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Outpatient Care Compared with Hospitalization for Community-Acquired Pneumonia

Background: In the United Sates, the estimated average cost of an episode of community-acquired pneumonia (CAP) in a hospitalized patient is $6,000 to $7,000, compared with less than $200 for patients treated in the outpatient setting. Thus, a significant cost savings could be obtained if certain patients could be treated as outpatients rather than being admitted to the hospital for CAP.

Objective: To determine whether outpatient care of patients with CAP with PSI-defined low-risk [class II and III (PSI scores £ 90 points)] is as safe and effective as hospitalization.

Methods: This was a multi-center, active-controlled, randomized, un-blinded study that lasted for 1 year in Barcelona, Spain. Patients over the age of 18 with a diagnosis of community- acquired pneumonia in the emergency department who were considered to be in either class II or III were considered for randomization. Patients were excluded if they had neutropenia, HIV infection, transplantation, splenectomy, taking immunosuppressive medications, pregnant, breast-feeding, allergic to quinolone antibiotics, received any quinolone 3 months prior to the study, respiratory failure, using pulse oximetry, concomitant unstable comorbid conditions, complicated pleural effusion, shock, lung abscess, metastatic infection, severe social problems, cognitive or psychiatric impairment, or the inability to maintain oral intake. 224 immunocompetent adults enrolled received either intravenous levofloxacin 500 mg/day followed by oral therapy 500 mg/day in the inpatient setting or oral levofloxacin 500 mg/day in the outpatient setting. All of the patients enrolled in the study were seen at the outpatient clinic at 7 and 30 days after pneumonia diagnosis. The primary end point of the trial was the percentage of patients with an overall successful outcome, defined as meeting all of the 7 predefined criteria: cure of pneumonia, absence of adverse drug reactions, absence of medical complications during treatment, no need for additional visits, no changes in initial treatment with levofloxacin, and absence of subsequent hospital admission or death from any cause in the 30 days after randomization. Secondary endpoints included patients’ health-related quality of life and satisfaction with the care received for pneumonia. The data for the primary end point was analyzed on an intention-to-treat basis in both the inpatient and outpatient groups. Secondary endpoints were measured with two surveys. The Short Form –36 (SF-36) was used to measure health-related quality of life. The question, “How would you rate your overall care for this episode of pneumonia?,” was used to measure patients satisfaction with care. The investigators had estimated that they would need a sample size of approximately 200 patients to achieve 90% power at a 5% significance level.

Results: 102 patients completed the outpatient setting, and 101 patients completed the hospitalization setting. An overall successful outcome was achieved in 83.6% of outpatients and 80.7% of hospitalized patients with an absolute difference of 2.9 % [95% CI, -7.1 to 12.9 %]. In the intention-to-treat analysis, the overall odds ratio for successful outcome linked to treatment group (outpatient care vs. hospitalization) was 0.76 (CI, 0.37 to 1.54) for both hospitals combined. There were no differences between groups in health-related quality of life at days 7 and 30 after diagnosis of pneumonia. Outpatients more frequently reported satisfaction with overall care than did hospitalized patients (83 of 91 [91.2%] vs. 68 of 86 [79.1%]; absolute difference, 12.1% [CI, 1.8 to 22.5 percentage points]; p = 0.03. 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. The authors stated that their results concur with results from 2 previous studies done, and concluded in selected patients who had community acquired pneumonia, PSI risk classes II and III, and were treated with levofloxacin, outpatient care in patients that did not have respiratory failure, unstable comorbid conditions, complicated pleural effusions, and social problems was as safe and effective as hospitalization and provided greater patient satisfaction.

Strengths: This study followed criteria for diagnosis from the American Thoracic Society (ATS) guidelines for the management of community-acquired pneumonia. The sponsor of the study had no affiliation with the manufacturer of the medication and did not advise on the set-up of the study, which decreased the probability of bias. There have been no other studies conducted with this type of design to show which setting could be potentially better for the treatment of pneumonia.

Weaknesses: This study had four major limitations. It has a relatively small sample size and was not powered to detect differences in mortality. Second, the conclusions apply to only a subset of patients in PSI risk class II and III who met the inclusion criteria. Third, the finding that outpatient care of low-risk patients treated with levofloxacin was as safe and effective as hospitalization might not apply in settings with higher rates of quinolone resistance among respiratory pathogens or higher rates of previous quinolone use. Fourth, investigators who were aware of patient treatment assignments assessed outcomes. Compliance was also not assessed in this study.

Conclusion: The results of this study show that successful outcomes with pneumonia can occur in the hospital or in outpatient care. The results may not be fully applied to the general population because the study population was based on strict inclusion/exclusion criteria that may not be a true representation of the general population. Due to the weaknesses of the study, it is hard to conclude that the outpatient setting is superior. Based on the current guidelines, drug therapy for the outpatient setting is different than the inpatient setting for patients with community-acquired pneumonia, so standard of care is different in both settings. Overall, more studies need to be done, especially with possible head to head studies, comparing the standards of care in each type of setting.

Carratala J, Sabe N, Ortega L, Castellsague X, Roson B, Dorca J, Aguera A, Verdaguer R, Martinez J, Manresa F, Gudiol F. Annals of Internal Medicine. Feb 2005; (142) 3, p165-72.

Chanda Saucerman, Pharm D. Candidate