BACKGROUND: The Pneumonia Severity Index (PSI) has been advocated as an objective measure of risk stratification to help determine the initial site of treatment for patients with community-acquired pneumonia. OBJECTIVE: To determine whether outpatient care of PSI-defined low-risk patients with community-acquired pneumonia is as safe and effective as hospitalization. DESIGN: Unblinded, randomized, controlled trial. SETTING: 2 tertiary care hospitals. PATIENTS: 224 immunocompetent adults in risk class II or III (PSI scores <or=90 points) who received a diagnosis of community-acquired pneumonia in the emergency department and had no extenuating circumstances. INTERVENTION: Outpatient care with oral levofloxacin therapy or hospitalization with sequential intravenous and oral levofloxacin therapy. MEASUREMENTS: The primary end point was the percentage of patients with an overall successful outcome at the end of treatment, according to 7 predefined criteria. Secondary end points included patients' quality of life and satisfaction. RESULTS:Overall successful outcome was achieved in 83.6% of outpatients and 80.7% of hospitalized patients (absolute difference, 2.9 percentage points [95% CI, -7.1 to 12.9 percentage points]). More outpatients were satisfied with their overall care (91.2% vs. 79.1%; absolute difference, 12.1 percentage points [CI, 1.8 to 22.5 percentage points]). Quality of life and the percentages of patients with adverse drug reactions (9.1% vs. 9.6%), medical complications (0.9% vs. 2.6%), subsequent hospital admissions (6.3% vs. 7.0%), and overall mortality (0.9% vs. 0%) were similar in the outpatient and hospitalization groups. LIMITATIONS: The power to detect a serious complication, such as death, was limited given the relatively small sample size. CONCLUSIONS: In selected patients who had community-acquired pneumonia, PSI risk class II and III, and were treated withlevofloxacin, outpatient care in the absence of respiratory failure, unstable comorbid conditions, complicated pleural effusions, and social problems was as safe and effective as hospitalization and provided greater patient satisfaction.
RCT Entities:
BACKGROUND: The Pneumonia Severity Index (PSI) has been advocated as an objective measure of risk stratification to help determine the initial site of treatment for patients with community-acquired pneumonia. OBJECTIVE: To determine whether outpatient care of PSI-defined low-risk patients with community-acquired pneumonia is as safe and effective as hospitalization. DESIGN: Unblinded, randomized, controlled trial. SETTING: 2 tertiary care hospitals. PATIENTS: 224 immunocompetent adults in risk class II or III (PSI scores <or=90 points) who received a diagnosis of community-acquired pneumonia in the emergency department and had no extenuating circumstances. INTERVENTION: Outpatient care with oral levofloxacin therapy or hospitalization with sequential intravenous and oral levofloxacin therapy. MEASUREMENTS: The primary end point was the percentage of patients with an overall successful outcome at the end of treatment, according to 7 predefined criteria. Secondary end points included patients' quality of life and satisfaction. RESULTS: Overall successful outcome was achieved in 83.6% of outpatients and 80.7% of hospitalized patients (absolute difference, 2.9 percentage points [95% CI, -7.1 to 12.9 percentage points]). More outpatients were satisfied with their overall care (91.2% vs. 79.1%; absolute difference, 12.1 percentage points [CI, 1.8 to 22.5 percentage points]). Quality of life and the percentages of patients with adverse drug reactions (9.1% vs. 9.6%), medical complications (0.9% vs. 2.6%), subsequent hospital admissions (6.3% vs. 7.0%), and overall mortality (0.9% vs. 0%) were similar in the outpatient and hospitalization groups. LIMITATIONS: The power to detect a serious complication, such as death, was limited given the relatively small sample size. CONCLUSIONS: In selected patients who had community-acquired pneumonia, PSI risk class II and III, and were treated with levofloxacin, outpatient care in the absence of respiratory failure, unstable comorbid conditions, complicated pleural effusions, and social problems was as safe and effective as hospitalization and provided greater patient satisfaction.
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