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Should Health Care Systems and Health Care Providers Implement a New Pathway for Hospitalized Patients With Community-Acquired Pneumonia?

Should Health Care Systems and Health Care Providers Implement a New Pathway for Hospitalized... We read with interest the study recently published by Carratalà and coworkers.1 The authors developed a 3-step critical pathway to reduce duration of intravenous antibiotic therapy and length of stay (LOS) of hospitalized patients with community-acquired pneumonia (CAP). The median duration of LOS was 3.9 days and 6.0 days in the interventional and usual care group, respectively. The authors found no significant differences between the 2 study groups in terms of 30-day mortality, and they concluded that this pathway is effective and safe to use. In his commentary, Sharpe2 called for a rapid implementation of this strategy. However, some remarks should be pointed out in this regard. Length of stay was used as the primary end point in the sample size calculation. The authors estimated a total sample size of 380 patients to achieve 82% power at a 5% significant level to detect a 1.5-day difference in LOS between the study groups. The 30-day death due to any cause was reported as a secondary end point. Secondary end points are not conclusive, and they should not be used to modify clinical practice. Further trials are needed to assess the safety of this pathway. Considering a mortality rate in the control group of 0.14, an α value of .05, and a β value of .20, the number of patients needed in each study arm to show significant differences of 25% and 50% is 1360 and 291, respectively.3 If health care costs for patients with CAP are relevant and interventions to increase the efficiency of patients' care are desirable, aggressive programs to shorten LOS may introduce unnecessary risks for the patient. Policies to save health care resources should take into consideration in-hospital costs as well as costs related to the occurrence of adverse outcomes after discharge. Finally, the generalizability of the results of this study is affected by some important exclusion criteria, such as intensive care unit admission from the emergency department, imminent death, shock, complicated pleural effusion, pregnancy, aspiration pneumonia, and severe social problems. Because previous studies documented high rates of clinical failure and intensive care unit admissions during the first days of hospitalization, the results of the study of Carratalà et al1 should not be generalized to patients with severe CAP.4 In conclusion, the study published by Carratalà and coworkers1 should be an impetus to design clinical trials focused on evaluating the safety and the external validity of this new algorithm. Back to top Article Information Correspondence: Dr Carugati, Department of Clinical Science, University of Milan, Luigi Sacco Hospital, University of Milan, Milan 20157, Italy (manuela.carugati@unimi.it). Conflict of Interest Disclosures: None reported. Additional Contributions: Vivian Chu, MD, MHS, Internal Medicine, Duke University, assisted with scientific review of the manuscript. References 1. Carratalà J, Garcia-Vidal C, Ortega L, et al. Effect of a 3-step critical pathway to reduce duration of intravenous antibiotic therapy and length of stay in community-acquired pneumonia: a randomized controlled trial. Arch Intern Med. 2012;172(12):922-92822732747PubMedGoogle Scholar 2. Sharpe BA. Putting a critical pathway into practice: the devil is in the implementation details. Arch Intern Med. 2012;172(12):928-92922732748PubMedGoogle ScholarCrossref 3. Garcia-Vidal C, Fernández-Sabé N, Carratalà J, et al. Early mortality in patients with community-acquired pneumonia: causes and risk factors. Eur Respir J. 2008;32(3):733-73918508820PubMedGoogle ScholarCrossref 4. Aliberti S, Amir A, Peyrani P, et al. Incidence, etiology, timing, and risk factors for clinical failure in hospitalized patients with community-acquired pneumonia. Chest. 2008;134(5):955-96218583514PubMedGoogle ScholarCrossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Internal Medicine American Medical Association

Should Health Care Systems and Health Care Providers Implement a New Pathway for Hospitalized Patients With Community-Acquired Pneumonia?

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References (9)

Publisher
American Medical Association
Copyright
Copyright © 2012 American Medical Association. All Rights Reserved.
ISSN
0003-9926
eISSN
1538-3679
DOI
10.1001/2013.jamainternmed.459
Publisher site
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Abstract

We read with interest the study recently published by Carratalà and coworkers.1 The authors developed a 3-step critical pathway to reduce duration of intravenous antibiotic therapy and length of stay (LOS) of hospitalized patients with community-acquired pneumonia (CAP). The median duration of LOS was 3.9 days and 6.0 days in the interventional and usual care group, respectively. The authors found no significant differences between the 2 study groups in terms of 30-day mortality, and they concluded that this pathway is effective and safe to use. In his commentary, Sharpe2 called for a rapid implementation of this strategy. However, some remarks should be pointed out in this regard. Length of stay was used as the primary end point in the sample size calculation. The authors estimated a total sample size of 380 patients to achieve 82% power at a 5% significant level to detect a 1.5-day difference in LOS between the study groups. The 30-day death due to any cause was reported as a secondary end point. Secondary end points are not conclusive, and they should not be used to modify clinical practice. Further trials are needed to assess the safety of this pathway. Considering a mortality rate in the control group of 0.14, an α value of .05, and a β value of .20, the number of patients needed in each study arm to show significant differences of 25% and 50% is 1360 and 291, respectively.3 If health care costs for patients with CAP are relevant and interventions to increase the efficiency of patients' care are desirable, aggressive programs to shorten LOS may introduce unnecessary risks for the patient. Policies to save health care resources should take into consideration in-hospital costs as well as costs related to the occurrence of adverse outcomes after discharge. Finally, the generalizability of the results of this study is affected by some important exclusion criteria, such as intensive care unit admission from the emergency department, imminent death, shock, complicated pleural effusion, pregnancy, aspiration pneumonia, and severe social problems. Because previous studies documented high rates of clinical failure and intensive care unit admissions during the first days of hospitalization, the results of the study of Carratalà et al1 should not be generalized to patients with severe CAP.4 In conclusion, the study published by Carratalà and coworkers1 should be an impetus to design clinical trials focused on evaluating the safety and the external validity of this new algorithm. Back to top Article Information Correspondence: Dr Carugati, Department of Clinical Science, University of Milan, Luigi Sacco Hospital, University of Milan, Milan 20157, Italy (manuela.carugati@unimi.it). Conflict of Interest Disclosures: None reported. Additional Contributions: Vivian Chu, MD, MHS, Internal Medicine, Duke University, assisted with scientific review of the manuscript. References 1. Carratalà J, Garcia-Vidal C, Ortega L, et al. Effect of a 3-step critical pathway to reduce duration of intravenous antibiotic therapy and length of stay in community-acquired pneumonia: a randomized controlled trial. Arch Intern Med. 2012;172(12):922-92822732747PubMedGoogle Scholar 2. Sharpe BA. Putting a critical pathway into practice: the devil is in the implementation details. Arch Intern Med. 2012;172(12):928-92922732748PubMedGoogle ScholarCrossref 3. Garcia-Vidal C, Fernández-Sabé N, Carratalà J, et al. Early mortality in patients with community-acquired pneumonia: causes and risk factors. Eur Respir J. 2008;32(3):733-73918508820PubMedGoogle ScholarCrossref 4. Aliberti S, Amir A, Peyrani P, et al. Incidence, etiology, timing, and risk factors for clinical failure in hospitalized patients with community-acquired pneumonia. Chest. 2008;134(5):955-96218583514PubMedGoogle ScholarCrossref

Journal

Archives of Internal Medicine – American Medical Association

Published: Dec 10, 2012

Keywords: community acquired pneumonia,health personnel,health care systems

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