Citation: Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817-1825.

MRSA Bundle Implementation at VA Hospitals Reduced Healthcare-Associated MRSA Infections

Clinical question: Can nationwide implementation of a “MRSA bundle,” including universal surveillance, contact isolation, hand hygiene, and institutional culture change, influence healthcare-associated MRSA infection rates?

Background: MRSA is a common cause of nosocomial infection. A pilot project at a single Veterans Affairs (VA) hospital utilized a “MRSA bundle” developed from published guidelines, which resulted in decreased healthcare-associated MRSA infections. In October 2007, the MRSA bundle was implemented throughout VA hospitals nationwide.

Study design: Quality-improvement (QI) observational initiative.

Setting: One hundred fifty-eight acute-care VA hospitals in the U.S.

Synopsis: From October 2007 to June 2010, there were 1,934,598 admissions, transfers, or discharges, and 8,318,675 patient-days. Of this study group, 96% of patients were screened at admission and 93% were screened at transfer or discharge. MRSA colonization or infection at the time of admission was 13.6%. Rates of healthcare-associated MRSA infection declined 45% in the non-ICU setting (0.47 to 0.26 per 1,000 patient-days, P<0.001) and 62% in the ICU setting (1.64 to 0.62 per 1,000 patient days, P<0.001).

It is unclear how much each individual component of the MRSA bundle impacted the declining MRSA infection rate.

Bottom line: Implementation of a “MRSA bundle,” including universal surveillance, contact isolation, hand hygiene, and institutional culture change, decreased the healthcare-associated MRSA infection rate in a large hospital system.

Citation: Jain R, Kralovi S, Evans M, et al. Veterans Affairs initiative to prevent methicillin-resistant Staphylococcus aureus infections. N Engl J Med. 2011;364(15):1419-1430.

New Left Bundle Branch Block Does Not Predict MI

Clinical question: How does the chronicity of left bundle branch block (LBBB) impact diagnosis and outcome in patients undergoing evaluation for acute myocardial infarction (MI)?

Background: ACA/AHA guidelines recommend that patients with new or presumed new LBBB undergo early reperfusion therapy. However, previous studies have shown that a minority of patients with new LBBB are diagnosed with MI.

Study design: Prospective cohort study.

 

Setting: University hospital in the U.S.

Synopsis: From 1994 to 2009, 401 consecutive patients undergoing evaluation for acute coronary syndrome with LBBB on initial ECG were included in the analysis. Of these patients, 64% had new (37%) or presumably new (27%) LBBB. Twenty-nine percent were diagnosed with MI, but there was no difference in frequency or size of MI between the new, presumably new, or chronic LBBB groups.

Concordant ST-T changes were an independent predictor of MI (OR 17, 95% CI 3.4-81, P<0.001) and mortality (OR 4.3, 95% CI 1.3-15, P<0.001), although this finding was present in only about 11% of the patient group.

Bottom line: Left bundle branch block is not a predictor of MI, although concordant ST-T changes were an independent predictor of MI and mortality.

Citation: Kontos MC, Aziz HA, Chau VQ, et al. Outcomes in patients with chronicity of left bundle-branch block with possible acute myocardial infarction. Am Heart J. 2011;161(4):698-704.

Acute Beta-Blocker Therapy for MI Increased Risk of Shock

Clinical question: How does acute beta-blocker therapy in myocardial infarction (MI) impact outcome?

Background: Long-term treatment with beta-blockers after myocardial infarction (MI) reduces mortality. However, data regarding outcome after acute use of beta-blockers in the first 24 hours of MI is conflicting. Updated ACA/AHA guidelines for STEMI and NSTEMI recommend caution when using beta-blockers in the first 24 hours, particularly in patients at risk for shock.

Study design: Observational registry study.

Setting: Two hundred ninety-one U.S hospitals.

Synopsis: More than 34,600 patients diagnosed with STEMI and NSTEMI from January 2007 to June 2008 were identified from a national QI MI registry. Patients were stratified by guideline-stated risk factors for shock; age >70, HR >110, and systolic BP <120 were associated with increased risk of composite outcome of shock or death.

At least one high-risk factor was present in 63% of the NSTEMI patients and 45% of STEMI patients; however, >90% of these patients received acute beta-blocker therapy. Nearly half (49%) of the NSTEMI patients received beta-blockers in the ED and 62% of the STEMI patients received beta-blockers before PCI.

In a multivariable model, NSTEMI patients receiving beta-blocker therapy in the ED were more likely to develop cardiogenic shock (OR 1.54, 95% CI 1.26-1.88, P<.001), as were STEMI patients receiving beta-blocker therapy prior to PCI (1.40, 95% CI 1.10-1.79, P=.006).

Bottom line: Caution should be exercised when using beta-blocker therapy during acute MI, particularly in the ED or prior to primary PCI.

Citation: Kontos MC, Diercks DB, Ho MP, Wang TY, Chen AY, Roe MT. Treatment and outcomes in patients with myocardial infarction treated with acute beta-blocker therapy: results from the American College of Cardiology’s NCDR. Am Heart J. 2011;161(5):864-870.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. PCI Not Inferior to CABG in Left Main Coronary Artery Stenosis at One Year, But Requires Further Study
2. CABG Did Not Decrease Mortality in Patients with CAD and Left Ventricular Dysfunction
3. Linezolid Not Superior to Glycopeptide Antibiotics in Treatment of Nosocomial Pneumonia
4. CRP and Procalcitonin Independently Differentiated Pneumonia from Asthma or COPD Exacerbation
5. Survival Benefit Demonstrated with FOLFIRINOX in Select Patients with Metastatic Pancreatic Cancer
6. MRSA Bundle Implementation at VA Hospitals Reduced Healthcare-Associated MRSA Infections
7. New Left Bundle Branch Block Does Not Predict MI
8. Acute Beta-Blocker Therapy for MI Increased Risk of Shock

PCI Not Inferior to CABG in Left Main Coronary Artery Stenosis at One Year, But Requires Further Study

Clinical question: Is percutaneous coronary intervention (PCI) an acceptable alternative to coronary artery bypass grafting (CABG) in unprotected left main coronary artery disease (CAD)?

Background: The current standard of care for unprotected left main CAD is CABG. A sub-study from a large randomized trial suggests that PCI might be an alternative to CABG for patients with left main CAD. Outcomes after the two treatments have not been directly compared in an appropriately powered trial.

Study design: Prospective, open-label, randomized trial powered for noninferiority.

Setting: Thirteen sites in South Korea.

Synopsis: Six hundred patients with newly diagnosed left main disease with >50% stenosis were randomized to PCI with a sirolimus-eluting stent versus CABG. The primary endpoint of major adverse cardiac or cerebrovascular events occurred in 8.7% in the PCI group and 6.7% in the CABG group at one year (absolute risk difference 2 percentage points, 95% CI, -1.6 to 5.6; P=0.01), which was considered noninferior.

However, ischemia-driven target-vessel revascularization occurred in significantly more patients in the PCI group than in the CABG group. The wide noninferiority margin was due to an unexpectedly low rate of events, thus underpowering the study. Also, study duration was only two years.

Bottom line: PCI with a sirolimus-eluting stent was noninferior to CABG for unprotected left main CAD in this study, but the wide noninferiority margin and limited follow-up duration limit clinical application.

Reference: Park SJ, Kim YH, Park DW, et al. Randomized trial of stents versus bypass surgery for left main coronary artery disease. N Engl J Med. 2011;364(18):1718-1727.

CABG Did Not Decrease Mortality in Patients with CAD and Left Ventricular Dysfunction

Clinical question: What role does coronary-artery bypass grafting (CABG) have in the treatment of patients with both coronary artery disease (CAD) and heart failure?

Background: Although CAD is the most common cause of heart failure, early trials that evaluated the use of CABG in relieving angina excluded patients who had left ventricular (LV) dysfunction with ejection fraction <35%. It is unknown whether CABG adds mortality benefit to intensive medical treatment in patients with CAD and LV dysfunction.

Study design: Multicenter, nonblinded, randomized trial.

Setting: One hundred twenty-seven sites in 26 countries.

Synopsis: From July 2002 to May 2007, 1,212 patients with known CAD amenable to CABG and LV ejection fraction <35% were randomized to medical therapy alone versus CABG plus medical therapy with an average follow-up of five years. The primary outcome of death from any cause occurred in 41% of the medical-therapy-alone group and 36% of the CABG-plus-medical-therapy group (hazard ratio with CABG 0.86; 95% CI 0.72 to 1.04; P=0.12).

Despite subgroup analysis suggesting decreased death rates from cardiovascular causes in the latter group, there was no significant difference in the primary endpoint of death from any cause.

Bottom line: The addition of CABG to medical therapy for patients with CAD and left ventricular dysfunction does not decrease mortality.

 

Reference: Velazquez EJ, Lee KL, Deja MA, et al. Coronary-artery bypass surgery in patients with left ventricular dysfunction. N Engl J Med. 2011;364(17):1607-1616.

Linezolid Not Superior to Glycopeptide Antibiotics in Treatment of Nosocomial Pneumonia

Clinical question: Is linezolid superior to glycopeptide antibiotics in the treatment of nosocomial pneumonia?

Background: Current ATS/IDSA guidelines suggest that linezolid might be preferred over glycopeptide antibiotics (i.e. vancomycin and teicoplanin) for methicillin-resistant Staphylococcus aureus (MRSA) pneumonia, although this recommendation is based on a retrospective subgroup analysis of one randomized trial. No systematic reviews have looked at the comparative efficacy and safety of linezolid and glycopeptide antibiotics for nosocomial pneumonia.

Study design: Meta-analysis using a highly sensitive search method.

Setting: Eight multicenter, randomized controlled trials (RCTs).

Synopsis: The study authors retrieved 762 articles with a highly sensitive search strategy, from which eight RCTs were identified that met study criteria for a total of 1,641 patients. Primary outcome of clinical success at test-of-cure was not different between the two classes of antibiotics (pooled RR 1.04, 95% CI 0.97-1.11, P=0.28). Other endpoints, including mortality and microbiologic eradication, were similar between the two groups.

Clinical success in the subgroup of patients with culture-confirmed MRSA pneumonia was not different than those without culture-proven MRSA, although the study was not powered for subgroup analysis. Risk of thrombocytopenia and renal impairment were not statistically different in the limited subgroup of trials reporting this data.

The results should not be generalized to community-acquired MRSA or MRSA pneumonia with characteristics of PVL toxin-producing strain.

Bottom line: For the treatment of nosocomial pneumonia, there was no significant difference in clinical success or mortality between linezolid and glycopeptide antibiotics.

Citation: Walkey AJ, O’Donnell MR, Weiner RS. Linezolid vs. glycopeptide antibiotics for the treatment of suspected methicillin-resistant Staphylococcus aureus nosocomial pneumonia. Chest. 2011;139: 1148-1155.

CRP and Procalcitonin Independently Differentiated Pneumonia from Asthma or COPD Exacerbation

Clinical question: Are biomarkers such as CRP or procalcitonin useful in differentiating pneumonia from asthma or COPD exacerbation in hospitalized patients?

Background: Antibiotic overuse is associated with the emergence of drug resistance. One potential strategy to decrease antibiotic overuse is biomarker-guided therapy. Several randomized controlled trials (RCT) with procalcitonin-guided therapy have resulted in reduced antibiotic use for symptoms of acute respiratory tract infections (RTI). The use of CRP as a biomarker in acute RTI is not as well-described.

Study design: Prospective, observational, diagnostic accuracy study.

Setting: Winter months, 2006 to 2008, in two hospitals in England.

Synopsis: The study examined 319 patients: 62 with pneumonia, 96 with asthma exacerbation, and 161 with COPD exacerbation. Patients with pneumonia had significantly higher procalcitonin and CRP levels than those with COPD (P<0.0001) or asthma (P<0.0001). The area under receiver operator characteristic curve for distinguishing between pneumonia (requiring antibiotics) and asthma exacerbation (not requiring antibiotics) was 0.93 (0.88-0.98) for procalcitonin and 0.96 (0.93-1.00) for CRP. A CRP value >48 mg/L had a sensitivity of 91% (95% CI 80%-97%) and specificity of 93% (95% CI 86-98).

Using this CRP threshold, antibiotic use would have been reduced by 88% in asthma exacerbation, 76% in COPD exacerbation, and 9% in pneumonia cases.

This strategy was developed in a single-center study and requires further validation in a multicenter RCT.

Bottom line: Procalcitonin and CRP were elevated in patients with pneumonia compared to patients with asthma or COPD exacerbation and might be useful in guiding antibiotic usage.

Citation: Bafadhel, M, Clark TW, Reid, C, et al. Procalcitonin and C-reactive protein in hospitalized adult patients with community-acquired pneumonia or exacerbation of asthma or COPD. Chest. 2011;139:1410-1418.

 

Survival Benefit Demonstrated with FOLFIRINOX in Select Patients with Metastatic Pancreatic Cancer

Clinical question: How does FOLFIRINOX compare to gemcitabine as first-line treatment of metastatic pancreatic cancer?

Background: Single-agent gemcitabine is the standard first-line treatment for metastatic pancreatic cancer. Preclinical studies followed by Phase 1 and Phase 2 studies have demonstrated response to the oxaliplatin, irinotecan, leucovorin, and fluorouracil regimen (FOLFIRINOX).

Study design: Multicenter, randomized, controlled Phase 2-3 trial.

Setting: Fifteen centers in France during Phase 2, which then expanded to 48 centers for Phase 3.

Synopsis: Three hundred forty-two patients with good performance status (ECOG 0 or 1) and age <76 were randomized to receive FOLFIRINOX or gemcitabine. Median survival in the FOLFIRINOX group was significantly increased, at 11.1 months, compared with 6.8 months in the gemcitabine group (HR 0.57, CI 95%, 0.45-0.73, P<000.1).

Median progression-free survival, objective response rate, and quality of life score at six months were significantly increased in the FOLFIRINOX group. Significantly more grade 3 or grade 4 toxicity was reported in the FOLFIRINOX group.

Patients with elevated bilirubin were excluded due to increased risk of irinotecan-induced toxicity, resulting in only 38% of study patients with carcinoma of the pancreatic head and low proportion of enrolled patients (14.3%) with biliary stents.

Bottom line: FOLFIRONOX was associated with a significant survival advantage compared with single-agent gemcitabine in carefully selected patients with advanced pancreatic cancer, although it was associated with increased toxicity.

Citation: Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817-1825.

MRSA Bundle Implementation at VA Hospitals Reduced Healthcare-Associated MRSA Infections

Clinical question: Can nationwide implementation of a “MRSA bundle,” including universal surveillance, contact isolation, hand hygiene, and institutional culture change, influence healthcare-associated MRSA infection rates?

Background: MRSA is a common cause of nosocomial infection. A pilot project at a single Veterans Affairs (VA) hospital utilized a “MRSA bundle” developed from published guidelines, which resulted in decreased healthcare-associated MRSA infections. In October 2007, the MRSA bundle was implemented throughout VA hospitals nationwide.

Study design: Quality-improvement (QI) observational initiative.

Setting: One hundred fifty-eight acute-care VA hospitals in the U.S.

Synopsis: From October 2007 to June 2010, there were 1,934,598 admissions, transfers, or discharges, and 8,318,675 patient-days. Of this study group, 96% of patients were screened at admission and 93% were screened at transfer or discharge. MRSA colonization or infection at the time of admission was 13.6%. Rates of healthcare-associated MRSA infection declined 45% in the non-ICU setting (0.47 to 0.26 per 1,000 patient-days, P<0.001) and 62% in the ICU setting (1.64 to 0.62 per 1,000 patient days, P<0.001).

It is unclear how much each individual component of the MRSA bundle impacted the declining MRSA infection rate.

Bottom line: Implementation of a “MRSA bundle,” including universal surveillance, contact isolation, hand hygiene, and institutional culture change, decreased the healthcare-associated MRSA infection rate in a large hospital system.

Citation: Jain R, Kralovi S, Evans M, et al. Veterans Affairs initiative to prevent methicillin-resistant Staphylococcus aureus infections. N Engl J Med. 2011;364(15):1419-1430.

New Left Bundle Branch Block Does Not Predict MI

Clinical question: How does the chronicity of left bundle branch block (LBBB) impact diagnosis and outcome in patients undergoing evaluation for acute myocardial infarction (MI)?

Background: ACA/AHA guidelines recommend that patients with new or presumed new LBBB undergo early reperfusion therapy. However, previous studies have shown that a minority of patients with new LBBB are diagnosed with MI.

Study design: Prospective cohort study.

 

Setting: University hospital in the U.S.

Synopsis: From 1994 to 2009, 401 consecutive patients undergoing evaluation for acute coronary syndrome with LBBB on initial ECG were included in the analysis. Of these patients, 64% had new (37%) or presumably new (27%) LBBB. Twenty-nine percent were diagnosed with MI, but there was no difference in frequency or size of MI between the new, presumably new, or chronic LBBB groups.

Concordant ST-T changes were an independent predictor of MI (OR 17, 95% CI 3.4-81, P<0.001) and mortality (OR 4.3, 95% CI 1.3-15, P<0.001), although this finding was present in only about 11% of the patient group.

Bottom line: Left bundle branch block is not a predictor of MI, although concordant ST-T changes were an independent predictor of MI and mortality.

Citation: Kontos MC, Aziz HA, Chau VQ, et al. Outcomes in patients with chronicity of left bundle-branch block with possible acute myocardial infarction. Am Heart J. 2011;161(4):698-704.

Acute Beta-Blocker Therapy for MI Increased Risk of Shock

Clinical question: How does acute beta-blocker therapy in myocardial infarction (MI) impact outcome?

Background: Long-term treatment with beta-blockers after myocardial infarction (MI) reduces mortality. However, data regarding outcome after acute use of beta-blockers in the first 24 hours of MI is conflicting. Updated ACA/AHA guidelines for STEMI and NSTEMI recommend caution when using beta-blockers in the first 24 hours, particularly in patients at risk for shock.

Study design: Observational registry study.

Setting: Two hundred ninety-one U.S hospitals.

Synopsis: More than 34,600 patients diagnosed with STEMI and NSTEMI from January 2007 to June 2008 were identified from a national QI MI registry. Patients were stratified by guideline-stated risk factors for shock; age >70, HR >110, and systolic BP <120 were associated with increased risk of composite outcome of shock or death.

At least one high-risk factor was present in 63% of the NSTEMI patients and 45% of STEMI patients; however, >90% of these patients received acute beta-blocker therapy. Nearly half (49%) of the NSTEMI patients received beta-blockers in the ED and 62% of the STEMI patients received beta-blockers before PCI.

In a multivariable model, NSTEMI patients receiving beta-blocker therapy in the ED were more likely to develop cardiogenic shock (OR 1.54, 95% CI 1.26-1.88, P<.001), as were STEMI patients receiving beta-blocker therapy prior to PCI (1.40, 95% CI 1.10-1.79, P=.006).

Bottom line: Caution should be exercised when using beta-blocker therapy during acute MI, particularly in the ED or prior to primary PCI.

Citation: Kontos MC, Diercks DB, Ho MP, Wang TY, Chen AY, Roe MT. Treatment and outcomes in patients with myocardial infarction treated with acute beta-blocker therapy: results from the American College of Cardiology’s NCDR. Am Heart J. 2011;161(5):864-870.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. PCI Not Inferior to CABG in Left Main Coronary Artery Stenosis at One Year, But Requires Further Study
2. CABG Did Not Decrease Mortality in Patients with CAD and Left Ventricular Dysfunction
3. Linezolid Not Superior to Glycopeptide Antibiotics in Treatment of Nosocomial Pneumonia
4. CRP and Procalcitonin Independently Differentiated Pneumonia from Asthma or COPD Exacerbation
5. Survival Benefit Demonstrated with FOLFIRINOX in Select Patients with Metastatic Pancreatic Cancer
6. MRSA Bundle Implementation at VA Hospitals Reduced Healthcare-Associated MRSA Infections
7. New Left Bundle Branch Block Does Not Predict MI
8. Acute Beta-Blocker Therapy for MI Increased Risk of Shock

PCI Not Inferior to CABG in Left Main Coronary Artery Stenosis at One Year, But Requires Further Study

Clinical question: Is percutaneous coronary intervention (PCI) an acceptable alternative to coronary artery bypass grafting (CABG) in unprotected left main coronary artery disease (CAD)?

Background: The current standard of care for unprotected left main CAD is CABG. A sub-study from a large randomized trial suggests that PCI might be an alternative to CABG for patients with left main CAD. Outcomes after the two treatments have not been directly compared in an appropriately powered trial.

Study design: Prospective, open-label, randomized trial powered for noninferiority.

Setting: Thirteen sites in South Korea.

Synopsis: Six hundred patients with newly diagnosed left main disease with >50% stenosis were randomized to PCI with a sirolimus-eluting stent versus CABG. The primary endpoint of major adverse cardiac or cerebrovascular events occurred in 8.7% in the PCI group and 6.7% in the CABG group at one year (absolute risk difference 2 percentage points, 95% CI, -1.6 to 5.6; P=0.01), which was considered noninferior.

However, ischemia-driven target-vessel revascularization occurred in significantly more patients in the PCI group than in the CABG group. The wide noninferiority margin was due to an unexpectedly low rate of events, thus underpowering the study. Also, study duration was only two years.

Bottom line: PCI with a sirolimus-eluting stent was noninferior to CABG for unprotected left main CAD in this study, but the wide noninferiority margin and limited follow-up duration limit clinical application.

Reference: Park SJ, Kim YH, Park DW, et al. Randomized trial of stents versus bypass surgery for left main coronary artery disease. N Engl J Med. 2011;364(18):1718-1727.

CABG Did Not Decrease Mortality in Patients with CAD and Left Ventricular Dysfunction

Clinical question: What role does coronary-artery bypass grafting (CABG) have in the treatment of patients with both coronary artery disease (CAD) and heart failure?

Background: Although CAD is the most common cause of heart failure, early trials that evaluated the use of CABG in relieving angina excluded patients who had left ventricular (LV) dysfunction with ejection fraction <35%. It is unknown whether CABG adds mortality benefit to intensive medical treatment in patients with CAD and LV dysfunction.

Study design: Multicenter, nonblinded, randomized trial.

Setting: One hundred twenty-seven sites in 26 countries.

Synopsis: From July 2002 to May 2007, 1,212 patients with known CAD amenable to CABG and LV ejection fraction <35% were randomized to medical therapy alone versus CABG plus medical therapy with an average follow-up of five years. The primary outcome of death from any cause occurred in 41% of the medical-therapy-alone group and 36% of the CABG-plus-medical-therapy group (hazard ratio with CABG 0.86; 95% CI 0.72 to 1.04; P=0.12).

Despite subgroup analysis suggesting decreased death rates from cardiovascular causes in the latter group, there was no significant difference in the primary endpoint of death from any cause.

Bottom line: The addition of CABG to medical therapy for patients with CAD and left ventricular dysfunction does not decrease mortality.

 

Reference: Velazquez EJ, Lee KL, Deja MA, et al. Coronary-artery bypass surgery in patients with left ventricular dysfunction. N Engl J Med. 2011;364(17):1607-1616.

Linezolid Not Superior to Glycopeptide Antibiotics in Treatment of Nosocomial Pneumonia

Clinical question: Is linezolid superior to glycopeptide antibiotics in the treatment of nosocomial pneumonia?

Background: Current ATS/IDSA guidelines suggest that linezolid might be preferred over glycopeptide antibiotics (i.e. vancomycin and teicoplanin) for methicillin-resistant Staphylococcus aureus (MRSA) pneumonia, although this recommendation is based on a retrospective subgroup analysis of one randomized trial. No systematic reviews have looked at the comparative efficacy and safety of linezolid and glycopeptide antibiotics for nosocomial pneumonia.

Study design: Meta-analysis using a highly sensitive search method.

Setting: Eight multicenter, randomized controlled trials (RCTs).

Synopsis: The study authors retrieved 762 articles with a highly sensitive search strategy, from which eight RCTs were identified that met study criteria for a total of 1,641 patients. Primary outcome of clinical success at test-of-cure was not different between the two classes of antibiotics (pooled RR 1.04, 95% CI 0.97-1.11, P=0.28). Other endpoints, including mortality and microbiologic eradication, were similar between the two groups.

Clinical success in the subgroup of patients with culture-confirmed MRSA pneumonia was not different than those without culture-proven MRSA, although the study was not powered for subgroup analysis. Risk of thrombocytopenia and renal impairment were not statistically different in the limited subgroup of trials reporting this data.

The results should not be generalized to community-acquired MRSA or MRSA pneumonia with characteristics of PVL toxin-producing strain.

Bottom line: For the treatment of nosocomial pneumonia, there was no significant difference in clinical success or mortality between linezolid and glycopeptide antibiotics.

Citation: Walkey AJ, O’Donnell MR, Weiner RS. Linezolid vs. glycopeptide antibiotics for the treatment of suspected methicillin-resistant Staphylococcus aureus nosocomial pneumonia. Chest. 2011;139: 1148-1155.

CRP and Procalcitonin Independently Differentiated Pneumonia from Asthma or COPD Exacerbation

Clinical question: Are biomarkers such as CRP or procalcitonin useful in differentiating pneumonia from asthma or COPD exacerbation in hospitalized patients?

Background: Antibiotic overuse is associated with the emergence of drug resistance. One potential strategy to decrease antibiotic overuse is biomarker-guided therapy. Several randomized controlled trials (RCT) with procalcitonin-guided therapy have resulted in reduced antibiotic use for symptoms of acute respiratory tract infections (RTI). The use of CRP as a biomarker in acute RTI is not as well-described.

Study design: Prospective, observational, diagnostic accuracy study.

Setting: Winter months, 2006 to 2008, in two hospitals in England.

Synopsis: The study examined 319 patients: 62 with pneumonia, 96 with asthma exacerbation, and 161 with COPD exacerbation. Patients with pneumonia had significantly higher procalcitonin and CRP levels than those with COPD (P<0.0001) or asthma (P<0.0001). The area under receiver operator characteristic curve for distinguishing between pneumonia (requiring antibiotics) and asthma exacerbation (not requiring antibiotics) was 0.93 (0.88-0.98) for procalcitonin and 0.96 (0.93-1.00) for CRP. A CRP value >48 mg/L had a sensitivity of 91% (95% CI 80%-97%) and specificity of 93% (95% CI 86-98).

Using this CRP threshold, antibiotic use would have been reduced by 88% in asthma exacerbation, 76% in COPD exacerbation, and 9% in pneumonia cases.

This strategy was developed in a single-center study and requires further validation in a multicenter RCT.

Bottom line: Procalcitonin and CRP were elevated in patients with pneumonia compared to patients with asthma or COPD exacerbation and might be useful in guiding antibiotic usage.

Citation: Bafadhel, M, Clark TW, Reid, C, et al. Procalcitonin and C-reactive protein in hospitalized adult patients with community-acquired pneumonia or exacerbation of asthma or COPD. Chest. 2011;139:1410-1418.

 

Survival Benefit Demonstrated with FOLFIRINOX in Select Patients with Metastatic Pancreatic Cancer

Clinical question: How does FOLFIRINOX compare to gemcitabine as first-line treatment of metastatic pancreatic cancer?

Background: Single-agent gemcitabine is the standard first-line treatment for metastatic pancreatic cancer. Preclinical studies followed by Phase 1 and Phase 2 studies have demonstrated response to the oxaliplatin, irinotecan, leucovorin, and fluorouracil regimen (FOLFIRINOX).

Study design: Multicenter, randomized, controlled Phase 2-3 trial.

Setting: Fifteen centers in France during Phase 2, which then expanded to 48 centers for Phase 3.

Synopsis: Three hundred forty-two patients with good performance status (ECOG 0 or 1) and age <76 were randomized to receive FOLFIRINOX or gemcitabine. Median survival in the FOLFIRINOX group was significantly increased, at 11.1 months, compared with 6.8 months in the gemcitabine group (HR 0.57, CI 95%, 0.45-0.73, P<000.1).

Median progression-free survival, objective response rate, and quality of life score at six months were significantly increased in the FOLFIRINOX group. Significantly more grade 3 or grade 4 toxicity was reported in the FOLFIRINOX group.

Patients with elevated bilirubin were excluded due to increased risk of irinotecan-induced toxicity, resulting in only 38% of study patients with carcinoma of the pancreatic head and low proportion of enrolled patients (14.3%) with biliary stents.

Bottom line: FOLFIRONOX was associated with a significant survival advantage compared with single-agent gemcitabine in carefully selected patients with advanced pancreatic cancer, although it was associated with increased toxicity.

Citation: Conroy T, Desseigne F, Ychou M, et al. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011;364(19):1817-1825.

MRSA Bundle Implementation at VA Hospitals Reduced Healthcare-Associated MRSA Infections

Clinical question: Can nationwide implementation of a “MRSA bundle,” including universal surveillance, contact isolation, hand hygiene, and institutional culture change, influence healthcare-associated MRSA infection rates?

Background: MRSA is a common cause of nosocomial infection. A pilot project at a single Veterans Affairs (VA) hospital utilized a “MRSA bundle” developed from published guidelines, which resulted in decreased healthcare-associated MRSA infections. In October 2007, the MRSA bundle was implemented throughout VA hospitals nationwide.

Study design: Quality-improvement (QI) observational initiative.

Setting: One hundred fifty-eight acute-care VA hospitals in the U.S.

Synopsis: From October 2007 to June 2010, there were 1,934,598 admissions, transfers, or discharges, and 8,318,675 patient-days. Of this study group, 96% of patients were screened at admission and 93% were screened at transfer or discharge. MRSA colonization or infection at the time of admission was 13.6%. Rates of healthcare-associated MRSA infection declined 45% in the non-ICU setting (0.47 to 0.26 per 1,000 patient-days, P<0.001) and 62% in the ICU setting (1.64 to 0.62 per 1,000 patient days, P<0.001).

It is unclear how much each individual component of the MRSA bundle impacted the declining MRSA infection rate.

Bottom line: Implementation of a “MRSA bundle,” including universal surveillance, contact isolation, hand hygiene, and institutional culture change, decreased the healthcare-associated MRSA infection rate in a large hospital system.

Citation: Jain R, Kralovi S, Evans M, et al. Veterans Affairs initiative to prevent methicillin-resistant Staphylococcus aureus infections. N Engl J Med. 2011;364(15):1419-1430.

New Left Bundle Branch Block Does Not Predict MI

Clinical question: How does the chronicity of left bundle branch block (LBBB) impact diagnosis and outcome in patients undergoing evaluation for acute myocardial infarction (MI)?

Background: ACA/AHA guidelines recommend that patients with new or presumed new LBBB undergo early reperfusion therapy. However, previous studies have shown that a minority of patients with new LBBB are diagnosed with MI.

Study design: Prospective cohort study.

 

Setting: University hospital in the U.S.

Synopsis: From 1994 to 2009, 401 consecutive patients undergoing evaluation for acute coronary syndrome with LBBB on initial ECG were included in the analysis. Of these patients, 64% had new (37%) or presumably new (27%) LBBB. Twenty-nine percent were diagnosed with MI, but there was no difference in frequency or size of MI between the new, presumably new, or chronic LBBB groups.

Concordant ST-T changes were an independent predictor of MI (OR 17, 95% CI 3.4-81, P<0.001) and mortality (OR 4.3, 95% CI 1.3-15, P<0.001), although this finding was present in only about 11% of the patient group.

Bottom line: Left bundle branch block is not a predictor of MI, although concordant ST-T changes were an independent predictor of MI and mortality.

Citation: Kontos MC, Aziz HA, Chau VQ, et al. Outcomes in patients with chronicity of left bundle-branch block with possible acute myocardial infarction. Am Heart J. 2011;161(4):698-704.

Acute Beta-Blocker Therapy for MI Increased Risk of Shock

Clinical question: How does acute beta-blocker therapy in myocardial infarction (MI) impact outcome?

Background: Long-term treatment with beta-blockers after myocardial infarction (MI) reduces mortality. However, data regarding outcome after acute use of beta-blockers in the first 24 hours of MI is conflicting. Updated ACA/AHA guidelines for STEMI and NSTEMI recommend caution when using beta-blockers in the first 24 hours, particularly in patients at risk for shock.

Study design: Observational registry study.

Setting: Two hundred ninety-one U.S hospitals.

Synopsis: More than 34,600 patients diagnosed with STEMI and NSTEMI from January 2007 to June 2008 were identified from a national QI MI registry. Patients were stratified by guideline-stated risk factors for shock; age >70, HR >110, and systolic BP <120 were associated with increased risk of composite outcome of shock or death.

At least one high-risk factor was present in 63% of the NSTEMI patients and 45% of STEMI patients; however, >90% of these patients received acute beta-blocker therapy. Nearly half (49%) of the NSTEMI patients received beta-blockers in the ED and 62% of the STEMI patients received beta-blockers before PCI.

In a multivariable model, NSTEMI patients receiving beta-blocker therapy in the ED were more likely to develop cardiogenic shock (OR 1.54, 95% CI 1.26-1.88, P<.001), as were STEMI patients receiving beta-blocker therapy prior to PCI (1.40, 95% CI 1.10-1.79, P=.006).

Bottom line: Caution should be exercised when using beta-blocker therapy during acute MI, particularly in the ED or prior to primary PCI.

Citation: Kontos MC, Diercks DB, Ho MP, Wang TY, Chen AY, Roe MT. Treatment and outcomes in patients with myocardial infarction treated with acute beta-blocker therapy: results from the American College of Cardiology’s NCDR. Am Heart J. 2011;161(5):864-870.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. High-dose vs. low-dose clopidogrel after cardiac stenting
2. Rates of overdiagnosis of PE with CTPA
3. Outcomes of hospitalists with PAs or residents
4. White coats and MRSA
5. Correlation of vital signs and pain
6. Rate of asymptomatic perioperative MI
7. Relationship of opioid prescription patterns and overdose
8. Interdisciplinary rounds and rates of adverse events

High-Dose Clopidogrel Is Not Superior to Standard-Dose Clopidogrel in Patients with High On-Treatment Platelet Activity after Percutaneous Corona

Clinical question: In patients with high on-treatment platelet activity, does the use of high-dose clopidogrel after percutaneous coronary intervention (PCI) decrease the risk of cardiovascular events?

Background: In patients receiving clopidogrel, high platelet reactivity after PCI is associated with an increase in cardiovascular events. At present, treatments targeted at this population are not well-defined.

Study design: Randomized, double-blind, active-control trial.

Setting: Eighty-three centers in North America.

Synopsis: Researchers randomized 2,214 patients with drug-eluting stents to receive either high-dose clopidogrel (600 mg initial dose, 150 mg daily thereafter) or standard-dose clopidogrel (no additional loading dose, 75 mg daily). At six months, the primary endpoint of death from cardiovascular causes, nonfatal myocardial infarction, or stent thrombosis was no different in the two groups (2.3% in the high-dose group versus 2.3% in the standard-dose group; hazard ratio 1.01).

Bottom line: High-dose clopidogrel adds no benefit over standard-dose clopidogrel in patients with high platelet reactivity who have undergone PCI with drug-eluting stent placement.

Citation: Price MJ, Berger PB, Teirstein PS, et al. Standard- vs. high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA. 2011;305(11):1097-1105.

Computed Tomographic Pulmonary Angiography (CTPA) Is Associated with Overdiagnosis and Overtreatment of Pulmonary Embolism (PE)

Clinical question: Is the use of CTPA associated with increased incidence of PE and increased complications from anticoagulation treatment?

Background: CTPA is a sensitive, noninvasive test for diagnosing PE that could have a drawback: identifying potentially clinically unimportant (small) pulmonary emboli that subsequently are treated. Overtreatment might be associated with patient harm due to increased complications of anticoagulation therapy.

Study design: Time-trend analysis of PE between the pre-CTPA period (1993 to 1998) and the post-CTPA period (1998 to 2006).

Setting: Nongovernmental U.S. hospitals.

Synopsis: The Nationwide Inpatient Sample and Multiple Cause-of-Death databases were used to determine national estimates of hospitalization for PE, along with morbidity and mortality from PE.

The age-adjusted analysis revealed a statistically significant increase in the incidence of PE diagnosis after introduction of CTPA (to 112 per 100,000 from 62 per 100,000), with minimal change in overall PE mortality. This was accompanied by a substantial reduction in PE case-fatality rate, the rate of hospital deaths among patients with a diagnosis of pulmonary embolism.

Availability of CTPA was associated with a significant increase in anticoagulation complication rates (to 5.3 per 100,000 from 3.1 per 100,000), including statistically significant increases in gastrointestinal hemorrhage and secondary thrombocytopenia, and a trend toward higher rates of intracranial hemorrhage.

Bottom line: Introduction of CTPA was associated with changes suggestive of overdiagnosis (increased incidence, relatively unchanged mortality) and overtreatment (increased complication rates) of PE, but it remains unknown which small PEs are clinically significant.

Citation: Wiener RS, Schwartz LM, Woloshin S. Time trends in pulmonary embolism in the United States: evidence of overdiagnosis. Arch Intern Med. 2011;171(9):831-837.

Hospitalist-Physician Assistant Teams Associated with Longer Length of Stay, No Change in Mortality, Readmission Rates

Clinical question: Do length of stay (LOS), hospital mortality, or readmission rate change if hospitalists and physician assistants, or the traditional resident-hospitalist teams, provide the patient care?

 

Background: Resident work-hour limitations require new models of care for hospitalized patients. Many academic medical centers have hired physician assistants to work with hospitalists to provide care. Little is known about how these models affect such outcomes as LOS, inpatient mortality rates, and readmission rates.

Study design: Retrospective cohort.

Setting: A 430-bed urban academic medical center in Milwaukee.

Synopsis: Administrative data were gathered on 9,681 patients admitted to the general medical service. Of those enrolled, 2,171 were cared for by a hospitalist-physician assistant (H-PA) team, while resident-hospitalist teams cared for 7,510 patients. Patient assignment was dependent on time of admission but not on patient complexity. Patients admitted overnight after the resident team capped were assigned to the H-PA team the next morning, resulting in increased transitions of care for the H-PA team.

Adjusted analyses revealed a 6.45% increase in LOS for the H-PA team compared with the resident team. Charges, inpatient mortality, and readmission rates at seven, 14, and 30 days were unchanged. Subgroup analyses revealed smaller differences in LOS for H-PA teams and resident-hospitalist teams with the same hospitalist (LOS 5.44% higher, P=0.081).

Conclusions from this study are limited due to lack of randomization of assignment, the retrospective design, and the use of administrative data at one institution.

Bottom line: Hospitalist-PA teams might result in a slightly increased LOS compared with the traditional resident teams; however, inpatient mortality and readmission rates are similar.

Citation: Singh S, Fletcher KE, Schapira MM, et al. A comparison of outcomes of general medical inpatient care provided by a hospitalist-physician assistant model vs a traditional resident-based model. J Hosp Med. 2011;6:122-130.

 

Washing White Coats Does Not Lower MRSA Bacterial Contamination

Clinical question: Are clean, short-sleeved uniforms less likely to carry MRSA than regularly laundered long-sleeved white coats?

Background: Studies have shown that bacteria frequently colonize in physician garments. However, evidence that short-sleeved garments or newly laundered garments are less likely to be contaminated has been lacking. Despite the paucity of evidence, the British Department of Health barred the use of traditional white coats and long-sleeved garments in 2007.

Study design: Prospective, randomized, controlled trial.

Setting: Urban U.S. hospital.

Synopsis: Study authors randomized 100 internal-medicine residents and hospitalists to their own long-sleeved white coats or freshly laundered short-sleeved uniforms from August 2008 to November 2009. Swabs were taken from the sleeves of the white coats or uniform, the breast pocket, and the volar wrist surface of the dominant hand. Swabs were cultured for MRSA and for general colony count.

Results showed no significant difference in colony counts or MRSA colonization in any of the sites tested between the newly laundered uniforms and the white coats. Additionally, there was no effect in relation to the frequency of laundering the white coats. Notably, within three hours of donning freshly laundered uniforms, bacterial counts approached 50% of the total bacterial counts seen at eight hours.

Bottom line: Laundering of uniforms does not affect MRSA colonization rate or general bacterial burden on physician uniforms or skin surfaces, though the effect on nosocomial infection has not been established.

Citation: Burden M, Cervantes L, Weed D, Keniston A, Price CS, Albert RK. Newly cleaned physician uniforms and infrequently washed white coats have similar rates of bacterial contamination after an 8-hour workday: a randomized controlled trial. J Hosp Med. 2011;6:177-182.

Self-Reported Pain Severity Does Not Correlate with Heart Rate or Blood Pressure Measurements in Pre-Hospital Setting

Clinical question: Do measured vital signs, including heart rate, blood pressure, and respiratory rate, correlate with the degree of self-reported pain?

Background: Because pain often can be associated with alterations in autonomic tone, it has been hypothesized that alterations in vital signs will occur in patients who report pain.

Study design: Retrospective cohort study.

Setting: Pre-hospital in Melbourne, Australia.

Synopsis: The authors reviewed all ambulance patient care records for patients age >14 years with a Glasgow Coma Score (GCS) >12 transported to a hospital during a seven-day period in 2005. Patients were selected for analysis if their patient care record included an initial assessment of pain severity, as measured by a numeric rating scale (NRS), in which patients rate their pain from 0 to 10.

More than half of the 3,357 patients transported by paramedics during the period were included in this analysis (n=1286). There was no correlation between heart rate or systolic blood pressure with the degree of self-reported pain. Although an increased respiratory rate was statistically correlated with a higher rating of pain, this relationship was not clinically significant, as each one-point increase in the pain rating scale was associated with a 0.16-breaths-per-minute increase in the respiratory rate.

Limitations included the large number of records excluded from analysis because pain was not evaluated, as well as numerous unmeasured confounders, including active disease processes such as sepsis, that were not accounted for.

Bottom line: Severity of pain did not correlate with heart rate or systolic blood pressure in the pre-hospital setting.

Citation: Lord B, Woollard M. The reliability of vital signs in estimating pain severity among adult patients treated by paramedics. Emerg Med J. 2011;28:147-150.

Asymptomatic Perioperative Myocardial Infarction Is Common in Patients Undergoing Noncardiac Surgery

 

Clinical question: In patients undergoing noncardiac surgery, what is the incidence and clinical characteristics of perioperative myocardial infarction (MI)?

Background: Though millions of patients experience perioperative MI after noncardiac surgery, little is known about the characteristics and outcomes of these patients.

Study design: Cohort study.

Setting: One hundred ninety centers in 23 countries.

Synopsis: Using data from the 8,351 patients in the POISE (PeriOperative ISchemic Evaluation) trial, this study showed that perioperative MI occurred in 5% of patients; 65% were asymptomatic. Patients who experienced postoperative MI were older and had more cardiovascular risk factors when compared to those who did not. The 30-day mortality was higher in patients with a perioperative MI (11.6%) compared with those who did not (2.2%); the presence or absence of ischemic symptoms was not associated with mortality rate.

Of the 8.3% of patients who experienced an elevation in cardiac biomarkers but who did not meet the definition of MI, there was an increased risk of nonfatal cardiac arrest and nonacute coronary revascularization. Those in the highest quartile also had increased 30-day mortality.

Bottom line: Given the high proportion of asymptomatic MIs and isolated elevations in cardiac biomarkers and the association between these events and increased risk of death, hospitalists should consider routine monitoring of troponin in at-risk patients undergoing noncardiac surgery.

Citation: Devereaux PJ, Xavier D, Pogue J, et al. Characteristics and short-term prognosis of perioperative myocardial infarction in patients undergoing noncardiac surgery: a cohort study. Ann Intern Med. 2011;154(8):523-528.

Patients Prescribed Higher Opioid Doses Are at Increased Risk of Opioid Overdose Death

Clinical question: What is the association between opioid prescribing patterns and fatal opioid overdose?

Background: In the past 10 years, the rate of fatal overdose from opioid prescription for pain has more than doubled. Little is known about how the indications (substance abuse disorders, cancer-related pain, chronic pain, acute pain), maximal daily dose, and scheduling (standing, as-needed, or both) of opioid prescriptions relate to this increased risk.

Study design: Case-cohort study.

Setting: Veterans Health Administration (VHA) patients.

Synopsis: The VHA’s National Patient Care Database was used to randomly select a cohort of 154,684 nonhospice/nonpalliative-care patients who were prescribed opioids from 2004 to 2008. They were compared with 750 patients who were treated with prescription opioids who died from opioid overdose during this time.

Fatal opioid overdose was a rare event (0.04%), but risk increased with higher prescribed maximum daily morphine dose-equivalence, especially when greater than or equal to 50 mg/day in all subgroups (substance abuse, acute and chronic pain, and cancer). Fatal overdoses were higher in middle-aged white men with acute or chronic pain, substance abuse disorders, and other psychiatric illness. Patients with cancer were at increased risk of fatal overdose if they were prescribed as-needed opioids alone.

Treatment with both as-needed and standing opioids did not statistically affect risk of overdose death in any subgroup.

Bottom line: Although rare, risk of fatal opioid overdose in patients prescribed opiate medication increases with higher maximum prescribed daily dose.

Citation: Bohnert AS, Valenstein M, Bair M, et al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA. 2011; 305:1315-1321.

Structured Interdisciplinary Rounds on Medical Teaching Unit Significantly Decrease Adverse Events

Clinical question: Do structured interdisciplinary rounds have an impact on the rate of adverse events?

Background: Many preventable adverse events occurring during hospitalization can be attributed to communication failures. Structured interdisciplinary rounds provide a format as well as a forum for team members to discuss patient care. Prior studies demonstrated improvements in collaboration; whether this translates to better patient care is not known.

 

Study design: Retrospective cohort using historic and concurrent control.

Setting: Tertiary-care teaching hospital in Chicago.

Synopsis: Structured interdisciplinary rounds, led by a nurse manager and medical director, and including nurses, residents, pharmacists, social workers, and case managers, were implemented on a medical teaching unit. New patients were discussed using a structured communication tool; existing patients were discussed in an unstructured format. Medical records were abstracted for 370 patients hospitalized after implementation of the intervention, equally divided between intervention and control units. One hundred eighty-five patients hospitalized on the intervention unit prior to the implementation of rounds served as a historic control.

Patients in the intervention unit had significantly lower rates of total adverse events (3.9 per 100 patient days in the intervention, compared with 7.2 and 7.7 per 100 patient days for the concurrent and historic control units, respectively), and preventable adverse events (0.9 per 100 patient days, compared with 2.8 and 2.1 per 100 patient days for the concurrent and historic controls, respectively).

Limitations of the study include lack of blinding of the medical record, slightly different patient populations in intervention and control groups, and the one-hospital setting, which could limit generalizability.

Bottom line: Structured interdisciplinary rounds might serve to improve communication between nurses, pharmacists, and physicians, resulting in decreases in adverse events.

Citation: O’Leary KJ, Buck R, Fligiel HM, et al. Structured interdisciplinary rounds in a medical teaching unit: improving patient safety. Arch Intern Med. 2011;171(7):678-684.

 

 

In This Edition

Literature At A Glance

A guide to this month’s studies

1. High-dose vs. low-dose clopidogrel after cardiac stenting
2. Rates of overdiagnosis of PE with CTPA
3. Outcomes of hospitalists with PAs or residents
4. White coats and MRSA
5. Correlation of vital signs and pain
6. Rate of asymptomatic perioperative MI
7. Relationship of opioid prescription patterns and overdose
8. Interdisciplinary rounds and rates of adverse events

High-Dose Clopidogrel Is Not Superior to Standard-Dose Clopidogrel in Patients with High On-Treatment Platelet Activity after Percutaneous Corona

Clinical question: In patients with high on-treatment platelet activity, does the use of high-dose clopidogrel after percutaneous coronary intervention (PCI) decrease the risk of cardiovascular events?

Background: In patients receiving clopidogrel, high platelet reactivity after PCI is associated with an increase in cardiovascular events. At present, treatments targeted at this population are not well-defined.

Study design: Randomized, double-blind, active-control trial.

Setting: Eighty-three centers in North America.

Synopsis: Researchers randomized 2,214 patients with drug-eluting stents to receive either high-dose clopidogrel (600 mg initial dose, 150 mg daily thereafter) or standard-dose clopidogrel (no additional loading dose, 75 mg daily). At six months, the primary endpoint of death from cardiovascular causes, nonfatal myocardial infarction, or stent thrombosis was no different in the two groups (2.3% in the high-dose group versus 2.3% in the standard-dose group; hazard ratio 1.01).

Bottom line: High-dose clopidogrel adds no benefit over standard-dose clopidogrel in patients with high platelet reactivity who have undergone PCI with drug-eluting stent placement.

Citation: Price MJ, Berger PB, Teirstein PS, et al. Standard- vs. high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA. 2011;305(11):1097-1105.

Computed Tomographic Pulmonary Angiography (CTPA) Is Associated with Overdiagnosis and Overtreatment of Pulmonary Embolism (PE)

Clinical question: Is the use of CTPA associated with increased incidence of PE and increased complications from anticoagulation treatment?

Background: CTPA is a sensitive, noninvasive test for diagnosing PE that could have a drawback: identifying potentially clinically unimportant (small) pulmonary emboli that subsequently are treated. Overtreatment might be associated with patient harm due to increased complications of anticoagulation therapy.

Study design: Time-trend analysis of PE between the pre-CTPA period (1993 to 1998) and the post-CTPA period (1998 to 2006).

Setting: Nongovernmental U.S. hospitals.

Synopsis: The Nationwide Inpatient Sample and Multiple Cause-of-Death databases were used to determine national estimates of hospitalization for PE, along with morbidity and mortality from PE.

The age-adjusted analysis revealed a statistically significant increase in the incidence of PE diagnosis after introduction of CTPA (to 112 per 100,000 from 62 per 100,000), with minimal change in overall PE mortality. This was accompanied by a substantial reduction in PE case-fatality rate, the rate of hospital deaths among patients with a diagnosis of pulmonary embolism.

Availability of CTPA was associated with a significant increase in anticoagulation complication rates (to 5.3 per 100,000 from 3.1 per 100,000), including statistically significant increases in gastrointestinal hemorrhage and secondary thrombocytopenia, and a trend toward higher rates of intracranial hemorrhage.

Bottom line: Introduction of CTPA was associated with changes suggestive of overdiagnosis (increased incidence, relatively unchanged mortality) and overtreatment (increased complication rates) of PE, but it remains unknown which small PEs are clinically significant.

Citation: Wiener RS, Schwartz LM, Woloshin S. Time trends in pulmonary embolism in the United States: evidence of overdiagnosis. Arch Intern Med. 2011;171(9):831-837.

Hospitalist-Physician Assistant Teams Associated with Longer Length of Stay, No Change in Mortality, Readmission Rates

Clinical question: Do length of stay (LOS), hospital mortality, or readmission rate change if hospitalists and physician assistants, or the traditional resident-hospitalist teams, provide the patient care?

 

Background: Resident work-hour limitations require new models of care for hospitalized patients. Many academic medical centers have hired physician assistants to work with hospitalists to provide care. Little is known about how these models affect such outcomes as LOS, inpatient mortality rates, and readmission rates.

Study design: Retrospective cohort.

Setting: A 430-bed urban academic medical center in Milwaukee.

Synopsis: Administrative data were gathered on 9,681 patients admitted to the general medical service. Of those enrolled, 2,171 were cared for by a hospitalist-physician assistant (H-PA) team, while resident-hospitalist teams cared for 7,510 patients. Patient assignment was dependent on time of admission but not on patient complexity. Patients admitted overnight after the resident team capped were assigned to the H-PA team the next morning, resulting in increased transitions of care for the H-PA team.

Adjusted analyses revealed a 6.45% increase in LOS for the H-PA team compared with the resident team. Charges, inpatient mortality, and readmission rates at seven, 14, and 30 days were unchanged. Subgroup analyses revealed smaller differences in LOS for H-PA teams and resident-hospitalist teams with the same hospitalist (LOS 5.44% higher, P=0.081).

Conclusions from this study are limited due to lack of randomization of assignment, the retrospective design, and the use of administrative data at one institution.

Bottom line: Hospitalist-PA teams might result in a slightly increased LOS compared with the traditional resident teams; however, inpatient mortality and readmission rates are similar.

Citation: Singh S, Fletcher KE, Schapira MM, et al. A comparison of outcomes of general medical inpatient care provided by a hospitalist-physician assistant model vs a traditional resident-based model. J Hosp Med. 2011;6:122-130.

 

Washing White Coats Does Not Lower MRSA Bacterial Contamination

Clinical question: Are clean, short-sleeved uniforms less likely to carry MRSA than regularly laundered long-sleeved white coats?

Background: Studies have shown that bacteria frequently colonize in physician garments. However, evidence that short-sleeved garments or newly laundered garments are less likely to be contaminated has been lacking. Despite the paucity of evidence, the British Department of Health barred the use of traditional white coats and long-sleeved garments in 2007.

Study design: Prospective, randomized, controlled trial.

Setting: Urban U.S. hospital.

Synopsis: Study authors randomized 100 internal-medicine residents and hospitalists to their own long-sleeved white coats or freshly laundered short-sleeved uniforms from August 2008 to November 2009. Swabs were taken from the sleeves of the white coats or uniform, the breast pocket, and the volar wrist surface of the dominant hand. Swabs were cultured for MRSA and for general colony count.

Results showed no significant difference in colony counts or MRSA colonization in any of the sites tested between the newly laundered uniforms and the white coats. Additionally, there was no effect in relation to the frequency of laundering the white coats. Notably, within three hours of donning freshly laundered uniforms, bacterial counts approached 50% of the total bacterial counts seen at eight hours.

Bottom line: Laundering of uniforms does not affect MRSA colonization rate or general bacterial burden on physician uniforms or skin surfaces, though the effect on nosocomial infection has not been established.

Citation: Burden M, Cervantes L, Weed D, Keniston A, Price CS, Albert RK. Newly cleaned physician uniforms and infrequently washed white coats have similar rates of bacterial contamination after an 8-hour workday: a randomized controlled trial. J Hosp Med. 2011;6:177-182.

Self-Reported Pain Severity Does Not Correlate with Heart Rate or Blood Pressure Measurements in Pre-Hospital Setting

Clinical question: Do measured vital signs, including heart rate, blood pressure, and respiratory rate, correlate with the degree of self-reported pain?

Background: Because pain often can be associated with alterations in autonomic tone, it has been hypothesized that alterations in vital signs will occur in patients who report pain.

Study design: Retrospective cohort study.

Setting: Pre-hospital in Melbourne, Australia.

Synopsis: The authors reviewed all ambulance patient care records for patients age >14 years with a Glasgow Coma Score (GCS) >12 transported to a hospital during a seven-day period in 2005. Patients were selected for analysis if their patient care record included an initial assessment of pain severity, as measured by a numeric rating scale (NRS), in which patients rate their pain from 0 to 10.

More than half of the 3,357 patients transported by paramedics during the period were included in this analysis (n=1286). There was no correlation between heart rate or systolic blood pressure with the degree of self-reported pain. Although an increased respiratory rate was statistically correlated with a higher rating of pain, this relationship was not clinically significant, as each one-point increase in the pain rating scale was associated with a 0.16-breaths-per-minute increase in the respiratory rate.

Limitations included the large number of records excluded from analysis because pain was not evaluated, as well as numerous unmeasured confounders, including active disease processes such as sepsis, that were not accounted for.

Bottom line: Severity of pain did not correlate with heart rate or systolic blood pressure in the pre-hospital setting.

Citation: Lord B, Woollard M. The reliability of vital signs in estimating pain severity among adult patients treated by paramedics. Emerg Med J. 2011;28:147-150.

Asymptomatic Perioperative Myocardial Infarction Is Common in Patients Undergoing Noncardiac Surgery

 

Clinical question: In patients undergoing noncardiac surgery, what is the incidence and clinical characteristics of perioperative myocardial infarction (MI)?

Background: Though millions of patients experience perioperative MI after noncardiac surgery, little is known about the characteristics and outcomes of these patients.

Study design: Cohort study.

Setting: One hundred ninety centers in 23 countries.

Synopsis: Using data from the 8,351 patients in the POISE (PeriOperative ISchemic Evaluation) trial, this study showed that perioperative MI occurred in 5% of patients; 65% were asymptomatic. Patients who experienced postoperative MI were older and had more cardiovascular risk factors when compared to those who did not. The 30-day mortality was higher in patients with a perioperative MI (11.6%) compared with those who did not (2.2%); the presence or absence of ischemic symptoms was not associated with mortality rate.

Of the 8.3% of patients who experienced an elevation in cardiac biomarkers but who did not meet the definition of MI, there was an increased risk of nonfatal cardiac arrest and nonacute coronary revascularization. Those in the highest quartile also had increased 30-day mortality.

Bottom line: Given the high proportion of asymptomatic MIs and isolated elevations in cardiac biomarkers and the association between these events and increased risk of death, hospitalists should consider routine monitoring of troponin in at-risk patients undergoing noncardiac surgery.

Citation: Devereaux PJ, Xavier D, Pogue J, et al. Characteristics and short-term prognosis of perioperative myocardial infarction in patients undergoing noncardiac surgery: a cohort study. Ann Intern Med. 2011;154(8):523-528.

Patients Prescribed Higher Opioid Doses Are at Increased Risk of Opioid Overdose Death

Clinical question: What is the association between opioid prescribing patterns and fatal opioid overdose?

Background: In the past 10 years, the rate of fatal overdose from opioid prescription for pain has more than doubled. Little is known about how the indications (substance abuse disorders, cancer-related pain, chronic pain, acute pain), maximal daily dose, and scheduling (standing, as-needed, or both) of opioid prescriptions relate to this increased risk.

Study design: Case-cohort study.

Setting: Veterans Health Administration (VHA) patients.

Synopsis: The VHA’s National Patient Care Database was used to randomly select a cohort of 154,684 nonhospice/nonpalliative-care patients who were prescribed opioids from 2004 to 2008. They were compared with 750 patients who were treated with prescription opioids who died from opioid overdose during this time.

Fatal opioid overdose was a rare event (0.04%), but risk increased with higher prescribed maximum daily morphine dose-equivalence, especially when greater than or equal to 50 mg/day in all subgroups (substance abuse, acute and chronic pain, and cancer). Fatal overdoses were higher in middle-aged white men with acute or chronic pain, substance abuse disorders, and other psychiatric illness. Patients with cancer were at increased risk of fatal overdose if they were prescribed as-needed opioids alone.

Treatment with both as-needed and standing opioids did not statistically affect risk of overdose death in any subgroup.

Bottom line: Although rare, risk of fatal opioid overdose in patients prescribed opiate medication increases with higher maximum prescribed daily dose.

Citation: Bohnert AS, Valenstein M, Bair M, et al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA. 2011; 305:1315-1321.

Structured Interdisciplinary Rounds on Medical Teaching Unit Significantly Decrease Adverse Events

Clinical question: Do structured interdisciplinary rounds have an impact on the rate of adverse events?

Background: Many preventable adverse events occurring during hospitalization can be attributed to communication failures. Structured interdisciplinary rounds provide a format as well as a forum for team members to discuss patient care. Prior studies demonstrated improvements in collaboration; whether this translates to better patient care is not known.

 

Study design: Retrospective cohort using historic and concurrent control.

Setting: Tertiary-care teaching hospital in Chicago.

Synopsis: Structured interdisciplinary rounds, led by a nurse manager and medical director, and including nurses, residents, pharmacists, social workers, and case managers, were implemented on a medical teaching unit. New patients were discussed using a structured communication tool; existing patients were discussed in an unstructured format. Medical records were abstracted for 370 patients hospitalized after implementation of the intervention, equally divided between intervention and control units. One hundred eighty-five patients hospitalized on the intervention unit prior to the implementation of rounds served as a historic control.

Patients in the intervention unit had significantly lower rates of total adverse events (3.9 per 100 patient days in the intervention, compared with 7.2 and 7.7 per 100 patient days for the concurrent and historic control units, respectively), and preventable adverse events (0.9 per 100 patient days, compared with 2.8 and 2.1 per 100 patient days for the concurrent and historic controls, respectively).

Limitations of the study include lack of blinding of the medical record, slightly different patient populations in intervention and control groups, and the one-hospital setting, which could limit generalizability.

Bottom line: Structured interdisciplinary rounds might serve to improve communication between nurses, pharmacists, and physicians, resulting in decreases in adverse events.

Citation: O’Leary KJ, Buck R, Fligiel HM, et al. Structured interdisciplinary rounds in a medical teaching unit: improving patient safety. Arch Intern Med. 2011;171(7):678-684.

 

 

In This Edition

Literature At A Glance

A guide to this month’s studies

1. High-dose vs. low-dose clopidogrel after cardiac stenting
2. Rates of overdiagnosis of PE with CTPA
3. Outcomes of hospitalists with PAs or residents
4. White coats and MRSA
5. Correlation of vital signs and pain
6. Rate of asymptomatic perioperative MI
7. Relationship of opioid prescription patterns and overdose
8. Interdisciplinary rounds and rates of adverse events

High-Dose Clopidogrel Is Not Superior to Standard-Dose Clopidogrel in Patients with High On-Treatment Platelet Activity after Percutaneous Corona

Clinical question: In patients with high on-treatment platelet activity, does the use of high-dose clopidogrel after percutaneous coronary intervention (PCI) decrease the risk of cardiovascular events?

Background: In patients receiving clopidogrel, high platelet reactivity after PCI is associated with an increase in cardiovascular events. At present, treatments targeted at this population are not well-defined.

Study design: Randomized, double-blind, active-control trial.

Setting: Eighty-three centers in North America.

Synopsis: Researchers randomized 2,214 patients with drug-eluting stents to receive either high-dose clopidogrel (600 mg initial dose, 150 mg daily thereafter) or standard-dose clopidogrel (no additional loading dose, 75 mg daily). At six months, the primary endpoint of death from cardiovascular causes, nonfatal myocardial infarction, or stent thrombosis was no different in the two groups (2.3% in the high-dose group versus 2.3% in the standard-dose group; hazard ratio 1.01).

Bottom line: High-dose clopidogrel adds no benefit over standard-dose clopidogrel in patients with high platelet reactivity who have undergone PCI with drug-eluting stent placement.

Citation: Price MJ, Berger PB, Teirstein PS, et al. Standard- vs. high-dose clopidogrel based on platelet function testing after percutaneous coronary intervention: the GRAVITAS randomized trial. JAMA. 2011;305(11):1097-1105.

Computed Tomographic Pulmonary Angiography (CTPA) Is Associated with Overdiagnosis and Overtreatment of Pulmonary Embolism (PE)

Clinical question: Is the use of CTPA associated with increased incidence of PE and increased complications from anticoagulation treatment?

Background: CTPA is a sensitive, noninvasive test for diagnosing PE that could have a drawback: identifying potentially clinically unimportant (small) pulmonary emboli that subsequently are treated. Overtreatment might be associated with patient harm due to increased complications of anticoagulation therapy.

Study design: Time-trend analysis of PE between the pre-CTPA period (1993 to 1998) and the post-CTPA period (1998 to 2006).

Setting: Nongovernmental U.S. hospitals.

Synopsis: The Nationwide Inpatient Sample and Multiple Cause-of-Death databases were used to determine national estimates of hospitalization for PE, along with morbidity and mortality from PE.

The age-adjusted analysis revealed a statistically significant increase in the incidence of PE diagnosis after introduction of CTPA (to 112 per 100,000 from 62 per 100,000), with minimal change in overall PE mortality. This was accompanied by a substantial reduction in PE case-fatality rate, the rate of hospital deaths among patients with a diagnosis of pulmonary embolism.

Availability of CTPA was associated with a significant increase in anticoagulation complication rates (to 5.3 per 100,000 from 3.1 per 100,000), including statistically significant increases in gastrointestinal hemorrhage and secondary thrombocytopenia, and a trend toward higher rates of intracranial hemorrhage.

Bottom line: Introduction of CTPA was associated with changes suggestive of overdiagnosis (increased incidence, relatively unchanged mortality) and overtreatment (increased complication rates) of PE, but it remains unknown which small PEs are clinically significant.

Citation: Wiener RS, Schwartz LM, Woloshin S. Time trends in pulmonary embolism in the United States: evidence of overdiagnosis. Arch Intern Med. 2011;171(9):831-837.

Hospitalist-Physician Assistant Teams Associated with Longer Length of Stay, No Change in Mortality, Readmission Rates

Clinical question: Do length of stay (LOS), hospital mortality, or readmission rate change if hospitalists and physician assistants, or the traditional resident-hospitalist teams, provide the patient care?

 

Background: Resident work-hour limitations require new models of care for hospitalized patients. Many academic medical centers have hired physician assistants to work with hospitalists to provide care. Little is known about how these models affect such outcomes as LOS, inpatient mortality rates, and readmission rates.

Study design: Retrospective cohort.

Setting: A 430-bed urban academic medical center in Milwaukee.

Synopsis: Administrative data were gathered on 9,681 patients admitted to the general medical service. Of those enrolled, 2,171 were cared for by a hospitalist-physician assistant (H-PA) team, while resident-hospitalist teams cared for 7,510 patients. Patient assignment was dependent on time of admission but not on patient complexity. Patients admitted overnight after the resident team capped were assigned to the H-PA team the next morning, resulting in increased transitions of care for the H-PA team.

Adjusted analyses revealed a 6.45% increase in LOS for the H-PA team compared with the resident team. Charges, inpatient mortality, and readmission rates at seven, 14, and 30 days were unchanged. Subgroup analyses revealed smaller differences in LOS for H-PA teams and resident-hospitalist teams with the same hospitalist (LOS 5.44% higher, P=0.081).

Conclusions from this study are limited due to lack of randomization of assignment, the retrospective design, and the use of administrative data at one institution.

Bottom line: Hospitalist-PA teams might result in a slightly increased LOS compared with the traditional resident teams; however, inpatient mortality and readmission rates are similar.

Citation: Singh S, Fletcher KE, Schapira MM, et al. A comparison of outcomes of general medical inpatient care provided by a hospitalist-physician assistant model vs a traditional resident-based model. J Hosp Med. 2011;6:122-130.

 

Washing White Coats Does Not Lower MRSA Bacterial Contamination

Clinical question: Are clean, short-sleeved uniforms less likely to carry MRSA than regularly laundered long-sleeved white coats?

Background: Studies have shown that bacteria frequently colonize in physician garments. However, evidence that short-sleeved garments or newly laundered garments are less likely to be contaminated has been lacking. Despite the paucity of evidence, the British Department of Health barred the use of traditional white coats and long-sleeved garments in 2007.

Study design: Prospective, randomized, controlled trial.

Setting: Urban U.S. hospital.

Synopsis: Study authors randomized 100 internal-medicine residents and hospitalists to their own long-sleeved white coats or freshly laundered short-sleeved uniforms from August 2008 to November 2009. Swabs were taken from the sleeves of the white coats or uniform, the breast pocket, and the volar wrist surface of the dominant hand. Swabs were cultured for MRSA and for general colony count.

Results showed no significant difference in colony counts or MRSA colonization in any of the sites tested between the newly laundered uniforms and the white coats. Additionally, there was no effect in relation to the frequency of laundering the white coats. Notably, within three hours of donning freshly laundered uniforms, bacterial counts approached 50% of the total bacterial counts seen at eight hours.

Bottom line: Laundering of uniforms does not affect MRSA colonization rate or general bacterial burden on physician uniforms or skin surfaces, though the effect on nosocomial infection has not been established.

Citation: Burden M, Cervantes L, Weed D, Keniston A, Price CS, Albert RK. Newly cleaned physician uniforms and infrequently washed white coats have similar rates of bacterial contamination after an 8-hour workday: a randomized controlled trial. J Hosp Med. 2011;6:177-182.

Self-Reported Pain Severity Does Not Correlate with Heart Rate or Blood Pressure Measurements in Pre-Hospital Setting

Clinical question: Do measured vital signs, including heart rate, blood pressure, and respiratory rate, correlate with the degree of self-reported pain?

Background: Because pain often can be associated with alterations in autonomic tone, it has been hypothesized that alterations in vital signs will occur in patients who report pain.

Study design: Retrospective cohort study.

Setting: Pre-hospital in Melbourne, Australia.

Synopsis: The authors reviewed all ambulance patient care records for patients age >14 years with a Glasgow Coma Score (GCS) >12 transported to a hospital during a seven-day period in 2005. Patients were selected for analysis if their patient care record included an initial assessment of pain severity, as measured by a numeric rating scale (NRS), in which patients rate their pain from 0 to 10.

More than half of the 3,357 patients transported by paramedics during the period were included in this analysis (n=1286). There was no correlation between heart rate or systolic blood pressure with the degree of self-reported pain. Although an increased respiratory rate was statistically correlated with a higher rating of pain, this relationship was not clinically significant, as each one-point increase in the pain rating scale was associated with a 0.16-breaths-per-minute increase in the respiratory rate.

Limitations included the large number of records excluded from analysis because pain was not evaluated, as well as numerous unmeasured confounders, including active disease processes such as sepsis, that were not accounted for.

Bottom line: Severity of pain did not correlate with heart rate or systolic blood pressure in the pre-hospital setting.

Citation: Lord B, Woollard M. The reliability of vital signs in estimating pain severity among adult patients treated by paramedics. Emerg Med J. 2011;28:147-150.

Asymptomatic Perioperative Myocardial Infarction Is Common in Patients Undergoing Noncardiac Surgery

 

Clinical question: In patients undergoing noncardiac surgery, what is the incidence and clinical characteristics of perioperative myocardial infarction (MI)?

Background: Though millions of patients experience perioperative MI after noncardiac surgery, little is known about the characteristics and outcomes of these patients.

Study design: Cohort study.

Setting: One hundred ninety centers in 23 countries.

Synopsis: Using data from the 8,351 patients in the POISE (PeriOperative ISchemic Evaluation) trial, this study showed that perioperative MI occurred in 5% of patients; 65% were asymptomatic. Patients who experienced postoperative MI were older and had more cardiovascular risk factors when compared to those who did not. The 30-day mortality was higher in patients with a perioperative MI (11.6%) compared with those who did not (2.2%); the presence or absence of ischemic symptoms was not associated with mortality rate.

Of the 8.3% of patients who experienced an elevation in cardiac biomarkers but who did not meet the definition of MI, there was an increased risk of nonfatal cardiac arrest and nonacute coronary revascularization. Those in the highest quartile also had increased 30-day mortality.

Bottom line: Given the high proportion of asymptomatic MIs and isolated elevations in cardiac biomarkers and the association between these events and increased risk of death, hospitalists should consider routine monitoring of troponin in at-risk patients undergoing noncardiac surgery.

Citation: Devereaux PJ, Xavier D, Pogue J, et al. Characteristics and short-term prognosis of perioperative myocardial infarction in patients undergoing noncardiac surgery: a cohort study. Ann Intern Med. 2011;154(8):523-528.

Patients Prescribed Higher Opioid Doses Are at Increased Risk of Opioid Overdose Death

Clinical question: What is the association between opioid prescribing patterns and fatal opioid overdose?

Background: In the past 10 years, the rate of fatal overdose from opioid prescription for pain has more than doubled. Little is known about how the indications (substance abuse disorders, cancer-related pain, chronic pain, acute pain), maximal daily dose, and scheduling (standing, as-needed, or both) of opioid prescriptions relate to this increased risk.

Study design: Case-cohort study.

Setting: Veterans Health Administration (VHA) patients.

Synopsis: The VHA’s National Patient Care Database was used to randomly select a cohort of 154,684 nonhospice/nonpalliative-care patients who were prescribed opioids from 2004 to 2008. They were compared with 750 patients who were treated with prescription opioids who died from opioid overdose during this time.

Fatal opioid overdose was a rare event (0.04%), but risk increased with higher prescribed maximum daily morphine dose-equivalence, especially when greater than or equal to 50 mg/day in all subgroups (substance abuse, acute and chronic pain, and cancer). Fatal overdoses were higher in middle-aged white men with acute or chronic pain, substance abuse disorders, and other psychiatric illness. Patients with cancer were at increased risk of fatal overdose if they were prescribed as-needed opioids alone.

Treatment with both as-needed and standing opioids did not statistically affect risk of overdose death in any subgroup.

Bottom line: Although rare, risk of fatal opioid overdose in patients prescribed opiate medication increases with higher maximum prescribed daily dose.

Citation: Bohnert AS, Valenstein M, Bair M, et al. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA. 2011; 305:1315-1321.

Structured Interdisciplinary Rounds on Medical Teaching Unit Significantly Decrease Adverse Events

Clinical question: Do structured interdisciplinary rounds have an impact on the rate of adverse events?

Background: Many preventable adverse events occurring during hospitalization can be attributed to communication failures. Structured interdisciplinary rounds provide a format as well as a forum for team members to discuss patient care. Prior studies demonstrated improvements in collaboration; whether this translates to better patient care is not known.

 

Study design: Retrospective cohort using historic and concurrent control.

Setting: Tertiary-care teaching hospital in Chicago.

Synopsis: Structured interdisciplinary rounds, led by a nurse manager and medical director, and including nurses, residents, pharmacists, social workers, and case managers, were implemented on a medical teaching unit. New patients were discussed using a structured communication tool; existing patients were discussed in an unstructured format. Medical records were abstracted for 370 patients hospitalized after implementation of the intervention, equally divided between intervention and control units. One hundred eighty-five patients hospitalized on the intervention unit prior to the implementation of rounds served as a historic control.

Patients in the intervention unit had significantly lower rates of total adverse events (3.9 per 100 patient days in the intervention, compared with 7.2 and 7.7 per 100 patient days for the concurrent and historic control units, respectively), and preventable adverse events (0.9 per 100 patient days, compared with 2.8 and 2.1 per 100 patient days for the concurrent and historic controls, respectively).

Limitations of the study include lack of blinding of the medical record, slightly different patient populations in intervention and control groups, and the one-hospital setting, which could limit generalizability.

Bottom line: Structured interdisciplinary rounds might serve to improve communication between nurses, pharmacists, and physicians, resulting in decreases in adverse events.

Citation: O’Leary KJ, Buck R, Fligiel HM, et al. Structured interdisciplinary rounds in a medical teaching unit: improving patient safety. Arch Intern Med. 2011;171(7):678-684.

 

 

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Screening for AAA
2. Adverse events in atrial fibrillation
3. Biological treatment of inflammatory bowel diseases
4. Steroid treatment of inflammatory bowel diseases
5. Levofloxacin for H. pylori
6. Natural history of tako-tsubo cardiomyopathy
7. Predicting postoperative pulmonary complications
8. Code status and goals of care in the ICU

 

New Screening Strategy To Identify Large Abdominal Aortic Aneurysms

Clinical question: Can an effective scoring system be developed to better identify patients at risk for large abdominal aortic aneurysms (AAA)?

Background: Screening reduces AAA-related mortality by about half in men aged >65. The United States Preventive Services Task Force (USPSTF) has recommended screening for AAA in men aged 65 to 75 with a history of smoking. However, more than 50% of AAA ruptures occur in individuals outside this patient cohort, and only some AAAs detected are large enough to warrant surgery.

Study design: Retrospective, observational cohort study.

Setting: More than 20,000 screening sites across the U.S.

Synopsis: Researchers collected demographics and risk factors from 3.1 million people undergoing ultrasound screening for AAA by Life Line Screening Inc. At the screening visit, subjects completed a questionnaire about their health status and medical history. Screening data also included diameter of the infrarenal abdominal aorta. To construct and test a risk model, the screened individuals were randomly allocated into two equal groups: a data set used for model development and one for validation.

Most of the AAAs greater than 5 cm in diameter discovered were in males (84.4%) and among subjects with a smoking history (83%). Other risk factors for large AAAs included advanced age, peripheral arterial disease, and obesity. The authors estimate that there are about 121,000 people with >5.0 cm aneurysms in the general population. Current guidelines would detect only 33.7% of the existing large AAAs. Study limitations include possible selection bias, as a majority of patients were self-referred. Also, the database did not include all comorbidities that could affect the risk of AAA. The self-reported nature of health data might cause misclassification of a patient’s true health status.

Bottom line: A screening strategy based on a newly developed scoring system is an effective way to identify patients at risk of large abdominal aortic aneurysms.

Citation: Greco G, Egorova NN, Gelijns AC, et al. Development of a novel scoring tool for the identification of large >5 cm abdominal aortic aneurysms. Ann Surg. 2010;252(4):675-682.

 

 

Risk Factors for Adverse Events in Patients with Symptomatic Atrial Fibrillation

Clinical question: What are the predictors of 30-day adverse events in ED patients evaluated for symptomatic atrial fibrillation?

Background: Atrial fibrillation (AF) affects more than 2 million people in the U.S. and accounts for nearly 1% of ED visits. Physicians have little information to guide risk stratification, and they admit more than 65% of patients. A strategy to better define the ED management of patients presenting with atrial fibrillation is required.

Study design: Retrospective, observational cohort study.

Setting: Urban academic tertiary-care referral center with an adult ED.

Synopsis: A systematic review of the electronic medical records of all ED patients presenting with symptomatic atrial fibrillation over a three-year period was performed. Predefined adverse outcomes included 30-day ED return visits, unscheduled hospitalizations, cardiovascular complications, or death.

Of 832 eligible patients, 216 (25.9%) experienced at least one of the 30-day adverse events. Adverse events occurred in 181 of the 638 (28.4%) admitted patients and 35 of the 192 (18.2%) patients discharged from the ED. Increasing age, complaint of dyspnea, smoking history, inadequate ventricular rate control, and patients receiving beta-blockers were factors independently associated with higher risk for adverse events.

Study results were limited by a number of factors. This was a single-center, retrospective, observational study, with all of its inherent limitations. The predictor model did not include laboratory data, such as BNP or troponin. Patients might have experienced additional events within the 30 days that were treated at other hospitals and not recorded in the database. Patient disposition might have affected the results, as patients initially admitted from the ED had a higher rate of 30-day adverse events than patients who were discharged from the ED.

Bottom line: Patients with increased age, smoking history, complaints of dyspnea, inadequate ventricular rate control in the ED, and home beta-blocker therapy are more likely to experience an atrial-fibrillation-related adverse event within 30 days.

Citation: Barrett TW, Martin AR, Storrow AB, et al. A clinical prediction model to estimate risk for 30-day adverse events in emergency department patients with symptomatic atrial fibrillation. Ann Emerg Med. 2011;57 (1):1-12.

 

Biological Therapies Are Effective in Inducing Remission in Inflammatory Bowel Disease

Clinical question: Are biological therapies useful in the treatment of ulcerative colitis (UC) and Crohn’s disease (CD)?

Background: Patients with CD and UC often experience flares of disease activity, despite maintenance therapy with 5-aminosalicylic acid compounds. These flares are usually treated with corticosteroids, which carry numerous adverse side effects. The role of biological therapies in inducing remission is uncertain.

Study design: Systematic review and meta-analysis.

Setting: Twenty-seven randomized controlled trials involving 7,416 patients.

Synopsis: Anti-TNF α antibodies and natalizumab were both superior to placebo in inducing remission of luminal CD (RR of no remission 0.87 and 0.88, respectively). Anti-TNF antibodies also were superior to placebo in preventing relapse of luminal CD (RR of relapse=0.71). Infliximab was superior to placebo in inducing remission of moderate to severely active UC (RR=0.72; 95% CI, 0.57-0.91). There were no significantly increased adverse drug effects with anti-TNF α antibodies or with infliximab compared with placebo. Natalizumab caused significantly higher rates of headache.

Limitations include risk of publication bias inherent in meta-analyses. There also was evidence of moderate heterogeneity in the studies analyzed. Finally, not every study was consistent in reporting adverse drug effects.

Bottom line: Biological therapies are superior to placebo in inducing remission of active UC and CD, as well as preventing relapse of quiescent CD.

Citation: Ford AC, Sandborn WJ, Khan KJ, Hanauer SB, Talley NJ, Moayyedi P. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011; 106(4):644-659.

 

 

Glucocortico­steroids Probably Effective in Treatment of Inflammatory Bowel Disease, Primarily in Active Ulcerative Colitis

Clinical question: Is glucocorticosteroid therapy effective in the treatment of active IBD and in preventing relapses?

Background: Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases of unclear etiology. Use of standard glucocorticosteroids and budesonide is widespread in inflammatory bowel disease (IBD) treatment. To date, there has been no large-scale meta-analysis to examine the effectiveness of both treatments in CD and UC.

Study design: Systematic review and meta-analysis.

Setting: Twenty randomized controlled trials totaling 2,398 patients.

Synopsis: Standard glucocorticosteroids were superior to placebo for UC remission (RR of no remission=0.65; 95% CI, 0.45-0.93). Both trials of standard glucocorticosteroids in CD remission reported a statistically significant effect, but the overall effect was not significant due to heterogeneity of the studies. Budesonide was superior to placebo for CD remission (RR=0.73; 95% CI, 0.63-0.84) but not in preventing CD relapse (RR=0.93; 95% CI, 0.83-1.04). Standard glucocorticosteroids were superior to budesonide for CD remission (RR=0.82; 95% CI, 0.68-0.98) but with more adverse effects (RR=1.64; 95% CI, 1.34-2.00).

The limitations of the study include the poor overall quality of the studies included in the meta-analysis, with only one study judged as low risk of bias. There was intermediate to high heterogeneity between study results.

Bottom line: Standard glucocorticosteroids are likely effective in inducing remission in UC and, possibly, in CD. Budesonide probably is effective at inducing remission in active CD. Neither therapy was recommended in preventing relapse of UC and CD.

Citation: Ford AC, Bernstein CN, Khan KJ, et al. Glucocorticosteroid therapy in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011;106(4):590-599.

 

Levofloxacin Effective in Treatment of H. Pylori in Settings of High Clarithromycin Resistance

Clinical question: In areas with high H. pylori clarithromycin resistance rates, is levofloxacin more effective in eradicating H. pylori than standard clarithromycin, based treatment regimens?

Background: The rise in antimicrobial drug resistance is a major cause for the decreasing rate of H. pylori eradication. In areas with higher than 15% H. pyloriclarithromycin-resistant strains, quadruple therapy has been suggested as first-line therapy. The efficacy of a levofloxacin-based sequential therapy in eradicating H. pylori is undetermined.

Study design: Prospective, randomized, controlled multicenter study with a parallel-group design.

Setting: Five gastroenterology clinics in Italy.

Synopsis: Researchers randomly assigned 375 patients who were infected with H. pylori and naive to treatment to one of three groups. All three treatment groups received an initial five days of omeprazole 20 mg BID and amoxicillin 1 gm BID, then five days of omeprazole 20 mg BID and tinidazole 500 mg BID. The groups also received either clarithromycin 500 mg BID, levofloxacin 250 mg BID, or levofloxacin 500 mg BID, respectively, during the second five days of treatment.

Eradication rates were 80.8% (95% CI, 72.8% to 87.3%) with clarithromycin sequential therapy, 96.0% (95% CI, 90.9% to 98.7%) with levofloxacin-250 sequential therapy, and 96.8% (95% CI, 92.0% to 99.1%) with levofloxacin-500 sequential therapy.

The clarithromycin-group eradication rate was significantly lower than both levofloxacin groups. No significant difference was observed between the levofloxacin-250 and levofloxacin-500 groups. No differences in prevalence of antimicrobial resistance or incidence of adverse events were observed between the groups. Levofloxacin-250 therapy does offer cost savings when compared with clarithromycin sequential therapy.

A potential limitation to the study is referral bias, as each of the patients first were sent by their primary physicians to a specialized GI clinic.

Bottom line: In areas with a high prevalence of clarithromycin-resistant strains of H. pylori levofloxacin-containing sequential therapy should be considered for a first-line eradication regimen.

 

Citation: Romano M, Cuomo A, Gravina AG, et al. Empirical levofloxacin-containing versus clarithromycin-containing sequential therapy for Helicobacter pylori eradication: a randomised trial. Gut. 2010;59(11):1465-1470.

 

Tako-Tsubo Cardiomyopathy Is Associated with Higher Hospital Readmission Rates and Long-Term Mortality

Clinical question: What is the natural history of patients who develop tako-tsubo cardiomyopathy?

Background: Stress-induced or tako-tsubo cardiomyopathy (TTC) is a rare acute cardiac syndrome, characterized by chest pain or dyspnea, ischemic electrocardiographic changes, transient left ventricular (LV) dysfunction, and limited release of cardiac injury markers, in the absence of epicardial coronary artery disease (CAD). The long-term outcome of this condition is unknown.

Study design: Prospective, case-control study.

Setting: Five urban-based hospitals in Italy.

Synopsis: One hundred-sixteen patients with TTC were included in the five-year study period. Patients were followed up at one and six months, then annually thereafter. Primary endpoints were death, TTC recurrence, and rehospitalization for any cause.

Mean initial LV ejection fraction (LVEF) was 36%. Two patients died of refractory heart failure during hospitalization. Of the patients who were discharged alive, all except one showed complete LV functional recovery.

At follow-up (mean two years), only 64 (55%) patients were asymptomatic. Rehospitalization rate was high (25%), with chest pain and dyspnea the most common causes. Only two patients had a recurrence of TTC. Eleven patients died (seven from cardiovascular causes). There was no significant difference in mortality or in other clinical events between patients with and without severe LV dysfunction at presentation. The standardized mortality ratio was 3.40 (95% CI, 1.83-6.34) in the TTC population, compared with the age- and sex-specific mortality of the general population.

The study is limited by a lack of patients with subclinical TTC disease and those who might have suffered from sudden cardiac death prior to enrollment, leading to a possible sampling bias, as well as the nonrandomized use of beta-blockers.

Bottom line: Tako-tsubo disease is associated with rare recurrence of the disease, common recurrence of chest pain and dyspnea, and three times the mortality rate of the general population.

Citation: Parodi G, Bellandi B, Del Pace S, et al. Natural history of tako-tsubo cardiomyopathy. Chest. 2011;139(4):887-892.

 

Seven Independent Risk Factors Predict Postoperative Pulmonary Complications

Clinical question: What are the clinical risk factors that predict higher rates of postoperative pulmonary complications?

 

Background: Postoperative pulmonary complications (PPCs) are a major cause of postoperative morbidity, mortality, and prolonged hospital stays. Previous studies looking at risk factors for PPCs were limited by sampling bias and small sample sizes.

Study design: Prospective, randomized-sample cohort study.

Setting: Fifty-nine participating Spanish hospitals (community, intermediate referral, or major tertiary-care facilities).

Synopsis: Patients undergoing surgical procedures with general, neuraxial, or regional anesthesia were selected randomly. The main outcome was the development of at least one of the following: respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, or aspiration pneumonitis. Of 2,464 patients enrolled, 252 events were observed in 123 patients (5%). The 30-day mortality rate was significantly higher in patients suffering a PPC than those who did not (19.5% vs. 0.5%). Additionally, regression modeling identified seven independent risk factors: low preoperative arterial oxygen saturation, acute respiratory infection within one month of surgery, advanced age, preoperative anemia, upper abdominal or intrathoracic surgery, surgical duration more than two hours, and emergency surgery.

The study was underpowered to assess the significance of all potential risk factors for PPCs. Also, given the number of centers involved in the study, variation in assessing development of PPCs is likely.

Bottom line: Postoperative pulmonary complications are a major cause of morbidity and mortality. Seven independent risk factors were identified for the development of PPCs, which could be useful in preoperative risk stratification.

Citation: Canet J, Gallart L, Gomar C, et al. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010;113(6):1338-1350.

 

Code Status Orders and Goals of Medical ICU Care

Clinical question: How familiar are patients in the medical ICU (MICU) or their surrogates regarding code-status orders and goals of care, what are their preferences, and to what extent do they and their physicians differ?

Background: Discussions about code-status orders and goals of care carry great import in the MICU. However, little data exist on patients’ code-status preferences and goals of care. More knowledge of these issues can help physicians deliver more patient-centered care.

Study design: Prospective interviews.

Setting: Twenty-six-bed MICU at a large Midwestern academic medical center.

Synopsis: Data were collected from December 2008 to December 2009 on a random sample of patients—or their surrogates—admitted to the MICU. Of 135 eligible patients/surrogates, 100 completed interviews. Patients primarily were white (95%) and from the ages of 41 to 80 (79%).

Only 28% of participants recalled having a discussion about CPR and one goal of care, while 27% recalled no discussion at all; 83% preferred full code status but had limited knowledge of CPR and its outcomes in the hospital setting. Only 4% were able to identify all components of CPR, and they estimated the mean probability of survival following in-hospital arrest with CPR to be 71.8%, although data suggest survival is closer to 18%. There was a correlation between a higher estimation of survival following CPR and preference for it. After learning about the evidence-based likelihood of a good neurologic outcome following CPR, 8% of the participants became less interested.

Discrepancies between patients’ stated code status and that in the medical record was identified 16% of the time. Additionally, 67.7% of participants differed with their physicians regarding the most important goal of care.

Bottom line: Discussions about code status and goals of care in the MICU occur less frequently than recommended, leading to widespread discrepancies between patients/surrogates and their physicians regarding the most important goal of care. This is compounded by the fact that patients and their surrogates have limited knowledge about in-hospital CPR and its likelihood of success.

 

Citation: Gehlbach TG, Shinkunas LA, Forman-Hoffman VL, Thomas KW, Schmidt GA, Kaldjian LC. Code status orders and goals of care in the medical ICU. Chest. 2011;139:802-809. TH

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Screening for AAA
2. Adverse events in atrial fibrillation
3. Biological treatment of inflammatory bowel diseases
4. Steroid treatment of inflammatory bowel diseases
5. Levofloxacin for H. pylori
6. Natural history of tako-tsubo cardiomyopathy
7. Predicting postoperative pulmonary complications
8. Code status and goals of care in the ICU

 

New Screening Strategy To Identify Large Abdominal Aortic Aneurysms

Clinical question: Can an effective scoring system be developed to better identify patients at risk for large abdominal aortic aneurysms (AAA)?

Background: Screening reduces AAA-related mortality by about half in men aged >65. The United States Preventive Services Task Force (USPSTF) has recommended screening for AAA in men aged 65 to 75 with a history of smoking. However, more than 50% of AAA ruptures occur in individuals outside this patient cohort, and only some AAAs detected are large enough to warrant surgery.

Study design: Retrospective, observational cohort study.

Setting: More than 20,000 screening sites across the U.S.

Synopsis: Researchers collected demographics and risk factors from 3.1 million people undergoing ultrasound screening for AAA by Life Line Screening Inc. At the screening visit, subjects completed a questionnaire about their health status and medical history. Screening data also included diameter of the infrarenal abdominal aorta. To construct and test a risk model, the screened individuals were randomly allocated into two equal groups: a data set used for model development and one for validation.

Most of the AAAs greater than 5 cm in diameter discovered were in males (84.4%) and among subjects with a smoking history (83%). Other risk factors for large AAAs included advanced age, peripheral arterial disease, and obesity. The authors estimate that there are about 121,000 people with >5.0 cm aneurysms in the general population. Current guidelines would detect only 33.7% of the existing large AAAs. Study limitations include possible selection bias, as a majority of patients were self-referred. Also, the database did not include all comorbidities that could affect the risk of AAA. The self-reported nature of health data might cause misclassification of a patient’s true health status.

Bottom line: A screening strategy based on a newly developed scoring system is an effective way to identify patients at risk of large abdominal aortic aneurysms.

Citation: Greco G, Egorova NN, Gelijns AC, et al. Development of a novel scoring tool for the identification of large >5 cm abdominal aortic aneurysms. Ann Surg. 2010;252(4):675-682.

 

 

Risk Factors for Adverse Events in Patients with Symptomatic Atrial Fibrillation

Clinical question: What are the predictors of 30-day adverse events in ED patients evaluated for symptomatic atrial fibrillation?

Background: Atrial fibrillation (AF) affects more than 2 million people in the U.S. and accounts for nearly 1% of ED visits. Physicians have little information to guide risk stratification, and they admit more than 65% of patients. A strategy to better define the ED management of patients presenting with atrial fibrillation is required.

Study design: Retrospective, observational cohort study.

Setting: Urban academic tertiary-care referral center with an adult ED.

Synopsis: A systematic review of the electronic medical records of all ED patients presenting with symptomatic atrial fibrillation over a three-year period was performed. Predefined adverse outcomes included 30-day ED return visits, unscheduled hospitalizations, cardiovascular complications, or death.

Of 832 eligible patients, 216 (25.9%) experienced at least one of the 30-day adverse events. Adverse events occurred in 181 of the 638 (28.4%) admitted patients and 35 of the 192 (18.2%) patients discharged from the ED. Increasing age, complaint of dyspnea, smoking history, inadequate ventricular rate control, and patients receiving beta-blockers were factors independently associated with higher risk for adverse events.

Study results were limited by a number of factors. This was a single-center, retrospective, observational study, with all of its inherent limitations. The predictor model did not include laboratory data, such as BNP or troponin. Patients might have experienced additional events within the 30 days that were treated at other hospitals and not recorded in the database. Patient disposition might have affected the results, as patients initially admitted from the ED had a higher rate of 30-day adverse events than patients who were discharged from the ED.

Bottom line: Patients with increased age, smoking history, complaints of dyspnea, inadequate ventricular rate control in the ED, and home beta-blocker therapy are more likely to experience an atrial-fibrillation-related adverse event within 30 days.

Citation: Barrett TW, Martin AR, Storrow AB, et al. A clinical prediction model to estimate risk for 30-day adverse events in emergency department patients with symptomatic atrial fibrillation. Ann Emerg Med. 2011;57 (1):1-12.

 

Biological Therapies Are Effective in Inducing Remission in Inflammatory Bowel Disease

Clinical question: Are biological therapies useful in the treatment of ulcerative colitis (UC) and Crohn’s disease (CD)?

Background: Patients with CD and UC often experience flares of disease activity, despite maintenance therapy with 5-aminosalicylic acid compounds. These flares are usually treated with corticosteroids, which carry numerous adverse side effects. The role of biological therapies in inducing remission is uncertain.

Study design: Systematic review and meta-analysis.

Setting: Twenty-seven randomized controlled trials involving 7,416 patients.

Synopsis: Anti-TNF α antibodies and natalizumab were both superior to placebo in inducing remission of luminal CD (RR of no remission 0.87 and 0.88, respectively). Anti-TNF antibodies also were superior to placebo in preventing relapse of luminal CD (RR of relapse=0.71). Infliximab was superior to placebo in inducing remission of moderate to severely active UC (RR=0.72; 95% CI, 0.57-0.91). There were no significantly increased adverse drug effects with anti-TNF α antibodies or with infliximab compared with placebo. Natalizumab caused significantly higher rates of headache.

Limitations include risk of publication bias inherent in meta-analyses. There also was evidence of moderate heterogeneity in the studies analyzed. Finally, not every study was consistent in reporting adverse drug effects.

Bottom line: Biological therapies are superior to placebo in inducing remission of active UC and CD, as well as preventing relapse of quiescent CD.

Citation: Ford AC, Sandborn WJ, Khan KJ, Hanauer SB, Talley NJ, Moayyedi P. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011; 106(4):644-659.

 

 

Glucocortico­steroids Probably Effective in Treatment of Inflammatory Bowel Disease, Primarily in Active Ulcerative Colitis

Clinical question: Is glucocorticosteroid therapy effective in the treatment of active IBD and in preventing relapses?

Background: Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases of unclear etiology. Use of standard glucocorticosteroids and budesonide is widespread in inflammatory bowel disease (IBD) treatment. To date, there has been no large-scale meta-analysis to examine the effectiveness of both treatments in CD and UC.

Study design: Systematic review and meta-analysis.

Setting: Twenty randomized controlled trials totaling 2,398 patients.

Synopsis: Standard glucocorticosteroids were superior to placebo for UC remission (RR of no remission=0.65; 95% CI, 0.45-0.93). Both trials of standard glucocorticosteroids in CD remission reported a statistically significant effect, but the overall effect was not significant due to heterogeneity of the studies. Budesonide was superior to placebo for CD remission (RR=0.73; 95% CI, 0.63-0.84) but not in preventing CD relapse (RR=0.93; 95% CI, 0.83-1.04). Standard glucocorticosteroids were superior to budesonide for CD remission (RR=0.82; 95% CI, 0.68-0.98) but with more adverse effects (RR=1.64; 95% CI, 1.34-2.00).

The limitations of the study include the poor overall quality of the studies included in the meta-analysis, with only one study judged as low risk of bias. There was intermediate to high heterogeneity between study results.

Bottom line: Standard glucocorticosteroids are likely effective in inducing remission in UC and, possibly, in CD. Budesonide probably is effective at inducing remission in active CD. Neither therapy was recommended in preventing relapse of UC and CD.

Citation: Ford AC, Bernstein CN, Khan KJ, et al. Glucocorticosteroid therapy in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011;106(4):590-599.

 

Levofloxacin Effective in Treatment of H. Pylori in Settings of High Clarithromycin Resistance

Clinical question: In areas with high H. pylori clarithromycin resistance rates, is levofloxacin more effective in eradicating H. pylori than standard clarithromycin, based treatment regimens?

Background: The rise in antimicrobial drug resistance is a major cause for the decreasing rate of H. pylori eradication. In areas with higher than 15% H. pyloriclarithromycin-resistant strains, quadruple therapy has been suggested as first-line therapy. The efficacy of a levofloxacin-based sequential therapy in eradicating H. pylori is undetermined.

Study design: Prospective, randomized, controlled multicenter study with a parallel-group design.

Setting: Five gastroenterology clinics in Italy.

Synopsis: Researchers randomly assigned 375 patients who were infected with H. pylori and naive to treatment to one of three groups. All three treatment groups received an initial five days of omeprazole 20 mg BID and amoxicillin 1 gm BID, then five days of omeprazole 20 mg BID and tinidazole 500 mg BID. The groups also received either clarithromycin 500 mg BID, levofloxacin 250 mg BID, or levofloxacin 500 mg BID, respectively, during the second five days of treatment.

Eradication rates were 80.8% (95% CI, 72.8% to 87.3%) with clarithromycin sequential therapy, 96.0% (95% CI, 90.9% to 98.7%) with levofloxacin-250 sequential therapy, and 96.8% (95% CI, 92.0% to 99.1%) with levofloxacin-500 sequential therapy.

The clarithromycin-group eradication rate was significantly lower than both levofloxacin groups. No significant difference was observed between the levofloxacin-250 and levofloxacin-500 groups. No differences in prevalence of antimicrobial resistance or incidence of adverse events were observed between the groups. Levofloxacin-250 therapy does offer cost savings when compared with clarithromycin sequential therapy.

A potential limitation to the study is referral bias, as each of the patients first were sent by their primary physicians to a specialized GI clinic.

Bottom line: In areas with a high prevalence of clarithromycin-resistant strains of H. pylori levofloxacin-containing sequential therapy should be considered for a first-line eradication regimen.

 

Citation: Romano M, Cuomo A, Gravina AG, et al. Empirical levofloxacin-containing versus clarithromycin-containing sequential therapy for Helicobacter pylori eradication: a randomised trial. Gut. 2010;59(11):1465-1470.

 

Tako-Tsubo Cardiomyopathy Is Associated with Higher Hospital Readmission Rates and Long-Term Mortality

Clinical question: What is the natural history of patients who develop tako-tsubo cardiomyopathy?

Background: Stress-induced or tako-tsubo cardiomyopathy (TTC) is a rare acute cardiac syndrome, characterized by chest pain or dyspnea, ischemic electrocardiographic changes, transient left ventricular (LV) dysfunction, and limited release of cardiac injury markers, in the absence of epicardial coronary artery disease (CAD). The long-term outcome of this condition is unknown.

Study design: Prospective, case-control study.

Setting: Five urban-based hospitals in Italy.

Synopsis: One hundred-sixteen patients with TTC were included in the five-year study period. Patients were followed up at one and six months, then annually thereafter. Primary endpoints were death, TTC recurrence, and rehospitalization for any cause.

Mean initial LV ejection fraction (LVEF) was 36%. Two patients died of refractory heart failure during hospitalization. Of the patients who were discharged alive, all except one showed complete LV functional recovery.

At follow-up (mean two years), only 64 (55%) patients were asymptomatic. Rehospitalization rate was high (25%), with chest pain and dyspnea the most common causes. Only two patients had a recurrence of TTC. Eleven patients died (seven from cardiovascular causes). There was no significant difference in mortality or in other clinical events between patients with and without severe LV dysfunction at presentation. The standardized mortality ratio was 3.40 (95% CI, 1.83-6.34) in the TTC population, compared with the age- and sex-specific mortality of the general population.

The study is limited by a lack of patients with subclinical TTC disease and those who might have suffered from sudden cardiac death prior to enrollment, leading to a possible sampling bias, as well as the nonrandomized use of beta-blockers.

Bottom line: Tako-tsubo disease is associated with rare recurrence of the disease, common recurrence of chest pain and dyspnea, and three times the mortality rate of the general population.

Citation: Parodi G, Bellandi B, Del Pace S, et al. Natural history of tako-tsubo cardiomyopathy. Chest. 2011;139(4):887-892.

 

Seven Independent Risk Factors Predict Postoperative Pulmonary Complications

Clinical question: What are the clinical risk factors that predict higher rates of postoperative pulmonary complications?

 

Background: Postoperative pulmonary complications (PPCs) are a major cause of postoperative morbidity, mortality, and prolonged hospital stays. Previous studies looking at risk factors for PPCs were limited by sampling bias and small sample sizes.

Study design: Prospective, randomized-sample cohort study.

Setting: Fifty-nine participating Spanish hospitals (community, intermediate referral, or major tertiary-care facilities).

Synopsis: Patients undergoing surgical procedures with general, neuraxial, or regional anesthesia were selected randomly. The main outcome was the development of at least one of the following: respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, or aspiration pneumonitis. Of 2,464 patients enrolled, 252 events were observed in 123 patients (5%). The 30-day mortality rate was significantly higher in patients suffering a PPC than those who did not (19.5% vs. 0.5%). Additionally, regression modeling identified seven independent risk factors: low preoperative arterial oxygen saturation, acute respiratory infection within one month of surgery, advanced age, preoperative anemia, upper abdominal or intrathoracic surgery, surgical duration more than two hours, and emergency surgery.

The study was underpowered to assess the significance of all potential risk factors for PPCs. Also, given the number of centers involved in the study, variation in assessing development of PPCs is likely.

Bottom line: Postoperative pulmonary complications are a major cause of morbidity and mortality. Seven independent risk factors were identified for the development of PPCs, which could be useful in preoperative risk stratification.

Citation: Canet J, Gallart L, Gomar C, et al. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010;113(6):1338-1350.

 

Code Status Orders and Goals of Medical ICU Care

Clinical question: How familiar are patients in the medical ICU (MICU) or their surrogates regarding code-status orders and goals of care, what are their preferences, and to what extent do they and their physicians differ?

Background: Discussions about code-status orders and goals of care carry great import in the MICU. However, little data exist on patients’ code-status preferences and goals of care. More knowledge of these issues can help physicians deliver more patient-centered care.

Study design: Prospective interviews.

Setting: Twenty-six-bed MICU at a large Midwestern academic medical center.

Synopsis: Data were collected from December 2008 to December 2009 on a random sample of patients—or their surrogates—admitted to the MICU. Of 135 eligible patients/surrogates, 100 completed interviews. Patients primarily were white (95%) and from the ages of 41 to 80 (79%).

Only 28% of participants recalled having a discussion about CPR and one goal of care, while 27% recalled no discussion at all; 83% preferred full code status but had limited knowledge of CPR and its outcomes in the hospital setting. Only 4% were able to identify all components of CPR, and they estimated the mean probability of survival following in-hospital arrest with CPR to be 71.8%, although data suggest survival is closer to 18%. There was a correlation between a higher estimation of survival following CPR and preference for it. After learning about the evidence-based likelihood of a good neurologic outcome following CPR, 8% of the participants became less interested.

Discrepancies between patients’ stated code status and that in the medical record was identified 16% of the time. Additionally, 67.7% of participants differed with their physicians regarding the most important goal of care.

Bottom line: Discussions about code status and goals of care in the MICU occur less frequently than recommended, leading to widespread discrepancies between patients/surrogates and their physicians regarding the most important goal of care. This is compounded by the fact that patients and their surrogates have limited knowledge about in-hospital CPR and its likelihood of success.

 

Citation: Gehlbach TG, Shinkunas LA, Forman-Hoffman VL, Thomas KW, Schmidt GA, Kaldjian LC. Code status orders and goals of care in the medical ICU. Chest. 2011;139:802-809. TH

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Screening for AAA
2. Adverse events in atrial fibrillation
3. Biological treatment of inflammatory bowel diseases
4. Steroid treatment of inflammatory bowel diseases
5. Levofloxacin for H. pylori
6. Natural history of tako-tsubo cardiomyopathy
7. Predicting postoperative pulmonary complications
8. Code status and goals of care in the ICU

 

New Screening Strategy To Identify Large Abdominal Aortic Aneurysms

Clinical question: Can an effective scoring system be developed to better identify patients at risk for large abdominal aortic aneurysms (AAA)?

Background: Screening reduces AAA-related mortality by about half in men aged >65. The United States Preventive Services Task Force (USPSTF) has recommended screening for AAA in men aged 65 to 75 with a history of smoking. However, more than 50% of AAA ruptures occur in individuals outside this patient cohort, and only some AAAs detected are large enough to warrant surgery.

Study design: Retrospective, observational cohort study.

Setting: More than 20,000 screening sites across the U.S.

Synopsis: Researchers collected demographics and risk factors from 3.1 million people undergoing ultrasound screening for AAA by Life Line Screening Inc. At the screening visit, subjects completed a questionnaire about their health status and medical history. Screening data also included diameter of the infrarenal abdominal aorta. To construct and test a risk model, the screened individuals were randomly allocated into two equal groups: a data set used for model development and one for validation.

Most of the AAAs greater than 5 cm in diameter discovered were in males (84.4%) and among subjects with a smoking history (83%). Other risk factors for large AAAs included advanced age, peripheral arterial disease, and obesity. The authors estimate that there are about 121,000 people with >5.0 cm aneurysms in the general population. Current guidelines would detect only 33.7% of the existing large AAAs. Study limitations include possible selection bias, as a majority of patients were self-referred. Also, the database did not include all comorbidities that could affect the risk of AAA. The self-reported nature of health data might cause misclassification of a patient’s true health status.

Bottom line: A screening strategy based on a newly developed scoring system is an effective way to identify patients at risk of large abdominal aortic aneurysms.

Citation: Greco G, Egorova NN, Gelijns AC, et al. Development of a novel scoring tool for the identification of large >5 cm abdominal aortic aneurysms. Ann Surg. 2010;252(4):675-682.

 

 

Risk Factors for Adverse Events in Patients with Symptomatic Atrial Fibrillation

Clinical question: What are the predictors of 30-day adverse events in ED patients evaluated for symptomatic atrial fibrillation?

Background: Atrial fibrillation (AF) affects more than 2 million people in the U.S. and accounts for nearly 1% of ED visits. Physicians have little information to guide risk stratification, and they admit more than 65% of patients. A strategy to better define the ED management of patients presenting with atrial fibrillation is required.

Study design: Retrospective, observational cohort study.

Setting: Urban academic tertiary-care referral center with an adult ED.

Synopsis: A systematic review of the electronic medical records of all ED patients presenting with symptomatic atrial fibrillation over a three-year period was performed. Predefined adverse outcomes included 30-day ED return visits, unscheduled hospitalizations, cardiovascular complications, or death.

Of 832 eligible patients, 216 (25.9%) experienced at least one of the 30-day adverse events. Adverse events occurred in 181 of the 638 (28.4%) admitted patients and 35 of the 192 (18.2%) patients discharged from the ED. Increasing age, complaint of dyspnea, smoking history, inadequate ventricular rate control, and patients receiving beta-blockers were factors independently associated with higher risk for adverse events.

Study results were limited by a number of factors. This was a single-center, retrospective, observational study, with all of its inherent limitations. The predictor model did not include laboratory data, such as BNP or troponin. Patients might have experienced additional events within the 30 days that were treated at other hospitals and not recorded in the database. Patient disposition might have affected the results, as patients initially admitted from the ED had a higher rate of 30-day adverse events than patients who were discharged from the ED.

Bottom line: Patients with increased age, smoking history, complaints of dyspnea, inadequate ventricular rate control in the ED, and home beta-blocker therapy are more likely to experience an atrial-fibrillation-related adverse event within 30 days.

Citation: Barrett TW, Martin AR, Storrow AB, et al. A clinical prediction model to estimate risk for 30-day adverse events in emergency department patients with symptomatic atrial fibrillation. Ann Emerg Med. 2011;57 (1):1-12.

 

Biological Therapies Are Effective in Inducing Remission in Inflammatory Bowel Disease

Clinical question: Are biological therapies useful in the treatment of ulcerative colitis (UC) and Crohn’s disease (CD)?

Background: Patients with CD and UC often experience flares of disease activity, despite maintenance therapy with 5-aminosalicylic acid compounds. These flares are usually treated with corticosteroids, which carry numerous adverse side effects. The role of biological therapies in inducing remission is uncertain.

Study design: Systematic review and meta-analysis.

Setting: Twenty-seven randomized controlled trials involving 7,416 patients.

Synopsis: Anti-TNF α antibodies and natalizumab were both superior to placebo in inducing remission of luminal CD (RR of no remission 0.87 and 0.88, respectively). Anti-TNF antibodies also were superior to placebo in preventing relapse of luminal CD (RR of relapse=0.71). Infliximab was superior to placebo in inducing remission of moderate to severely active UC (RR=0.72; 95% CI, 0.57-0.91). There were no significantly increased adverse drug effects with anti-TNF α antibodies or with infliximab compared with placebo. Natalizumab caused significantly higher rates of headache.

Limitations include risk of publication bias inherent in meta-analyses. There also was evidence of moderate heterogeneity in the studies analyzed. Finally, not every study was consistent in reporting adverse drug effects.

Bottom line: Biological therapies are superior to placebo in inducing remission of active UC and CD, as well as preventing relapse of quiescent CD.

Citation: Ford AC, Sandborn WJ, Khan KJ, Hanauer SB, Talley NJ, Moayyedi P. Efficacy of biological therapies in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011; 106(4):644-659.

 

 

Glucocortico­steroids Probably Effective in Treatment of Inflammatory Bowel Disease, Primarily in Active Ulcerative Colitis

Clinical question: Is glucocorticosteroid therapy effective in the treatment of active IBD and in preventing relapses?

Background: Crohn’s disease (CD) and ulcerative colitis (UC) are chronic inflammatory bowel diseases of unclear etiology. Use of standard glucocorticosteroids and budesonide is widespread in inflammatory bowel disease (IBD) treatment. To date, there has been no large-scale meta-analysis to examine the effectiveness of both treatments in CD and UC.

Study design: Systematic review and meta-analysis.

Setting: Twenty randomized controlled trials totaling 2,398 patients.

Synopsis: Standard glucocorticosteroids were superior to placebo for UC remission (RR of no remission=0.65; 95% CI, 0.45-0.93). Both trials of standard glucocorticosteroids in CD remission reported a statistically significant effect, but the overall effect was not significant due to heterogeneity of the studies. Budesonide was superior to placebo for CD remission (RR=0.73; 95% CI, 0.63-0.84) but not in preventing CD relapse (RR=0.93; 95% CI, 0.83-1.04). Standard glucocorticosteroids were superior to budesonide for CD remission (RR=0.82; 95% CI, 0.68-0.98) but with more adverse effects (RR=1.64; 95% CI, 1.34-2.00).

The limitations of the study include the poor overall quality of the studies included in the meta-analysis, with only one study judged as low risk of bias. There was intermediate to high heterogeneity between study results.

Bottom line: Standard glucocorticosteroids are likely effective in inducing remission in UC and, possibly, in CD. Budesonide probably is effective at inducing remission in active CD. Neither therapy was recommended in preventing relapse of UC and CD.

Citation: Ford AC, Bernstein CN, Khan KJ, et al. Glucocorticosteroid therapy in inflammatory bowel disease: systematic review and meta-analysis. Am J Gastroenterol. 2011;106(4):590-599.

 

Levofloxacin Effective in Treatment of H. Pylori in Settings of High Clarithromycin Resistance

Clinical question: In areas with high H. pylori clarithromycin resistance rates, is levofloxacin more effective in eradicating H. pylori than standard clarithromycin, based treatment regimens?

Background: The rise in antimicrobial drug resistance is a major cause for the decreasing rate of H. pylori eradication. In areas with higher than 15% H. pyloriclarithromycin-resistant strains, quadruple therapy has been suggested as first-line therapy. The efficacy of a levofloxacin-based sequential therapy in eradicating H. pylori is undetermined.

Study design: Prospective, randomized, controlled multicenter study with a parallel-group design.

Setting: Five gastroenterology clinics in Italy.

Synopsis: Researchers randomly assigned 375 patients who were infected with H. pylori and naive to treatment to one of three groups. All three treatment groups received an initial five days of omeprazole 20 mg BID and amoxicillin 1 gm BID, then five days of omeprazole 20 mg BID and tinidazole 500 mg BID. The groups also received either clarithromycin 500 mg BID, levofloxacin 250 mg BID, or levofloxacin 500 mg BID, respectively, during the second five days of treatment.

Eradication rates were 80.8% (95% CI, 72.8% to 87.3%) with clarithromycin sequential therapy, 96.0% (95% CI, 90.9% to 98.7%) with levofloxacin-250 sequential therapy, and 96.8% (95% CI, 92.0% to 99.1%) with levofloxacin-500 sequential therapy.

The clarithromycin-group eradication rate was significantly lower than both levofloxacin groups. No significant difference was observed between the levofloxacin-250 and levofloxacin-500 groups. No differences in prevalence of antimicrobial resistance or incidence of adverse events were observed between the groups. Levofloxacin-250 therapy does offer cost savings when compared with clarithromycin sequential therapy.

A potential limitation to the study is referral bias, as each of the patients first were sent by their primary physicians to a specialized GI clinic.

Bottom line: In areas with a high prevalence of clarithromycin-resistant strains of H. pylori levofloxacin-containing sequential therapy should be considered for a first-line eradication regimen.

 

Citation: Romano M, Cuomo A, Gravina AG, et al. Empirical levofloxacin-containing versus clarithromycin-containing sequential therapy for Helicobacter pylori eradication: a randomised trial. Gut. 2010;59(11):1465-1470.

 

Tako-Tsubo Cardiomyopathy Is Associated with Higher Hospital Readmission Rates and Long-Term Mortality

Clinical question: What is the natural history of patients who develop tako-tsubo cardiomyopathy?

Background: Stress-induced or tako-tsubo cardiomyopathy (TTC) is a rare acute cardiac syndrome, characterized by chest pain or dyspnea, ischemic electrocardiographic changes, transient left ventricular (LV) dysfunction, and limited release of cardiac injury markers, in the absence of epicardial coronary artery disease (CAD). The long-term outcome of this condition is unknown.

Study design: Prospective, case-control study.

Setting: Five urban-based hospitals in Italy.

Synopsis: One hundred-sixteen patients with TTC were included in the five-year study period. Patients were followed up at one and six months, then annually thereafter. Primary endpoints were death, TTC recurrence, and rehospitalization for any cause.

Mean initial LV ejection fraction (LVEF) was 36%. Two patients died of refractory heart failure during hospitalization. Of the patients who were discharged alive, all except one showed complete LV functional recovery.

At follow-up (mean two years), only 64 (55%) patients were asymptomatic. Rehospitalization rate was high (25%), with chest pain and dyspnea the most common causes. Only two patients had a recurrence of TTC. Eleven patients died (seven from cardiovascular causes). There was no significant difference in mortality or in other clinical events between patients with and without severe LV dysfunction at presentation. The standardized mortality ratio was 3.40 (95% CI, 1.83-6.34) in the TTC population, compared with the age- and sex-specific mortality of the general population.

The study is limited by a lack of patients with subclinical TTC disease and those who might have suffered from sudden cardiac death prior to enrollment, leading to a possible sampling bias, as well as the nonrandomized use of beta-blockers.

Bottom line: Tako-tsubo disease is associated with rare recurrence of the disease, common recurrence of chest pain and dyspnea, and three times the mortality rate of the general population.

Citation: Parodi G, Bellandi B, Del Pace S, et al. Natural history of tako-tsubo cardiomyopathy. Chest. 2011;139(4):887-892.

 

Seven Independent Risk Factors Predict Postoperative Pulmonary Complications

Clinical question: What are the clinical risk factors that predict higher rates of postoperative pulmonary complications?

 

Background: Postoperative pulmonary complications (PPCs) are a major cause of postoperative morbidity, mortality, and prolonged hospital stays. Previous studies looking at risk factors for PPCs were limited by sampling bias and small sample sizes.

Study design: Prospective, randomized-sample cohort study.

Setting: Fifty-nine participating Spanish hospitals (community, intermediate referral, or major tertiary-care facilities).

Synopsis: Patients undergoing surgical procedures with general, neuraxial, or regional anesthesia were selected randomly. The main outcome was the development of at least one of the following: respiratory infection, respiratory failure, bronchospasm, atelectasis, pleural effusion, pneumothorax, or aspiration pneumonitis. Of 2,464 patients enrolled, 252 events were observed in 123 patients (5%). The 30-day mortality rate was significantly higher in patients suffering a PPC than those who did not (19.5% vs. 0.5%). Additionally, regression modeling identified seven independent risk factors: low preoperative arterial oxygen saturation, acute respiratory infection within one month of surgery, advanced age, preoperative anemia, upper abdominal or intrathoracic surgery, surgical duration more than two hours, and emergency surgery.

The study was underpowered to assess the significance of all potential risk factors for PPCs. Also, given the number of centers involved in the study, variation in assessing development of PPCs is likely.

Bottom line: Postoperative pulmonary complications are a major cause of morbidity and mortality. Seven independent risk factors were identified for the development of PPCs, which could be useful in preoperative risk stratification.

Citation: Canet J, Gallart L, Gomar C, et al. Prediction of postoperative pulmonary complications in a population-based surgical cohort. Anesthesiology. 2010;113(6):1338-1350.

 

Code Status Orders and Goals of Medical ICU Care

Clinical question: How familiar are patients in the medical ICU (MICU) or their surrogates regarding code-status orders and goals of care, what are their preferences, and to what extent do they and their physicians differ?

Background: Discussions about code-status orders and goals of care carry great import in the MICU. However, little data exist on patients’ code-status preferences and goals of care. More knowledge of these issues can help physicians deliver more patient-centered care.

Study design: Prospective interviews.

Setting: Twenty-six-bed MICU at a large Midwestern academic medical center.

Synopsis: Data were collected from December 2008 to December 2009 on a random sample of patients—or their surrogates—admitted to the MICU. Of 135 eligible patients/surrogates, 100 completed interviews. Patients primarily were white (95%) and from the ages of 41 to 80 (79%).

Only 28% of participants recalled having a discussion about CPR and one goal of care, while 27% recalled no discussion at all; 83% preferred full code status but had limited knowledge of CPR and its outcomes in the hospital setting. Only 4% were able to identify all components of CPR, and they estimated the mean probability of survival following in-hospital arrest with CPR to be 71.8%, although data suggest survival is closer to 18%. There was a correlation between a higher estimation of survival following CPR and preference for it. After learning about the evidence-based likelihood of a good neurologic outcome following CPR, 8% of the participants became less interested.

Discrepancies between patients’ stated code status and that in the medical record was identified 16% of the time. Additionally, 67.7% of participants differed with their physicians regarding the most important goal of care.

Bottom line: Discussions about code status and goals of care in the MICU occur less frequently than recommended, leading to widespread discrepancies between patients/surrogates and their physicians regarding the most important goal of care. This is compounded by the fact that patients and their surrogates have limited knowledge about in-hospital CPR and its likelihood of success.

 

Citation: Gehlbach TG, Shinkunas LA, Forman-Hoffman VL, Thomas KW, Schmidt GA, Kaldjian LC. Code status orders and goals of care in the medical ICU. Chest. 2011;139:802-809. TH

Clinical question: What is the risk of adverse events and bacteremia in febrile infants aged 29-60 days with urinary tract infections (UTIs)?

Background: The management of young febrile infants with UTIs is marked by uncertainty and variation. Although recent studies have demonstrated the safety and efficacy of oral antibiotics as primary treatment in infants younger than six months of age, younger infants tend to receive a longer duration of intravenous antibiotics. This might reflect a lack of clear delineation of the risk of adverse events and bacteremia in this population.

Study design: Retrospective chart review.

Setting: Twenty primarily tertiary-care EDs.

Synopsis: Infants aged 29 to 60 days with febrile UTIs were identified through laboratory and chart review at the participating centers. Bacteremia and adverse events (death, shock, bacterial meningitis, intensive care, surgical intervention, or other substantial clinical complications) were identified, as well as patients with a high-risk past medical history (PMH) or who were clinically ill on examination, based on a priori definitions of chart wording.

Adverse events occurred in 2.8% of the 1,895 patients; bacteremia occurred in 6.5%. Recursive partitioning analysis was used to identify a very-low-risk population for adverse events—those who were not clinically ill and without high-risk PMH (prediction model sensitivity 98% and negative predictive value 99.9%)—but it was not as successful in accurately identifying infants at very low risk for bacteremia.

Limitations of this study include the lack of a clear description of the adverse events identified (and their presumed relationship to the UTIs), the reliance on ED documentation, and conservative definitions of bacterial meningitis. Nonetheless, this is a study of significant magnitude in a population marked by uncertainty. Results of this study further strengthen data that support the feasibility of outpatient antibiotic therapy in well-appearing infants.

Bottom line: Well-appearing infants aged 29-60 days and without significant past medical history are at very low risk for adverse events.

Citation: Schnadower D, Kupperman N, Macias CG, et al. Febrile infants with urinary tract infections at very low risk for adverse events and bacteremia. Pediatrics. 2010;126:1074-1083.

Clinical question: What is the risk of adverse events and bacteremia in febrile infants aged 29-60 days with urinary tract infections (UTIs)?

Background: The management of young febrile infants with UTIs is marked by uncertainty and variation. Although recent studies have demonstrated the safety and efficacy of oral antibiotics as primary treatment in infants younger than six months of age, younger infants tend to receive a longer duration of intravenous antibiotics. This might reflect a lack of clear delineation of the risk of adverse events and bacteremia in this population.

Study design: Retrospective chart review.

Setting: Twenty primarily tertiary-care EDs.

Synopsis: Infants aged 29 to 60 days with febrile UTIs were identified through laboratory and chart review at the participating centers. Bacteremia and adverse events (death, shock, bacterial meningitis, intensive care, surgical intervention, or other substantial clinical complications) were identified, as well as patients with a high-risk past medical history (PMH) or who were clinically ill on examination, based on a priori definitions of chart wording.

Adverse events occurred in 2.8% of the 1,895 patients; bacteremia occurred in 6.5%. Recursive partitioning analysis was used to identify a very-low-risk population for adverse events—those who were not clinically ill and without high-risk PMH (prediction model sensitivity 98% and negative predictive value 99.9%)—but it was not as successful in accurately identifying infants at very low risk for bacteremia.

Limitations of this study include the lack of a clear description of the adverse events identified (and their presumed relationship to the UTIs), the reliance on ED documentation, and conservative definitions of bacterial meningitis. Nonetheless, this is a study of significant magnitude in a population marked by uncertainty. Results of this study further strengthen data that support the feasibility of outpatient antibiotic therapy in well-appearing infants.

Bottom line: Well-appearing infants aged 29-60 days and without significant past medical history are at very low risk for adverse events.

Citation: Schnadower D, Kupperman N, Macias CG, et al. Febrile infants with urinary tract infections at very low risk for adverse events and bacteremia. Pediatrics. 2010;126:1074-1083.

Clinical question: What is the risk of adverse events and bacteremia in febrile infants aged 29-60 days with urinary tract infections (UTIs)?

Background: The management of young febrile infants with UTIs is marked by uncertainty and variation. Although recent studies have demonstrated the safety and efficacy of oral antibiotics as primary treatment in infants younger than six months of age, younger infants tend to receive a longer duration of intravenous antibiotics. This might reflect a lack of clear delineation of the risk of adverse events and bacteremia in this population.

Study design: Retrospective chart review.

Setting: Twenty primarily tertiary-care EDs.

Synopsis: Infants aged 29 to 60 days with febrile UTIs were identified through laboratory and chart review at the participating centers. Bacteremia and adverse events (death, shock, bacterial meningitis, intensive care, surgical intervention, or other substantial clinical complications) were identified, as well as patients with a high-risk past medical history (PMH) or who were clinically ill on examination, based on a priori definitions of chart wording.

Adverse events occurred in 2.8% of the 1,895 patients; bacteremia occurred in 6.5%. Recursive partitioning analysis was used to identify a very-low-risk population for adverse events—those who were not clinically ill and without high-risk PMH (prediction model sensitivity 98% and negative predictive value 99.9%)—but it was not as successful in accurately identifying infants at very low risk for bacteremia.

Limitations of this study include the lack of a clear description of the adverse events identified (and their presumed relationship to the UTIs), the reliance on ED documentation, and conservative definitions of bacterial meningitis. Nonetheless, this is a study of significant magnitude in a population marked by uncertainty. Results of this study further strengthen data that support the feasibility of outpatient antibiotic therapy in well-appearing infants.

Bottom line: Well-appearing infants aged 29-60 days and without significant past medical history are at very low risk for adverse events.

Citation: Schnadower D, Kupperman N, Macias CG, et al. Febrile infants with urinary tract infections at very low risk for adverse events and bacteremia. Pediatrics. 2010;126:1074-1083.

Literature at a Glance

A guide to this month’s studies

1. Risks of preoperative tobacco use
2. Timing of perioperative beta-blocker use and outcomes
3. Continuous vs. bolus dose diuretics in CHF
4. Outcomes of carotid endearterectomy and carotid artery stenting
5. Protocol for low-risk chest pain
6. Effect of esomeprazole on recurrent ulcer rates in clopidogrel users
7. Effect of ICU QI project on hospital mortality
8. Acute kidney injury risks after coronary angiography

 

Smokers Have Worse Perioperative Outcomes

Clinical question: Do current smokers have worse 30-day postoperative outcomes than nonsmokers after noncardiac surgery?

Background: Approximately 20% of adults in the U.S. smoke cigarettes, and a significant fraction of surgical patients are current smokers. Despite concerns that smoking is associated with worse postoperative outcomes, these increased risks have not been quantified across multiple outcomes.

Study design: Retrospective cohort study.

Setting: Surgical patients in 200 centers throughout the United States.

Synopsis: Data from the American College of Surgeons National Surgical Quality Improvement Program from 2005 to 2008 were acquired, and 391,006 patient records were reviewed. Postoperative morbidity and mortality were significantly greater in smokers. Current smokers had a 40% increased odds of death at 30 days compared to people who had never smoked (OR 1.38, 95% CI, 1.11-1.72). Current smokers also had significantly greater odds of pulmonary complications, including pneumonia (OR 2.09, 95% CI, 1.80-2.43), unplanned intubation (OR 1.87, 95% CI, 1.58-2.21), and mechanical ventilation (OR 1.53, 95% CI, 1.31-1.79).

Furthermore, current smokers had significantly greater odds of postoperative cardiac arrest (OR 1.57, 95% CI, 1.10-2.25), myocardial infarction (OR 1.80, 95% CI, 1.11-2.25), and stroke (OR 1.73, 95% CI, 1.18-2.53). Odds of infectious complications were increased in current smokers, including deep incisional infections (OR 1.42, 95% CI, 1.21-1.68), sepsis (OR 1.30, 95% CI, 1.20-1.60), and septic shock (OR 1.55, 95% CI, 1.29-1.87).

Limitations of this study include self-reporting of smoking habits and absence of detailed smoking history just before and after surgery.

Bottom line: Current smokers have significantly increased postoperative morbidity and mortality after noncardiac surgery.

Citation: Turan A, Mascha EJ, Roberman D, et al. Smoking and perioperative outcomes. Anesthesiology. 2011;114(4):837-846.

 

Chronic Beta-Blockade Reduces Postoperative Myocardial Ischemia

Clinical question: Does the timing of beta-blocker exposure affect cardiovascular outcomes in patients undergoing elective, noncardiac surgery?

Background: Several studies have demonstrated that beta-blockers are associated with decreased perioperative cardiovascular morbidity and mortality. Study designs have varied greatly, and differences in dosing and timing of beta-blocker administration have caused conflicting results. The question of when to initiate beta-blockers prior to surgery remains controversial.

Study design: Prospective cohort study.

Setting: Three academic medical centers in Canada.

Synopsis: Data from 1,398 patients who had elective, noncardiac surgery with either acute (n=436) or chronic (n=962) beta-blocker exposure were analyzed. Acute exposure was defined as receiving a beta-blocker for the first time within 48 hours after surgery, whereas chronic beta-blocker exposure was defined as receiving a beta-blocker seven to 10 days prior to surgery.

Patients with chronic beta-blocker exposure were more likely to have a history of coronary disease, heart failure, or hypertension and were more likely to be receiving statins, antiplatelet agents, and angiotensin-converting enzyme inhibitors. The primary outcome was a composite of major cardiac events, including myocardial infarction, nonfatal cardiac arrest, and 30-day mortality.

 

Major cardiac events occurred more often in patients with acute versus chronic beta-blocker exposure in both the entire cohort (8.3% vs. 4.7%) and in the propensity-matched cohort (8.0% vs. 3.0%). Myocardial infarction accounted for the majority of cardiac events.

There are several limitations of this study: The sample size was small, the beta-blocker and dosage used varied, and the indication and exact duration of chronic beta-blocker therapy was unknown.

Bottom line: Chronic beta-blocker therapy reduces major cardiac events compared with acute beta-blocker therapy in patients undergoing elective, noncardiac surgery.

Citation: Ellenberger C, Tait G, Beattie WS. Chronic beta-blockade is associated with a better outcome after elective noncardiac surgery than acute beta-blockade: a single-center propensity-matched cohort study. Anesthesiology. 2011;114(4):817-823.

 

Continuous and Bolus Dosing of Furosemide Provides Similar Outcomes in Heart Failure

Clinical question: Does continuous infusion compared to bolus dosing of furosemide improve clinical outcomes in patients with acute decompensated heart failure?

Background: Diuresis with furosemide is commonly used to manage acute decompensated heart failure, but it is uncertain which dosing strategy is optimal. Continuous infusion of furosemide has been proposed as a more effective method of diuresis compared with bolus dosing, especially when higher doses are required, but data comparing the two strategies are limited.

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

Setting: Twenty-six clinical sites in the U.S. and Canada.

Synopsis: Researchers randomized 308 patients with acute decompensated heart failure to either continuous or bolus intravenous dosing, which was calculated as either the equivalent of their daily oral dose (low-dose strategy) or 2.5 times their daily dose (high-dose strategy). Mean ejection fraction was 35%. Primary endpoints were patients’ assessment of symptoms based on a visual-analogue scale quantified as area under the curve, as well as change in serum creatinine level at 72 hours.

No significant differences between the continuous and bolus dosing groups were evidenced in primary endpoints at 72 hours. Patients in the bolus group had more dose increases at 48 hours (21% vs. 11%, P=0.01). Patients in the high-dose group were more likely to change from intravenous to oral doses at 48 hours (31% vs. 17%, P<0.001) and had greater net fluid loss (4.9L vs. 3.6L, P=0.01). More patients in the high-dose versus low-dose group had an increase in creatinine ≥0.3 mg/dL (23% vs. 14%, P=0.04). Hospital length of stay, readmission, and mortality rates were similar between the groups.

Bottom line: Diuretic therapy administered by continuous infusion or bolus dosing in patients with acute decompensated heart failure have equivocal effects on patients’ symptoms and kidney function.

Citation: Felker GM, Lee KL, Bull DA, et al. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med. 2011;364(9):797-805.

 

Carotid Endarterectomy Is Better than Carotid Artery Stenting

Clinical question: How do the clinical outcomes of carotid artery stenting compare with those of carotid endarterectomy?

Background: Whether carotid artery stenting or carotid endarterectomy is the preferred therapy for patients with carotid artery stenosis has been highly controversial. This study was a meta-analysis of all available data from randomized trials comparing carotid endarterectomy to carotid artery stenting.

Study design: Meta-analysis.

Setting: Teaching and nonteaching hospitals.

 

Synopsis: Thirteen randomized trials were identified with 3,723 patients who had undergone endarterectomy and 3,754 patients who had undergone carotid artery stenting. Outcomes included stroke, myocardial infarction, cranial nerve injury, and death or stroke, and these outcomes were divided as either short-term (<30 days) or long-term (>1 year) outcomes.

Patients who had undergone carotid artery stenting had less risk of short-term myocardial infarction (OR 0.48, 95% CI, 0.29–9.78, P=0.003) and less risk of cranial nerve injury (OR 0.09, 95% CI, 0.05–0.16, P<0.001). However, carotid artery stenting had a significantly higher risk of short-term stroke and combined death or stroke, and also significantly higher long-term risk of stroke and combined death or stroke. The association between carotid artery stenting and stroke was stronger in the subgroup of patients >68 years but not in patients <68 years. There was no significant heterogeneity, and no significant modifying associations were revealed by meta-regression analysis.

Limitations include potentially unpublished small studies favoring carotid endarterectomy and a significant publication bias regarding short-term death.

Bottom line: Although carotid artery stenting has less short-term risk of myocardial infarction and cranial nerve injury, carotid endarterectomy has less short-term and long-term risks of stroke and death.

Citation: Economopoulus KP, Sergentanis TN, Tsivgoulis G, Mariolis AD, Stefanadis C. Carotid artery stenting versus carotid endarterectomy: a comprehensive meta-analysis of short-term and long-term outcomes. Stroke. 2011;42:687-692.

 

Chest Pain Protocol Can Identify Low-Risk Chest Pain in Emergency Departments

Clinical question: Can a two-hour accelerated diagnostic protocol (ADP) based on electrocardiogram, point-of-care biomarkers, and Thrombolysis in Myocardial Infarction (TIMI) score safely identify patients with chest pain at very low short-term risk of major cardiac events?

Background: Evaluation of patients presenting to EDs with chest pain utilize significant amounts of hospital resources. A safe, reproducible, and expeditious process to identify patients at low risk for short-term cardiac events is desired.

Study design: Prospective cohort study.

Setting: Fourteen urban EDs in nine countries across the Asia-Pacific region.

Synopsis: The study included 3,582 patients presenting to an ED with at least five minutes of chest pain suggestive of an acute coronary syndrome and for whom further evaluation with serial cardiac biomarkers was planned. A negative ADP was defined as TIMI score of 0, no new ischemic changes on initial electrocardiogram, and normal cardiac biomarkers at zero and two hours after arrival.

All components of the ADP were negative for 352 patients (9.8%). Only three low-risk patients (0.9%) by ADP had a major cardiac event during the 30-day follow-up period, yielding a negative predictive value of 99.1% (95% CI, 97.3-99.8%). Mean hospital stay for the low-risk group with a negative ADP was 43 hours with a median of 26 hours. The authors suggest that a 10% reduction in prolonged workups of patients with chest pain could be seen with implementation of this protocol.

Potential limitations include applicability only to a select cohort of patients with chest pain and the low specificity of the protocol.

Bottom line: A two-hour diagnostic protocol can help expedite discharge of patients with very-low-risk chest pain.

Citation: Than T, Cullen L, Reid CM, et al. A 2-h diagnostic protocol to assess patients with chest pain symptoms in the Asia-Pacific region (ASPECT): a prospective observational validation study. Lancet. 2011;337:1077-1084.

 

 

Esomeprazole Reduces Peptic Ulcer Recurrence in Patients on Clopidogrel

Clinical question: Does esomeprazole prevent recurrent peptic ulcers in patients with atherosclerosis on clopidogrel?

Background: Although clopidogrel is sometimes used as an alternative antiplatelet agent to aspirin, a significant rate of recurrent ulcer bleeding on clopidogrel has been described. No previous prospective trial has studied whether a proton-pump inhibitor (PPI) can reduce the risk of peptic ulcer recurrence or bleeding in atherosclerotic patients on clopidogrel.

Study design: Randomized controlled trial.

Setting: A single veterans hospital in Taiwan.

Synopsis: One hundred sixty-five patients were enrolled with a past history of peptic ulcer disease, no signs of ulcer recurrence by endoscopy, and current use of clopidogrel 37.5 mg to 75 mg per day. All patients had atherosclerosis and had been on clopidogrel for at least two weeks, without aspirin, corticosteroids, anticoagulants, or recent treatment with a PPI. Patients were randomized to clopidogrel 75 mg at night (n=82) or clopidogrel 75 mg at night plus esomeprazole 20 mg before breakfast. Follow-up endoscopy was performed at six months or as needed for symptoms.

Recurrence of ulcer was found in 1.2% of patients on clopidogrel plus esomeprazole versus 11.0% in patients on clopidogrel alone (95% CI, 2.6-17.0%; P=0.009). The pharmacodynamic study revealed no significant differences in platelet aggregation within or between treatment groups on day 1 or day 28. No significant differences were seen on the incidence of ischemic events in this setting, but the trial was underpowered to draw conclusions on this outcome.

An important limitation is that the findings of this study are applicable only to patients on clopidogrel monotherapy and not dual antiplatelet therapy.

Bottom line: A significant reduction in recurrent peptic ulcers is seen with the combination of esomeprazole plus clopidogrel, versus clopidogrel alone, in patients with atherosclerosis and a history of peptic ulcer disease.

Citation: Hsu PI, Lai KH, Liu CP. Esomeprazole with clopidogrel reduces peptic ulcer recurrence, compared with clopidogrel alone, in patients with atherosclerosis. Gastroenterology. 2011;140:791-798.

 

ICU Quality-Improvement Project Reduces Hospital Mortality

Clinical question: Does a quality-improvement (QI) project in the ICU reduce in-hospital mortality and length of stay among elderly adults?

Background: Previous studies have shown that ICU-acquired infections are associated with increased morbidity and mortality, and QI initiatives reduce hospital-acquired infections. However, it has not been demonstrated that QI projects in the ICU reduce in-hospital mortality or length of stay.

Study design: Retrospective cohort study.

Setting: Four hundred fifty-nine Midwestern hospitals.

Synopsis: This study included 238,937 adults age >65 who were hospitalized in an ICU from 2001 to 2006 at one of 95 hospitals invited to implement the Keystone ICU Project. The control group included 1,091,547 elderly adults at one of 364 hospitals not invited to participate in the project. The Keystone ICU Project implements evidence-based practices to reduce rates of catheter-related bloodstream infections and ventilator-associated pneumonia.

Hospital mortality was not significantly reduced during initiation or implementation of the project; however, a significant reduction in hospital mortality occurred in the study group during one to 12 months post-implementation (OR=0.83 vs. 0.88, P=0.041) and 13 to 22 months post-implementation (OR=0.76 vs. 0.84, P=0.007). In contrast, length of stay did not differ significantly between the two groups, but the study was underpowered for this outcome.

The study is limited by the complexity of the Keystone ICU Project, as well as the exclusion of smaller hospitals and nonelderly adults. The study is promising because implementing a QI project in the ICU is associated with no known harms and might confer a mortality benefit at a relatively low cost.

 

Bottom line: Elderly adults had lower in-hospital mortality after implementation of the Keystone QI project in ICUs.

Citation: Lipitz-Snyderman A, Steinwachs D, Needham DM, Colantuoni E, Morlock LL, Pronovost PJ. Impact of a statewide intensive care unit quality improvement initiative on hospital mortality and length of stay: retrospective comparative analysis. BMJ. 2011;342:d219.

 

Serious Long-Term Risks with Acute Kidney Injury after Coronary Angiography

Clinical question: Does postcoronary angiography acute kidney injury (AKI) increase the risk of poor long-term clinical outcomes?

Background: Previous studies have shown that AKI following coronary angiography increases the risk of poor short-term clinical outcomes, such as in-hospital myocardial infarction, prolonged hospital stay, and early mortality. Little is known about the long-term cardiovascular and renal outcomes following post-coronary angiography AKI.

Study design: Retrospective cohort study.

Setting: All coronary angiography centers in Alberta, Canada.

Synopsis: The study included 14,782 adults who were ≥18 years of age, underwent coronary angiography, had a baseline creatinine measurement, did not have end-stage renal disease (ESRD), and had a creatinine measurement within seven days after coronary angiography.

During a median follow-up period of 19.7 months, 1,099 (7.4%) patients developed stage 1 AKI and 321 (2.2%) developed stage 2 or 3 AKI. Mortality increased twofold with stage 1 AKI and >3-fold with stage 2 or 3 AKI. Risk of ESRD increased substantially by >11-fold in patients with stage 2 or 3 AKI. Risk of hospitalization for subsequent AKI, myocardial infarction, and heart failure also increased significantly following post-coronary angiography AKI.

Patients who experienced AKI were older, had more severe CAD, were more likely to have such comorbidities as DM, HTN, and heart failure, and had lower baseline GFRs. However, the underlying comorbidities do not completely explain the increased risk of poor long-term outcomes in the adjusted analysis.

Limitations include missing or underestimating mild cases of AKI, residual confounding from unmeasured variables, and inability of retrospective comparative studies to establish causality.

Bottom line: Adults with post-coronary angiography AKI are at increased risk of poor long-term cardiovascular and renal outcomes.

Citation: James MT, Ghali WA, Knudtson ML, et al. Associations between acute kidney injury and cardiovascular and renal outcomes after coronary angiography. Circulation. 2011;123(4):409-416. TH

Literature at a Glance

A guide to this month’s studies

1. Risks of preoperative tobacco use
2. Timing of perioperative beta-blocker use and outcomes
3. Continuous vs. bolus dose diuretics in CHF
4. Outcomes of carotid endearterectomy and carotid artery stenting
5. Protocol for low-risk chest pain
6. Effect of esomeprazole on recurrent ulcer rates in clopidogrel users
7. Effect of ICU QI project on hospital mortality
8. Acute kidney injury risks after coronary angiography

 

Smokers Have Worse Perioperative Outcomes

Clinical question: Do current smokers have worse 30-day postoperative outcomes than nonsmokers after noncardiac surgery?

Background: Approximately 20% of adults in the U.S. smoke cigarettes, and a significant fraction of surgical patients are current smokers. Despite concerns that smoking is associated with worse postoperative outcomes, these increased risks have not been quantified across multiple outcomes.

Study design: Retrospective cohort study.

Setting: Surgical patients in 200 centers throughout the United States.

Synopsis: Data from the American College of Surgeons National Surgical Quality Improvement Program from 2005 to 2008 were acquired, and 391,006 patient records were reviewed. Postoperative morbidity and mortality were significantly greater in smokers. Current smokers had a 40% increased odds of death at 30 days compared to people who had never smoked (OR 1.38, 95% CI, 1.11-1.72). Current smokers also had significantly greater odds of pulmonary complications, including pneumonia (OR 2.09, 95% CI, 1.80-2.43), unplanned intubation (OR 1.87, 95% CI, 1.58-2.21), and mechanical ventilation (OR 1.53, 95% CI, 1.31-1.79).

Furthermore, current smokers had significantly greater odds of postoperative cardiac arrest (OR 1.57, 95% CI, 1.10-2.25), myocardial infarction (OR 1.80, 95% CI, 1.11-2.25), and stroke (OR 1.73, 95% CI, 1.18-2.53). Odds of infectious complications were increased in current smokers, including deep incisional infections (OR 1.42, 95% CI, 1.21-1.68), sepsis (OR 1.30, 95% CI, 1.20-1.60), and septic shock (OR 1.55, 95% CI, 1.29-1.87).

Limitations of this study include self-reporting of smoking habits and absence of detailed smoking history just before and after surgery.

Bottom line: Current smokers have significantly increased postoperative morbidity and mortality after noncardiac surgery.

Citation: Turan A, Mascha EJ, Roberman D, et al. Smoking and perioperative outcomes. Anesthesiology. 2011;114(4):837-846.

 

Chronic Beta-Blockade Reduces Postoperative Myocardial Ischemia

Clinical question: Does the timing of beta-blocker exposure affect cardiovascular outcomes in patients undergoing elective, noncardiac surgery?

Background: Several studies have demonstrated that beta-blockers are associated with decreased perioperative cardiovascular morbidity and mortality. Study designs have varied greatly, and differences in dosing and timing of beta-blocker administration have caused conflicting results. The question of when to initiate beta-blockers prior to surgery remains controversial.

Study design: Prospective cohort study.

Setting: Three academic medical centers in Canada.

Synopsis: Data from 1,398 patients who had elective, noncardiac surgery with either acute (n=436) or chronic (n=962) beta-blocker exposure were analyzed. Acute exposure was defined as receiving a beta-blocker for the first time within 48 hours after surgery, whereas chronic beta-blocker exposure was defined as receiving a beta-blocker seven to 10 days prior to surgery.

Patients with chronic beta-blocker exposure were more likely to have a history of coronary disease, heart failure, or hypertension and were more likely to be receiving statins, antiplatelet agents, and angiotensin-converting enzyme inhibitors. The primary outcome was a composite of major cardiac events, including myocardial infarction, nonfatal cardiac arrest, and 30-day mortality.

 

Major cardiac events occurred more often in patients with acute versus chronic beta-blocker exposure in both the entire cohort (8.3% vs. 4.7%) and in the propensity-matched cohort (8.0% vs. 3.0%). Myocardial infarction accounted for the majority of cardiac events.

There are several limitations of this study: The sample size was small, the beta-blocker and dosage used varied, and the indication and exact duration of chronic beta-blocker therapy was unknown.

Bottom line: Chronic beta-blocker therapy reduces major cardiac events compared with acute beta-blocker therapy in patients undergoing elective, noncardiac surgery.

Citation: Ellenberger C, Tait G, Beattie WS. Chronic beta-blockade is associated with a better outcome after elective noncardiac surgery than acute beta-blockade: a single-center propensity-matched cohort study. Anesthesiology. 2011;114(4):817-823.

 

Continuous and Bolus Dosing of Furosemide Provides Similar Outcomes in Heart Failure

Clinical question: Does continuous infusion compared to bolus dosing of furosemide improve clinical outcomes in patients with acute decompensated heart failure?

Background: Diuresis with furosemide is commonly used to manage acute decompensated heart failure, but it is uncertain which dosing strategy is optimal. Continuous infusion of furosemide has been proposed as a more effective method of diuresis compared with bolus dosing, especially when higher doses are required, but data comparing the two strategies are limited.

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

Setting: Twenty-six clinical sites in the U.S. and Canada.

Synopsis: Researchers randomized 308 patients with acute decompensated heart failure to either continuous or bolus intravenous dosing, which was calculated as either the equivalent of their daily oral dose (low-dose strategy) or 2.5 times their daily dose (high-dose strategy). Mean ejection fraction was 35%. Primary endpoints were patients’ assessment of symptoms based on a visual-analogue scale quantified as area under the curve, as well as change in serum creatinine level at 72 hours.

No significant differences between the continuous and bolus dosing groups were evidenced in primary endpoints at 72 hours. Patients in the bolus group had more dose increases at 48 hours (21% vs. 11%, P=0.01). Patients in the high-dose group were more likely to change from intravenous to oral doses at 48 hours (31% vs. 17%, P<0.001) and had greater net fluid loss (4.9L vs. 3.6L, P=0.01). More patients in the high-dose versus low-dose group had an increase in creatinine ≥0.3 mg/dL (23% vs. 14%, P=0.04). Hospital length of stay, readmission, and mortality rates were similar between the groups.

Bottom line: Diuretic therapy administered by continuous infusion or bolus dosing in patients with acute decompensated heart failure have equivocal effects on patients’ symptoms and kidney function.

Citation: Felker GM, Lee KL, Bull DA, et al. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med. 2011;364(9):797-805.

 

Carotid Endarterectomy Is Better than Carotid Artery Stenting

Clinical question: How do the clinical outcomes of carotid artery stenting compare with those of carotid endarterectomy?

Background: Whether carotid artery stenting or carotid endarterectomy is the preferred therapy for patients with carotid artery stenosis has been highly controversial. This study was a meta-analysis of all available data from randomized trials comparing carotid endarterectomy to carotid artery stenting.

Study design: Meta-analysis.

Setting: Teaching and nonteaching hospitals.

 

Synopsis: Thirteen randomized trials were identified with 3,723 patients who had undergone endarterectomy and 3,754 patients who had undergone carotid artery stenting. Outcomes included stroke, myocardial infarction, cranial nerve injury, and death or stroke, and these outcomes were divided as either short-term (<30 days) or long-term (>1 year) outcomes.

Patients who had undergone carotid artery stenting had less risk of short-term myocardial infarction (OR 0.48, 95% CI, 0.29–9.78, P=0.003) and less risk of cranial nerve injury (OR 0.09, 95% CI, 0.05–0.16, P<0.001). However, carotid artery stenting had a significantly higher risk of short-term stroke and combined death or stroke, and also significantly higher long-term risk of stroke and combined death or stroke. The association between carotid artery stenting and stroke was stronger in the subgroup of patients >68 years but not in patients <68 years. There was no significant heterogeneity, and no significant modifying associations were revealed by meta-regression analysis.

Limitations include potentially unpublished small studies favoring carotid endarterectomy and a significant publication bias regarding short-term death.

Bottom line: Although carotid artery stenting has less short-term risk of myocardial infarction and cranial nerve injury, carotid endarterectomy has less short-term and long-term risks of stroke and death.

Citation: Economopoulus KP, Sergentanis TN, Tsivgoulis G, Mariolis AD, Stefanadis C. Carotid artery stenting versus carotid endarterectomy: a comprehensive meta-analysis of short-term and long-term outcomes. Stroke. 2011;42:687-692.

 

Chest Pain Protocol Can Identify Low-Risk Chest Pain in Emergency Departments

Clinical question: Can a two-hour accelerated diagnostic protocol (ADP) based on electrocardiogram, point-of-care biomarkers, and Thrombolysis in Myocardial Infarction (TIMI) score safely identify patients with chest pain at very low short-term risk of major cardiac events?

Background: Evaluation of patients presenting to EDs with chest pain utilize significant amounts of hospital resources. A safe, reproducible, and expeditious process to identify patients at low risk for short-term cardiac events is desired.

Study design: Prospective cohort study.

Setting: Fourteen urban EDs in nine countries across the Asia-Pacific region.

Synopsis: The study included 3,582 patients presenting to an ED with at least five minutes of chest pain suggestive of an acute coronary syndrome and for whom further evaluation with serial cardiac biomarkers was planned. A negative ADP was defined as TIMI score of 0, no new ischemic changes on initial electrocardiogram, and normal cardiac biomarkers at zero and two hours after arrival.

All components of the ADP were negative for 352 patients (9.8%). Only three low-risk patients (0.9%) by ADP had a major cardiac event during the 30-day follow-up period, yielding a negative predictive value of 99.1% (95% CI, 97.3-99.8%). Mean hospital stay for the low-risk group with a negative ADP was 43 hours with a median of 26 hours. The authors suggest that a 10% reduction in prolonged workups of patients with chest pain could be seen with implementation of this protocol.

Potential limitations include applicability only to a select cohort of patients with chest pain and the low specificity of the protocol.

Bottom line: A two-hour diagnostic protocol can help expedite discharge of patients with very-low-risk chest pain.

Citation: Than T, Cullen L, Reid CM, et al. A 2-h diagnostic protocol to assess patients with chest pain symptoms in the Asia-Pacific region (ASPECT): a prospective observational validation study. Lancet. 2011;337:1077-1084.

 

 

Esomeprazole Reduces Peptic Ulcer Recurrence in Patients on Clopidogrel

Clinical question: Does esomeprazole prevent recurrent peptic ulcers in patients with atherosclerosis on clopidogrel?

Background: Although clopidogrel is sometimes used as an alternative antiplatelet agent to aspirin, a significant rate of recurrent ulcer bleeding on clopidogrel has been described. No previous prospective trial has studied whether a proton-pump inhibitor (PPI) can reduce the risk of peptic ulcer recurrence or bleeding in atherosclerotic patients on clopidogrel.

Study design: Randomized controlled trial.

Setting: A single veterans hospital in Taiwan.

Synopsis: One hundred sixty-five patients were enrolled with a past history of peptic ulcer disease, no signs of ulcer recurrence by endoscopy, and current use of clopidogrel 37.5 mg to 75 mg per day. All patients had atherosclerosis and had been on clopidogrel for at least two weeks, without aspirin, corticosteroids, anticoagulants, or recent treatment with a PPI. Patients were randomized to clopidogrel 75 mg at night (n=82) or clopidogrel 75 mg at night plus esomeprazole 20 mg before breakfast. Follow-up endoscopy was performed at six months or as needed for symptoms.

Recurrence of ulcer was found in 1.2% of patients on clopidogrel plus esomeprazole versus 11.0% in patients on clopidogrel alone (95% CI, 2.6-17.0%; P=0.009). The pharmacodynamic study revealed no significant differences in platelet aggregation within or between treatment groups on day 1 or day 28. No significant differences were seen on the incidence of ischemic events in this setting, but the trial was underpowered to draw conclusions on this outcome.

An important limitation is that the findings of this study are applicable only to patients on clopidogrel monotherapy and not dual antiplatelet therapy.

Bottom line: A significant reduction in recurrent peptic ulcers is seen with the combination of esomeprazole plus clopidogrel, versus clopidogrel alone, in patients with atherosclerosis and a history of peptic ulcer disease.

Citation: Hsu PI, Lai KH, Liu CP. Esomeprazole with clopidogrel reduces peptic ulcer recurrence, compared with clopidogrel alone, in patients with atherosclerosis. Gastroenterology. 2011;140:791-798.

 

ICU Quality-Improvement Project Reduces Hospital Mortality

Clinical question: Does a quality-improvement (QI) project in the ICU reduce in-hospital mortality and length of stay among elderly adults?

Background: Previous studies have shown that ICU-acquired infections are associated with increased morbidity and mortality, and QI initiatives reduce hospital-acquired infections. However, it has not been demonstrated that QI projects in the ICU reduce in-hospital mortality or length of stay.

Study design: Retrospective cohort study.

Setting: Four hundred fifty-nine Midwestern hospitals.

Synopsis: This study included 238,937 adults age >65 who were hospitalized in an ICU from 2001 to 2006 at one of 95 hospitals invited to implement the Keystone ICU Project. The control group included 1,091,547 elderly adults at one of 364 hospitals not invited to participate in the project. The Keystone ICU Project implements evidence-based practices to reduce rates of catheter-related bloodstream infections and ventilator-associated pneumonia.

Hospital mortality was not significantly reduced during initiation or implementation of the project; however, a significant reduction in hospital mortality occurred in the study group during one to 12 months post-implementation (OR=0.83 vs. 0.88, P=0.041) and 13 to 22 months post-implementation (OR=0.76 vs. 0.84, P=0.007). In contrast, length of stay did not differ significantly between the two groups, but the study was underpowered for this outcome.

The study is limited by the complexity of the Keystone ICU Project, as well as the exclusion of smaller hospitals and nonelderly adults. The study is promising because implementing a QI project in the ICU is associated with no known harms and might confer a mortality benefit at a relatively low cost.

 

Bottom line: Elderly adults had lower in-hospital mortality after implementation of the Keystone QI project in ICUs.

Citation: Lipitz-Snyderman A, Steinwachs D, Needham DM, Colantuoni E, Morlock LL, Pronovost PJ. Impact of a statewide intensive care unit quality improvement initiative on hospital mortality and length of stay: retrospective comparative analysis. BMJ. 2011;342:d219.

 

Serious Long-Term Risks with Acute Kidney Injury after Coronary Angiography

Clinical question: Does postcoronary angiography acute kidney injury (AKI) increase the risk of poor long-term clinical outcomes?

Background: Previous studies have shown that AKI following coronary angiography increases the risk of poor short-term clinical outcomes, such as in-hospital myocardial infarction, prolonged hospital stay, and early mortality. Little is known about the long-term cardiovascular and renal outcomes following post-coronary angiography AKI.

Study design: Retrospective cohort study.

Setting: All coronary angiography centers in Alberta, Canada.

Synopsis: The study included 14,782 adults who were ≥18 years of age, underwent coronary angiography, had a baseline creatinine measurement, did not have end-stage renal disease (ESRD), and had a creatinine measurement within seven days after coronary angiography.

During a median follow-up period of 19.7 months, 1,099 (7.4%) patients developed stage 1 AKI and 321 (2.2%) developed stage 2 or 3 AKI. Mortality increased twofold with stage 1 AKI and >3-fold with stage 2 or 3 AKI. Risk of ESRD increased substantially by >11-fold in patients with stage 2 or 3 AKI. Risk of hospitalization for subsequent AKI, myocardial infarction, and heart failure also increased significantly following post-coronary angiography AKI.

Patients who experienced AKI were older, had more severe CAD, were more likely to have such comorbidities as DM, HTN, and heart failure, and had lower baseline GFRs. However, the underlying comorbidities do not completely explain the increased risk of poor long-term outcomes in the adjusted analysis.

Limitations include missing or underestimating mild cases of AKI, residual confounding from unmeasured variables, and inability of retrospective comparative studies to establish causality.

Bottom line: Adults with post-coronary angiography AKI are at increased risk of poor long-term cardiovascular and renal outcomes.

Citation: James MT, Ghali WA, Knudtson ML, et al. Associations between acute kidney injury and cardiovascular and renal outcomes after coronary angiography. Circulation. 2011;123(4):409-416. TH

Literature at a Glance

A guide to this month’s studies

1. Risks of preoperative tobacco use
2. Timing of perioperative beta-blocker use and outcomes
3. Continuous vs. bolus dose diuretics in CHF
4. Outcomes of carotid endearterectomy and carotid artery stenting
5. Protocol for low-risk chest pain
6. Effect of esomeprazole on recurrent ulcer rates in clopidogrel users
7. Effect of ICU QI project on hospital mortality
8. Acute kidney injury risks after coronary angiography

 

Smokers Have Worse Perioperative Outcomes

Clinical question: Do current smokers have worse 30-day postoperative outcomes than nonsmokers after noncardiac surgery?

Background: Approximately 20% of adults in the U.S. smoke cigarettes, and a significant fraction of surgical patients are current smokers. Despite concerns that smoking is associated with worse postoperative outcomes, these increased risks have not been quantified across multiple outcomes.

Study design: Retrospective cohort study.

Setting: Surgical patients in 200 centers throughout the United States.

Synopsis: Data from the American College of Surgeons National Surgical Quality Improvement Program from 2005 to 2008 were acquired, and 391,006 patient records were reviewed. Postoperative morbidity and mortality were significantly greater in smokers. Current smokers had a 40% increased odds of death at 30 days compared to people who had never smoked (OR 1.38, 95% CI, 1.11-1.72). Current smokers also had significantly greater odds of pulmonary complications, including pneumonia (OR 2.09, 95% CI, 1.80-2.43), unplanned intubation (OR 1.87, 95% CI, 1.58-2.21), and mechanical ventilation (OR 1.53, 95% CI, 1.31-1.79).

Furthermore, current smokers had significantly greater odds of postoperative cardiac arrest (OR 1.57, 95% CI, 1.10-2.25), myocardial infarction (OR 1.80, 95% CI, 1.11-2.25), and stroke (OR 1.73, 95% CI, 1.18-2.53). Odds of infectious complications were increased in current smokers, including deep incisional infections (OR 1.42, 95% CI, 1.21-1.68), sepsis (OR 1.30, 95% CI, 1.20-1.60), and septic shock (OR 1.55, 95% CI, 1.29-1.87).

Limitations of this study include self-reporting of smoking habits and absence of detailed smoking history just before and after surgery.

Bottom line: Current smokers have significantly increased postoperative morbidity and mortality after noncardiac surgery.

Citation: Turan A, Mascha EJ, Roberman D, et al. Smoking and perioperative outcomes. Anesthesiology. 2011;114(4):837-846.

 

Chronic Beta-Blockade Reduces Postoperative Myocardial Ischemia

Clinical question: Does the timing of beta-blocker exposure affect cardiovascular outcomes in patients undergoing elective, noncardiac surgery?

Background: Several studies have demonstrated that beta-blockers are associated with decreased perioperative cardiovascular morbidity and mortality. Study designs have varied greatly, and differences in dosing and timing of beta-blocker administration have caused conflicting results. The question of when to initiate beta-blockers prior to surgery remains controversial.

Study design: Prospective cohort study.

Setting: Three academic medical centers in Canada.

Synopsis: Data from 1,398 patients who had elective, noncardiac surgery with either acute (n=436) or chronic (n=962) beta-blocker exposure were analyzed. Acute exposure was defined as receiving a beta-blocker for the first time within 48 hours after surgery, whereas chronic beta-blocker exposure was defined as receiving a beta-blocker seven to 10 days prior to surgery.

Patients with chronic beta-blocker exposure were more likely to have a history of coronary disease, heart failure, or hypertension and were more likely to be receiving statins, antiplatelet agents, and angiotensin-converting enzyme inhibitors. The primary outcome was a composite of major cardiac events, including myocardial infarction, nonfatal cardiac arrest, and 30-day mortality.

 

Major cardiac events occurred more often in patients with acute versus chronic beta-blocker exposure in both the entire cohort (8.3% vs. 4.7%) and in the propensity-matched cohort (8.0% vs. 3.0%). Myocardial infarction accounted for the majority of cardiac events.

There are several limitations of this study: The sample size was small, the beta-blocker and dosage used varied, and the indication and exact duration of chronic beta-blocker therapy was unknown.

Bottom line: Chronic beta-blocker therapy reduces major cardiac events compared with acute beta-blocker therapy in patients undergoing elective, noncardiac surgery.

Citation: Ellenberger C, Tait G, Beattie WS. Chronic beta-blockade is associated with a better outcome after elective noncardiac surgery than acute beta-blockade: a single-center propensity-matched cohort study. Anesthesiology. 2011;114(4):817-823.

 

Continuous and Bolus Dosing of Furosemide Provides Similar Outcomes in Heart Failure

Clinical question: Does continuous infusion compared to bolus dosing of furosemide improve clinical outcomes in patients with acute decompensated heart failure?

Background: Diuresis with furosemide is commonly used to manage acute decompensated heart failure, but it is uncertain which dosing strategy is optimal. Continuous infusion of furosemide has been proposed as a more effective method of diuresis compared with bolus dosing, especially when higher doses are required, but data comparing the two strategies are limited.

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

Setting: Twenty-six clinical sites in the U.S. and Canada.

Synopsis: Researchers randomized 308 patients with acute decompensated heart failure to either continuous or bolus intravenous dosing, which was calculated as either the equivalent of their daily oral dose (low-dose strategy) or 2.5 times their daily dose (high-dose strategy). Mean ejection fraction was 35%. Primary endpoints were patients’ assessment of symptoms based on a visual-analogue scale quantified as area under the curve, as well as change in serum creatinine level at 72 hours.

No significant differences between the continuous and bolus dosing groups were evidenced in primary endpoints at 72 hours. Patients in the bolus group had more dose increases at 48 hours (21% vs. 11%, P=0.01). Patients in the high-dose group were more likely to change from intravenous to oral doses at 48 hours (31% vs. 17%, P<0.001) and had greater net fluid loss (4.9L vs. 3.6L, P=0.01). More patients in the high-dose versus low-dose group had an increase in creatinine ≥0.3 mg/dL (23% vs. 14%, P=0.04). Hospital length of stay, readmission, and mortality rates were similar between the groups.

Bottom line: Diuretic therapy administered by continuous infusion or bolus dosing in patients with acute decompensated heart failure have equivocal effects on patients’ symptoms and kidney function.

Citation: Felker GM, Lee KL, Bull DA, et al. Diuretic strategies in patients with acute decompensated heart failure. N Engl J Med. 2011;364(9):797-805.

 

Carotid Endarterectomy Is Better than Carotid Artery Stenting

Clinical question: How do the clinical outcomes of carotid artery stenting compare with those of carotid endarterectomy?

Background: Whether carotid artery stenting or carotid endarterectomy is the preferred therapy for patients with carotid artery stenosis has been highly controversial. This study was a meta-analysis of all available data from randomized trials comparing carotid endarterectomy to carotid artery stenting.

Study design: Meta-analysis.

Setting: Teaching and nonteaching hospitals.

 

Synopsis: Thirteen randomized trials were identified with 3,723 patients who had undergone endarterectomy and 3,754 patients who had undergone carotid artery stenting. Outcomes included stroke, myocardial infarction, cranial nerve injury, and death or stroke, and these outcomes were divided as either short-term (<30 days) or long-term (>1 year) outcomes.

Patients who had undergone carotid artery stenting had less risk of short-term myocardial infarction (OR 0.48, 95% CI, 0.29–9.78, P=0.003) and less risk of cranial nerve injury (OR 0.09, 95% CI, 0.05–0.16, P<0.001). However, carotid artery stenting had a significantly higher risk of short-term stroke and combined death or stroke, and also significantly higher long-term risk of stroke and combined death or stroke. The association between carotid artery stenting and stroke was stronger in the subgroup of patients >68 years but not in patients <68 years. There was no significant heterogeneity, and no significant modifying associations were revealed by meta-regression analysis.

Limitations include potentially unpublished small studies favoring carotid endarterectomy and a significant publication bias regarding short-term death.

Bottom line: Although carotid artery stenting has less short-term risk of myocardial infarction and cranial nerve injury, carotid endarterectomy has less short-term and long-term risks of stroke and death.

Citation: Economopoulus KP, Sergentanis TN, Tsivgoulis G, Mariolis AD, Stefanadis C. Carotid artery stenting versus carotid endarterectomy: a comprehensive meta-analysis of short-term and long-term outcomes. Stroke. 2011;42:687-692.

 

Chest Pain Protocol Can Identify Low-Risk Chest Pain in Emergency Departments

Clinical question: Can a two-hour accelerated diagnostic protocol (ADP) based on electrocardiogram, point-of-care biomarkers, and Thrombolysis in Myocardial Infarction (TIMI) score safely identify patients with chest pain at very low short-term risk of major cardiac events?

Background: Evaluation of patients presenting to EDs with chest pain utilize significant amounts of hospital resources. A safe, reproducible, and expeditious process to identify patients at low risk for short-term cardiac events is desired.

Study design: Prospective cohort study.

Setting: Fourteen urban EDs in nine countries across the Asia-Pacific region.

Synopsis: The study included 3,582 patients presenting to an ED with at least five minutes of chest pain suggestive of an acute coronary syndrome and for whom further evaluation with serial cardiac biomarkers was planned. A negative ADP was defined as TIMI score of 0, no new ischemic changes on initial electrocardiogram, and normal cardiac biomarkers at zero and two hours after arrival.

All components of the ADP were negative for 352 patients (9.8%). Only three low-risk patients (0.9%) by ADP had a major cardiac event during the 30-day follow-up period, yielding a negative predictive value of 99.1% (95% CI, 97.3-99.8%). Mean hospital stay for the low-risk group with a negative ADP was 43 hours with a median of 26 hours. The authors suggest that a 10% reduction in prolonged workups of patients with chest pain could be seen with implementation of this protocol.

Potential limitations include applicability only to a select cohort of patients with chest pain and the low specificity of the protocol.

Bottom line: A two-hour diagnostic protocol can help expedite discharge of patients with very-low-risk chest pain.

Citation: Than T, Cullen L, Reid CM, et al. A 2-h diagnostic protocol to assess patients with chest pain symptoms in the Asia-Pacific region (ASPECT): a prospective observational validation study. Lancet. 2011;337:1077-1084.

 

 

Esomeprazole Reduces Peptic Ulcer Recurrence in Patients on Clopidogrel

Clinical question: Does esomeprazole prevent recurrent peptic ulcers in patients with atherosclerosis on clopidogrel?

Background: Although clopidogrel is sometimes used as an alternative antiplatelet agent to aspirin, a significant rate of recurrent ulcer bleeding on clopidogrel has been described. No previous prospective trial has studied whether a proton-pump inhibitor (PPI) can reduce the risk of peptic ulcer recurrence or bleeding in atherosclerotic patients on clopidogrel.

Study design: Randomized controlled trial.

Setting: A single veterans hospital in Taiwan.

Synopsis: One hundred sixty-five patients were enrolled with a past history of peptic ulcer disease, no signs of ulcer recurrence by endoscopy, and current use of clopidogrel 37.5 mg to 75 mg per day. All patients had atherosclerosis and had been on clopidogrel for at least two weeks, without aspirin, corticosteroids, anticoagulants, or recent treatment with a PPI. Patients were randomized to clopidogrel 75 mg at night (n=82) or clopidogrel 75 mg at night plus esomeprazole 20 mg before breakfast. Follow-up endoscopy was performed at six months or as needed for symptoms.

Recurrence of ulcer was found in 1.2% of patients on clopidogrel plus esomeprazole versus 11.0% in patients on clopidogrel alone (95% CI, 2.6-17.0%; P=0.009). The pharmacodynamic study revealed no significant differences in platelet aggregation within or between treatment groups on day 1 or day 28. No significant differences were seen on the incidence of ischemic events in this setting, but the trial was underpowered to draw conclusions on this outcome.

An important limitation is that the findings of this study are applicable only to patients on clopidogrel monotherapy and not dual antiplatelet therapy.

Bottom line: A significant reduction in recurrent peptic ulcers is seen with the combination of esomeprazole plus clopidogrel, versus clopidogrel alone, in patients with atherosclerosis and a history of peptic ulcer disease.

Citation: Hsu PI, Lai KH, Liu CP. Esomeprazole with clopidogrel reduces peptic ulcer recurrence, compared with clopidogrel alone, in patients with atherosclerosis. Gastroenterology. 2011;140:791-798.

 

ICU Quality-Improvement Project Reduces Hospital Mortality

Clinical question: Does a quality-improvement (QI) project in the ICU reduce in-hospital mortality and length of stay among elderly adults?

Background: Previous studies have shown that ICU-acquired infections are associated with increased morbidity and mortality, and QI initiatives reduce hospital-acquired infections. However, it has not been demonstrated that QI projects in the ICU reduce in-hospital mortality or length of stay.

Study design: Retrospective cohort study.

Setting: Four hundred fifty-nine Midwestern hospitals.

Synopsis: This study included 238,937 adults age >65 who were hospitalized in an ICU from 2001 to 2006 at one of 95 hospitals invited to implement the Keystone ICU Project. The control group included 1,091,547 elderly adults at one of 364 hospitals not invited to participate in the project. The Keystone ICU Project implements evidence-based practices to reduce rates of catheter-related bloodstream infections and ventilator-associated pneumonia.

Hospital mortality was not significantly reduced during initiation or implementation of the project; however, a significant reduction in hospital mortality occurred in the study group during one to 12 months post-implementation (OR=0.83 vs. 0.88, P=0.041) and 13 to 22 months post-implementation (OR=0.76 vs. 0.84, P=0.007). In contrast, length of stay did not differ significantly between the two groups, but the study was underpowered for this outcome.

The study is limited by the complexity of the Keystone ICU Project, as well as the exclusion of smaller hospitals and nonelderly adults. The study is promising because implementing a QI project in the ICU is associated with no known harms and might confer a mortality benefit at a relatively low cost.

 

Bottom line: Elderly adults had lower in-hospital mortality after implementation of the Keystone QI project in ICUs.

Citation: Lipitz-Snyderman A, Steinwachs D, Needham DM, Colantuoni E, Morlock LL, Pronovost PJ. Impact of a statewide intensive care unit quality improvement initiative on hospital mortality and length of stay: retrospective comparative analysis. BMJ. 2011;342:d219.

 

Serious Long-Term Risks with Acute Kidney Injury after Coronary Angiography

Clinical question: Does postcoronary angiography acute kidney injury (AKI) increase the risk of poor long-term clinical outcomes?

Background: Previous studies have shown that AKI following coronary angiography increases the risk of poor short-term clinical outcomes, such as in-hospital myocardial infarction, prolonged hospital stay, and early mortality. Little is known about the long-term cardiovascular and renal outcomes following post-coronary angiography AKI.

Study design: Retrospective cohort study.

Setting: All coronary angiography centers in Alberta, Canada.

Synopsis: The study included 14,782 adults who were ≥18 years of age, underwent coronary angiography, had a baseline creatinine measurement, did not have end-stage renal disease (ESRD), and had a creatinine measurement within seven days after coronary angiography.

During a median follow-up period of 19.7 months, 1,099 (7.4%) patients developed stage 1 AKI and 321 (2.2%) developed stage 2 or 3 AKI. Mortality increased twofold with stage 1 AKI and >3-fold with stage 2 or 3 AKI. Risk of ESRD increased substantially by >11-fold in patients with stage 2 or 3 AKI. Risk of hospitalization for subsequent AKI, myocardial infarction, and heart failure also increased significantly following post-coronary angiography AKI.

Patients who experienced AKI were older, had more severe CAD, were more likely to have such comorbidities as DM, HTN, and heart failure, and had lower baseline GFRs. However, the underlying comorbidities do not completely explain the increased risk of poor long-term outcomes in the adjusted analysis.

Limitations include missing or underestimating mild cases of AKI, residual confounding from unmeasured variables, and inability of retrospective comparative studies to establish causality.

Bottom line: Adults with post-coronary angiography AKI are at increased risk of poor long-term cardiovascular and renal outcomes.

Citation: James MT, Ghali WA, Knudtson ML, et al. Associations between acute kidney injury and cardiovascular and renal outcomes after coronary angiography. Circulation. 2011;123(4):409-416. TH

In This Edition

Literature at a Glance

A guide to this month’s studies

1. Eplerenone and heart failure mortality
2. Fidaxomicin for C. difficile diarrhea
3. Guidelines for intensive insulin therapy
4. Benefits of hospitalist comanagement
5. Peritoneal dialysis versus hemodialysis
6. Pneumococcal urinary antigen to guide CAP treatment
7. Race and readmission rate
8. Factors associated with readmission
9. Unplanned transfers to the ICU

 

Eplerenone Improves Mortality in Patients with Systolic Heart Failure and Mild Symptoms

Clinical question: Does the selective mineralocorticoid antagonist eplerenone improve outcomes in patients with chronic heart failure and mild symptoms?

Background: In prior studies of miner alocorticoid antagonists in systolic heart failure, spironolactone reduced mortality in patients with moderate to severe heart failure symptoms, and eplerenone reduced mortality in patients with acute myocardial infarction complicated by left ventricular dysfunction. The use of eplerenone in patients with systolic heart failure and mild symptoms has not previously been examined.

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

Setting: Two hundred seventy-eight centers in 29 countries.

Synopsis: The study authors randomized 2,737 patients with New York Heart Association Class II heart failure and an ejection fraction of no more than 35% to either eplerenone (up to 50 mg daily) or placebo, in addition to recommended therapy. Patients with baseline potassium levels >5 mmol/L or estimated GFR <30 were excluded. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure.

The trial was stopped early, after a median follow-up period of 21 months, when an interim analysis showed significant benefit with eplerenone. The primary outcome occurred in 18.3% of patients in the eplerenone group and 25.9% in the placebo group (hazard ratio [HR], 0.63; 95% CI, 0.54 to 0.74; P<0.001). All-cause mortality was 12.5% in the eplerenone group and 15.5% in the placebo group (HR 0.76; 95% CI, 0.62 to 0.93; P=0.008). A serum potassium level exceeding 5.5 mmol/L occurred in 11.8% of patients in the eplerenone group and 7.2% of those in the placebo group (P<0.001).

Bottom line: Eplerenone reduces both the risk of death and the risk of hospitalization in patients with systolic heart failure and mild symptoms.

Citation: Zannad F, McMurray JJ, Krum H, et al. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011;364(1):11-21.

 

Fidaxomicin Noninferior to Vancomycin for C. Difficile Treatment

Clinical question: What is the safety and efficacy of fidaxomicin compared to vancomycin in the treatment of patients with C. difficile infection?

Background: Fidaxomicin, a new macrocyclic antibiotic, has shown high efficacy in vitro against C. diff, minimal systemic absorption, and a narrow-spectrum profile. In previously published Phase 2 trials of fidaxomicin for the treatment of C. diff, it has been associated with good clinical response and low recurrence rates.

Study design: Prospective, multicenter, double-blind, randomized trial.

Setting: Fifty-two sites in the United States and 15 in Canada.

Synopsis: The study included 629 adults with acute symptoms of C. diff and a positive stool toxin test. The patients were randomly assigned to 200-mg twice-daily fidaxomicin or 125-mg four-times-daily vancomycin for a course of 10 days. The primary endpoint was rate of clinical cure (resolution of diarrhea), and secondary endpoints were recurrence of C. diff and global cure (clinical cure and lack of relapse within four weeks of cessation of therapy).

The rate of clinical cure associated with fidaxomicin was noninferior to that associated with vancomycin (88.2% vs. 85.8%, respectively). Patients receiving fidaxomicin had a lower rate of relapse than those receiving vancomycin (15.4% vs. 25.3%, respectively, P=0.005) and a higher global cure rate (74.6 vs. 61.1%, P=0.006). In subgroup analysis, the lower rate of recurrence was seen in patients with non-North American pulsed-field Type 1 strain (NAP1/BI/027 strain), while in patients with the NAP1/BI/027 strain, the recurrence rate was similar for both drugs. There was no difference in adverse event rates.

 

Bottom line: Clinical cure rates of C. diff with fidaxomicin are noninferior to those with vancomycin; however, fidaxomicin is associated with a significantly lower rate of recurrence among those infected with the non-NAP1/BI/027 strain.

Citation: Louie TJ, Miller MA, Mullane KM, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011;364(5):422-431.

 

ACP Guideline Discourages Use of Intensive Insulin Therapy in Hospitalized Patients

Clinical question: Does the use of intensive insulin therapy (IIT) to achieve tight glycemic control in hospitalized patients (whether in the SICU, MICU, or on the general medicine floor) improve important health outcomes?

Background: Hyperglycemia is a common finding in hospitalized patients and is associated with prolonged length of stay (LOS), death, and worsening health outcomes. Despite this, prospective studies have yet to provide consistent evidence that using IIT to achieve strict glycemic control (80 mg/dL-110 mg/dL) improves outcomes in hospitalized patients.

Study design: Systematic review of MEDLINE and the Cochrane Database of Systematic Reviews from 1950 to January 2010.

Setting: Trials included subjects with myocardial infarction, stroke, and brain injury, as well as those in perioperative settings and ICUs.

Synopsis: The review informing this guideline meta-analyzed 21 trials and found that IIT did not improve short-term mortality, long-term mortality, infection rates, LOS, or the need for renal replacement therapy. Furthermore, IIT was associated with a sixfold increase in risk for severe hypoglycemia in all hospital settings.

Based on these findings, the American College of Physicians (ACP) issued three recommendations:

• To not use IIT to strictly control blood glucose in non-SICU/non-MICU patients with or without diabetes (strong recommendation, moderate-quality evidence);
• To not use IIT to normalize blood glucose in SICU or MICU patients with or without diabetes (strong recommendation, high-quality evidence); and
• To consider a target blood glucose level of 140 mg to 200 mg if insulin therapy is used in SICU or MICU patients (weak recommendation, moderate-quality evidence).

Bottom line: The ACP recommends against using IIT to strictly control blood glucose (80 mg/dL-180 mg/dL) in hospitalized patients, whether in the SICU, MICU, or on the general medicine floor.

Citation: Qaseem A, Humphrey LL, Chou R, Snow V, Shekelle P. Use of intensive insulin therapy for the management of glycemic control in hospitalized patients: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2011;154(4):260-267.

 

Limited Benefits Seen with Hospitalist-Neurosurgeon Comanagement

Clinical question: Does hospitalist-neurosurgeon comanagement improve patient outcomes?

Background: The shared management of surgical patients between surgeons and hospitalists is increasingly common despite limited data supporting its effectiveness in reducing costs or improving patient outcomes.

Study design: Single-center, retrospective study.

Setting: Tertiary-care academic medical center.

Synopsis: Data were collected on the 7,596 patients who were admitted to the neurosurgical service of the University of California San Francisco Medical Center from June 1, 2005, to December 31, 2008. The study looked at 4,203 patients (55.3%) admitted before July 1, 2007, when hospitalist comanagement was implemented, and 3,393 patients (44.7%) after comanagement began. Of those admitted during the post-implementation period, 988 (29.1%) were comanaged.

After adjusting for patient characteristics and background trends, and accounting for clustering at the physician level, no differences were found in patient mortality rate, readmissions, or LOS after implementation of comanagement. No consistent improvements were seen in patient satisfaction.

However, physician and staff perceptions of safety and quality of care were significantly better after comanagement. There was a moderate decrease in adjusted hospital costs after implementation (adjusted cost ratio 0.94, range 0.88-1.00) equivalent to a cost savings of about $1,439 per hospitalization.

 

Bottom line: The implementation of a hospitalist-neurosurgery comanagement service did not improve patient outcomes or satisfaction, but it did appear to improve providers’ perception of care quality and reduce hospital costs.

Citation: Auerbach AD, Wachter RM, Cheng HQ, et al. Comanagement of surgical patients between neurosurgeons and hospitalists. Arch Intern Med. 2010;170(22):2004-2010.

 

Comparable Mortality Between Hemodialysis and Peritoneal Dialysis

Clinical question: What effect does the initial dialysis modality used have on mortality for patients with end-stage renal disease (ESRD)?

Background: Despite the substantially lower annual per-person costs of peritoneal dialysis (PD) as compared with hemodialysis (HD), only 7% of dialysis patients were treated with PD in 2008. It is unknown whether there are differences in mortality between those using PD and HD when examined in contemporary cohorts.

Study design: Retrospective cohort study.

Setting: National cohort.

Synopsis: Data for patients with incident ESRD over a nine-year period were obtained from the U.S. Renal Data Systems (USRDS), a national registry of all patients with ESRD. Initial dialysis modality was defined as the dialysis modality used 90 days after initiation of dialysis. Patients were divided into three three-year cohorts (1996-1998, 1999-2001, and 2002-2004) based on the date dialysis was initiated and followed for up to five years.

A substantial and consistent reduction in mortality was seen for PD patients across the three time periods. No such improvements were observed across the time periods for the HD patients. PD patients were, on average, younger, healthier, and more likely to be white. In an analysis of the most recent cohort adjusting for these factors, there was no significant difference in the risk of death between HD and PD patients. The median life expectancy of HD and PD patients was 38.4 and 36.6 months, respectively.

Limitations of the study include a lack of randomization and failure to consider switches from one dialysis modality to the other.

Bottom line: Patients beginning their renal replacement therapy with PD had similar mortality after five years compared to patients using in-center HD.

Citation: Mehrotra R, Chiu YW, Kalantar-Zadeh K, Bargman J, Vonesh E. Similar outcomes with hemodialysis and peritoneal dialysis in patients with end-stage renal disease. Arch Intern Med. 2011;171(2):110-118.

 

Pneumococcal Urinary Antigen Test Might Guide Community-Acquired Pneumonia Treatment

Clinical question: What is the diagnostic accuracy and clinical utility of pneumococcal urinary antigen testing in adult patients hospitalized with community-acquired pneumonia (CAP)?

Background: Although CAP is common, our ability to determine its etiology is limited, and empirical broad-spectrum antibiotic therapy is the norm. Pneumococcal urinary antigen testing could allow for the more frequent use of narrow-spectrum pathogen-focused antibiotic therapy.

Study design: Prospective cohort study.

Setting: University-affiliated hospital in Spain.

Synopsis: This study included consecutive adult patients hospitalized with CAP from February 2007 though January 2008. A total of 464 patients with 474 episodes of CAP were included. Pneumococcal urinary antigen testing was performed in 383 (80.8%) episodes of CAP. Streptococcus pneumoniae was felt to be the causative pathogen in 171 cases (36.1%). It was detected exclusively by urinary antigen test in 75 of those cases (43.8%).

For the urine antigen test, specificity was 96% (95% CI, 86.5 to 99.5), and the positive predictive value was 96.5% (95% CI, 87.9 to 99.5). The results of the test led clinicians to reduce the spectrum of antibiotics in 41 patients, and pneumonia was cured in all 41 of these patients. Treatment was not modified despite positive antigen test results in 89 patients.

Limitations of this study include a lack of complete microbiological data for all patients. The study also highlighted the difficulty in changing clinicians’ prescribing patterns, even when test results indicate the need for treatment modification.

 

Bottom line: A positive pneumococcal urinary antigen test result in adult patients hospitalized with CAP can help clinicians narrow antimicrobial therapy with good clinical outcomes.

Citation: Sordé R, Falcó V, Lowak M, et al. Current and potential usefulness of pneumococcal urinary antigen detection in hospitalized patients with community-acquired pneumonia to guide antimicrobial therapy. Arch Intern Med. 2011;171(2):166-172.

 

Racial Disparities Detected in Hospital Readmission Rates

Clinical question: Do black patients have higher odds of readmission than white patients, and, if so, are these disparities related to where black patients receive care?

Background: Racial disparities in healthcare are well documented. Understanding and eliminating those disparities remains a national priority. Reducing hospital readmissions also is a policy focus, as it represents an opportunity to improve quality while reducing costs. Whether there are racial disparities in hospital readmissions at the national level is unknown.

Study design: Retrospective cohort study.

Setting: Medicare fee-for-service beneficiaries from 2006 to 2008.

Synopsis: Medicare discharge data for more than 3 million Medicare fee-for-service beneficiaries aged 65 years or older discharged from January 1, 2006, to November 30, 2008, with the primary discharge diagnosis of acute myocardial infarction (MI), congestive heart failure, or pneumonia were used to calculate risk-adjusted odds of readmission within 30 days of discharge. Hospitals in the highest decile of proportion of black patients were categorized as minority-serving.

Overall, black patients had 13% higher odds of all-cause 30-day readmission than white patients (24.8% vs. 22.6%, OR 1.13, 95% CI, 1.11-1.14), and patients discharged from minority-serving hospitals had 23% higher odds of readmission than patients from non-minority-serving hospitals (25.5% vs. 22.0%, OR 1.23, 95% CI, 1.20-1.27). Among those with acute MI, black patients had 13% higher odds of readmission (OR 1.13, 95% CI, 1.10-1.16), irrespective of the site of care, while patients from minority-serving hospitals had 22% higher odds of readmissions (OR 1.22, 95% CI, 1.17-1.27), even after adjusting for patient race. Similar disparities were seen for CHF and pneumonia. Results were unchanged after adjusting for hospital characteristics, including markers of caring for poor patients.

Bottom line: Compared with white patients, elderly black Medicare patients have a higher 30-day hospital readmission rate for MI, CHF, and pneumonia that is not fully explained by the higher readmission rates seen among hospitals that disproportionately care for black patients.

Citation: Joynt KE, Orav EJ, Jha AK. Thirty-day readmission rates for Medicare beneficiaries by race and site of care. JAMA. 2011;305(7):675-681.

 

 

Easily Identifiable Clinical and Demographic Factors Associated with Hospital Readmission

Clinical question: Which clinical, operational, or demographic factors are associated with 30-day readmission for general medicine patients?

Background: While a few clinical risk factors for hospital readmission have been well defined in subgroups of inpatients, there are still limited data regarding readmission risk that might be associated with a broad range of operational, demographic, and clinical factors in a heterogeneous population of general medicine patients.

Study design: Retrospective observational study.

Setting: Single academic medical center.

Synopsis: The study examined more than 10,300 consecutive admissions (6,805 patients) discharged over a two-year period from 2006 to 2008 from the general medicine service of an urban academic medical center. The 30-day readmission rate was 17.0%.

In multivariate analysis, factors associated with readmission included black race (OR 1.43, 95% CI, 1.24-1.65), inpatient use of narcotics (OR 1.33, 95% CI, 1.16-1.53) and corticosteroids (OR 1.24, 95% CI, 1.09-1.42), and the disease states of cancer (with metastasis 1.61, 95% CI, 1.33-1.95; without metastasis 1.95, 95% CI 1.54-2.47), renal failure (OR 1.19, 95% CI 1.05-1.36), congestive heart failure (OR 1.30, 95% CI, 1.09-1.56), and weight loss (OR 1.26, 95% CI, 1.09-1.47). Medicaid payor status (OR 1.15, 95% CI, 0.97-1.36) had a trend toward readmission. None of the operational factors were significantly associated with readmission, including discharge to skilled nursing facility or weekend discharge.

A major limitation of the study was its inability to capture readmissions to hospitals other than the study hospital, which, based on prior studies, could have accounted for nearly a quarter of readmissions.

Bottom line: Readmission of general medicine patients within 30 days is common and associated with several easily identifiable clinical and nonclinical factors.

Citation: Allaudeen N, Vidyarthi A, Maselli J, Auerbach A. Redefining readmission risk factors for general medicine patients. J Hosp Med. 2011;6(2):54-60.

 

Unplanned Medical ICU Transfers Tied to Preventable Errors

Clinical question: What fraction of unplanned medical ICU (MICU) transfers result from errors in care and why do they occur?

Background: Prior studies have suggested that 14% to 28% of patients admitted to the MICU are unplanned transfers. It is not known what fraction of these transfers result from errors in care, and whether these transfers could be prevented.

Study design: Retrospective cohort study.

Setting: University-affiliated academic medical center.

Synopsis: All unplanned transfers to the MICU from June 1, 2005, to May 30, 2006, were included in the study. Three independent observers, all hospitalists for more than three years, reviewed patient records to determine the cause of unplanned transfers according to a taxonomy the researchers developed for classifying the transfers. They also determined whether the transfer could have been prevented.

Of the 4,468 general medicine admissions during the study period, 152 met inclusion criteria for an unplanned MICU transfer. Errors in care were judged to account for 19% (n=29) of unplanned transfers, 15 of which were due to incorrect triage at admission and 14 to iatrogenic errors, such as opiate overdose during pain treatment or delayed treatment. All 15 triage errors were considered preventable. Of the iatrogenic errors, eight were considered preventable through an earlier intervention. Overall, 23 errors (15%) were thought to be preventable. Observer agreement was moderate to almost perfect (κ0.55-0.90).

Bottom line: Nearly 1 in 7 unplanned transfers to the medical ICU are associated with preventable errors in care, with the most common error being inappropriate admission triage.

Citation: Bapoje SR, Gaudiani JL, Narayanan V, Albert RK. Unplanned transfers to a medical intensive care unit: causes and relationship to preventable errors in care. J Hosp Med. 2011;6(2):68-72. TH

 

In This Edition

Literature at a Glance

A guide to this month’s studies

1. Eplerenone and heart failure mortality
2. Fidaxomicin for C. difficile diarrhea
3. Guidelines for intensive insulin therapy
4. Benefits of hospitalist comanagement
5. Peritoneal dialysis versus hemodialysis
6. Pneumococcal urinary antigen to guide CAP treatment
7. Race and readmission rate
8. Factors associated with readmission
9. Unplanned transfers to the ICU

 

Eplerenone Improves Mortality in Patients with Systolic Heart Failure and Mild Symptoms

Clinical question: Does the selective mineralocorticoid antagonist eplerenone improve outcomes in patients with chronic heart failure and mild symptoms?

Background: In prior studies of miner alocorticoid antagonists in systolic heart failure, spironolactone reduced mortality in patients with moderate to severe heart failure symptoms, and eplerenone reduced mortality in patients with acute myocardial infarction complicated by left ventricular dysfunction. The use of eplerenone in patients with systolic heart failure and mild symptoms has not previously been examined.

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

Setting: Two hundred seventy-eight centers in 29 countries.

Synopsis: The study authors randomized 2,737 patients with New York Heart Association Class II heart failure and an ejection fraction of no more than 35% to either eplerenone (up to 50 mg daily) or placebo, in addition to recommended therapy. Patients with baseline potassium levels >5 mmol/L or estimated GFR <30 were excluded. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure.

The trial was stopped early, after a median follow-up period of 21 months, when an interim analysis showed significant benefit with eplerenone. The primary outcome occurred in 18.3% of patients in the eplerenone group and 25.9% in the placebo group (hazard ratio [HR], 0.63; 95% CI, 0.54 to 0.74; P<0.001). All-cause mortality was 12.5% in the eplerenone group and 15.5% in the placebo group (HR 0.76; 95% CI, 0.62 to 0.93; P=0.008). A serum potassium level exceeding 5.5 mmol/L occurred in 11.8% of patients in the eplerenone group and 7.2% of those in the placebo group (P<0.001).

Bottom line: Eplerenone reduces both the risk of death and the risk of hospitalization in patients with systolic heart failure and mild symptoms.

Citation: Zannad F, McMurray JJ, Krum H, et al. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011;364(1):11-21.

 

Fidaxomicin Noninferior to Vancomycin for C. Difficile Treatment

Clinical question: What is the safety and efficacy of fidaxomicin compared to vancomycin in the treatment of patients with C. difficile infection?

Background: Fidaxomicin, a new macrocyclic antibiotic, has shown high efficacy in vitro against C. diff, minimal systemic absorption, and a narrow-spectrum profile. In previously published Phase 2 trials of fidaxomicin for the treatment of C. diff, it has been associated with good clinical response and low recurrence rates.

Study design: Prospective, multicenter, double-blind, randomized trial.

Setting: Fifty-two sites in the United States and 15 in Canada.

Synopsis: The study included 629 adults with acute symptoms of C. diff and a positive stool toxin test. The patients were randomly assigned to 200-mg twice-daily fidaxomicin or 125-mg four-times-daily vancomycin for a course of 10 days. The primary endpoint was rate of clinical cure (resolution of diarrhea), and secondary endpoints were recurrence of C. diff and global cure (clinical cure and lack of relapse within four weeks of cessation of therapy).

The rate of clinical cure associated with fidaxomicin was noninferior to that associated with vancomycin (88.2% vs. 85.8%, respectively). Patients receiving fidaxomicin had a lower rate of relapse than those receiving vancomycin (15.4% vs. 25.3%, respectively, P=0.005) and a higher global cure rate (74.6 vs. 61.1%, P=0.006). In subgroup analysis, the lower rate of recurrence was seen in patients with non-North American pulsed-field Type 1 strain (NAP1/BI/027 strain), while in patients with the NAP1/BI/027 strain, the recurrence rate was similar for both drugs. There was no difference in adverse event rates.

 

Bottom line: Clinical cure rates of C. diff with fidaxomicin are noninferior to those with vancomycin; however, fidaxomicin is associated with a significantly lower rate of recurrence among those infected with the non-NAP1/BI/027 strain.

Citation: Louie TJ, Miller MA, Mullane KM, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011;364(5):422-431.

 

ACP Guideline Discourages Use of Intensive Insulin Therapy in Hospitalized Patients

Clinical question: Does the use of intensive insulin therapy (IIT) to achieve tight glycemic control in hospitalized patients (whether in the SICU, MICU, or on the general medicine floor) improve important health outcomes?

Background: Hyperglycemia is a common finding in hospitalized patients and is associated with prolonged length of stay (LOS), death, and worsening health outcomes. Despite this, prospective studies have yet to provide consistent evidence that using IIT to achieve strict glycemic control (80 mg/dL-110 mg/dL) improves outcomes in hospitalized patients.

Study design: Systematic review of MEDLINE and the Cochrane Database of Systematic Reviews from 1950 to January 2010.

Setting: Trials included subjects with myocardial infarction, stroke, and brain injury, as well as those in perioperative settings and ICUs.

Synopsis: The review informing this guideline meta-analyzed 21 trials and found that IIT did not improve short-term mortality, long-term mortality, infection rates, LOS, or the need for renal replacement therapy. Furthermore, IIT was associated with a sixfold increase in risk for severe hypoglycemia in all hospital settings.

Based on these findings, the American College of Physicians (ACP) issued three recommendations:

• To not use IIT to strictly control blood glucose in non-SICU/non-MICU patients with or without diabetes (strong recommendation, moderate-quality evidence);
• To not use IIT to normalize blood glucose in SICU or MICU patients with or without diabetes (strong recommendation, high-quality evidence); and
• To consider a target blood glucose level of 140 mg to 200 mg if insulin therapy is used in SICU or MICU patients (weak recommendation, moderate-quality evidence).

Bottom line: The ACP recommends against using IIT to strictly control blood glucose (80 mg/dL-180 mg/dL) in hospitalized patients, whether in the SICU, MICU, or on the general medicine floor.

Citation: Qaseem A, Humphrey LL, Chou R, Snow V, Shekelle P. Use of intensive insulin therapy for the management of glycemic control in hospitalized patients: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2011;154(4):260-267.

 

Limited Benefits Seen with Hospitalist-Neurosurgeon Comanagement

Clinical question: Does hospitalist-neurosurgeon comanagement improve patient outcomes?

Background: The shared management of surgical patients between surgeons and hospitalists is increasingly common despite limited data supporting its effectiveness in reducing costs or improving patient outcomes.

Study design: Single-center, retrospective study.

Setting: Tertiary-care academic medical center.

Synopsis: Data were collected on the 7,596 patients who were admitted to the neurosurgical service of the University of California San Francisco Medical Center from June 1, 2005, to December 31, 2008. The study looked at 4,203 patients (55.3%) admitted before July 1, 2007, when hospitalist comanagement was implemented, and 3,393 patients (44.7%) after comanagement began. Of those admitted during the post-implementation period, 988 (29.1%) were comanaged.

After adjusting for patient characteristics and background trends, and accounting for clustering at the physician level, no differences were found in patient mortality rate, readmissions, or LOS after implementation of comanagement. No consistent improvements were seen in patient satisfaction.

However, physician and staff perceptions of safety and quality of care were significantly better after comanagement. There was a moderate decrease in adjusted hospital costs after implementation (adjusted cost ratio 0.94, range 0.88-1.00) equivalent to a cost savings of about $1,439 per hospitalization.

 

Bottom line: The implementation of a hospitalist-neurosurgery comanagement service did not improve patient outcomes or satisfaction, but it did appear to improve providers’ perception of care quality and reduce hospital costs.

Citation: Auerbach AD, Wachter RM, Cheng HQ, et al. Comanagement of surgical patients between neurosurgeons and hospitalists. Arch Intern Med. 2010;170(22):2004-2010.

 

Comparable Mortality Between Hemodialysis and Peritoneal Dialysis

Clinical question: What effect does the initial dialysis modality used have on mortality for patients with end-stage renal disease (ESRD)?

Background: Despite the substantially lower annual per-person costs of peritoneal dialysis (PD) as compared with hemodialysis (HD), only 7% of dialysis patients were treated with PD in 2008. It is unknown whether there are differences in mortality between those using PD and HD when examined in contemporary cohorts.

Study design: Retrospective cohort study.

Setting: National cohort.

Synopsis: Data for patients with incident ESRD over a nine-year period were obtained from the U.S. Renal Data Systems (USRDS), a national registry of all patients with ESRD. Initial dialysis modality was defined as the dialysis modality used 90 days after initiation of dialysis. Patients were divided into three three-year cohorts (1996-1998, 1999-2001, and 2002-2004) based on the date dialysis was initiated and followed for up to five years.

A substantial and consistent reduction in mortality was seen for PD patients across the three time periods. No such improvements were observed across the time periods for the HD patients. PD patients were, on average, younger, healthier, and more likely to be white. In an analysis of the most recent cohort adjusting for these factors, there was no significant difference in the risk of death between HD and PD patients. The median life expectancy of HD and PD patients was 38.4 and 36.6 months, respectively.

Limitations of the study include a lack of randomization and failure to consider switches from one dialysis modality to the other.

Bottom line: Patients beginning their renal replacement therapy with PD had similar mortality after five years compared to patients using in-center HD.

Citation: Mehrotra R, Chiu YW, Kalantar-Zadeh K, Bargman J, Vonesh E. Similar outcomes with hemodialysis and peritoneal dialysis in patients with end-stage renal disease. Arch Intern Med. 2011;171(2):110-118.

 

Pneumococcal Urinary Antigen Test Might Guide Community-Acquired Pneumonia Treatment

Clinical question: What is the diagnostic accuracy and clinical utility of pneumococcal urinary antigen testing in adult patients hospitalized with community-acquired pneumonia (CAP)?

Background: Although CAP is common, our ability to determine its etiology is limited, and empirical broad-spectrum antibiotic therapy is the norm. Pneumococcal urinary antigen testing could allow for the more frequent use of narrow-spectrum pathogen-focused antibiotic therapy.

Study design: Prospective cohort study.

Setting: University-affiliated hospital in Spain.

Synopsis: This study included consecutive adult patients hospitalized with CAP from February 2007 though January 2008. A total of 464 patients with 474 episodes of CAP were included. Pneumococcal urinary antigen testing was performed in 383 (80.8%) episodes of CAP. Streptococcus pneumoniae was felt to be the causative pathogen in 171 cases (36.1%). It was detected exclusively by urinary antigen test in 75 of those cases (43.8%).

For the urine antigen test, specificity was 96% (95% CI, 86.5 to 99.5), and the positive predictive value was 96.5% (95% CI, 87.9 to 99.5). The results of the test led clinicians to reduce the spectrum of antibiotics in 41 patients, and pneumonia was cured in all 41 of these patients. Treatment was not modified despite positive antigen test results in 89 patients.

Limitations of this study include a lack of complete microbiological data for all patients. The study also highlighted the difficulty in changing clinicians’ prescribing patterns, even when test results indicate the need for treatment modification.

 

Bottom line: A positive pneumococcal urinary antigen test result in adult patients hospitalized with CAP can help clinicians narrow antimicrobial therapy with good clinical outcomes.

Citation: Sordé R, Falcó V, Lowak M, et al. Current and potential usefulness of pneumococcal urinary antigen detection in hospitalized patients with community-acquired pneumonia to guide antimicrobial therapy. Arch Intern Med. 2011;171(2):166-172.

 

Racial Disparities Detected in Hospital Readmission Rates

Clinical question: Do black patients have higher odds of readmission than white patients, and, if so, are these disparities related to where black patients receive care?

Background: Racial disparities in healthcare are well documented. Understanding and eliminating those disparities remains a national priority. Reducing hospital readmissions also is a policy focus, as it represents an opportunity to improve quality while reducing costs. Whether there are racial disparities in hospital readmissions at the national level is unknown.

Study design: Retrospective cohort study.

Setting: Medicare fee-for-service beneficiaries from 2006 to 2008.

Synopsis: Medicare discharge data for more than 3 million Medicare fee-for-service beneficiaries aged 65 years or older discharged from January 1, 2006, to November 30, 2008, with the primary discharge diagnosis of acute myocardial infarction (MI), congestive heart failure, or pneumonia were used to calculate risk-adjusted odds of readmission within 30 days of discharge. Hospitals in the highest decile of proportion of black patients were categorized as minority-serving.

Overall, black patients had 13% higher odds of all-cause 30-day readmission than white patients (24.8% vs. 22.6%, OR 1.13, 95% CI, 1.11-1.14), and patients discharged from minority-serving hospitals had 23% higher odds of readmission than patients from non-minority-serving hospitals (25.5% vs. 22.0%, OR 1.23, 95% CI, 1.20-1.27). Among those with acute MI, black patients had 13% higher odds of readmission (OR 1.13, 95% CI, 1.10-1.16), irrespective of the site of care, while patients from minority-serving hospitals had 22% higher odds of readmissions (OR 1.22, 95% CI, 1.17-1.27), even after adjusting for patient race. Similar disparities were seen for CHF and pneumonia. Results were unchanged after adjusting for hospital characteristics, including markers of caring for poor patients.

Bottom line: Compared with white patients, elderly black Medicare patients have a higher 30-day hospital readmission rate for MI, CHF, and pneumonia that is not fully explained by the higher readmission rates seen among hospitals that disproportionately care for black patients.

Citation: Joynt KE, Orav EJ, Jha AK. Thirty-day readmission rates for Medicare beneficiaries by race and site of care. JAMA. 2011;305(7):675-681.

 

 

Easily Identifiable Clinical and Demographic Factors Associated with Hospital Readmission

Clinical question: Which clinical, operational, or demographic factors are associated with 30-day readmission for general medicine patients?

Background: While a few clinical risk factors for hospital readmission have been well defined in subgroups of inpatients, there are still limited data regarding readmission risk that might be associated with a broad range of operational, demographic, and clinical factors in a heterogeneous population of general medicine patients.

Study design: Retrospective observational study.

Setting: Single academic medical center.

Synopsis: The study examined more than 10,300 consecutive admissions (6,805 patients) discharged over a two-year period from 2006 to 2008 from the general medicine service of an urban academic medical center. The 30-day readmission rate was 17.0%.

In multivariate analysis, factors associated with readmission included black race (OR 1.43, 95% CI, 1.24-1.65), inpatient use of narcotics (OR 1.33, 95% CI, 1.16-1.53) and corticosteroids (OR 1.24, 95% CI, 1.09-1.42), and the disease states of cancer (with metastasis 1.61, 95% CI, 1.33-1.95; without metastasis 1.95, 95% CI 1.54-2.47), renal failure (OR 1.19, 95% CI 1.05-1.36), congestive heart failure (OR 1.30, 95% CI, 1.09-1.56), and weight loss (OR 1.26, 95% CI, 1.09-1.47). Medicaid payor status (OR 1.15, 95% CI, 0.97-1.36) had a trend toward readmission. None of the operational factors were significantly associated with readmission, including discharge to skilled nursing facility or weekend discharge.

A major limitation of the study was its inability to capture readmissions to hospitals other than the study hospital, which, based on prior studies, could have accounted for nearly a quarter of readmissions.

Bottom line: Readmission of general medicine patients within 30 days is common and associated with several easily identifiable clinical and nonclinical factors.

Citation: Allaudeen N, Vidyarthi A, Maselli J, Auerbach A. Redefining readmission risk factors for general medicine patients. J Hosp Med. 2011;6(2):54-60.

 

Unplanned Medical ICU Transfers Tied to Preventable Errors

Clinical question: What fraction of unplanned medical ICU (MICU) transfers result from errors in care and why do they occur?

Background: Prior studies have suggested that 14% to 28% of patients admitted to the MICU are unplanned transfers. It is not known what fraction of these transfers result from errors in care, and whether these transfers could be prevented.

Study design: Retrospective cohort study.

Setting: University-affiliated academic medical center.

Synopsis: All unplanned transfers to the MICU from June 1, 2005, to May 30, 2006, were included in the study. Three independent observers, all hospitalists for more than three years, reviewed patient records to determine the cause of unplanned transfers according to a taxonomy the researchers developed for classifying the transfers. They also determined whether the transfer could have been prevented.

Of the 4,468 general medicine admissions during the study period, 152 met inclusion criteria for an unplanned MICU transfer. Errors in care were judged to account for 19% (n=29) of unplanned transfers, 15 of which were due to incorrect triage at admission and 14 to iatrogenic errors, such as opiate overdose during pain treatment or delayed treatment. All 15 triage errors were considered preventable. Of the iatrogenic errors, eight were considered preventable through an earlier intervention. Overall, 23 errors (15%) were thought to be preventable. Observer agreement was moderate to almost perfect (κ0.55-0.90).

Bottom line: Nearly 1 in 7 unplanned transfers to the medical ICU are associated with preventable errors in care, with the most common error being inappropriate admission triage.

Citation: Bapoje SR, Gaudiani JL, Narayanan V, Albert RK. Unplanned transfers to a medical intensive care unit: causes and relationship to preventable errors in care. J Hosp Med. 2011;6(2):68-72. TH

 

In This Edition

Literature at a Glance

A guide to this month’s studies

1. Eplerenone and heart failure mortality
2. Fidaxomicin for C. difficile diarrhea
3. Guidelines for intensive insulin therapy
4. Benefits of hospitalist comanagement
5. Peritoneal dialysis versus hemodialysis
6. Pneumococcal urinary antigen to guide CAP treatment
7. Race and readmission rate
8. Factors associated with readmission
9. Unplanned transfers to the ICU

 

Eplerenone Improves Mortality in Patients with Systolic Heart Failure and Mild Symptoms

Clinical question: Does the selective mineralocorticoid antagonist eplerenone improve outcomes in patients with chronic heart failure and mild symptoms?

Background: In prior studies of miner alocorticoid antagonists in systolic heart failure, spironolactone reduced mortality in patients with moderate to severe heart failure symptoms, and eplerenone reduced mortality in patients with acute myocardial infarction complicated by left ventricular dysfunction. The use of eplerenone in patients with systolic heart failure and mild symptoms has not previously been examined.

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

Setting: Two hundred seventy-eight centers in 29 countries.

Synopsis: The study authors randomized 2,737 patients with New York Heart Association Class II heart failure and an ejection fraction of no more than 35% to either eplerenone (up to 50 mg daily) or placebo, in addition to recommended therapy. Patients with baseline potassium levels >5 mmol/L or estimated GFR <30 were excluded. The primary outcome was a composite of death from cardiovascular causes or hospitalization for heart failure.

The trial was stopped early, after a median follow-up period of 21 months, when an interim analysis showed significant benefit with eplerenone. The primary outcome occurred in 18.3% of patients in the eplerenone group and 25.9% in the placebo group (hazard ratio [HR], 0.63; 95% CI, 0.54 to 0.74; P<0.001). All-cause mortality was 12.5% in the eplerenone group and 15.5% in the placebo group (HR 0.76; 95% CI, 0.62 to 0.93; P=0.008). A serum potassium level exceeding 5.5 mmol/L occurred in 11.8% of patients in the eplerenone group and 7.2% of those in the placebo group (P<0.001).

Bottom line: Eplerenone reduces both the risk of death and the risk of hospitalization in patients with systolic heart failure and mild symptoms.

Citation: Zannad F, McMurray JJ, Krum H, et al. Eplerenone in patients with systolic heart failure and mild symptoms. N Engl J Med. 2011;364(1):11-21.

 

Fidaxomicin Noninferior to Vancomycin for C. Difficile Treatment

Clinical question: What is the safety and efficacy of fidaxomicin compared to vancomycin in the treatment of patients with C. difficile infection?

Background: Fidaxomicin, a new macrocyclic antibiotic, has shown high efficacy in vitro against C. diff, minimal systemic absorption, and a narrow-spectrum profile. In previously published Phase 2 trials of fidaxomicin for the treatment of C. diff, it has been associated with good clinical response and low recurrence rates.

Study design: Prospective, multicenter, double-blind, randomized trial.

Setting: Fifty-two sites in the United States and 15 in Canada.

Synopsis: The study included 629 adults with acute symptoms of C. diff and a positive stool toxin test. The patients were randomly assigned to 200-mg twice-daily fidaxomicin or 125-mg four-times-daily vancomycin for a course of 10 days. The primary endpoint was rate of clinical cure (resolution of diarrhea), and secondary endpoints were recurrence of C. diff and global cure (clinical cure and lack of relapse within four weeks of cessation of therapy).

The rate of clinical cure associated with fidaxomicin was noninferior to that associated with vancomycin (88.2% vs. 85.8%, respectively). Patients receiving fidaxomicin had a lower rate of relapse than those receiving vancomycin (15.4% vs. 25.3%, respectively, P=0.005) and a higher global cure rate (74.6 vs. 61.1%, P=0.006). In subgroup analysis, the lower rate of recurrence was seen in patients with non-North American pulsed-field Type 1 strain (NAP1/BI/027 strain), while in patients with the NAP1/BI/027 strain, the recurrence rate was similar for both drugs. There was no difference in adverse event rates.

 

Bottom line: Clinical cure rates of C. diff with fidaxomicin are noninferior to those with vancomycin; however, fidaxomicin is associated with a significantly lower rate of recurrence among those infected with the non-NAP1/BI/027 strain.

Citation: Louie TJ, Miller MA, Mullane KM, et al. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011;364(5):422-431.

 

ACP Guideline Discourages Use of Intensive Insulin Therapy in Hospitalized Patients

Clinical question: Does the use of intensive insulin therapy (IIT) to achieve tight glycemic control in hospitalized patients (whether in the SICU, MICU, or on the general medicine floor) improve important health outcomes?

Background: Hyperglycemia is a common finding in hospitalized patients and is associated with prolonged length of stay (LOS), death, and worsening health outcomes. Despite this, prospective studies have yet to provide consistent evidence that using IIT to achieve strict glycemic control (80 mg/dL-110 mg/dL) improves outcomes in hospitalized patients.

Study design: Systematic review of MEDLINE and the Cochrane Database of Systematic Reviews from 1950 to January 2010.

Setting: Trials included subjects with myocardial infarction, stroke, and brain injury, as well as those in perioperative settings and ICUs.

Synopsis: The review informing this guideline meta-analyzed 21 trials and found that IIT did not improve short-term mortality, long-term mortality, infection rates, LOS, or the need for renal replacement therapy. Furthermore, IIT was associated with a sixfold increase in risk for severe hypoglycemia in all hospital settings.

Based on these findings, the American College of Physicians (ACP) issued three recommendations:

• To not use IIT to strictly control blood glucose in non-SICU/non-MICU patients with or without diabetes (strong recommendation, moderate-quality evidence);
• To not use IIT to normalize blood glucose in SICU or MICU patients with or without diabetes (strong recommendation, high-quality evidence); and
• To consider a target blood glucose level of 140 mg to 200 mg if insulin therapy is used in SICU or MICU patients (weak recommendation, moderate-quality evidence).

Bottom line: The ACP recommends against using IIT to strictly control blood glucose (80 mg/dL-180 mg/dL) in hospitalized patients, whether in the SICU, MICU, or on the general medicine floor.

Citation: Qaseem A, Humphrey LL, Chou R, Snow V, Shekelle P. Use of intensive insulin therapy for the management of glycemic control in hospitalized patients: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2011;154(4):260-267.

 

Limited Benefits Seen with Hospitalist-Neurosurgeon Comanagement

Clinical question: Does hospitalist-neurosurgeon comanagement improve patient outcomes?

Background: The shared management of surgical patients between surgeons and hospitalists is increasingly common despite limited data supporting its effectiveness in reducing costs or improving patient outcomes.

Study design: Single-center, retrospective study.

Setting: Tertiary-care academic medical center.

Synopsis: Data were collected on the 7,596 patients who were admitted to the neurosurgical service of the University of California San Francisco Medical Center from June 1, 2005, to December 31, 2008. The study looked at 4,203 patients (55.3%) admitted before July 1, 2007, when hospitalist comanagement was implemented, and 3,393 patients (44.7%) after comanagement began. Of those admitted during the post-implementation period, 988 (29.1%) were comanaged.

After adjusting for patient characteristics and background trends, and accounting for clustering at the physician level, no differences were found in patient mortality rate, readmissions, or LOS after implementation of comanagement. No consistent improvements were seen in patient satisfaction.

However, physician and staff perceptions of safety and quality of care were significantly better after comanagement. There was a moderate decrease in adjusted hospital costs after implementation (adjusted cost ratio 0.94, range 0.88-1.00) equivalent to a cost savings of about $1,439 per hospitalization.

 

Bottom line: The implementation of a hospitalist-neurosurgery comanagement service did not improve patient outcomes or satisfaction, but it did appear to improve providers’ perception of care quality and reduce hospital costs.

Citation: Auerbach AD, Wachter RM, Cheng HQ, et al. Comanagement of surgical patients between neurosurgeons and hospitalists. Arch Intern Med. 2010;170(22):2004-2010.

 

Comparable Mortality Between Hemodialysis and Peritoneal Dialysis

Clinical question: What effect does the initial dialysis modality used have on mortality for patients with end-stage renal disease (ESRD)?

Background: Despite the substantially lower annual per-person costs of peritoneal dialysis (PD) as compared with hemodialysis (HD), only 7% of dialysis patients were treated with PD in 2008. It is unknown whether there are differences in mortality between those using PD and HD when examined in contemporary cohorts.

Study design: Retrospective cohort study.

Setting: National cohort.

Synopsis: Data for patients with incident ESRD over a nine-year period were obtained from the U.S. Renal Data Systems (USRDS), a national registry of all patients with ESRD. Initial dialysis modality was defined as the dialysis modality used 90 days after initiation of dialysis. Patients were divided into three three-year cohorts (1996-1998, 1999-2001, and 2002-2004) based on the date dialysis was initiated and followed for up to five years.

A substantial and consistent reduction in mortality was seen for PD patients across the three time periods. No such improvements were observed across the time periods for the HD patients. PD patients were, on average, younger, healthier, and more likely to be white. In an analysis of the most recent cohort adjusting for these factors, there was no significant difference in the risk of death between HD and PD patients. The median life expectancy of HD and PD patients was 38.4 and 36.6 months, respectively.

Limitations of the study include a lack of randomization and failure to consider switches from one dialysis modality to the other.

Bottom line: Patients beginning their renal replacement therapy with PD had similar mortality after five years compared to patients using in-center HD.

Citation: Mehrotra R, Chiu YW, Kalantar-Zadeh K, Bargman J, Vonesh E. Similar outcomes with hemodialysis and peritoneal dialysis in patients with end-stage renal disease. Arch Intern Med. 2011;171(2):110-118.

 

Pneumococcal Urinary Antigen Test Might Guide Community-Acquired Pneumonia Treatment

Clinical question: What is the diagnostic accuracy and clinical utility of pneumococcal urinary antigen testing in adult patients hospitalized with community-acquired pneumonia (CAP)?

Background: Although CAP is common, our ability to determine its etiology is limited, and empirical broad-spectrum antibiotic therapy is the norm. Pneumococcal urinary antigen testing could allow for the more frequent use of narrow-spectrum pathogen-focused antibiotic therapy.

Study design: Prospective cohort study.

Setting: University-affiliated hospital in Spain.

Synopsis: This study included consecutive adult patients hospitalized with CAP from February 2007 though January 2008. A total of 464 patients with 474 episodes of CAP were included. Pneumococcal urinary antigen testing was performed in 383 (80.8%) episodes of CAP. Streptococcus pneumoniae was felt to be the causative pathogen in 171 cases (36.1%). It was detected exclusively by urinary antigen test in 75 of those cases (43.8%).

For the urine antigen test, specificity was 96% (95% CI, 86.5 to 99.5), and the positive predictive value was 96.5% (95% CI, 87.9 to 99.5). The results of the test led clinicians to reduce the spectrum of antibiotics in 41 patients, and pneumonia was cured in all 41 of these patients. Treatment was not modified despite positive antigen test results in 89 patients.

Limitations of this study include a lack of complete microbiological data for all patients. The study also highlighted the difficulty in changing clinicians’ prescribing patterns, even when test results indicate the need for treatment modification.

 

Bottom line: A positive pneumococcal urinary antigen test result in adult patients hospitalized with CAP can help clinicians narrow antimicrobial therapy with good clinical outcomes.

Citation: Sordé R, Falcó V, Lowak M, et al. Current and potential usefulness of pneumococcal urinary antigen detection in hospitalized patients with community-acquired pneumonia to guide antimicrobial therapy. Arch Intern Med. 2011;171(2):166-172.

 

Racial Disparities Detected in Hospital Readmission Rates

Clinical question: Do black patients have higher odds of readmission than white patients, and, if so, are these disparities related to where black patients receive care?

Background: Racial disparities in healthcare are well documented. Understanding and eliminating those disparities remains a national priority. Reducing hospital readmissions also is a policy focus, as it represents an opportunity to improve quality while reducing costs. Whether there are racial disparities in hospital readmissions at the national level is unknown.

Study design: Retrospective cohort study.

Setting: Medicare fee-for-service beneficiaries from 2006 to 2008.

Synopsis: Medicare discharge data for more than 3 million Medicare fee-for-service beneficiaries aged 65 years or older discharged from January 1, 2006, to November 30, 2008, with the primary discharge diagnosis of acute myocardial infarction (MI), congestive heart failure, or pneumonia were used to calculate risk-adjusted odds of readmission within 30 days of discharge. Hospitals in the highest decile of proportion of black patients were categorized as minority-serving.

Overall, black patients had 13% higher odds of all-cause 30-day readmission than white patients (24.8% vs. 22.6%, OR 1.13, 95% CI, 1.11-1.14), and patients discharged from minority-serving hospitals had 23% higher odds of readmission than patients from non-minority-serving hospitals (25.5% vs. 22.0%, OR 1.23, 95% CI, 1.20-1.27). Among those with acute MI, black patients had 13% higher odds of readmission (OR 1.13, 95% CI, 1.10-1.16), irrespective of the site of care, while patients from minority-serving hospitals had 22% higher odds of readmissions (OR 1.22, 95% CI, 1.17-1.27), even after adjusting for patient race. Similar disparities were seen for CHF and pneumonia. Results were unchanged after adjusting for hospital characteristics, including markers of caring for poor patients.

Bottom line: Compared with white patients, elderly black Medicare patients have a higher 30-day hospital readmission rate for MI, CHF, and pneumonia that is not fully explained by the higher readmission rates seen among hospitals that disproportionately care for black patients.

Citation: Joynt KE, Orav EJ, Jha AK. Thirty-day readmission rates for Medicare beneficiaries by race and site of care. JAMA. 2011;305(7):675-681.

 

 

Easily Identifiable Clinical and Demographic Factors Associated with Hospital Readmission

Clinical question: Which clinical, operational, or demographic factors are associated with 30-day readmission for general medicine patients?

Background: While a few clinical risk factors for hospital readmission have been well defined in subgroups of inpatients, there are still limited data regarding readmission risk that might be associated with a broad range of operational, demographic, and clinical factors in a heterogeneous population of general medicine patients.

Study design: Retrospective observational study.

Setting: Single academic medical center.

Synopsis: The study examined more than 10,300 consecutive admissions (6,805 patients) discharged over a two-year period from 2006 to 2008 from the general medicine service of an urban academic medical center. The 30-day readmission rate was 17.0%.

In multivariate analysis, factors associated with readmission included black race (OR 1.43, 95% CI, 1.24-1.65), inpatient use of narcotics (OR 1.33, 95% CI, 1.16-1.53) and corticosteroids (OR 1.24, 95% CI, 1.09-1.42), and the disease states of cancer (with metastasis 1.61, 95% CI, 1.33-1.95; without metastasis 1.95, 95% CI 1.54-2.47), renal failure (OR 1.19, 95% CI 1.05-1.36), congestive heart failure (OR 1.30, 95% CI, 1.09-1.56), and weight loss (OR 1.26, 95% CI, 1.09-1.47). Medicaid payor status (OR 1.15, 95% CI, 0.97-1.36) had a trend toward readmission. None of the operational factors were significantly associated with readmission, including discharge to skilled nursing facility or weekend discharge.

A major limitation of the study was its inability to capture readmissions to hospitals other than the study hospital, which, based on prior studies, could have accounted for nearly a quarter of readmissions.

Bottom line: Readmission of general medicine patients within 30 days is common and associated with several easily identifiable clinical and nonclinical factors.

Citation: Allaudeen N, Vidyarthi A, Maselli J, Auerbach A. Redefining readmission risk factors for general medicine patients. J Hosp Med. 2011;6(2):54-60.

 

Unplanned Medical ICU Transfers Tied to Preventable Errors

Clinical question: What fraction of unplanned medical ICU (MICU) transfers result from errors in care and why do they occur?

Background: Prior studies have suggested that 14% to 28% of patients admitted to the MICU are unplanned transfers. It is not known what fraction of these transfers result from errors in care, and whether these transfers could be prevented.

Study design: Retrospective cohort study.

Setting: University-affiliated academic medical center.

Synopsis: All unplanned transfers to the MICU from June 1, 2005, to May 30, 2006, were included in the study. Three independent observers, all hospitalists for more than three years, reviewed patient records to determine the cause of unplanned transfers according to a taxonomy the researchers developed for classifying the transfers. They also determined whether the transfer could have been prevented.

Of the 4,468 general medicine admissions during the study period, 152 met inclusion criteria for an unplanned MICU transfer. Errors in care were judged to account for 19% (n=29) of unplanned transfers, 15 of which were due to incorrect triage at admission and 14 to iatrogenic errors, such as opiate overdose during pain treatment or delayed treatment. All 15 triage errors were considered preventable. Of the iatrogenic errors, eight were considered preventable through an earlier intervention. Overall, 23 errors (15%) were thought to be preventable. Observer agreement was moderate to almost perfect (κ0.55-0.90).

Bottom line: Nearly 1 in 7 unplanned transfers to the medical ICU are associated with preventable errors in care, with the most common error being inappropriate admission triage.

Citation: Bapoje SR, Gaudiani JL, Narayanan V, Albert RK. Unplanned transfers to a medical intensive care unit: causes and relationship to preventable errors in care. J Hosp Med. 2011;6(2):68-72. TH