In This Edition

Literature At A Glance

A guide to this month’s studies

1. Initial trophic feedings effective for patients with acute lung injury
2. IM vs. IV benzodiazepines in status epilepticus
3. CDI risk following antibiotic cessation
4. Acid suppression associated with increased complications in CDI patients
5. Perioperative statins and cardiac events in surgical patients
6. Enoxaparin vs. unfractionated heparin during PCI
7. Optimal serum potassium levels for AMI patients
8. PPIs superior to H2-blockers for lowering UGI bleeding following ACS and STEMI

Initial Lower-Volume Enteral Feeding Better Tolerated, but Has No Mortality Benefit

Clinical question: In mechanically ventilated patients with acute lung injury, do initial lower-volume enteral feedings (trophic feedings) improve clinical outcomes when compared with full enteral feedings?

Background: Malnutrition in critically ill patients is associated with poor outcomes, but conflicting data exist regarding the best timing, amount, and formulation of enteral nutrition to initiate. Initiation of lower-volume enteral feeding with periodic assessment of gastric residual volume is common practice, but the effects of this practice are unknown.

Study design: Multicenter randomized controlled open-label study.

Setting: Forty-four hospitals in the National Heart, Lung, and Blood Institute (NHLBI) Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network.

Synopsis: One thousand patients with acute lung injury receiving mechanical ventilation for longer than 72 hours were randomized using a Web-based system to receive either trophic or full enteric feedings for the first six days of mechanical ventilation. After the sixth day, a full enteric feeding protocol was used in all patients. All analyses were by intention-to-treat.

There was no significant difference between the trophic and full enteral feeding groups with regard to the primary outcome of ventilator-free days through Day 28 (14.9% vs. 15.0%, P=0.89). There were also no significant differences between groups in secondary outcomes, which included 60-day mortality, ICU-free days, organ-failure-free days, or the incidence of new infections. However, gastrointestinal intolerances occurred less often in the trophic feeding group, and these patients received fewer anti-diarrheal and prokinetic agents. The full feeding group gained 2.1 liters of fluid by Day 7, but this fluid gain did not cause significant differences in measures of circulatory or pulmonary physiology.

Limitations include open-label study design and inclusion of only critically ill adult medical patients with acute lung injury.

Bottom line: Initial lower-volume tube feedings in mechanically ventilated patients with acute lung injury did not improve clinical outcomes compared with full enteral feedings, but they were associated with fewer instances of gastrointestinal intolerance.

Citation: National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012;307:795-803.

Intramuscular Benzodiazepines as Good as IV Benzodiazepines in Status Epilepticus

Clinical question: Is intramuscular (IM) midazolam noninferior to intravenous lorazepam in patients in status epilepticus?

Background: Studies have shown that IV benzodiazepines, particularly lorazepam, are effective for patients in status epilepticus. Studies have not evaluated IM benzodiazepines. However, many emergency medical service (EMS) agencies use IM midazolam because IM administration is easier than IV administration, and midazolam has a longer nonrefrigerated shelf life than lorazepam does.

Study design: Randomized, double-blinded clinical trial.

Setting: Thirty-three EMS agencies across the United States.

Synopsis: Based on the 893 adults and children in status epilepticus included in this double-blind study, the researchers found IM midazolam to be noninferior to, and in fact superior to, IV lorazepam for treating seizures prior to arrival at EDs. Specifically, they found 10% more (95% CI 4.0% to 16.1%; P<0.001 for noninferiority and P<0.001 for superiority) seizure-free patients arriving at EDs when IM midazolam was administered. Seizures ceased in patients given IM midazolam in less time on average than it took for paramedics to administer IV lorazepam.

Hospitalists might be less inclined than EMS personnel to use IM midazolam because their patients have established IV access and refrigerated drugs are readily available. However, since IM midazolam was superior to IV lorazepam in this prehospital study, a similar trial in hospitalized patients is warranted. In subsequent trials, it would be useful to administer both midazolam and lorazepam via IM and IV routes, and IM injections by an autoinjector could be compared with the conventional manner.

Bottom line: In the prehospital setting, IM midazolam is at least as good as IV lorazepam in treating status epilepticus in children and adults.

Citation: Silbergleit R, Durkalski V, Lowenstein D, et al. Intramuscular versus intravenous therapy for prehospital status epilepticus. N Engl J Med. 2012;366:591-600.

Clostridium Difficile Infection Risk Remains High at Least Three Months after Antibiotics Are Stopped

Clinical question: How long are patients at higher risk for Clostridium difficile infection (CDI) after completing antibiotics?

Background: Studies have shown that patients given antibiotics are at higher risk for CDI than those who are not, particularly if they take multiple antibiotics at high doses for a prolonged period of time. However, it is not known how long a patient remains at high risk for CDI after completing antibiotic therapy.

Study design: Case-control study.

Setting: Nine hospitals in Netherlands.

Synopsis: The study compared 337 hospitalized patients who had CDI with 337 nondiarrheal controls and 227 non-CDI diarrheal controls. The study showed a seven- to tenfold increased risk for CDI during antibiotic treatment and in the 30 days following cessation of antibiotics. A 2.7-fold increased risk of CDI was seen in the one- to three-month period after antibiotic treatment was stopped.

Because researchers only obtained information about antibiotic use in the three months preceding the onset of diarrhea, it is unknown if CDI risk remains elevated longer than three months after antibiotics are stopped. Also of note, the enzyme immunoassays used in this study to diagnose C. diff had sensitivities of between 60% and 85%.

As hospitalists, this information can be used to advise patients about their continued risk for CDI after cessation of antibiotics. Further studies are needed to determine the risk after three months.

Bottom line: Patients are at highest risk for CDI up to one month after stopping antibiotics but continue to be at higher risk for at least two additional months.

Citation: Hensgens MPN, Goorhuis A, Dekkers OM, Kuijper EJ. Time interval of increased risk for Clostridium difficile infection after exposure to antibiotics. J Antimicrob Chemother. 2012;67:742-748.

Acid Suppression and Poor Outcomes in C. Diff Patients

Clinical question: What are potential modifiable risk factors associated with increased complications and mortality in patients hospitalized with C. diff infection (CDI)?

Background: CDI is a growing cause of morbidity and mortality in hospitalized patients. Evidence is growing for the association of acid suppression, among other modifiable risk factors, with complications and mortality in patients with CDI.

Study design: Retrospective case review.

Setting: Naval medical center.

Synopsis: A laboratory, medical record, and pharmacy database query found 485 patients with CDI. Complications of CDI were defined as ICU admission, surgery, and megacolon. Factors significantly associated with CDI complications and mortality were admission for CDI, corticosteroid use >5 mg per day, age ≥80 years, and prescription acid suppression (including H2-blockers and proton-pump inhibitors).

The latter two risk factors were associated with mortality alone. In multivariable regression, the odds of mortality among patients on acid suppression was more than four times the odds of those not on acid suppression (OR 4.74, 95% CI, 1.57 to 14.36).

Although this is a retrospective cohort study and cannot prove a causal relationship, the data add to a growing body of evidence supporting the risk of CDI complications and mortality for those on acid suppression.

Bottom line: In hospitalized patients with CDI, acid suppression is associated with increased complications and mortality and should be discontinued in this population when possible.

Citation: Morrison RH, Hall NS, Said M, et al. Risk factors associated with complications and mortality in patients with Clostridium difficile infection. Clin Infect Dis. 2011;53:1173-1178.

Perioperative Statins Reduce Cardiac Events for Surgical Patients

Clinical question: Does perioperative statin use improve cardiac outcomes (death, myocardial infarction, atrial fibrillation, and ICU and hospital lengths of stay) in statin-naive patients undergoing cardiac or non-cardiac surgery?

Background: Statins have been hypothesized to reduce perioperative cardiac complications because they reduce vascular and systemic inflammation caused by surgery, and several meta-analyses have demonstrated their efficacy. To date, no meta-analyses have specifically evaluated the benefits of perioperative statins in non-cardiac surgery from randomized controlled trials.

Study design: Systematic review of the literature and meta-analysis.

Setting: Fifteen randomized controlled trials of hospitalized surgical patients.

Synopsis: A systematic review examined the effects of statins on a variety of perioperative cardiac outcomes (death, myocardial infarction, atrial fibrillation, and ICU and hospital lengths of stay); 11 of the 15 patients were undergoing cardiac surgery.

Perioperative statins decreased the risk of atrial fibrillation in patients undergoing cardiac surgery (RR 0.56; 95% CI 0.45-0.69; number needed to treat [NNT], 6). In both cardiac and non-cardiac surgical patients, statins reduced the risk of myocardial infarction (RR 0.53; 95% CI 0.38 to 0.74; NNT 23). Statin treatment also reduced the mean length of hospital stay (in days, mean difference -0.32; 95% CI, -0.53 to -0.11) but did not reduce the length of ICU stay (mean difference -0.08; 95% CI, -0.25 to 0.10). Risk of death was not reduced with statin treatment (RR 0.62; 95% CI, 0.34 to 1.14).

Bottom line: Perioperative statins reduce the risk of postoperative atrial fibrillation in cardiac surgical patients, the risk of postoperative MI in cardiac and non-cardiac surgical patients, and the mean length of hospital stay.

Citation: Chopra V, Wesorick DH, Sussman JB, et al. Effect of perioperative statins on death, myocardial infarction, atrial fibrillation, and length of stay: a systematic review and meta-analysis. Arch Surg. 2012;147:181-188.

Enoxaparin Safe and Effective during Percutaneous Coronary Intervention

Clinical question: Is enoxaparin safe and efficacious compared with unfractionated heparin during percutaneous coronary intervention (PCI)?

Background: Despite problems with the use of unfractionated heparin during PCI, current guidelines give it a Class 1 recommendation for PCI in ST-elevation myocardial infarction (MI). There is growing evidence that enoxaparin can provide predictable, effective anticoagulation during PCI. Although several trials have examined this issue, none have been sufficiently powered to evaluate mortality.

Study design: Systematic review and meta-analysis.

Setting: Twenty-three trials or registries of patients undergoing PCI.

Synopsis: A systematic review found 23 trials representing 30,966 patients that examined the effects of enoxaparin versus unfractionated heparin on risk of mortality, MI, complications of MI, and major bleeding. Of these, 10,243 (33.1%) patients underwent primary PCI for ST elevation MI, 8,750 (28.2%) underwent PCI after fibrinolysis, and 11,973 (38.7%) patients had either scheduled PCI or PCI for non-ST elevation acute coronary syndrome.

Of all the patients, 13,943 (45%) received enoxaparin and 17,023 (55%) received unfractionated heparin. Enoxaparin was associated with significant reductions in all-cause mortality (RR 0.66; 95% CI, 0.57 to 0.76), composite of death or MI (RR 0.68; 95% CI, 0.57 to 0.81), and complications of MI (RR 0.75; 95% CI, 0.6 to 0.85). For patients who received primary PCI for ST elevation MI, enoxaparin reduced the risk of complications of MI by 44% (RR 0.56; 95% CI, 0.42 to 0.76). Enoxaparin also reduced the risk of major bleeding (RR 0.80, 95% CI, 0.68 to 0.95) with even more striking results for the 14 studies that compared intravenous enoxaparin to unfractionated heparin (RR 0.66; 95% CI, 0.52 to 0.83).

Bottom line: Enoxaparin is safe and efficacious when used during PCI. Patients who receive enoxaparin during PCI have reduced risk for death, MI, complications of MI, and major bleeding when compared with patients who receive unfractionated heparin.

Citation: Silvain J, Beygui F, Barthelmy O, et al. Efficacy and safety of enoxaparin versus unfractionated heparin during percutaneous coronary intervention: systematic review and meta-analysis. BMJ. 2012;344:e553.

Serum Potassium Levels and Mortality in Acute Myocardial Infarction

Clinical question: What is the relationship between serum potassium levels and mortality in acute myocardial infarction (AMI) patients?

Background: Several smaller studies in the pre-beta-blocker and pre-reperfusion era recommended maintaining serum potassium levels between 4.0 mEq/L and 5.0 mEq/L in AMI patients. However, current studies examining the relationship between potassium levels and mortality in AMI patients are lacking.

Study design: Retrospective cohort study.

Setting: Multicenter study involving 67 hospitals in the U.S.

Synopsis: Using the Cerner Health Facts database, which included 38,689 patients with biomarker-confirmed AMI, this study showed there was a U-shaped relationship between mean post-admission serum potassium level and in-hospital mortality.

Compared with the reference group of 3.5 mEq/L to less than 4.0 mEq/L (mortality rate 4.8%; 95% CI, 4.4% to 5.2%), mortality was comparable for those with mean post-admission potassium of 4.0 mEq/L to less than 4.5 mEq/L (5.0%; 95% CI, 4.7% to 5.3%). Mortality was twice as great for potassium of 4.5 mEq/L to less than 5.0 mEq/L (10.0%; 95% CI, 9.1% to 10.9%), and even greater for higher potassium strata. Similarly, mortality rates were higher for potassium levels of less than 3.5 mEq/L. Rates of ventricular fibrillation or cardiac arrest were higher among patients with potassium levels of less than 3.0 mEq/L or more than 5.0 mEq/L.

Bottom line: For inpatients with AMI, serum potassium levels of 3.5 mEq/L to 4.5 mEq/L should be maintained for the best outcomes. Repletion of serum potassium to levels greater than 4.5 mEq/L is associated with increased mortality and should be avoided.

Citation: Goyal A, Spertus JA, Gosch K, et al. Serum potassium levels and mortality in acute myocardial infarction. JAMA. 2012;307:157-164.

Proton-Pump Inhibitors Better than H2-Blockers in ACS and STEMI

Clinical question: Are proton-pump inhibitors (PPIs) better than H2-blockers at preventing UGI bleeding in patients after acute coronary syndrome (ACS) or ST-elevation myocardial infarction (STEMI)?

Background: It is not definitively known if PPIs are the same or better than H2-blockers in preventing UGI bleeding in patients on high-risk medications (aspirin, clopidogrel, and anticoagulants) after ACS or STEMI.

Study design: Randomized double-blinded controlled trial.

Setting: Single hospital.

Synopsis: Patients with ACS or STEMI were treated with aspirin, clopidogrel, and enoxaparin or thrombolytics. They were then randomized to either esomeprazole 20 mg or famotidine 40 mg, both administered nightly. They were followed throughout their hospital stay and were then followed between four and 52 weeks after discharge (mean duration: 19 weeks for esomeprazole, 18 weeks for famotidine). The primary end point was time to a composite outcome, consisting of UGI bleeding, obstruction, or perforation. Overall, 313 patients were randomized (164 to esomeprazole and 149 to famotidine).

The treatment groups were equivalent in baseline characteristics, and compliance in both groups was excellent (>98%). The primary endpoint occurred in three patients in the esomeprazole group and in 12 patients in the famotidine group (hazard ratio 0.21; 95% CI, 0.06 to 0.75; P=0.008).

Bottom line: PPIs are superior to H2-blockers in reducing UGI bleeding in patients on high-risk medications (aspirin, clopidogrel, and enoxaparin or thrombolytics) after ACS and STEMI. This confirms the recommendations of the 2010 ACCF/ACG/AHA Expert Consensus that PPIs should be used in those on dual antiplatelet therapy on anticoagulants.

Citation: Ng FH, Tunggal P, Chu WM, et al. Esomeprazole compared with famotidine in the prevention of upper gastrointestinal bleeding in patients with acute coronary syndrome or myocardial infarction. Am J Gastroenterol. 2012;107:389-396.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Initial trophic feedings effective for patients with acute lung injury
2. IM vs. IV benzodiazepines in status epilepticus
3. CDI risk following antibiotic cessation
4. Acid suppression associated with increased complications in CDI patients
5. Perioperative statins and cardiac events in surgical patients
6. Enoxaparin vs. unfractionated heparin during PCI
7. Optimal serum potassium levels for AMI patients
8. PPIs superior to H2-blockers for lowering UGI bleeding following ACS and STEMI

Initial Lower-Volume Enteral Feeding Better Tolerated, but Has No Mortality Benefit

Clinical question: In mechanically ventilated patients with acute lung injury, do initial lower-volume enteral feedings (trophic feedings) improve clinical outcomes when compared with full enteral feedings?

Background: Malnutrition in critically ill patients is associated with poor outcomes, but conflicting data exist regarding the best timing, amount, and formulation of enteral nutrition to initiate. Initiation of lower-volume enteral feeding with periodic assessment of gastric residual volume is common practice, but the effects of this practice are unknown.

Study design: Multicenter randomized controlled open-label study.

Setting: Forty-four hospitals in the National Heart, Lung, and Blood Institute (NHLBI) Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network.

Synopsis: One thousand patients with acute lung injury receiving mechanical ventilation for longer than 72 hours were randomized using a Web-based system to receive either trophic or full enteric feedings for the first six days of mechanical ventilation. After the sixth day, a full enteric feeding protocol was used in all patients. All analyses were by intention-to-treat.

There was no significant difference between the trophic and full enteral feeding groups with regard to the primary outcome of ventilator-free days through Day 28 (14.9% vs. 15.0%, P=0.89). There were also no significant differences between groups in secondary outcomes, which included 60-day mortality, ICU-free days, organ-failure-free days, or the incidence of new infections. However, gastrointestinal intolerances occurred less often in the trophic feeding group, and these patients received fewer anti-diarrheal and prokinetic agents. The full feeding group gained 2.1 liters of fluid by Day 7, but this fluid gain did not cause significant differences in measures of circulatory or pulmonary physiology.

Limitations include open-label study design and inclusion of only critically ill adult medical patients with acute lung injury.

Bottom line: Initial lower-volume tube feedings in mechanically ventilated patients with acute lung injury did not improve clinical outcomes compared with full enteral feedings, but they were associated with fewer instances of gastrointestinal intolerance.

Citation: National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012;307:795-803.

Intramuscular Benzodiazepines as Good as IV Benzodiazepines in Status Epilepticus

Clinical question: Is intramuscular (IM) midazolam noninferior to intravenous lorazepam in patients in status epilepticus?

Background: Studies have shown that IV benzodiazepines, particularly lorazepam, are effective for patients in status epilepticus. Studies have not evaluated IM benzodiazepines. However, many emergency medical service (EMS) agencies use IM midazolam because IM administration is easier than IV administration, and midazolam has a longer nonrefrigerated shelf life than lorazepam does.

Study design: Randomized, double-blinded clinical trial.

Setting: Thirty-three EMS agencies across the United States.

Synopsis: Based on the 893 adults and children in status epilepticus included in this double-blind study, the researchers found IM midazolam to be noninferior to, and in fact superior to, IV lorazepam for treating seizures prior to arrival at EDs. Specifically, they found 10% more (95% CI 4.0% to 16.1%; P<0.001 for noninferiority and P<0.001 for superiority) seizure-free patients arriving at EDs when IM midazolam was administered. Seizures ceased in patients given IM midazolam in less time on average than it took for paramedics to administer IV lorazepam.

Hospitalists might be less inclined than EMS personnel to use IM midazolam because their patients have established IV access and refrigerated drugs are readily available. However, since IM midazolam was superior to IV lorazepam in this prehospital study, a similar trial in hospitalized patients is warranted. In subsequent trials, it would be useful to administer both midazolam and lorazepam via IM and IV routes, and IM injections by an autoinjector could be compared with the conventional manner.

Bottom line: In the prehospital setting, IM midazolam is at least as good as IV lorazepam in treating status epilepticus in children and adults.

Citation: Silbergleit R, Durkalski V, Lowenstein D, et al. Intramuscular versus intravenous therapy for prehospital status epilepticus. N Engl J Med. 2012;366:591-600.

Clostridium Difficile Infection Risk Remains High at Least Three Months after Antibiotics Are Stopped

Clinical question: How long are patients at higher risk for Clostridium difficile infection (CDI) after completing antibiotics?

Background: Studies have shown that patients given antibiotics are at higher risk for CDI than those who are not, particularly if they take multiple antibiotics at high doses for a prolonged period of time. However, it is not known how long a patient remains at high risk for CDI after completing antibiotic therapy.

Study design: Case-control study.

Setting: Nine hospitals in Netherlands.

Synopsis: The study compared 337 hospitalized patients who had CDI with 337 nondiarrheal controls and 227 non-CDI diarrheal controls. The study showed a seven- to tenfold increased risk for CDI during antibiotic treatment and in the 30 days following cessation of antibiotics. A 2.7-fold increased risk of CDI was seen in the one- to three-month period after antibiotic treatment was stopped.

Because researchers only obtained information about antibiotic use in the three months preceding the onset of diarrhea, it is unknown if CDI risk remains elevated longer than three months after antibiotics are stopped. Also of note, the enzyme immunoassays used in this study to diagnose C. diff had sensitivities of between 60% and 85%.

As hospitalists, this information can be used to advise patients about their continued risk for CDI after cessation of antibiotics. Further studies are needed to determine the risk after three months.

Bottom line: Patients are at highest risk for CDI up to one month after stopping antibiotics but continue to be at higher risk for at least two additional months.

Citation: Hensgens MPN, Goorhuis A, Dekkers OM, Kuijper EJ. Time interval of increased risk for Clostridium difficile infection after exposure to antibiotics. J Antimicrob Chemother. 2012;67:742-748.

Acid Suppression and Poor Outcomes in C. Diff Patients

Clinical question: What are potential modifiable risk factors associated with increased complications and mortality in patients hospitalized with C. diff infection (CDI)?

Background: CDI is a growing cause of morbidity and mortality in hospitalized patients. Evidence is growing for the association of acid suppression, among other modifiable risk factors, with complications and mortality in patients with CDI.

Study design: Retrospective case review.

Setting: Naval medical center.

Synopsis: A laboratory, medical record, and pharmacy database query found 485 patients with CDI. Complications of CDI were defined as ICU admission, surgery, and megacolon. Factors significantly associated with CDI complications and mortality were admission for CDI, corticosteroid use >5 mg per day, age ≥80 years, and prescription acid suppression (including H2-blockers and proton-pump inhibitors).

The latter two risk factors were associated with mortality alone. In multivariable regression, the odds of mortality among patients on acid suppression was more than four times the odds of those not on acid suppression (OR 4.74, 95% CI, 1.57 to 14.36).

Although this is a retrospective cohort study and cannot prove a causal relationship, the data add to a growing body of evidence supporting the risk of CDI complications and mortality for those on acid suppression.

Bottom line: In hospitalized patients with CDI, acid suppression is associated with increased complications and mortality and should be discontinued in this population when possible.

Citation: Morrison RH, Hall NS, Said M, et al. Risk factors associated with complications and mortality in patients with Clostridium difficile infection. Clin Infect Dis. 2011;53:1173-1178.

Perioperative Statins Reduce Cardiac Events for Surgical Patients

Clinical question: Does perioperative statin use improve cardiac outcomes (death, myocardial infarction, atrial fibrillation, and ICU and hospital lengths of stay) in statin-naive patients undergoing cardiac or non-cardiac surgery?

Background: Statins have been hypothesized to reduce perioperative cardiac complications because they reduce vascular and systemic inflammation caused by surgery, and several meta-analyses have demonstrated their efficacy. To date, no meta-analyses have specifically evaluated the benefits of perioperative statins in non-cardiac surgery from randomized controlled trials.

Study design: Systematic review of the literature and meta-analysis.

Setting: Fifteen randomized controlled trials of hospitalized surgical patients.

Synopsis: A systematic review examined the effects of statins on a variety of perioperative cardiac outcomes (death, myocardial infarction, atrial fibrillation, and ICU and hospital lengths of stay); 11 of the 15 patients were undergoing cardiac surgery.

Perioperative statins decreased the risk of atrial fibrillation in patients undergoing cardiac surgery (RR 0.56; 95% CI 0.45-0.69; number needed to treat [NNT], 6). In both cardiac and non-cardiac surgical patients, statins reduced the risk of myocardial infarction (RR 0.53; 95% CI 0.38 to 0.74; NNT 23). Statin treatment also reduced the mean length of hospital stay (in days, mean difference -0.32; 95% CI, -0.53 to -0.11) but did not reduce the length of ICU stay (mean difference -0.08; 95% CI, -0.25 to 0.10). Risk of death was not reduced with statin treatment (RR 0.62; 95% CI, 0.34 to 1.14).

Bottom line: Perioperative statins reduce the risk of postoperative atrial fibrillation in cardiac surgical patients, the risk of postoperative MI in cardiac and non-cardiac surgical patients, and the mean length of hospital stay.

Citation: Chopra V, Wesorick DH, Sussman JB, et al. Effect of perioperative statins on death, myocardial infarction, atrial fibrillation, and length of stay: a systematic review and meta-analysis. Arch Surg. 2012;147:181-188.

Enoxaparin Safe and Effective during Percutaneous Coronary Intervention

Clinical question: Is enoxaparin safe and efficacious compared with unfractionated heparin during percutaneous coronary intervention (PCI)?

Background: Despite problems with the use of unfractionated heparin during PCI, current guidelines give it a Class 1 recommendation for PCI in ST-elevation myocardial infarction (MI). There is growing evidence that enoxaparin can provide predictable, effective anticoagulation during PCI. Although several trials have examined this issue, none have been sufficiently powered to evaluate mortality.

Study design: Systematic review and meta-analysis.

Setting: Twenty-three trials or registries of patients undergoing PCI.

Synopsis: A systematic review found 23 trials representing 30,966 patients that examined the effects of enoxaparin versus unfractionated heparin on risk of mortality, MI, complications of MI, and major bleeding. Of these, 10,243 (33.1%) patients underwent primary PCI for ST elevation MI, 8,750 (28.2%) underwent PCI after fibrinolysis, and 11,973 (38.7%) patients had either scheduled PCI or PCI for non-ST elevation acute coronary syndrome.

Of all the patients, 13,943 (45%) received enoxaparin and 17,023 (55%) received unfractionated heparin. Enoxaparin was associated with significant reductions in all-cause mortality (RR 0.66; 95% CI, 0.57 to 0.76), composite of death or MI (RR 0.68; 95% CI, 0.57 to 0.81), and complications of MI (RR 0.75; 95% CI, 0.6 to 0.85). For patients who received primary PCI for ST elevation MI, enoxaparin reduced the risk of complications of MI by 44% (RR 0.56; 95% CI, 0.42 to 0.76). Enoxaparin also reduced the risk of major bleeding (RR 0.80, 95% CI, 0.68 to 0.95) with even more striking results for the 14 studies that compared intravenous enoxaparin to unfractionated heparin (RR 0.66; 95% CI, 0.52 to 0.83).

Bottom line: Enoxaparin is safe and efficacious when used during PCI. Patients who receive enoxaparin during PCI have reduced risk for death, MI, complications of MI, and major bleeding when compared with patients who receive unfractionated heparin.

Citation: Silvain J, Beygui F, Barthelmy O, et al. Efficacy and safety of enoxaparin versus unfractionated heparin during percutaneous coronary intervention: systematic review and meta-analysis. BMJ. 2012;344:e553.

Serum Potassium Levels and Mortality in Acute Myocardial Infarction

Clinical question: What is the relationship between serum potassium levels and mortality in acute myocardial infarction (AMI) patients?

Background: Several smaller studies in the pre-beta-blocker and pre-reperfusion era recommended maintaining serum potassium levels between 4.0 mEq/L and 5.0 mEq/L in AMI patients. However, current studies examining the relationship between potassium levels and mortality in AMI patients are lacking.

Study design: Retrospective cohort study.

Setting: Multicenter study involving 67 hospitals in the U.S.

Synopsis: Using the Cerner Health Facts database, which included 38,689 patients with biomarker-confirmed AMI, this study showed there was a U-shaped relationship between mean post-admission serum potassium level and in-hospital mortality.

Compared with the reference group of 3.5 mEq/L to less than 4.0 mEq/L (mortality rate 4.8%; 95% CI, 4.4% to 5.2%), mortality was comparable for those with mean post-admission potassium of 4.0 mEq/L to less than 4.5 mEq/L (5.0%; 95% CI, 4.7% to 5.3%). Mortality was twice as great for potassium of 4.5 mEq/L to less than 5.0 mEq/L (10.0%; 95% CI, 9.1% to 10.9%), and even greater for higher potassium strata. Similarly, mortality rates were higher for potassium levels of less than 3.5 mEq/L. Rates of ventricular fibrillation or cardiac arrest were higher among patients with potassium levels of less than 3.0 mEq/L or more than 5.0 mEq/L.

Bottom line: For inpatients with AMI, serum potassium levels of 3.5 mEq/L to 4.5 mEq/L should be maintained for the best outcomes. Repletion of serum potassium to levels greater than 4.5 mEq/L is associated with increased mortality and should be avoided.

Citation: Goyal A, Spertus JA, Gosch K, et al. Serum potassium levels and mortality in acute myocardial infarction. JAMA. 2012;307:157-164.

Proton-Pump Inhibitors Better than H2-Blockers in ACS and STEMI

Clinical question: Are proton-pump inhibitors (PPIs) better than H2-blockers at preventing UGI bleeding in patients after acute coronary syndrome (ACS) or ST-elevation myocardial infarction (STEMI)?

Background: It is not definitively known if PPIs are the same or better than H2-blockers in preventing UGI bleeding in patients on high-risk medications (aspirin, clopidogrel, and anticoagulants) after ACS or STEMI.

Study design: Randomized double-blinded controlled trial.

Setting: Single hospital.

Synopsis: Patients with ACS or STEMI were treated with aspirin, clopidogrel, and enoxaparin or thrombolytics. They were then randomized to either esomeprazole 20 mg or famotidine 40 mg, both administered nightly. They were followed throughout their hospital stay and were then followed between four and 52 weeks after discharge (mean duration: 19 weeks for esomeprazole, 18 weeks for famotidine). The primary end point was time to a composite outcome, consisting of UGI bleeding, obstruction, or perforation. Overall, 313 patients were randomized (164 to esomeprazole and 149 to famotidine).

The treatment groups were equivalent in baseline characteristics, and compliance in both groups was excellent (>98%). The primary endpoint occurred in three patients in the esomeprazole group and in 12 patients in the famotidine group (hazard ratio 0.21; 95% CI, 0.06 to 0.75; P=0.008).

Bottom line: PPIs are superior to H2-blockers in reducing UGI bleeding in patients on high-risk medications (aspirin, clopidogrel, and enoxaparin or thrombolytics) after ACS and STEMI. This confirms the recommendations of the 2010 ACCF/ACG/AHA Expert Consensus that PPIs should be used in those on dual antiplatelet therapy on anticoagulants.

Citation: Ng FH, Tunggal P, Chu WM, et al. Esomeprazole compared with famotidine in the prevention of upper gastrointestinal bleeding in patients with acute coronary syndrome or myocardial infarction. Am J Gastroenterol. 2012;107:389-396.

In This Edition

Literature At A Glance

A guide to this month’s studies

1. Initial trophic feedings effective for patients with acute lung injury
2. IM vs. IV benzodiazepines in status epilepticus
3. CDI risk following antibiotic cessation
4. Acid suppression associated with increased complications in CDI patients
5. Perioperative statins and cardiac events in surgical patients
6. Enoxaparin vs. unfractionated heparin during PCI
7. Optimal serum potassium levels for AMI patients
8. PPIs superior to H2-blockers for lowering UGI bleeding following ACS and STEMI

Initial Lower-Volume Enteral Feeding Better Tolerated, but Has No Mortality Benefit

Clinical question: In mechanically ventilated patients with acute lung injury, do initial lower-volume enteral feedings (trophic feedings) improve clinical outcomes when compared with full enteral feedings?

Background: Malnutrition in critically ill patients is associated with poor outcomes, but conflicting data exist regarding the best timing, amount, and formulation of enteral nutrition to initiate. Initiation of lower-volume enteral feeding with periodic assessment of gastric residual volume is common practice, but the effects of this practice are unknown.

Study design: Multicenter randomized controlled open-label study.

Setting: Forty-four hospitals in the National Heart, Lung, and Blood Institute (NHLBI) Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network.

Synopsis: One thousand patients with acute lung injury receiving mechanical ventilation for longer than 72 hours were randomized using a Web-based system to receive either trophic or full enteric feedings for the first six days of mechanical ventilation. After the sixth day, a full enteric feeding protocol was used in all patients. All analyses were by intention-to-treat.

There was no significant difference between the trophic and full enteral feeding groups with regard to the primary outcome of ventilator-free days through Day 28 (14.9% vs. 15.0%, P=0.89). There were also no significant differences between groups in secondary outcomes, which included 60-day mortality, ICU-free days, organ-failure-free days, or the incidence of new infections. However, gastrointestinal intolerances occurred less often in the trophic feeding group, and these patients received fewer anti-diarrheal and prokinetic agents. The full feeding group gained 2.1 liters of fluid by Day 7, but this fluid gain did not cause significant differences in measures of circulatory or pulmonary physiology.

Limitations include open-label study design and inclusion of only critically ill adult medical patients with acute lung injury.

Bottom line: Initial lower-volume tube feedings in mechanically ventilated patients with acute lung injury did not improve clinical outcomes compared with full enteral feedings, but they were associated with fewer instances of gastrointestinal intolerance.

Citation: National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012;307:795-803.

Intramuscular Benzodiazepines as Good as IV Benzodiazepines in Status Epilepticus

Clinical question: Is intramuscular (IM) midazolam noninferior to intravenous lorazepam in patients in status epilepticus?

Background: Studies have shown that IV benzodiazepines, particularly lorazepam, are effective for patients in status epilepticus. Studies have not evaluated IM benzodiazepines. However, many emergency medical service (EMS) agencies use IM midazolam because IM administration is easier than IV administration, and midazolam has a longer nonrefrigerated shelf life than lorazepam does.

Study design: Randomized, double-blinded clinical trial.

Setting: Thirty-three EMS agencies across the United States.

Synopsis: Based on the 893 adults and children in status epilepticus included in this double-blind study, the researchers found IM midazolam to be noninferior to, and in fact superior to, IV lorazepam for treating seizures prior to arrival at EDs. Specifically, they found 10% more (95% CI 4.0% to 16.1%; P<0.001 for noninferiority and P<0.001 for superiority) seizure-free patients arriving at EDs when IM midazolam was administered. Seizures ceased in patients given IM midazolam in less time on average than it took for paramedics to administer IV lorazepam.

Hospitalists might be less inclined than EMS personnel to use IM midazolam because their patients have established IV access and refrigerated drugs are readily available. However, since IM midazolam was superior to IV lorazepam in this prehospital study, a similar trial in hospitalized patients is warranted. In subsequent trials, it would be useful to administer both midazolam and lorazepam via IM and IV routes, and IM injections by an autoinjector could be compared with the conventional manner.

Bottom line: In the prehospital setting, IM midazolam is at least as good as IV lorazepam in treating status epilepticus in children and adults.

Citation: Silbergleit R, Durkalski V, Lowenstein D, et al. Intramuscular versus intravenous therapy for prehospital status epilepticus. N Engl J Med. 2012;366:591-600.

Clostridium Difficile Infection Risk Remains High at Least Three Months after Antibiotics Are Stopped

Clinical question: How long are patients at higher risk for Clostridium difficile infection (CDI) after completing antibiotics?

Background: Studies have shown that patients given antibiotics are at higher risk for CDI than those who are not, particularly if they take multiple antibiotics at high doses for a prolonged period of time. However, it is not known how long a patient remains at high risk for CDI after completing antibiotic therapy.

Study design: Case-control study.

Setting: Nine hospitals in Netherlands.

Synopsis: The study compared 337 hospitalized patients who had CDI with 337 nondiarrheal controls and 227 non-CDI diarrheal controls. The study showed a seven- to tenfold increased risk for CDI during antibiotic treatment and in the 30 days following cessation of antibiotics. A 2.7-fold increased risk of CDI was seen in the one- to three-month period after antibiotic treatment was stopped.

Because researchers only obtained information about antibiotic use in the three months preceding the onset of diarrhea, it is unknown if CDI risk remains elevated longer than three months after antibiotics are stopped. Also of note, the enzyme immunoassays used in this study to diagnose C. diff had sensitivities of between 60% and 85%.

As hospitalists, this information can be used to advise patients about their continued risk for CDI after cessation of antibiotics. Further studies are needed to determine the risk after three months.

Bottom line: Patients are at highest risk for CDI up to one month after stopping antibiotics but continue to be at higher risk for at least two additional months.

Citation: Hensgens MPN, Goorhuis A, Dekkers OM, Kuijper EJ. Time interval of increased risk for Clostridium difficile infection after exposure to antibiotics. J Antimicrob Chemother. 2012;67:742-748.

Acid Suppression and Poor Outcomes in C. Diff Patients

Clinical question: What are potential modifiable risk factors associated with increased complications and mortality in patients hospitalized with C. diff infection (CDI)?

Background: CDI is a growing cause of morbidity and mortality in hospitalized patients. Evidence is growing for the association of acid suppression, among other modifiable risk factors, with complications and mortality in patients with CDI.

Study design: Retrospective case review.

Setting: Naval medical center.

Synopsis: A laboratory, medical record, and pharmacy database query found 485 patients with CDI. Complications of CDI were defined as ICU admission, surgery, and megacolon. Factors significantly associated with CDI complications and mortality were admission for CDI, corticosteroid use >5 mg per day, age ≥80 years, and prescription acid suppression (including H2-blockers and proton-pump inhibitors).

The latter two risk factors were associated with mortality alone. In multivariable regression, the odds of mortality among patients on acid suppression was more than four times the odds of those not on acid suppression (OR 4.74, 95% CI, 1.57 to 14.36).

Although this is a retrospective cohort study and cannot prove a causal relationship, the data add to a growing body of evidence supporting the risk of CDI complications and mortality for those on acid suppression.

Bottom line: In hospitalized patients with CDI, acid suppression is associated with increased complications and mortality and should be discontinued in this population when possible.

Citation: Morrison RH, Hall NS, Said M, et al. Risk factors associated with complications and mortality in patients with Clostridium difficile infection. Clin Infect Dis. 2011;53:1173-1178.

Perioperative Statins Reduce Cardiac Events for Surgical Patients

Clinical question: Does perioperative statin use improve cardiac outcomes (death, myocardial infarction, atrial fibrillation, and ICU and hospital lengths of stay) in statin-naive patients undergoing cardiac or non-cardiac surgery?

Background: Statins have been hypothesized to reduce perioperative cardiac complications because they reduce vascular and systemic inflammation caused by surgery, and several meta-analyses have demonstrated their efficacy. To date, no meta-analyses have specifically evaluated the benefits of perioperative statins in non-cardiac surgery from randomized controlled trials.

Study design: Systematic review of the literature and meta-analysis.

Setting: Fifteen randomized controlled trials of hospitalized surgical patients.

Synopsis: A systematic review examined the effects of statins on a variety of perioperative cardiac outcomes (death, myocardial infarction, atrial fibrillation, and ICU and hospital lengths of stay); 11 of the 15 patients were undergoing cardiac surgery.

Perioperative statins decreased the risk of atrial fibrillation in patients undergoing cardiac surgery (RR 0.56; 95% CI 0.45-0.69; number needed to treat [NNT], 6). In both cardiac and non-cardiac surgical patients, statins reduced the risk of myocardial infarction (RR 0.53; 95% CI 0.38 to 0.74; NNT 23). Statin treatment also reduced the mean length of hospital stay (in days, mean difference -0.32; 95% CI, -0.53 to -0.11) but did not reduce the length of ICU stay (mean difference -0.08; 95% CI, -0.25 to 0.10). Risk of death was not reduced with statin treatment (RR 0.62; 95% CI, 0.34 to 1.14).

Bottom line: Perioperative statins reduce the risk of postoperative atrial fibrillation in cardiac surgical patients, the risk of postoperative MI in cardiac and non-cardiac surgical patients, and the mean length of hospital stay.

Citation: Chopra V, Wesorick DH, Sussman JB, et al. Effect of perioperative statins on death, myocardial infarction, atrial fibrillation, and length of stay: a systematic review and meta-analysis. Arch Surg. 2012;147:181-188.

Enoxaparin Safe and Effective during Percutaneous Coronary Intervention

Clinical question: Is enoxaparin safe and efficacious compared with unfractionated heparin during percutaneous coronary intervention (PCI)?

Background: Despite problems with the use of unfractionated heparin during PCI, current guidelines give it a Class 1 recommendation for PCI in ST-elevation myocardial infarction (MI). There is growing evidence that enoxaparin can provide predictable, effective anticoagulation during PCI. Although several trials have examined this issue, none have been sufficiently powered to evaluate mortality.

Study design: Systematic review and meta-analysis.

Setting: Twenty-three trials or registries of patients undergoing PCI.

Synopsis: A systematic review found 23 trials representing 30,966 patients that examined the effects of enoxaparin versus unfractionated heparin on risk of mortality, MI, complications of MI, and major bleeding. Of these, 10,243 (33.1%) patients underwent primary PCI for ST elevation MI, 8,750 (28.2%) underwent PCI after fibrinolysis, and 11,973 (38.7%) patients had either scheduled PCI or PCI for non-ST elevation acute coronary syndrome.

Of all the patients, 13,943 (45%) received enoxaparin and 17,023 (55%) received unfractionated heparin. Enoxaparin was associated with significant reductions in all-cause mortality (RR 0.66; 95% CI, 0.57 to 0.76), composite of death or MI (RR 0.68; 95% CI, 0.57 to 0.81), and complications of MI (RR 0.75; 95% CI, 0.6 to 0.85). For patients who received primary PCI for ST elevation MI, enoxaparin reduced the risk of complications of MI by 44% (RR 0.56; 95% CI, 0.42 to 0.76). Enoxaparin also reduced the risk of major bleeding (RR 0.80, 95% CI, 0.68 to 0.95) with even more striking results for the 14 studies that compared intravenous enoxaparin to unfractionated heparin (RR 0.66; 95% CI, 0.52 to 0.83).

Bottom line: Enoxaparin is safe and efficacious when used during PCI. Patients who receive enoxaparin during PCI have reduced risk for death, MI, complications of MI, and major bleeding when compared with patients who receive unfractionated heparin.

Citation: Silvain J, Beygui F, Barthelmy O, et al. Efficacy and safety of enoxaparin versus unfractionated heparin during percutaneous coronary intervention: systematic review and meta-analysis. BMJ. 2012;344:e553.

Serum Potassium Levels and Mortality in Acute Myocardial Infarction

Clinical question: What is the relationship between serum potassium levels and mortality in acute myocardial infarction (AMI) patients?

Background: Several smaller studies in the pre-beta-blocker and pre-reperfusion era recommended maintaining serum potassium levels between 4.0 mEq/L and 5.0 mEq/L in AMI patients. However, current studies examining the relationship between potassium levels and mortality in AMI patients are lacking.

Study design: Retrospective cohort study.

Setting: Multicenter study involving 67 hospitals in the U.S.

Synopsis: Using the Cerner Health Facts database, which included 38,689 patients with biomarker-confirmed AMI, this study showed there was a U-shaped relationship between mean post-admission serum potassium level and in-hospital mortality.

Compared with the reference group of 3.5 mEq/L to less than 4.0 mEq/L (mortality rate 4.8%; 95% CI, 4.4% to 5.2%), mortality was comparable for those with mean post-admission potassium of 4.0 mEq/L to less than 4.5 mEq/L (5.0%; 95% CI, 4.7% to 5.3%). Mortality was twice as great for potassium of 4.5 mEq/L to less than 5.0 mEq/L (10.0%; 95% CI, 9.1% to 10.9%), and even greater for higher potassium strata. Similarly, mortality rates were higher for potassium levels of less than 3.5 mEq/L. Rates of ventricular fibrillation or cardiac arrest were higher among patients with potassium levels of less than 3.0 mEq/L or more than 5.0 mEq/L.

Bottom line: For inpatients with AMI, serum potassium levels of 3.5 mEq/L to 4.5 mEq/L should be maintained for the best outcomes. Repletion of serum potassium to levels greater than 4.5 mEq/L is associated with increased mortality and should be avoided.

Citation: Goyal A, Spertus JA, Gosch K, et al. Serum potassium levels and mortality in acute myocardial infarction. JAMA. 2012;307:157-164.

Proton-Pump Inhibitors Better than H2-Blockers in ACS and STEMI

Clinical question: Are proton-pump inhibitors (PPIs) better than H2-blockers at preventing UGI bleeding in patients after acute coronary syndrome (ACS) or ST-elevation myocardial infarction (STEMI)?

Background: It is not definitively known if PPIs are the same or better than H2-blockers in preventing UGI bleeding in patients on high-risk medications (aspirin, clopidogrel, and anticoagulants) after ACS or STEMI.

Study design: Randomized double-blinded controlled trial.

Setting: Single hospital.

Synopsis: Patients with ACS or STEMI were treated with aspirin, clopidogrel, and enoxaparin or thrombolytics. They were then randomized to either esomeprazole 20 mg or famotidine 40 mg, both administered nightly. They were followed throughout their hospital stay and were then followed between four and 52 weeks after discharge (mean duration: 19 weeks for esomeprazole, 18 weeks for famotidine). The primary end point was time to a composite outcome, consisting of UGI bleeding, obstruction, or perforation. Overall, 313 patients were randomized (164 to esomeprazole and 149 to famotidine).

The treatment groups were equivalent in baseline characteristics, and compliance in both groups was excellent (>98%). The primary endpoint occurred in three patients in the esomeprazole group and in 12 patients in the famotidine group (hazard ratio 0.21; 95% CI, 0.06 to 0.75; P=0.008).

Bottom line: PPIs are superior to H2-blockers in reducing UGI bleeding in patients on high-risk medications (aspirin, clopidogrel, and enoxaparin or thrombolytics) after ACS and STEMI. This confirms the recommendations of the 2010 ACCF/ACG/AHA Expert Consensus that PPIs should be used in those on dual antiplatelet therapy on anticoagulants.

Citation: Ng FH, Tunggal P, Chu WM, et al. Esomeprazole compared with famotidine in the prevention of upper gastrointestinal bleeding in patients with acute coronary syndrome or myocardial infarction. Am J Gastroenterol. 2012;107:389-396.

Clinical question: What is the association between delayed acyclovir therapy and death in neonates with herpes simplex virus (HSV) infection?

Background: Neonatal HSV infection may result in significant morbidity and mortality if untreated. Because symptoms upon presentation may be nonspecific and testing may take several days, clinicians must often decide whether to initiate empiric therapy with acyclovir. However, this may also have consequences related to increased costs of care and the side effects of acyclovir.

Study design: Multicenter retrospective cohort study.

Setting: Forty-one freestanding tertiary-care children’s hospitals.

Synopsis: The Pediatric Health Information System (PHIS) database was used to identify 1,086 infants <28 days of age with a discharge diagnosis of HSV from 2003 to 2009 who received their first dose of intravenous acyclovir within the first seven days of admission. Delayed acyclovir was defined as administration after hospital Day One. Propensity scores and multivariate logistic regression analysis were used to attempt to account for patient (e.g. severity of illness) and hospital confounders. The mortality rate was 9.5% (95% confidence interval [CI]: 6.3%-13.82%) for delayed therapy compared with 6.6% (95% CI: 5.0%-8.5%) for early therapy.

Limitations of this study include the inability to identify all potential patient-level confounders that might have led clinicians to initiate early acyclovir therapy. Although the authors attempted to account for variables that might have defined sicker patients, such as intubation or vasoactive agent infusion, they could not identify patients with just skin, eye, or mouth disease from this database, nor could they identify specific clinical concerns, such as hypothermia. Thus, while the authors conclude that empiric acyclovir is prudent if HSV testing is performed, more specific clinical indications cannot be gleaned from this review.

Bottom line: Delayed initiation of acyclovir increases mortality in neonatal HSV infection.

Citation: Shah SS, Aronson PL, Mohamad Z, Lorch SA. Delayed acyclovir therapy and death among neonates with herpes simplex virus infection. Pediatrics. 2011;128(6):1153-1160.

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

Clinical question: What is the association between delayed acyclovir therapy and death in neonates with herpes simplex virus (HSV) infection?

Background: Neonatal HSV infection may result in significant morbidity and mortality if untreated. Because symptoms upon presentation may be nonspecific and testing may take several days, clinicians must often decide whether to initiate empiric therapy with acyclovir. However, this may also have consequences related to increased costs of care and the side effects of acyclovir.

Study design: Multicenter retrospective cohort study.

Setting: Forty-one freestanding tertiary-care children’s hospitals.

Synopsis: The Pediatric Health Information System (PHIS) database was used to identify 1,086 infants <28 days of age with a discharge diagnosis of HSV from 2003 to 2009 who received their first dose of intravenous acyclovir within the first seven days of admission. Delayed acyclovir was defined as administration after hospital Day One. Propensity scores and multivariate logistic regression analysis were used to attempt to account for patient (e.g. severity of illness) and hospital confounders. The mortality rate was 9.5% (95% confidence interval [CI]: 6.3%-13.82%) for delayed therapy compared with 6.6% (95% CI: 5.0%-8.5%) for early therapy.

Limitations of this study include the inability to identify all potential patient-level confounders that might have led clinicians to initiate early acyclovir therapy. Although the authors attempted to account for variables that might have defined sicker patients, such as intubation or vasoactive agent infusion, they could not identify patients with just skin, eye, or mouth disease from this database, nor could they identify specific clinical concerns, such as hypothermia. Thus, while the authors conclude that empiric acyclovir is prudent if HSV testing is performed, more specific clinical indications cannot be gleaned from this review.

Bottom line: Delayed initiation of acyclovir increases mortality in neonatal HSV infection.

Citation: Shah SS, Aronson PL, Mohamad Z, Lorch SA. Delayed acyclovir therapy and death among neonates with herpes simplex virus infection. Pediatrics. 2011;128(6):1153-1160.

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

Clinical question: What is the association between delayed acyclovir therapy and death in neonates with herpes simplex virus (HSV) infection?

Background: Neonatal HSV infection may result in significant morbidity and mortality if untreated. Because symptoms upon presentation may be nonspecific and testing may take several days, clinicians must often decide whether to initiate empiric therapy with acyclovir. However, this may also have consequences related to increased costs of care and the side effects of acyclovir.

Study design: Multicenter retrospective cohort study.

Setting: Forty-one freestanding tertiary-care children’s hospitals.

Synopsis: The Pediatric Health Information System (PHIS) database was used to identify 1,086 infants <28 days of age with a discharge diagnosis of HSV from 2003 to 2009 who received their first dose of intravenous acyclovir within the first seven days of admission. Delayed acyclovir was defined as administration after hospital Day One. Propensity scores and multivariate logistic regression analysis were used to attempt to account for patient (e.g. severity of illness) and hospital confounders. The mortality rate was 9.5% (95% confidence interval [CI]: 6.3%-13.82%) for delayed therapy compared with 6.6% (95% CI: 5.0%-8.5%) for early therapy.

Limitations of this study include the inability to identify all potential patient-level confounders that might have led clinicians to initiate early acyclovir therapy. Although the authors attempted to account for variables that might have defined sicker patients, such as intubation or vasoactive agent infusion, they could not identify patients with just skin, eye, or mouth disease from this database, nor could they identify specific clinical concerns, such as hypothermia. Thus, while the authors conclude that empiric acyclovir is prudent if HSV testing is performed, more specific clinical indications cannot be gleaned from this review.

Bottom line: Delayed initiation of acyclovir increases mortality in neonatal HSV infection.

Citation: Shah SS, Aronson PL, Mohamad Z, Lorch SA. Delayed acyclovir therapy and death among neonates with herpes simplex virus infection. Pediatrics. 2011;128(6):1153-1160.

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

Soon, hospitals with unnecessary 30-day readmissions will be penalized. Some proactive hospitals are already tackling care transitions to reduce readmissions, improve patient care, and reduce costs.

Lodi Memorial Hospital in Northern California is one such hospital. The 214-bed facility has made preventing readmissions a key strategic goal for improving care, especially for vulnerable, frail elderly patients.

Lodi executives say readmissions are a challenge at the hospital because many different specialties and house staff are involved in the discharge process.

With many options from which to choose, Lodi selected SHM’s Project BOOST (Better Outcomes for Older Adults through Safe Transitions). Project BOOST, unlike other programs, focuses on first identifying system deficiencies, then building cohesive multidisciplinary teams.

“If you layer a clinical intervention onto a broken system,” says BOOST mentor Stephanie Rennke, MD, “success isn’t likely. Project BOOST helps the team map current processes, find deficiencies, assess resources, and redefine a culture of safety.

“BOOST starts with an assessment of how the system functions, and identifies its strengths and weaknesses so you can focus your efforts on critical areas for improvement and tailor the BOOST intervention to fit the unique dynamics of an institution,” she says.

Search for a Solution

No two institutions are exactly the same, especially when analyzing patient-safety culture. Project BOOST is customized to the needs of each BOOST site, which has proven useful to Lodi, as it found it had different needs than other hospitals.

“We chose Project BOOST because it seemed workable and implementable, while offering a less expensive and less complicated solution than competitors’ products,” says Valerie Cronin, Lodi’s director of utilization.

The BOOST mentor, key to this customization, provided Lodi with the reassurance that comes with working directly with someone who has faced similar challenges—not just theoretically, but also on the floor—and was willing to work with Lodi to develop practical solutions. The mentor provided reassurance, support, and perspective as Lodi walked through the BOOST implementation process.

Keys to Success

Team-focused care, clear communication, and administrative support were keys to successful BOOST implementation at Lodi, says Cronin.

The house staff was overwhelmed, and adding a quality-improvement (QI) project to implement and manage might have seemed like an impossible challenge. By developing multidisciplinary teams, however, Lodi was able to distribute the tasks of implementation and began to recognize the value and benefit of Project BOOST, which already had strong support from hospital executives.

A 14-member multidisciplinary team was formed to oversee the Project BOOST implementation. The team then was divided into sub-groups to work on the main components of Project BOOST: Passport to Care Form, Target Assessment Tool, the Teachback process, and Follow-Up Phone Calls. The sub-groups’ main objectives were to ensure that BOOST effectively changed processes and work practices for a stronger and safer discharge process.

To support these teams and foster communication laterally among healthcare providers and vertically with hospital administration, Lodi established a structured meeting format, delegated task assignments for accountability, and appointed an implementation champion.

Capitalizing on the experience of its BOOST mentor, the Lodi multidisciplinary teams mapped out the process to assess threats to the system and opportunities for improvement, and began moving forward with implementable solutions for sustainable change.

“Evaluating the whole discharge process allowed us to see the gaps and discrepancies in the discharge process,” Cronin says. “Each discipline had their own set of procedures and materials, which proved lacking and inconsistent for our patients. It was an essential and eye-opening experience for Lodi to make change.”

One of the biggest revelations was learning how broken the discharge process was for the nurses. When Lodi looked at its current process of using case managers to handle high-risk patients and leaving the remaining patient discharges to the nurses, they found that the process was not strong enough to support patient load.

Knowledge Is Power

Cronin says Lodi has standardized its patient educational materials and started the patient education process as soon as patients are admitted. This step optimizes a patient’s understanding of diagnoses and care instructions when the time comes for discharge.

Through the Project BOOST assessment, Lodi ascertained that many of its patients were being discharged to skilled-nursing facilities, which heightens the complexity of post-care and introduces the potential for increased risks. Lodi is now working to better communicate with the skilled-nursing facilities using its Project BOOST training to streamline the discharge process.

The implementation of the Teach Back communication strategy has been critical in increasing patient knowledge and adherence to care instructions, official say. Based on the success of Project BOOST implementation, Teach Back has been incorporated into mandatory nurse training throughout the hospital.

Improved Care

More than 80 patients were discharged through the BOOST process in the first 90 days of implementation. Lodi is already experiencing the benefits of Project BOOST organizationally and

expects to see the financial impacts soon through a lower 30-day readmission rate.

“Lodi has experienced a shift in patient safety culture with improved communication through a team approach to care,” Cronin says. “Lodi expects high success through Project BOOST with the goal of implementing Project BOOST across all disease states and every discipline using Teachback.

“Project BOOST has been the ideal program to align with our strategic organizational goals to improve transitions of care and re-create the patient safety culture to make systemwide sustainable change,” she says.

For more information about Project BOOST, visit www.hospitalmedicine.org/boost.

Jacqui Petock, marketing project manager

Soon, hospitals with unnecessary 30-day readmissions will be penalized. Some proactive hospitals are already tackling care transitions to reduce readmissions, improve patient care, and reduce costs.

Lodi Memorial Hospital in Northern California is one such hospital. The 214-bed facility has made preventing readmissions a key strategic goal for improving care, especially for vulnerable, frail elderly patients.

Lodi executives say readmissions are a challenge at the hospital because many different specialties and house staff are involved in the discharge process.

With many options from which to choose, Lodi selected SHM’s Project BOOST (Better Outcomes for Older Adults through Safe Transitions). Project BOOST, unlike other programs, focuses on first identifying system deficiencies, then building cohesive multidisciplinary teams.

“If you layer a clinical intervention onto a broken system,” says BOOST mentor Stephanie Rennke, MD, “success isn’t likely. Project BOOST helps the team map current processes, find deficiencies, assess resources, and redefine a culture of safety.

“BOOST starts with an assessment of how the system functions, and identifies its strengths and weaknesses so you can focus your efforts on critical areas for improvement and tailor the BOOST intervention to fit the unique dynamics of an institution,” she says.

Search for a Solution

No two institutions are exactly the same, especially when analyzing patient-safety culture. Project BOOST is customized to the needs of each BOOST site, which has proven useful to Lodi, as it found it had different needs than other hospitals.

“We chose Project BOOST because it seemed workable and implementable, while offering a less expensive and less complicated solution than competitors’ products,” says Valerie Cronin, Lodi’s director of utilization.

The BOOST mentor, key to this customization, provided Lodi with the reassurance that comes with working directly with someone who has faced similar challenges—not just theoretically, but also on the floor—and was willing to work with Lodi to develop practical solutions. The mentor provided reassurance, support, and perspective as Lodi walked through the BOOST implementation process.

Keys to Success

Team-focused care, clear communication, and administrative support were keys to successful BOOST implementation at Lodi, says Cronin.

The house staff was overwhelmed, and adding a quality-improvement (QI) project to implement and manage might have seemed like an impossible challenge. By developing multidisciplinary teams, however, Lodi was able to distribute the tasks of implementation and began to recognize the value and benefit of Project BOOST, which already had strong support from hospital executives.

A 14-member multidisciplinary team was formed to oversee the Project BOOST implementation. The team then was divided into sub-groups to work on the main components of Project BOOST: Passport to Care Form, Target Assessment Tool, the Teachback process, and Follow-Up Phone Calls. The sub-groups’ main objectives were to ensure that BOOST effectively changed processes and work practices for a stronger and safer discharge process.

To support these teams and foster communication laterally among healthcare providers and vertically with hospital administration, Lodi established a structured meeting format, delegated task assignments for accountability, and appointed an implementation champion.

Capitalizing on the experience of its BOOST mentor, the Lodi multidisciplinary teams mapped out the process to assess threats to the system and opportunities for improvement, and began moving forward with implementable solutions for sustainable change.

“Evaluating the whole discharge process allowed us to see the gaps and discrepancies in the discharge process,” Cronin says. “Each discipline had their own set of procedures and materials, which proved lacking and inconsistent for our patients. It was an essential and eye-opening experience for Lodi to make change.”

One of the biggest revelations was learning how broken the discharge process was for the nurses. When Lodi looked at its current process of using case managers to handle high-risk patients and leaving the remaining patient discharges to the nurses, they found that the process was not strong enough to support patient load.

Knowledge Is Power

Cronin says Lodi has standardized its patient educational materials and started the patient education process as soon as patients are admitted. This step optimizes a patient’s understanding of diagnoses and care instructions when the time comes for discharge.

Through the Project BOOST assessment, Lodi ascertained that many of its patients were being discharged to skilled-nursing facilities, which heightens the complexity of post-care and introduces the potential for increased risks. Lodi is now working to better communicate with the skilled-nursing facilities using its Project BOOST training to streamline the discharge process.

The implementation of the Teach Back communication strategy has been critical in increasing patient knowledge and adherence to care instructions, official say. Based on the success of Project BOOST implementation, Teach Back has been incorporated into mandatory nurse training throughout the hospital.

Improved Care

More than 80 patients were discharged through the BOOST process in the first 90 days of implementation. Lodi is already experiencing the benefits of Project BOOST organizationally and

expects to see the financial impacts soon through a lower 30-day readmission rate.

“Lodi has experienced a shift in patient safety culture with improved communication through a team approach to care,” Cronin says. “Lodi expects high success through Project BOOST with the goal of implementing Project BOOST across all disease states and every discipline using Teachback.

“Project BOOST has been the ideal program to align with our strategic organizational goals to improve transitions of care and re-create the patient safety culture to make systemwide sustainable change,” she says.

For more information about Project BOOST, visit www.hospitalmedicine.org/boost.

Jacqui Petock, marketing project manager

Soon, hospitals with unnecessary 30-day readmissions will be penalized. Some proactive hospitals are already tackling care transitions to reduce readmissions, improve patient care, and reduce costs.

Lodi Memorial Hospital in Northern California is one such hospital. The 214-bed facility has made preventing readmissions a key strategic goal for improving care, especially for vulnerable, frail elderly patients.

Lodi executives say readmissions are a challenge at the hospital because many different specialties and house staff are involved in the discharge process.

With many options from which to choose, Lodi selected SHM’s Project BOOST (Better Outcomes for Older Adults through Safe Transitions). Project BOOST, unlike other programs, focuses on first identifying system deficiencies, then building cohesive multidisciplinary teams.

“If you layer a clinical intervention onto a broken system,” says BOOST mentor Stephanie Rennke, MD, “success isn’t likely. Project BOOST helps the team map current processes, find deficiencies, assess resources, and redefine a culture of safety.

“BOOST starts with an assessment of how the system functions, and identifies its strengths and weaknesses so you can focus your efforts on critical areas for improvement and tailor the BOOST intervention to fit the unique dynamics of an institution,” she says.

Search for a Solution

No two institutions are exactly the same, especially when analyzing patient-safety culture. Project BOOST is customized to the needs of each BOOST site, which has proven useful to Lodi, as it found it had different needs than other hospitals.

“We chose Project BOOST because it seemed workable and implementable, while offering a less expensive and less complicated solution than competitors’ products,” says Valerie Cronin, Lodi’s director of utilization.

The BOOST mentor, key to this customization, provided Lodi with the reassurance that comes with working directly with someone who has faced similar challenges—not just theoretically, but also on the floor—and was willing to work with Lodi to develop practical solutions. The mentor provided reassurance, support, and perspective as Lodi walked through the BOOST implementation process.

Keys to Success

Team-focused care, clear communication, and administrative support were keys to successful BOOST implementation at Lodi, says Cronin.

The house staff was overwhelmed, and adding a quality-improvement (QI) project to implement and manage might have seemed like an impossible challenge. By developing multidisciplinary teams, however, Lodi was able to distribute the tasks of implementation and began to recognize the value and benefit of Project BOOST, which already had strong support from hospital executives.

A 14-member multidisciplinary team was formed to oversee the Project BOOST implementation. The team then was divided into sub-groups to work on the main components of Project BOOST: Passport to Care Form, Target Assessment Tool, the Teachback process, and Follow-Up Phone Calls. The sub-groups’ main objectives were to ensure that BOOST effectively changed processes and work practices for a stronger and safer discharge process.

To support these teams and foster communication laterally among healthcare providers and vertically with hospital administration, Lodi established a structured meeting format, delegated task assignments for accountability, and appointed an implementation champion.

Capitalizing on the experience of its BOOST mentor, the Lodi multidisciplinary teams mapped out the process to assess threats to the system and opportunities for improvement, and began moving forward with implementable solutions for sustainable change.

“Evaluating the whole discharge process allowed us to see the gaps and discrepancies in the discharge process,” Cronin says. “Each discipline had their own set of procedures and materials, which proved lacking and inconsistent for our patients. It was an essential and eye-opening experience for Lodi to make change.”

One of the biggest revelations was learning how broken the discharge process was for the nurses. When Lodi looked at its current process of using case managers to handle high-risk patients and leaving the remaining patient discharges to the nurses, they found that the process was not strong enough to support patient load.

Knowledge Is Power

Cronin says Lodi has standardized its patient educational materials and started the patient education process as soon as patients are admitted. This step optimizes a patient’s understanding of diagnoses and care instructions when the time comes for discharge.

Through the Project BOOST assessment, Lodi ascertained that many of its patients were being discharged to skilled-nursing facilities, which heightens the complexity of post-care and introduces the potential for increased risks. Lodi is now working to better communicate with the skilled-nursing facilities using its Project BOOST training to streamline the discharge process.

The implementation of the Teach Back communication strategy has been critical in increasing patient knowledge and adherence to care instructions, official say. Based on the success of Project BOOST implementation, Teach Back has been incorporated into mandatory nurse training throughout the hospital.

Improved Care

More than 80 patients were discharged through the BOOST process in the first 90 days of implementation. Lodi is already experiencing the benefits of Project BOOST organizationally and

expects to see the financial impacts soon through a lower 30-day readmission rate.

“Lodi has experienced a shift in patient safety culture with improved communication through a team approach to care,” Cronin says. “Lodi expects high success through Project BOOST with the goal of implementing Project BOOST across all disease states and every discipline using Teachback.

“Project BOOST has been the ideal program to align with our strategic organizational goals to improve transitions of care and re-create the patient safety culture to make systemwide sustainable change,” she says.

For more information about Project BOOST, visit www.hospitalmedicine.org/boost.

Jacqui Petock, marketing project manager

As America weighs the value of healthcare and health reform, many moving parts of the Patient Protection and Affordable Care Act (ACA) will continue to reshape the healthcare system. And hospitalists continue to be part of the reshaping.

The full title of the bill should serve as a reminder to hospitalists of the dual purposes of the ACA: patient protection and cost control. The bulk of popular consciousness about the ACA focused around the favored positions (no pre-existing conditions and children remaining on parents’ plans until age 26) or around points of contention (the individual mandate and the Medicaid expansion).

The lesser-mentioned provisions centering around cost, quality, and payment reform have the potential to substantively reframe the conversation, particularly from the provider perspective. Hospitalists have a unique expertise that positions them to be critical in shaping these programs and regulations.

Two initiatives aim at moving the traditional fee-for-service models of payment for health services toward pay-for-performance. Both the hospital value-based purchasing and physician value-based payment modifier use quality measures to link the performance of care with payments. Hospitals and associated groups are in the process of working with the Centers for Medicare & Medicaid Services (CMS) as the value-based purchasing program moves forward.

The physician value-based modifier will combine quality measures and reports, similar to the 2010 Quality and Resource Use Reports piloted this year in Nebraska, Iowa, Kansas, and Missouri, with a to-be-determined payment adjustment. These reports represent a major step toward Medicare providing large-scale feedback to providers on healthcare quality and costs. When the modifier is enforced, a percentage of payments will reflect quality scores, making the feedback from hospitalists important in creating meaningful and useful measures.

Concurrently, the ACA spurred the development of additional quality-improvement (QI) programs. Quality efforts ranging from reducing hospital-acquired infections, stemming preventable complications, meaningful use of electronic health records (EHRs), and reducing readmissions round out a complement of programs that strive to create safer, more cost-effective care for patients. For example, the Partnership for Patients is a collaborative program between providers, patient groups, and the government that catalyzes care improvement in hospitals. Hospitalists have been QI leaders at the front lines in their hospitals for years, affording an informed perspective on policy development.

The ACA is a constellation of programs and initiatives that seek to test new systems for care delivery and payment reform while providing access and quality protections for patients. Even without the ACA, reforms in quality and payment models are necessary and will occur.

Through SHM, hospitalists actively are sharing their experiences with policymakers in an effort to create responsive and reflective programs. It is precisely this expertise with hospitalized patients that affords hospitalists a ground- and systems-level perspective on healthcare. With so many reforms taking place, it is vital that hospitalists remain connected and informed about these issues and engage the opportunities for policy leadership and feedback.

To get involved with SHM’s advocacy efforts, visit www.hospitalmedicine.org/advocacy.

As America weighs the value of healthcare and health reform, many moving parts of the Patient Protection and Affordable Care Act (ACA) will continue to reshape the healthcare system. And hospitalists continue to be part of the reshaping.

The full title of the bill should serve as a reminder to hospitalists of the dual purposes of the ACA: patient protection and cost control. The bulk of popular consciousness about the ACA focused around the favored positions (no pre-existing conditions and children remaining on parents’ plans until age 26) or around points of contention (the individual mandate and the Medicaid expansion).

The lesser-mentioned provisions centering around cost, quality, and payment reform have the potential to substantively reframe the conversation, particularly from the provider perspective. Hospitalists have a unique expertise that positions them to be critical in shaping these programs and regulations.

Two initiatives aim at moving the traditional fee-for-service models of payment for health services toward pay-for-performance. Both the hospital value-based purchasing and physician value-based payment modifier use quality measures to link the performance of care with payments. Hospitals and associated groups are in the process of working with the Centers for Medicare & Medicaid Services (CMS) as the value-based purchasing program moves forward.

The physician value-based modifier will combine quality measures and reports, similar to the 2010 Quality and Resource Use Reports piloted this year in Nebraska, Iowa, Kansas, and Missouri, with a to-be-determined payment adjustment. These reports represent a major step toward Medicare providing large-scale feedback to providers on healthcare quality and costs. When the modifier is enforced, a percentage of payments will reflect quality scores, making the feedback from hospitalists important in creating meaningful and useful measures.

Concurrently, the ACA spurred the development of additional quality-improvement (QI) programs. Quality efforts ranging from reducing hospital-acquired infections, stemming preventable complications, meaningful use of electronic health records (EHRs), and reducing readmissions round out a complement of programs that strive to create safer, more cost-effective care for patients. For example, the Partnership for Patients is a collaborative program between providers, patient groups, and the government that catalyzes care improvement in hospitals. Hospitalists have been QI leaders at the front lines in their hospitals for years, affording an informed perspective on policy development.

The ACA is a constellation of programs and initiatives that seek to test new systems for care delivery and payment reform while providing access and quality protections for patients. Even without the ACA, reforms in quality and payment models are necessary and will occur.

Through SHM, hospitalists actively are sharing their experiences with policymakers in an effort to create responsive and reflective programs. It is precisely this expertise with hospitalized patients that affords hospitalists a ground- and systems-level perspective on healthcare. With so many reforms taking place, it is vital that hospitalists remain connected and informed about these issues and engage the opportunities for policy leadership and feedback.

To get involved with SHM’s advocacy efforts, visit www.hospitalmedicine.org/advocacy.

As America weighs the value of healthcare and health reform, many moving parts of the Patient Protection and Affordable Care Act (ACA) will continue to reshape the healthcare system. And hospitalists continue to be part of the reshaping.

The full title of the bill should serve as a reminder to hospitalists of the dual purposes of the ACA: patient protection and cost control. The bulk of popular consciousness about the ACA focused around the favored positions (no pre-existing conditions and children remaining on parents’ plans until age 26) or around points of contention (the individual mandate and the Medicaid expansion).

The lesser-mentioned provisions centering around cost, quality, and payment reform have the potential to substantively reframe the conversation, particularly from the provider perspective. Hospitalists have a unique expertise that positions them to be critical in shaping these programs and regulations.

Two initiatives aim at moving the traditional fee-for-service models of payment for health services toward pay-for-performance. Both the hospital value-based purchasing and physician value-based payment modifier use quality measures to link the performance of care with payments. Hospitals and associated groups are in the process of working with the Centers for Medicare & Medicaid Services (CMS) as the value-based purchasing program moves forward.

The physician value-based modifier will combine quality measures and reports, similar to the 2010 Quality and Resource Use Reports piloted this year in Nebraska, Iowa, Kansas, and Missouri, with a to-be-determined payment adjustment. These reports represent a major step toward Medicare providing large-scale feedback to providers on healthcare quality and costs. When the modifier is enforced, a percentage of payments will reflect quality scores, making the feedback from hospitalists important in creating meaningful and useful measures.

Concurrently, the ACA spurred the development of additional quality-improvement (QI) programs. Quality efforts ranging from reducing hospital-acquired infections, stemming preventable complications, meaningful use of electronic health records (EHRs), and reducing readmissions round out a complement of programs that strive to create safer, more cost-effective care for patients. For example, the Partnership for Patients is a collaborative program between providers, patient groups, and the government that catalyzes care improvement in hospitals. Hospitalists have been QI leaders at the front lines in their hospitals for years, affording an informed perspective on policy development.

The ACA is a constellation of programs and initiatives that seek to test new systems for care delivery and payment reform while providing access and quality protections for patients. Even without the ACA, reforms in quality and payment models are necessary and will occur.

Through SHM, hospitalists actively are sharing their experiences with policymakers in an effort to create responsive and reflective programs. It is precisely this expertise with hospitalized patients that affords hospitalists a ground- and systems-level perspective on healthcare. With so many reforms taking place, it is vital that hospitalists remain connected and informed about these issues and engage the opportunities for policy leadership and feedback.

To get involved with SHM’s advocacy efforts, visit www.hospitalmedicine.org/advocacy.

click for large version

One of the most eagerly awaited results from an SHM compensation and productivity survey is the amount of financial support provided by hospitals or other organizations to HM groups (note that we’ve carefully avoided the dreaded “S” word). SHM has been asking this question since at least 2003, when the median annual support per hospitalist FTE was reported at $60,000. By 2007, that number had grown by 62% to $97,375. But the 2007 findings that might have caused the greatest uproar were that fully 37% of responding HM group leaders did not know their program’s annual expenses, and 35% did not know their program’s revenues.

Fast-forward to today. The median annual financial support per FTE reported in the 2011 SHM/MGMA State of Hospital Medicine report is $136,403, a whopping 39% increase over the 2010 median of $98,253.

What caused this big increase in HM’s financial support requirement? Did costs go up that dramatically in just one year? Well, the median compensation for adult medicine hospitalists (the vast majority of hospitalists in the data set) went up by a mere 2.6% during the same period. The amount of support staffing reported by HM groups did not change appreciably. And since labor accounts for the vast majority of virtually every HM practice’s costs, it’s unlikely that the increase in financial support per FTE was caused by a dramatic increase in program costs.

Perhaps program revenues went down significantly, then. It’s true that the median professional fee collections per FTE for adult hospitalists declined between the 2010 and 2011 reports, but only by about 3.3%—probably a result of gearing up for healthcare reform, increases in indigent care and bad debt due to the weak economy, and similar revenue pressures. So it doesn’t appear that declining revenues can explain the big jump in financial support per FTE, either.

I’d like to think that one of the reasons financial support per FTE has increased so much is that we are getting better at how we ask the question. Early on, we simply asked, “If your group receives OTHER INCOME (besides collections for direct patient care), indicate source and amount of payments.” In recent years, the question has been fine-tuned to ask about “financial support over and above professional fee revenues from one or more hospitals or integrated delivery systems (or other sources),” and the survey guide has given even more detailed instructions. But in truth, the question was worded almost identically in 2010 and 2011.

All of this leads me to the unavoidable speculation that HM groups (and/or the hospitals they work for) probably are becoming more sophisticated about how they account for the costs of their hospitalist programs, and that HM group leaders are becoming more knowledgeable about their own programs’ costs and revenues (and, yes, the amount of financial support they receive). We haven’t asked respondents recently whether they know their practice’s costs and revenues, but maybe next time we should. I’ll bet the results will differ a lot from 2007.

—Leslie Flores, MHA, SHM senior advisor

click for large version

One of the most eagerly awaited results from an SHM compensation and productivity survey is the amount of financial support provided by hospitals or other organizations to HM groups (note that we’ve carefully avoided the dreaded “S” word). SHM has been asking this question since at least 2003, when the median annual support per hospitalist FTE was reported at $60,000. By 2007, that number had grown by 62% to $97,375. But the 2007 findings that might have caused the greatest uproar were that fully 37% of responding HM group leaders did not know their program’s annual expenses, and 35% did not know their program’s revenues.

Fast-forward to today. The median annual financial support per FTE reported in the 2011 SHM/MGMA State of Hospital Medicine report is $136,403, a whopping 39% increase over the 2010 median of $98,253.

What caused this big increase in HM’s financial support requirement? Did costs go up that dramatically in just one year? Well, the median compensation for adult medicine hospitalists (the vast majority of hospitalists in the data set) went up by a mere 2.6% during the same period. The amount of support staffing reported by HM groups did not change appreciably. And since labor accounts for the vast majority of virtually every HM practice’s costs, it’s unlikely that the increase in financial support per FTE was caused by a dramatic increase in program costs.

Perhaps program revenues went down significantly, then. It’s true that the median professional fee collections per FTE for adult hospitalists declined between the 2010 and 2011 reports, but only by about 3.3%—probably a result of gearing up for healthcare reform, increases in indigent care and bad debt due to the weak economy, and similar revenue pressures. So it doesn’t appear that declining revenues can explain the big jump in financial support per FTE, either.

I’d like to think that one of the reasons financial support per FTE has increased so much is that we are getting better at how we ask the question. Early on, we simply asked, “If your group receives OTHER INCOME (besides collections for direct patient care), indicate source and amount of payments.” In recent years, the question has been fine-tuned to ask about “financial support over and above professional fee revenues from one or more hospitals or integrated delivery systems (or other sources),” and the survey guide has given even more detailed instructions. But in truth, the question was worded almost identically in 2010 and 2011.

All of this leads me to the unavoidable speculation that HM groups (and/or the hospitals they work for) probably are becoming more sophisticated about how they account for the costs of their hospitalist programs, and that HM group leaders are becoming more knowledgeable about their own programs’ costs and revenues (and, yes, the amount of financial support they receive). We haven’t asked respondents recently whether they know their practice’s costs and revenues, but maybe next time we should. I’ll bet the results will differ a lot from 2007.

—Leslie Flores, MHA, SHM senior advisor

click for large version

One of the most eagerly awaited results from an SHM compensation and productivity survey is the amount of financial support provided by hospitals or other organizations to HM groups (note that we’ve carefully avoided the dreaded “S” word). SHM has been asking this question since at least 2003, when the median annual support per hospitalist FTE was reported at $60,000. By 2007, that number had grown by 62% to $97,375. But the 2007 findings that might have caused the greatest uproar were that fully 37% of responding HM group leaders did not know their program’s annual expenses, and 35% did not know their program’s revenues.

Fast-forward to today. The median annual financial support per FTE reported in the 2011 SHM/MGMA State of Hospital Medicine report is $136,403, a whopping 39% increase over the 2010 median of $98,253.

What caused this big increase in HM’s financial support requirement? Did costs go up that dramatically in just one year? Well, the median compensation for adult medicine hospitalists (the vast majority of hospitalists in the data set) went up by a mere 2.6% during the same period. The amount of support staffing reported by HM groups did not change appreciably. And since labor accounts for the vast majority of virtually every HM practice’s costs, it’s unlikely that the increase in financial support per FTE was caused by a dramatic increase in program costs.

Perhaps program revenues went down significantly, then. It’s true that the median professional fee collections per FTE for adult hospitalists declined between the 2010 and 2011 reports, but only by about 3.3%—probably a result of gearing up for healthcare reform, increases in indigent care and bad debt due to the weak economy, and similar revenue pressures. So it doesn’t appear that declining revenues can explain the big jump in financial support per FTE, either.

I’d like to think that one of the reasons financial support per FTE has increased so much is that we are getting better at how we ask the question. Early on, we simply asked, “If your group receives OTHER INCOME (besides collections for direct patient care), indicate source and amount of payments.” In recent years, the question has been fine-tuned to ask about “financial support over and above professional fee revenues from one or more hospitals or integrated delivery systems (or other sources),” and the survey guide has given even more detailed instructions. But in truth, the question was worded almost identically in 2010 and 2011.

All of this leads me to the unavoidable speculation that HM groups (and/or the hospitals they work for) probably are becoming more sophisticated about how they account for the costs of their hospitalist programs, and that HM group leaders are becoming more knowledgeable about their own programs’ costs and revenues (and, yes, the amount of financial support they receive). We haven’t asked respondents recently whether they know their practice’s costs and revenues, but maybe next time we should. I’ll bet the results will differ a lot from 2007.

—Leslie Flores, MHA, SHM senior advisor

Kenneth Donovan, MD, FHM

Sarada Sripada, MD, SFHM

Donald Quinn, MD, MBA, SFHM

Kenneth Donovan, MD, FHM and Sarada Sripada, MD, SFHM have been named the 2011 Hospitalists of the Year, and Donald Quinn, MD, MBA, SFHM was named the 2011 Post Acute Hospitalist of the Year by IPC: The Hospitalist Company Inc. Selected by IPC’s senior management team, the award includes an honorarium to each of the recipients. Additionally, IPC will make a $2,500 donation to the charity of their choice for each of the recipients.

Paul Fu Jr., MD, MPH, FAAP, recently was named chief medical informatics officer (CMIO) at Harbor-UCLA Medical Center in Los Angeles. He has served as chief of the division of pediatric hospital medicine since July 2011.

Anna-Gene O’Neal

Former Cogent HMG senior vice president in charge of quality initiatives Anna-Gene O’Neal has taken a CEO position with Alive Hospice, a Nashville, Tenn.-based end-of-life care and grief support company. As CEO, O’Neal will oversee hospice and palliative care, as well as grief-support programs in a service area of 12 Middle Tennessee counties.

Kasra Djalayer, MD, a hospitalist based in Franklin, N.H., has received the 2011 Patients’ Choice Award from Patients’ Choice, an organization that collects and analyzes rankings from various patient-feedback websites, such as Vitals.com. Dr. Djalayer was honored based on a top ranking among physicians across the nation.

Glenn Rosenbluth, MD

Hospitalist Glenn Rosenbluth, MD, has been appointed director of quality and safety programs for graduate medical education (GME) at University of California at San Francisco Medical Center. In his new role, Dr. Rosenbluth will lead multiple GME-related programs while still continuing his leadership as associated director of the pediatrics residency training program.

Business Moves

Cogent HMG has established a new critical-care program at Saint Francis Hospital in Brentwood, Tenn., which marks the hospitalist management company’s 11th full-service intensivist program. The new program will be operated by The Intensivist Group, recently acquired by Cogent HMG, and will include the development and implementation of literature-based ICU guidelines, a staff intensivist in the hospital seven days a week, and intensivist consultation and comanagement for all ICU patients.

IPC: The Hospitalist Company Inc. has acquired the facility-based practice of Asana Integrated Medical Group, a professional medical corporation that serves Southern California and Phoenix. Headquartered in Agoura Hills, Calif., the acquisition will add approximately 65,000 patient encounters annually to IPC.

IPC: The Hospitalist Company Inc. has entered into agreements to provide hospitalist services to four Methodist Healthcare System hospitals in San Antonio. The agreements are with Methodist Stone Oak Hospital, Methodist Specialty and Transplant Hospital, Northeast Methodist Hospital, and Metropolitan Methodist Hospital.

Apollo Medical Holdings Inc. has appointed Gary Augusta to its board of directors. Augusta brings more than 20 years of experience as an executive to the job.

University of Pittsburgh Medical Center has extended its hospitalist program to three additional Pennsylvania campuses, including the McKeesport, Greenville and Farrell hospitals.

Colquitt Regional Medical Center in Moultrie, Ga., has started a hospitalist program. The new team will be led by Marshall Tanner, MD, and will also include Alan Brown, MD, MBA, Frank Wilson, MD, and Ndubuisi Apu Ndukwe, MD.

—Alexandra Schultz

Kenneth Donovan, MD, FHM

Sarada Sripada, MD, SFHM

Donald Quinn, MD, MBA, SFHM

Kenneth Donovan, MD, FHM and Sarada Sripada, MD, SFHM have been named the 2011 Hospitalists of the Year, and Donald Quinn, MD, MBA, SFHM was named the 2011 Post Acute Hospitalist of the Year by IPC: The Hospitalist Company Inc. Selected by IPC’s senior management team, the award includes an honorarium to each of the recipients. Additionally, IPC will make a $2,500 donation to the charity of their choice for each of the recipients.

Paul Fu Jr., MD, MPH, FAAP, recently was named chief medical informatics officer (CMIO) at Harbor-UCLA Medical Center in Los Angeles. He has served as chief of the division of pediatric hospital medicine since July 2011.

Anna-Gene O’Neal

Former Cogent HMG senior vice president in charge of quality initiatives Anna-Gene O’Neal has taken a CEO position with Alive Hospice, a Nashville, Tenn.-based end-of-life care and grief support company. As CEO, O’Neal will oversee hospice and palliative care, as well as grief-support programs in a service area of 12 Middle Tennessee counties.

Kasra Djalayer, MD, a hospitalist based in Franklin, N.H., has received the 2011 Patients’ Choice Award from Patients’ Choice, an organization that collects and analyzes rankings from various patient-feedback websites, such as Vitals.com. Dr. Djalayer was honored based on a top ranking among physicians across the nation.

Glenn Rosenbluth, MD

Hospitalist Glenn Rosenbluth, MD, has been appointed director of quality and safety programs for graduate medical education (GME) at University of California at San Francisco Medical Center. In his new role, Dr. Rosenbluth will lead multiple GME-related programs while still continuing his leadership as associated director of the pediatrics residency training program.

Business Moves

Cogent HMG has established a new critical-care program at Saint Francis Hospital in Brentwood, Tenn., which marks the hospitalist management company’s 11th full-service intensivist program. The new program will be operated by The Intensivist Group, recently acquired by Cogent HMG, and will include the development and implementation of literature-based ICU guidelines, a staff intensivist in the hospital seven days a week, and intensivist consultation and comanagement for all ICU patients.

IPC: The Hospitalist Company Inc. has acquired the facility-based practice of Asana Integrated Medical Group, a professional medical corporation that serves Southern California and Phoenix. Headquartered in Agoura Hills, Calif., the acquisition will add approximately 65,000 patient encounters annually to IPC.

IPC: The Hospitalist Company Inc. has entered into agreements to provide hospitalist services to four Methodist Healthcare System hospitals in San Antonio. The agreements are with Methodist Stone Oak Hospital, Methodist Specialty and Transplant Hospital, Northeast Methodist Hospital, and Metropolitan Methodist Hospital.

Apollo Medical Holdings Inc. has appointed Gary Augusta to its board of directors. Augusta brings more than 20 years of experience as an executive to the job.

University of Pittsburgh Medical Center has extended its hospitalist program to three additional Pennsylvania campuses, including the McKeesport, Greenville and Farrell hospitals.

Colquitt Regional Medical Center in Moultrie, Ga., has started a hospitalist program. The new team will be led by Marshall Tanner, MD, and will also include Alan Brown, MD, MBA, Frank Wilson, MD, and Ndubuisi Apu Ndukwe, MD.

—Alexandra Schultz

Kenneth Donovan, MD, FHM

Sarada Sripada, MD, SFHM

Donald Quinn, MD, MBA, SFHM

Kenneth Donovan, MD, FHM and Sarada Sripada, MD, SFHM have been named the 2011 Hospitalists of the Year, and Donald Quinn, MD, MBA, SFHM was named the 2011 Post Acute Hospitalist of the Year by IPC: The Hospitalist Company Inc. Selected by IPC’s senior management team, the award includes an honorarium to each of the recipients. Additionally, IPC will make a $2,500 donation to the charity of their choice for each of the recipients.

Paul Fu Jr., MD, MPH, FAAP, recently was named chief medical informatics officer (CMIO) at Harbor-UCLA Medical Center in Los Angeles. He has served as chief of the division of pediatric hospital medicine since July 2011.

Anna-Gene O’Neal

Former Cogent HMG senior vice president in charge of quality initiatives Anna-Gene O’Neal has taken a CEO position with Alive Hospice, a Nashville, Tenn.-based end-of-life care and grief support company. As CEO, O’Neal will oversee hospice and palliative care, as well as grief-support programs in a service area of 12 Middle Tennessee counties.

Kasra Djalayer, MD, a hospitalist based in Franklin, N.H., has received the 2011 Patients’ Choice Award from Patients’ Choice, an organization that collects and analyzes rankings from various patient-feedback websites, such as Vitals.com. Dr. Djalayer was honored based on a top ranking among physicians across the nation.

Glenn Rosenbluth, MD

Hospitalist Glenn Rosenbluth, MD, has been appointed director of quality and safety programs for graduate medical education (GME) at University of California at San Francisco Medical Center. In his new role, Dr. Rosenbluth will lead multiple GME-related programs while still continuing his leadership as associated director of the pediatrics residency training program.

Business Moves

Cogent HMG has established a new critical-care program at Saint Francis Hospital in Brentwood, Tenn., which marks the hospitalist management company’s 11th full-service intensivist program. The new program will be operated by The Intensivist Group, recently acquired by Cogent HMG, and will include the development and implementation of literature-based ICU guidelines, a staff intensivist in the hospital seven days a week, and intensivist consultation and comanagement for all ICU patients.

IPC: The Hospitalist Company Inc. has acquired the facility-based practice of Asana Integrated Medical Group, a professional medical corporation that serves Southern California and Phoenix. Headquartered in Agoura Hills, Calif., the acquisition will add approximately 65,000 patient encounters annually to IPC.

IPC: The Hospitalist Company Inc. has entered into agreements to provide hospitalist services to four Methodist Healthcare System hospitals in San Antonio. The agreements are with Methodist Stone Oak Hospital, Methodist Specialty and Transplant Hospital, Northeast Methodist Hospital, and Metropolitan Methodist Hospital.

Apollo Medical Holdings Inc. has appointed Gary Augusta to its board of directors. Augusta brings more than 20 years of experience as an executive to the job.

University of Pittsburgh Medical Center has extended its hospitalist program to three additional Pennsylvania campuses, including the McKeesport, Greenville and Farrell hospitals.

Colquitt Regional Medical Center in Moultrie, Ga., has started a hospitalist program. The new team will be led by Marshall Tanner, MD, and will also include Alan Brown, MD, MBA, Frank Wilson, MD, and Ndubuisi Apu Ndukwe, MD.

—Alexandra Schultz

Physician assistants and other non-physician providers (NPPs) can stay up to date on the fastest-growing specialty in medicine through the Adult Hospital Medicine Boot Camp, Oct. 18-21 in New Orleans, with optional half-day pre-courses on Oct. 17.

Co-hosted by SHM and the American Academy of Physician Assistants, this annual boot-camp-style educational event will immerse clinicians who are practicing in HM or who are interested in an intensive internal-medicine review of commonly encountered diagnoses and diseases of the hospitalized adult patient.

In addition to educating those already practicing in the HM setting, the boot camp provides an ideal introduction for clinicians who plan to practice in HM soon.

The boot camp has been approved for a maximum of 29.5 AAPA Category I CME credits.

For more information, visit the link on the SHM “Events” page at www.hospitalmedicine.org/events.

Physician assistants and other non-physician providers (NPPs) can stay up to date on the fastest-growing specialty in medicine through the Adult Hospital Medicine Boot Camp, Oct. 18-21 in New Orleans, with optional half-day pre-courses on Oct. 17.

Co-hosted by SHM and the American Academy of Physician Assistants, this annual boot-camp-style educational event will immerse clinicians who are practicing in HM or who are interested in an intensive internal-medicine review of commonly encountered diagnoses and diseases of the hospitalized adult patient.

In addition to educating those already practicing in the HM setting, the boot camp provides an ideal introduction for clinicians who plan to practice in HM soon.

The boot camp has been approved for a maximum of 29.5 AAPA Category I CME credits.

For more information, visit the link on the SHM “Events” page at www.hospitalmedicine.org/events.

Physician assistants and other non-physician providers (NPPs) can stay up to date on the fastest-growing specialty in medicine through the Adult Hospital Medicine Boot Camp, Oct. 18-21 in New Orleans, with optional half-day pre-courses on Oct. 17.

Co-hosted by SHM and the American Academy of Physician Assistants, this annual boot-camp-style educational event will immerse clinicians who are practicing in HM or who are interested in an intensive internal-medicine review of commonly encountered diagnoses and diseases of the hospitalized adult patient.

In addition to educating those already practicing in the HM setting, the boot camp provides an ideal introduction for clinicians who plan to practice in HM soon.

The boot camp has been approved for a maximum of 29.5 AAPA Category I CME credits.

For more information, visit the link on the SHM “Events” page at www.hospitalmedicine.org/events.

A key engine of healthcare reform is poised to accelerate, with the potential to improve clinical decision-making and care quality, curtail inappropriate utilization of ineffective treatments, and lower costs. Comparative-effectiveness research (CER), until now, has received relatively meager funding and has occupied a relatively low profile among policymakers, clinicians, and the public.

With a $1.1 billion injection from the American Recovery and Reinvestment Act of 2009 (better known as the “stimulus”) and dedicated funding mandated by the Affordable Care Act, a new national center dedicated to CER—the Patient-Centered Outcomes Research Institute (PCORI)—has recently released a draft of its national priorities and is mobilizing a national research agenda for CER.¹

Demonized by critics as a prelude to coverage denials, healthcare rationing, and intrusion upon physicians’ clinical autonomy, CER is reconstituting its reputation as a non-coercive yet powerful tool to reduce uncertainty about which healthcare options work best for which patients, and to encourage adoption of care practices that are truly effective.

“I practice on weekends as a pediatric hospitalist, and it is still far too common to encounter a case for which we don’t have good, evidence-based guidance—such as whether surgery or medical management is best for a neurologically impaired child presenting with aspiration and gastroesophageal reflux disease,” says Patrick Conway, MD, MSc, SFHM, chief medical officer of the Center for Medicare & Medicaid Services (CMS) and director of its Office of Clinical Standards and Quality.

SHM strongly supported the creation of PCORI during the health reform debate, and hospitalists have important opportunities to be part of the nation’s CER agenda, as well as key beneficiaries of its results, according to Dr. Conway.

Efficacy vs. Effectiveness

While the traditional “gold standard” of clinical research is the randomized controlled trial, its focus on efficacy typically involves comparing some treatment to no treatment at all (a placebo), and requires highly controlled, ideal conditions, often with narrow patient-inclusion criteria. All of those requirements sacrifice generalizability to patients whom physicians encounter daily in clinical settings who often have multiple chronic conditions and comorbidities and might require multiple therapies, Dr. Conway says.

CER studies larger, more representative patient populations treated in real-world clinical circumstances, explains SHM Research Committee chairman David Meltzer, MD, PhD, FHM, who is a member of the PCORI’s Methodology Committee. “One of the big initial tasks of the PCORI is to produce a translation table of what research study designs—randomized controlled trials, head-to-head, observational studies, and others—can best answer which kinds of questions,” he says.

The PCORI’s ultimate goal, says Dr. Conway, is to enable better-informed decision-making between physicians and their patients by allowing for the “right treatments to the right patients at the right time.”

The Case for CER

The unrelenting reality of an unsustainable healthcare cost spiral that threatens to bankrupt the national economy might be changing the conversation about CER (see “PCORI: Built to Reject the Myth of Coercive Rationing,” at left). Add to that increasing gravitation by government and private insurers toward reimbursement models that reward providers for better outcomes, more efficient care, and evidence-based practices (and penalizes the opposite), and CER makes a lot of sense.

An estimated $158 billion to $226 billion in wasteful healthcare spending last year came from “subjecting patients to care that, according to sound science and the patients’ own preferences, cannot possibly help them—care rooted in outmoded habits, supply-driven behaviors, and ignoring science,” wrote former CMS administrator Donald Berwick, MD, MPP, and RAND researcher Andrew Hackbarth, MPhil.²

It appears as though physicians are becoming more receptive to their role as responsible stewards of finite healthcare resources, and are willing to abandon some common clinical practices that add little value to patient care when given credible evidence. In the recent Choosing Wisely campaign (www.ChoosingWisely.org), for example, nine medical specialty societies worked with the ABIM Foundation and Consumer Reports to publicize 45 tests and procedures—five from each society—that are commonly used in their field, but which evidence suggests might be unnecessary and inappropriate for many patients.

Physicians who in the past might have resisted traditional evidence-based guidelines as “cookie cutter” algorithms that “don’t apply to my particular patient” will find it harder to dismiss CER findings on that basis, Dr. Meltzer notes, because CER is designed at the outset to be relevant to specific subsets of patients in actual clinical settings.

Nevertheless, incentives will be required to drive rapid and widespread adoption of CER findings, Dr. Conway believes.

“Just creating evidence doesn’t create change,” he says. “Cycle time from research finding to implementation matters, and the typical 17 years [time lag from bench to bedside] is not going to cut it. We need to work with clinicians and patients to take new findings and implement them sooner.”

CMS already has selected some evidence-based process and outcome metrics for its value-based purchasing program. “As CER identifies new evidence-based process and outcome metrics, we could incorporate them,” Dr. Conway adds.

Private insurers could use CER findings when making coverage decisions for their health plans. By law, CMS is obligated to provide coverage to Medicare beneficiaries for healthcare services that are “reasonable and necessary,” and cannot exclude coverage based on the cost of services.

“CMS could use CER findings to make coverage determinations based on ineffectiveness, when there is compelling evidence that a service is ‘not reasonable and necessary,’” Dr. Conway states.

HM Opportunity

Dr. Conway says hospitalists are uniquely poised to seek funding for CER that builds upon several critically important topics, such as examining the best discharge planning processes and transition-of-care protocols for certain types of patients. Dr. Meltzer, who is chief of the section of hospital medicine at University of Chicago, says he is seeking funding for a study of alternative transfusion thresholds for older patients with anemia across different levels of patients’ functional status.

“That’s the type of patient-centered study that CER is especially equipped to handle,” Dr. Meltzer says.

CER promises to produce important evidence for clinical questions that hospitalists struggle with day to day, Dr. Conway says. “Hospitalists should take the lead in developing effective ways to disseminate those findings, to teach medical trainees about them, and to spearhead CER-based QI [quality improvement] implementation and tracking efforts at their institutions,” he adds.

Christopher Guadagnino is a freelance medical writer in Philadelphia.

References

1. Patient-Centered Outcome Research Institute. Draft National Priorities for Research and Research Agenda, Version 1. Patient-Centered Outcome Research Institute website. Available at: http://interactive.snm.org/docs/PCORI-Draft-National-Priorities-and-Research-Agenda2.pdf. Accessed April 15, 2012.
2. Berwick DM, Hackbarth AD. Eliminating waste in U.S. health care. Journal of the American Medical Association website. Available at: http://jama.ama-assn.org/content/307/14/1513.full. Accessed April 15, 2012.
3. Selby JV. The researcher-in-chief at the Patient-Centered Outcomes Research Institute. Inverview by Susan Dentzer. Health Aff (Millwood). 2011;30(12):2252-2258.

A key engine of healthcare reform is poised to accelerate, with the potential to improve clinical decision-making and care quality, curtail inappropriate utilization of ineffective treatments, and lower costs. Comparative-effectiveness research (CER), until now, has received relatively meager funding and has occupied a relatively low profile among policymakers, clinicians, and the public.

With a $1.1 billion injection from the American Recovery and Reinvestment Act of 2009 (better known as the “stimulus”) and dedicated funding mandated by the Affordable Care Act, a new national center dedicated to CER—the Patient-Centered Outcomes Research Institute (PCORI)—has recently released a draft of its national priorities and is mobilizing a national research agenda for CER.¹

Demonized by critics as a prelude to coverage denials, healthcare rationing, and intrusion upon physicians’ clinical autonomy, CER is reconstituting its reputation as a non-coercive yet powerful tool to reduce uncertainty about which healthcare options work best for which patients, and to encourage adoption of care practices that are truly effective.

“I practice on weekends as a pediatric hospitalist, and it is still far too common to encounter a case for which we don’t have good, evidence-based guidance—such as whether surgery or medical management is best for a neurologically impaired child presenting with aspiration and gastroesophageal reflux disease,” says Patrick Conway, MD, MSc, SFHM, chief medical officer of the Center for Medicare & Medicaid Services (CMS) and director of its Office of Clinical Standards and Quality.

SHM strongly supported the creation of PCORI during the health reform debate, and hospitalists have important opportunities to be part of the nation’s CER agenda, as well as key beneficiaries of its results, according to Dr. Conway.

Efficacy vs. Effectiveness

While the traditional “gold standard” of clinical research is the randomized controlled trial, its focus on efficacy typically involves comparing some treatment to no treatment at all (a placebo), and requires highly controlled, ideal conditions, often with narrow patient-inclusion criteria. All of those requirements sacrifice generalizability to patients whom physicians encounter daily in clinical settings who often have multiple chronic conditions and comorbidities and might require multiple therapies, Dr. Conway says.

CER studies larger, more representative patient populations treated in real-world clinical circumstances, explains SHM Research Committee chairman David Meltzer, MD, PhD, FHM, who is a member of the PCORI’s Methodology Committee. “One of the big initial tasks of the PCORI is to produce a translation table of what research study designs—randomized controlled trials, head-to-head, observational studies, and others—can best answer which kinds of questions,” he says.

The PCORI’s ultimate goal, says Dr. Conway, is to enable better-informed decision-making between physicians and their patients by allowing for the “right treatments to the right patients at the right time.”

The Case for CER

The unrelenting reality of an unsustainable healthcare cost spiral that threatens to bankrupt the national economy might be changing the conversation about CER (see “PCORI: Built to Reject the Myth of Coercive Rationing,” at left). Add to that increasing gravitation by government and private insurers toward reimbursement models that reward providers for better outcomes, more efficient care, and evidence-based practices (and penalizes the opposite), and CER makes a lot of sense.

An estimated $158 billion to $226 billion in wasteful healthcare spending last year came from “subjecting patients to care that, according to sound science and the patients’ own preferences, cannot possibly help them—care rooted in outmoded habits, supply-driven behaviors, and ignoring science,” wrote former CMS administrator Donald Berwick, MD, MPP, and RAND researcher Andrew Hackbarth, MPhil.²

It appears as though physicians are becoming more receptive to their role as responsible stewards of finite healthcare resources, and are willing to abandon some common clinical practices that add little value to patient care when given credible evidence. In the recent Choosing Wisely campaign (www.ChoosingWisely.org), for example, nine medical specialty societies worked with the ABIM Foundation and Consumer Reports to publicize 45 tests and procedures—five from each society—that are commonly used in their field, but which evidence suggests might be unnecessary and inappropriate for many patients.

Physicians who in the past might have resisted traditional evidence-based guidelines as “cookie cutter” algorithms that “don’t apply to my particular patient” will find it harder to dismiss CER findings on that basis, Dr. Meltzer notes, because CER is designed at the outset to be relevant to specific subsets of patients in actual clinical settings.

Nevertheless, incentives will be required to drive rapid and widespread adoption of CER findings, Dr. Conway believes.

“Just creating evidence doesn’t create change,” he says. “Cycle time from research finding to implementation matters, and the typical 17 years [time lag from bench to bedside] is not going to cut it. We need to work with clinicians and patients to take new findings and implement them sooner.”

CMS already has selected some evidence-based process and outcome metrics for its value-based purchasing program. “As CER identifies new evidence-based process and outcome metrics, we could incorporate them,” Dr. Conway adds.

Private insurers could use CER findings when making coverage decisions for their health plans. By law, CMS is obligated to provide coverage to Medicare beneficiaries for healthcare services that are “reasonable and necessary,” and cannot exclude coverage based on the cost of services.

“CMS could use CER findings to make coverage determinations based on ineffectiveness, when there is compelling evidence that a service is ‘not reasonable and necessary,’” Dr. Conway states.

HM Opportunity

Dr. Conway says hospitalists are uniquely poised to seek funding for CER that builds upon several critically important topics, such as examining the best discharge planning processes and transition-of-care protocols for certain types of patients. Dr. Meltzer, who is chief of the section of hospital medicine at University of Chicago, says he is seeking funding for a study of alternative transfusion thresholds for older patients with anemia across different levels of patients’ functional status.

“That’s the type of patient-centered study that CER is especially equipped to handle,” Dr. Meltzer says.

CER promises to produce important evidence for clinical questions that hospitalists struggle with day to day, Dr. Conway says. “Hospitalists should take the lead in developing effective ways to disseminate those findings, to teach medical trainees about them, and to spearhead CER-based QI [quality improvement] implementation and tracking efforts at their institutions,” he adds.

Christopher Guadagnino is a freelance medical writer in Philadelphia.

References

1. Patient-Centered Outcome Research Institute. Draft National Priorities for Research and Research Agenda, Version 1. Patient-Centered Outcome Research Institute website. Available at: http://interactive.snm.org/docs/PCORI-Draft-National-Priorities-and-Research-Agenda2.pdf. Accessed April 15, 2012.
2. Berwick DM, Hackbarth AD. Eliminating waste in U.S. health care. Journal of the American Medical Association website. Available at: http://jama.ama-assn.org/content/307/14/1513.full. Accessed April 15, 2012.
3. Selby JV. The researcher-in-chief at the Patient-Centered Outcomes Research Institute. Inverview by Susan Dentzer. Health Aff (Millwood). 2011;30(12):2252-2258.

A key engine of healthcare reform is poised to accelerate, with the potential to improve clinical decision-making and care quality, curtail inappropriate utilization of ineffective treatments, and lower costs. Comparative-effectiveness research (CER), until now, has received relatively meager funding and has occupied a relatively low profile among policymakers, clinicians, and the public.

With a $1.1 billion injection from the American Recovery and Reinvestment Act of 2009 (better known as the “stimulus”) and dedicated funding mandated by the Affordable Care Act, a new national center dedicated to CER—the Patient-Centered Outcomes Research Institute (PCORI)—has recently released a draft of its national priorities and is mobilizing a national research agenda for CER.¹

Demonized by critics as a prelude to coverage denials, healthcare rationing, and intrusion upon physicians’ clinical autonomy, CER is reconstituting its reputation as a non-coercive yet powerful tool to reduce uncertainty about which healthcare options work best for which patients, and to encourage adoption of care practices that are truly effective.

“I practice on weekends as a pediatric hospitalist, and it is still far too common to encounter a case for which we don’t have good, evidence-based guidance—such as whether surgery or medical management is best for a neurologically impaired child presenting with aspiration and gastroesophageal reflux disease,” says Patrick Conway, MD, MSc, SFHM, chief medical officer of the Center for Medicare & Medicaid Services (CMS) and director of its Office of Clinical Standards and Quality.

SHM strongly supported the creation of PCORI during the health reform debate, and hospitalists have important opportunities to be part of the nation’s CER agenda, as well as key beneficiaries of its results, according to Dr. Conway.

Efficacy vs. Effectiveness

While the traditional “gold standard” of clinical research is the randomized controlled trial, its focus on efficacy typically involves comparing some treatment to no treatment at all (a placebo), and requires highly controlled, ideal conditions, often with narrow patient-inclusion criteria. All of those requirements sacrifice generalizability to patients whom physicians encounter daily in clinical settings who often have multiple chronic conditions and comorbidities and might require multiple therapies, Dr. Conway says.

CER studies larger, more representative patient populations treated in real-world clinical circumstances, explains SHM Research Committee chairman David Meltzer, MD, PhD, FHM, who is a member of the PCORI’s Methodology Committee. “One of the big initial tasks of the PCORI is to produce a translation table of what research study designs—randomized controlled trials, head-to-head, observational studies, and others—can best answer which kinds of questions,” he says.

The PCORI’s ultimate goal, says Dr. Conway, is to enable better-informed decision-making between physicians and their patients by allowing for the “right treatments to the right patients at the right time.”

The Case for CER

The unrelenting reality of an unsustainable healthcare cost spiral that threatens to bankrupt the national economy might be changing the conversation about CER (see “PCORI: Built to Reject the Myth of Coercive Rationing,” at left). Add to that increasing gravitation by government and private insurers toward reimbursement models that reward providers for better outcomes, more efficient care, and evidence-based practices (and penalizes the opposite), and CER makes a lot of sense.

An estimated $158 billion to $226 billion in wasteful healthcare spending last year came from “subjecting patients to care that, according to sound science and the patients’ own preferences, cannot possibly help them—care rooted in outmoded habits, supply-driven behaviors, and ignoring science,” wrote former CMS administrator Donald Berwick, MD, MPP, and RAND researcher Andrew Hackbarth, MPhil.²

It appears as though physicians are becoming more receptive to their role as responsible stewards of finite healthcare resources, and are willing to abandon some common clinical practices that add little value to patient care when given credible evidence. In the recent Choosing Wisely campaign (www.ChoosingWisely.org), for example, nine medical specialty societies worked with the ABIM Foundation and Consumer Reports to publicize 45 tests and procedures—five from each society—that are commonly used in their field, but which evidence suggests might be unnecessary and inappropriate for many patients.

Physicians who in the past might have resisted traditional evidence-based guidelines as “cookie cutter” algorithms that “don’t apply to my particular patient” will find it harder to dismiss CER findings on that basis, Dr. Meltzer notes, because CER is designed at the outset to be relevant to specific subsets of patients in actual clinical settings.

Nevertheless, incentives will be required to drive rapid and widespread adoption of CER findings, Dr. Conway believes.

“Just creating evidence doesn’t create change,” he says. “Cycle time from research finding to implementation matters, and the typical 17 years [time lag from bench to bedside] is not going to cut it. We need to work with clinicians and patients to take new findings and implement them sooner.”

CMS already has selected some evidence-based process and outcome metrics for its value-based purchasing program. “As CER identifies new evidence-based process and outcome metrics, we could incorporate them,” Dr. Conway adds.

Private insurers could use CER findings when making coverage decisions for their health plans. By law, CMS is obligated to provide coverage to Medicare beneficiaries for healthcare services that are “reasonable and necessary,” and cannot exclude coverage based on the cost of services.

“CMS could use CER findings to make coverage determinations based on ineffectiveness, when there is compelling evidence that a service is ‘not reasonable and necessary,’” Dr. Conway states.

HM Opportunity

Dr. Conway says hospitalists are uniquely poised to seek funding for CER that builds upon several critically important topics, such as examining the best discharge planning processes and transition-of-care protocols for certain types of patients. Dr. Meltzer, who is chief of the section of hospital medicine at University of Chicago, says he is seeking funding for a study of alternative transfusion thresholds for older patients with anemia across different levels of patients’ functional status.

“That’s the type of patient-centered study that CER is especially equipped to handle,” Dr. Meltzer says.

CER promises to produce important evidence for clinical questions that hospitalists struggle with day to day, Dr. Conway says. “Hospitalists should take the lead in developing effective ways to disseminate those findings, to teach medical trainees about them, and to spearhead CER-based QI [quality improvement] implementation and tracking efforts at their institutions,” he adds.

Christopher Guadagnino is a freelance medical writer in Philadelphia.

References

1. Patient-Centered Outcome Research Institute. Draft National Priorities for Research and Research Agenda, Version 1. Patient-Centered Outcome Research Institute website. Available at: http://interactive.snm.org/docs/PCORI-Draft-National-Priorities-and-Research-Agenda2.pdf. Accessed April 15, 2012.
2. Berwick DM, Hackbarth AD. Eliminating waste in U.S. health care. Journal of the American Medical Association website. Available at: http://jama.ama-assn.org/content/307/14/1513.full. Accessed April 15, 2012.
3. Selby JV. The researcher-in-chief at the Patient-Centered Outcomes Research Institute. Inverview by Susan Dentzer. Health Aff (Millwood). 2011;30(12):2252-2258.

A recent study in the Journal of Hospital Medicine that found inpatients are similarly satisfied with the care provided by hospitalists and the care of primary-care physicians (PCPs) should be considered a positive for HM, says lead author Adrianne Seiler, MD, of the Division of Healthcare Quality at Baystate Medical Center in Springfield, Mass.¹

The results are drawn from scripted patient-satisfaction telephone interviews of 8,295 patients discharged from three Massachusetts hospitals from 2003 to 2009. Starting in 2007, questions were added from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) federal quality reporting system. Multivariate-adjusted satisfaction scores for physician care quality were only slightly higher for PCPs (4.24 on a five-point scale) than for hospitalists (4.20), with no statistical difference for individual hospitals or for different hospitalist groups.

“What has been passed down as dogma is the discontinuity in care introduced by the hospitalist model,” Dr. Seiler says. But actual data on the effects of the hospitalist model on patient satisfaction are scant. “Our finding that patients essentially were equally satisfied with either model of medical care—that’s huge.”

HCAHPS scores have not been validated to evaluate patient satisfaction with individual hospitalist providers specifically, Dr. Seiler says, but they are standardized nationwide. “Is this the best way to measure patient experience?” she asks. “It’s the best tool we have at this time.”

Another wrinkle in patient satisfaction was presented as an oral research abstract at HM12. Researchers from the Veterans Administration and the University of Michigan examined the association between hospitalist staffing levels and patient satisfaction.² Hospitals with the highest hospitalist staffing had modestly higher patient satisfaction scores than those with the lowest hospitalist staffing. Overall satisfaction was 65.6 for hospitals in the highest tertile of hospitalist staffing versus 62.7 those in the lowest tertile.

References

1. Seiler A, Visintainer P, Brzostek R, et al. Patient satisfaction with hospital care provided by hospitalists and primary care physicians. J Hosp Med. 2012;7:131-136.
2. Chen L, Birkmeyer J, Saint S, Ashish J. Hospitalist staffing and patient satisfaction in the national Medicare population. Abstract presented at HM12, April 2, 2012, San Diego.

A recent study in the Journal of Hospital Medicine that found inpatients are similarly satisfied with the care provided by hospitalists and the care of primary-care physicians (PCPs) should be considered a positive for HM, says lead author Adrianne Seiler, MD, of the Division of Healthcare Quality at Baystate Medical Center in Springfield, Mass.¹

The results are drawn from scripted patient-satisfaction telephone interviews of 8,295 patients discharged from three Massachusetts hospitals from 2003 to 2009. Starting in 2007, questions were added from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) federal quality reporting system. Multivariate-adjusted satisfaction scores for physician care quality were only slightly higher for PCPs (4.24 on a five-point scale) than for hospitalists (4.20), with no statistical difference for individual hospitals or for different hospitalist groups.

“What has been passed down as dogma is the discontinuity in care introduced by the hospitalist model,” Dr. Seiler says. But actual data on the effects of the hospitalist model on patient satisfaction are scant. “Our finding that patients essentially were equally satisfied with either model of medical care—that’s huge.”

HCAHPS scores have not been validated to evaluate patient satisfaction with individual hospitalist providers specifically, Dr. Seiler says, but they are standardized nationwide. “Is this the best way to measure patient experience?” she asks. “It’s the best tool we have at this time.”

Another wrinkle in patient satisfaction was presented as an oral research abstract at HM12. Researchers from the Veterans Administration and the University of Michigan examined the association between hospitalist staffing levels and patient satisfaction.² Hospitals with the highest hospitalist staffing had modestly higher patient satisfaction scores than those with the lowest hospitalist staffing. Overall satisfaction was 65.6 for hospitals in the highest tertile of hospitalist staffing versus 62.7 those in the lowest tertile.

References

1. Seiler A, Visintainer P, Brzostek R, et al. Patient satisfaction with hospital care provided by hospitalists and primary care physicians. J Hosp Med. 2012;7:131-136.
2. Chen L, Birkmeyer J, Saint S, Ashish J. Hospitalist staffing and patient satisfaction in the national Medicare population. Abstract presented at HM12, April 2, 2012, San Diego.

A recent study in the Journal of Hospital Medicine that found inpatients are similarly satisfied with the care provided by hospitalists and the care of primary-care physicians (PCPs) should be considered a positive for HM, says lead author Adrianne Seiler, MD, of the Division of Healthcare Quality at Baystate Medical Center in Springfield, Mass.¹

The results are drawn from scripted patient-satisfaction telephone interviews of 8,295 patients discharged from three Massachusetts hospitals from 2003 to 2009. Starting in 2007, questions were added from the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) federal quality reporting system. Multivariate-adjusted satisfaction scores for physician care quality were only slightly higher for PCPs (4.24 on a five-point scale) than for hospitalists (4.20), with no statistical difference for individual hospitals or for different hospitalist groups.

“What has been passed down as dogma is the discontinuity in care introduced by the hospitalist model,” Dr. Seiler says. But actual data on the effects of the hospitalist model on patient satisfaction are scant. “Our finding that patients essentially were equally satisfied with either model of medical care—that’s huge.”

HCAHPS scores have not been validated to evaluate patient satisfaction with individual hospitalist providers specifically, Dr. Seiler says, but they are standardized nationwide. “Is this the best way to measure patient experience?” she asks. “It’s the best tool we have at this time.”

Another wrinkle in patient satisfaction was presented as an oral research abstract at HM12. Researchers from the Veterans Administration and the University of Michigan examined the association between hospitalist staffing levels and patient satisfaction.² Hospitals with the highest hospitalist staffing had modestly higher patient satisfaction scores than those with the lowest hospitalist staffing. Overall satisfaction was 65.6 for hospitals in the highest tertile of hospitalist staffing versus 62.7 those in the lowest tertile.

References

1. Seiler A, Visintainer P, Brzostek R, et al. Patient satisfaction with hospital care provided by hospitalists and primary care physicians. J Hosp Med. 2012;7:131-136.
2. Chen L, Birkmeyer J, Saint S, Ashish J. Hospitalist staffing and patient satisfaction in the national Medicare population. Abstract presented at HM12, April 2, 2012, San Diego.

Average difference in length of stay (LOS) between hospitalist groups and non-hospitalist groups, according to a meta-analysis of 17 studies of outcomes from the hospitalist approach.¹ The authors, from Cooper University Hospital in Camden, N.J., and elsewhere, searched medical literature through February 2011 for studies comparing length of stay or cost outcomes of hospitalist groups with non-hospitalist “comparator groups.” In studies comparing non-resident hospitalist services with non-resident, non-hospitalist services, LOS was shorter by 0.69 days for the hospitalist model. A total of 137,561 patients were included in the meta-analysis. No significant difference was found in cost between the hospitalist and comparison groups.

Reference

1. Rachoin JS, Skaf J, Cerceo E et al. The impact of hospitalists on length of stay and costs: Systematic review and meta-analysis. Am J Manag Care. 2012;18(1):e23-e30.

Average difference in length of stay (LOS) between hospitalist groups and non-hospitalist groups, according to a meta-analysis of 17 studies of outcomes from the hospitalist approach.¹ The authors, from Cooper University Hospital in Camden, N.J., and elsewhere, searched medical literature through February 2011 for studies comparing length of stay or cost outcomes of hospitalist groups with non-hospitalist “comparator groups.” In studies comparing non-resident hospitalist services with non-resident, non-hospitalist services, LOS was shorter by 0.69 days for the hospitalist model. A total of 137,561 patients were included in the meta-analysis. No significant difference was found in cost between the hospitalist and comparison groups.

Reference

1. Rachoin JS, Skaf J, Cerceo E et al. The impact of hospitalists on length of stay and costs: Systematic review and meta-analysis. Am J Manag Care. 2012;18(1):e23-e30.

Average difference in length of stay (LOS) between hospitalist groups and non-hospitalist groups, according to a meta-analysis of 17 studies of outcomes from the hospitalist approach.¹ The authors, from Cooper University Hospital in Camden, N.J., and elsewhere, searched medical literature through February 2011 for studies comparing length of stay or cost outcomes of hospitalist groups with non-hospitalist “comparator groups.” In studies comparing non-resident hospitalist services with non-resident, non-hospitalist services, LOS was shorter by 0.69 days for the hospitalist model. A total of 137,561 patients were included in the meta-analysis. No significant difference was found in cost between the hospitalist and comparison groups.

Reference

1. Rachoin JS, Skaf J, Cerceo E et al. The impact of hospitalists on length of stay and costs: Systematic review and meta-analysis. Am J Manag Care. 2012;18(1):e23-e30.