Annals of Emergency Medicine
Volume 54, Issue 5 , Pages 704-731, November 2009

Clinical Policy: Critical Issues in the Management of Adult Patients Presenting to the Emergency Department With Community-Acquired Pneumonia

American College of Emergency Physicians Clinical Policies Subcommittee (Writing Committee) on Critical Issues in the Evaluation and Management of Adult Patients Presenting to the Emergency Department With Community-Acquired Pneumonia

Article Outline

 

Members of the American College of Emergency Physicians Clinical Policies Committee (Oversight Committee):

Wyatt W. Decker, MD (Co-Chair 2006-2007, Chair 2007-2009)

Andy S. Jagoda, MD (Chair 2003-2006, Co-Chair 2006-2007)

Deborah B. Diercks, MD

Barry M. Diner, MD (Methodologist)

Jonathan A. Edlow, MD

Francis M. Fesmire, MD

John T. Finnell, II, MD, MSc (Liaison for Emergency Medical Informatics Section 2004-2006)

Steven A. Godwin, MD

Sigrid A. Hahn, MD

John M. Howell, MD

J. Stephen Huff, MD

Eric J. Lavonas, MD

Thomas W. Lukens, MD, PhD

Donna L. Mason, RN, MS, CEN (ENA Representative 2004-2006)

Edward Melnick, MD (EMRA Representative 2007-2008)

Anthony M. Napoli, MD (EMRA Representative 2004-2006)

Devorah Nazarian, MD

AnnMarie Papa, RN, MSN, CEN, FAEN (ENA Representative 2007-2009)

Jim Richmann, RN, BS, MA(c), CEN (ENA Representative 2006-2007)

Scott M. Silvers, MD

Edward P. Sloan, MD, MPH

Molly E. W. Thiessen, MD (EMRA Representative 2006-2008)

Robert L. Wears, MD, MS (Methodologist)

Stephen J. Wolf, MD

Cherri D. Hobgood, MD (Board Liaison 2004-2006)

David C. Seaberg, MD, CPE (Board Liaison 2006-2009)

Rhonda R. Whitson, RHIA, Staff Liaison, Clinical Policies Committee and Subcommittees

[Ann Emerg Med. 2009;54:704-731.]

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Abstract 

This clinical policy from the American College of Emergency Physicians focuses on critical issues concerning the management of adult patients presenting to the emergency department (ED) with community-acquired pneumonia. It is an update of the 2001 clinical policy for the management and risk stratification of adult patients presenting to the ED with community-acquired pneumonia. A subcommittee reviewed the current literature to derive evidence-based recommendations to help answer the following questions: (1) Are routine blood cultures indicated in patients admitted with community-acquired pneumonia? (2) In adult patients with community-acquired pneumonia without severe sepsis, is there a benefit in mortality or morbidity from the administration of antibiotics within a specific time course? The evidence was graded and recommendations were given based on the strength of evidence.

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Introduction 

Community-acquired pneumonia (CAP) is a major health problem in the United States. CAP is the seventh leading cause of death in the United States, with 1.7 million hospital admissions per year.1, 2 The annual economic costs of CAP-related hospitalizations have been estimated at $9 billion.3 Pneumonia carries an age-adjusted mortality rate up to 22%.1 Despite clinical advances, pneumonia mortality rates have not decreased significantly since penicillin became routinely available.4

Pneumonia can be divided into 4 categories based on the site of acquisition of illness: CAP, hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), and health care-associated pneumonia (HCAP).5 CAP has recently been defined as an acute pulmonary infection in a patient who is not hospitalized or living in a long-term care facility 14 or more days before presentation and does not meet the criteria for HCAP.5 HAP is defined as a new infection occurring 48 hours or longer after hospital admission. VAP is defined as pneumonia occurring 48 to 72 hours after endotracheal intubation. HCAP encompasses many patients previously defined as having CAP. HCAP is defined as infection occurring within 90 days of a 2-day or longer hospitalization; in a nursing home or long-term care residence; within 30 days of receiving intravenous antibacterial therapy, chemotherapy, or wound care or after a hospital or hemodialysis clinic visit; or in any patient in contact with a multidrug-resistant pathogen.6 An emerging body of evidence suggests that patients with HCAP more closely resemble patients with HAP and may require HAP-like treatments.6, 7, 8

Given the significance of CAP, improving pneumonia care has become a recent focus of many organizations such as The Joint Commission and the Centers for Medicare & Medicaid Services (CMS). There are a number of core measures for patients admitted with the diagnosis of pneumonia. Core measures that evaluate the emergency department (ED) care of CAP patients include blood culture collection prior to first antibiotic administration (when ED blood cultures are drawn), administration of initial antibiotics within 6 hours of ED arrival (previously within 4 hours), and appropriate antibiotic selection.9

To comply with antibiotic quality measures and CMS and private payer pay for performance programs, some EDs have moved toward treating possible CAP patients with antibiotics before the diagnosis is confirmed.10 In this age of increasing antibiotic resistance, this may have negative consequences in excess of any putative benefit. Kanwar et al11 studied 2 cohorts of patients with the ED diagnosis of CAP, before and after the implementation of antibiotic timing guidelines. To achieve an increase in the number of patients with time to first antibiotic dose less than 4 hours, an additional 17% of patients were unnecessarily treated with antibiotics. Khalil et al12 performed a retrospective analysis of factors associated with the eventual diagnosis of CAP in patients presenting to the ED. Of 1,948 patients who presented with respiratory complaints, only 198 eventually were diagnosed with CAP. If half of the patients in this study received empiric antibiotics, at least 40% of the patients would have received antibiotics unnecessarily, potentially increasing antibiotic resistance in the community. In an online questionnaire, Pines et al10 found that 37% of academic EDs administer antibiotics before obtaining chest radiograph. In a retrospective chart review of patients admitted with pneumonia, 22% of the patients presented in a manner that can result in delayed antibiotics delivery as a result of diagnostic uncertainty.13 The most recent iteration of the CMS guidelines includes provisions for diagnostic uncertainty when assessing time to first antibiotic dose. With the current ED crowding crisis, the feasibility of rapid antibiotic administration can be difficult.14, 15, 16

The disposition of patients with pneumonia is a major decision for emergency physicians, with impact on patient outcome. Prognostic tools such as the Pneumonia Severity Index (PSI) and severity-of-illness indexes such as the CURB and CURB-65 scores have been validated in several studies and can be used to aid in admission decisions.17, 18 The PSI stratifies patients into 5 categories on the basis of mortality risk. It has been suggested that patients in groups I and II be treated as outpatients, those in group III be treated in an observation unit or with a short hospitalization, and those patients who fall into groups IV and V be admitted for treatment.19 CURB-65 is an easy-to-use severity-of-illness score that uses the following factors as indicators of increased mortality: Confusion, Urea, Respiratory rate, low Blood pressure, and age 65 or greater. Lim et al20 suggested that patients with a CURB-65 score of 2 be treated as inpatients; those with a score of 3 or greater will often require an ICU. These prognostic tools do not take into account the psychosocial factors and other comorbidities that may also play a role in the emergency physician's determination of the best site of treatment for patients with CAP.

Most patients admitted for CAP are first cared for in the ED.21 This clinical policy critically evaluates the available evidence about 2 often controversial critical issues in the care of patients admitted with the diagnosis of CAP.11, 13, 22, 23, 24, 25 The focused critical questions addressed in this policy include the following:

1.Are routine blood cultures indicated in patients admitted with CAP?

2.In adult patients with CAP without severe sepsis, is there a benefit in mortality and morbidity from the administration of antibiotics within a specific time course?

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Methodology 

This clinical policy was created after careful review and critical analysis of the medical literature. Multiple searches of MEDLINE, MEDLINE In-Process, and the Cochrane database were performed. Specific key words/phrases used in the searches are identified under each critical question. All searches were limited to English-language sources, human studies, and adults. Additional articles were reviewed from the bibliography of articles cited and from published textbooks and review articles. Subcommittee members supplied articles from their own files, and more recent articles identified during the process were also included.

The reasons for developing clinical policies in emergency medicine and the approaches used in their development have been enumerated.26 This policy is a product of the American College of Emergency Physicians (ACEP) clinical policy development process, including expert review, and is based on the existing literature; when literature was not available, consensus of emergency physicians was used. Expert review comments were received from individual emergency physicians and from individual members of the American College of Chest Physicians, the American College of Physicians, the Infectious Diseases Society of America, the Institute for Clinical Systems Improvement, the Society for Academic Emergency Medicine, and ACEP's Section on Critical Care Medicine. Their responses were used to further refine and enhance this policy; however, their responses do not imply endorsement of this clinical policy. Clinical policies are scheduled for revision every 3 years; however, interim reviews are conducted when technology or the practice environment changes significantly.

All articles used in the formulation of this clinical policy were graded by at least 2 subcommittee members for strength of evidence and classified by the subcommittee members into 3 classes of evidence on the basis of the design of the study, with design 1 representing the strongest evidence and design 3 representing the weakest evidence for therapeutic, diagnostic, and prognostic clinical reports, respectively (Appendix A). Articles were then graded on 6 dimensions thought to be most relevant to the development of a clinical guideline: blinded versus nonblinded outcome assessment, blinded or randomized allocation, direct or indirect outcome measures (reliability and validity), biases (eg, selection, detection, transfer), external validity (ie, generalizability), and sufficient sample size. Articles received a final grade (Class I, II, III) on the basis of a predetermined formula, taking into account design and quality of study (Appendix B). Articles with fatal flaws were given an “X” grade and not used in formulating recommendations in this policy. Evidence grading was done with respect to the specific data being extracted and the specific critical question being reviewed. Thus, the level of evidence for any one study may vary according to the question, and it is possible for a single article to receive different levels of grading as different critical questions are answered. Question-specific level of evidence grading may be found in the Evidentiary Table included at the end of this policy.

Evidentiary table.

Clinical findings and strength of recommendations regarding patient management were then made according to the following criteria:

Level A recommendations 

Generally accepted principles for patient management that reflect a high degree of clinical certainty (ie, based on strength of evidence Class I or overwhelming evidence from strength of evidence Class II studies that directly address all of the issues).

Level B recommendations 

Recommendations for patient management that may identify a particular strategy or range of management strategies that reflect moderate clinical certainty (ie, based on strength of evidence Class II studies that directly address the issue, decision analysis that directly addresses the issue, or strong consensus of strength of evidence Class III studies).

Level C recommendations 

Other strategies for patient management that are based on preliminary, inconclusive, or conflicting evidence, or in the absence of any published literature, based on panel consensus.

There are certain circumstances in which the recommendations stemming from a body of evidence should not be rated as highly as the individual studies on which they are based. Factors such as heterogeneity of results, uncertainty about effect magnitude and consequences, strength of prior beliefs, and publication bias, among others, might lead to such a downgrading of recommendations.

This policy is not intended to be a complete manual on the evaluation and management of adult patients with CAP but rather a focused examination of critical issues that have particular relevance to the current practice of emergency medicine.

It is the goal of the Clinical Policies Committee to provide an evidence-based recommendation when the medical literature provides enough quality information to answer a critical question. When the medical literature does not contain enough quality information to answer a critical question, the members of the Clinical Policies Committee believe that it is equally important to alert emergency physicians to this fact.

Recommendations offered in this policy are not intended to represent the only diagnostic and management options that the emergency physician should consider. ACEP clearly recognizes the importance of the individual physician's judgment. Rather, this guideline defines for the physician those strategies for which medical literature exists to provide support for answers to the crucial questions addressed in this policy.

Scope of Application 

This guideline is intended for physicians working in hospital-based EDs.

Inclusion Criteria 

This guideline is intended for patients 18 years of age or older with signs and symptoms of CAP and radiographic evidence of pneumonia.

Exclusion Criteria 

This guideline is not intended for patients who are pregnant, or immunocompromised (including patients with HIV/AIDS, organ transplant, or recipients of corticosteroids, antineoplastic therapy, or other immunosuppressive agents), or have been hospitalized within the last 30 days.

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Critical Questions 

1. Are routine blood cultures indicated in patients admitted with CAP?

Patient Management Recommendations 

Level A recommendations 

None specified.

Level B recommendations 

Do not routinely obtain blood cultures in patients admitted with CAP.

Level C recommendations 

Consider obtaining blood cultures in higher-risk patients admitted with CAP (eg, severe disease, immunocompromise, significant comorbidities, or other risk factors for infection with resistant organisms).

Key words/phrases for literature searches: pneumonia, community-acquired pneumonia, blood cultures, microbiology, bacteremia, utility of blood cultures, timeline 1996 – May 20, 2009.

The following have been identified as CMS core measures for patients admitted with CAP: (1) the collection of blood cultures prior to antibiotic administration, when ED blood cultures are drawn; (2) blood cultures performed within 24 hours prior to or 24 hours after hospital arrival for patients who were transferred or admitted to the ICU within 24 hours of presentation to the hospital.9 The 2007 American Thoracic Society and Infectious Diseases Society of America guidelines for the management of patients with CAP recommended pretreatment blood cultures for those patients hospitalized with the following conditions: cavitary infiltrates, leukopenia, active alcohol abuse, chronic severe liver disease, asplenia, positive test result for pneumococcal urinary antigen, pleural effusion, or those admitted to the ICU. Blood cultures are optional for those without the specifically listed conditions.27

Ideally, blood cultures identify a pathogen and its susceptibility, allowing antibiotic therapy to be customized for each patient. However, blood cultures are infrequently positive, and blood culture results do not often lead to change in management. A variety of Class II and III studies have reported the incidence of positive culture results in patients admitted with CAP. The yield reported ranges from 0% in a series of 74 patients with nonsevere CAP without significant comorbidities28 to 33% in 146 ICU patients with CAP from Reunion Island.29 Typically, the range is 1% to 16%.30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41

A number of Class II and III studies have investigated the impact of blood cultures on antibiotic management in CAP patients. Antibiotic therapy was changed based on blood culture results in 0% to 5% of patients cultured.31, 32, 33, 38, 39, 42, 43, 44 Change in patient condition (either improvement or deterioration) was more likely to prompt antibiotic modification than results of blood cultures.33, 44, 45 Few changes were made for coverage of resistant organisms identified by blood cultures. The Class II study by Campbell et al31 found that only 0.4% of blood cultures drawn yielded an organism resistant to recommended empiric antibiotics. Similarly, the Class II study by Kennedy et al39 noted 4 of 414 cultures drawn (1%) yielded resistant organisms, resulting in 2 patients having their initial treatment changed (2 others had coverage altered to more effective antibiotics before culture results were known). One Class II study45 and multiple Class III studies reporting changes in empiric therapy based on blood culture results demonstrate similar findings. These studies, ranging in size from 86 to 517 patients, reported organisms resistant to empiric therapy in 0% to 2.7% of patients that were cultured.32, 33, 38, 42, 43, 44, 45, 46

There are few data about blood culture performance in CAP patients and association with outcomes such as mortality, time to clinical stability, and length of stay. In a Class II multicenter study, Dedier et al47 retrospectively examined 1,062 patients with a primary admission diagnosis of pneumonia. They found no difference in mortality or length of stay between patients who had blood cultures and those who did not have blood cultures before receiving antibiotics and no difference in mortality or length of stay between patients who had blood cultures and those who did not have blood cultures within 24 hours of admission. In the frequently cited Class III study by Meehan et al,48 investigators retrospectively examined a national study set of 1,343 Medicare patients with a discharge diagnosis of pneumonia. The authors concluded that blood culture collection within 24 hours was associated with lower 30-day mortality; however, the odds ratio (OR) was 0.9, with a confidence interval (CI) of 0.81 to 1.0 and a nonsignificant P value of 0.07. This same study examined collection of blood cultures before or after antibiotic administration and found no significant association with lower mortality if patients had blood cultures collected before receiving antibiotics.

Blood culture results may be misleading and may cause unintended consequences. False-positive or contaminated specimens are common, and in some studies, rates of false-positive blood cultures approach those of true-positive.32, 33, 39, 40, 42 Treatment based on preliminary false-positive blood culture results may lead to unnecessary antibiotic coverage and increased length of stay, pending final identification of the organism. Metersky et al40 retrospectively analyzed 13,043 Medicare patients with CAP and found 7% with true-positive blood cultures and 5% false-positive blood cultures. Patients with contaminated blood cultures had an average length of stay of 1 day longer than those who did not have contaminated blood cultures (P<0.01). False-positive blood cultures are also costly. Bates et al49 reported that total hospital charges were $4,000 greater for patients with contaminated blood cultures compared with those with negative blood cultures.

Data suggest that blood cultures are more likely to provide results leading to a change in management in select patients. Liver disease, hypotension, hypothermia or fever, tachycardia, uremia, hyponatremia, and leucopenia or leukocytosis have been identified as independent predictors of bacteremia.40 Immunocompromised patients and patients from nursing homes or other long-term care facilities are more likely to have unusual or resistant pathogens identified by blood cultures.34, 39, 50 Patients with severe pneumonia may also benefit from blood culture tests.29, 51 In a prospective Class III study of 209 patients, Waterer and Wunderink38 found that blood culture results led to change in antibiotics only in patients with PSI class IV and V disease, whereas patients in PSI class I to III had no antibiotic changes based on blood culture results.

In summary, the routine use of blood cultures in all patients admitted with CAP has a low yield and rarely leads to change in management or outcome for patients admitted with CAP. False-positive blood culture results may complicate the course for patients admitted with CAP. Therefore, blood cultures should be tailored to the individual patient. Patients with severe pneumonia, who are immunocompromised or have other significant comorbidities, may benefit from having blood cultures drawn. Because antibiotic administration before blood culture testing decreases blood culture yield, when blood cultures are necessary, they should be drawn before antibiotic administration.37, 40, 41

2. In adult patients with CAP without severe sepsis, is there a benefit in mortality or morbidity from the administration of antibiotics within a specific time course?

Patient Management Recommendations 

Level A recommendations 

None specified.

Level B recommendations 

There is insufficient evidence to establish a benefit in mortality or morbidity from antibiotics administered in less than 4, 6, or 8 hours from ED arrival.

Level C recommendations 

Administer antibiotics as soon as feasible once the diagnosis of CAP is established; there is insufficient evidence to establish a benefit in morbidity or mortality from antibiotics administered within any specific time course.

Key words/phrases for literature searches: pneumonia, community-acquired pneumonia, time to treatment, rapid antibiotic delivery, morbidity, mortality, outcomes, length of stay, quality of care, timeline 1988 – May 20, 2009.

The timely administration of antibiotics to infected patients is good emergency medical practice. Before giving antibiotics, a reasonable assurance of the diagnosis is essential to avoid mistreatment, medication overuse, and increased antibiotic resistance.13, 22, 52

In the most recent consensus guidelines on the management of CAP in adults, the Infectious Diseases Society of America and the American Thoracic Society agreed that there is a paucity of data to support a specific time recommendation for the administration of antibiotics in ED patients with CAP.27 Their recommendation states: for patients admitted through the ED, the first antibiotic dose should be administered while [the patient is] still in the ED.

Four-Hour Cutoff 

In a frequently cited article, Houck et al53 analyzed whether the time to first antibiotic dose might be associated with reductions in mortality and morbidity. In a retrospective multicenter, Class III study, Houck et al53 examined the charts of 13,771 Medicare patients with a primary or secondary International Classification of Diseases, Ninth Revision (ICD-9) diagnosis of pneumonia, who had not received out-of-hospital antibiotics. The patients analyzed were older than 65 years, had not received out-of-hospital antibiotics, and had radiographic evidence of pneumonia in the ED. This study showed an association between antibiotics administered within 4 hours and a decreased 30-day mortality, with an OR of 0.85 (95% CI 0.76 to 0.95). There was also a significant association with reduction of inhospital mortality and reduction of length of stay exceeding the 5-day median.

This study's limitations include the following: more patients in the group with time to first antibiotic dose less than 4 hours received appropriate antibiotics, though this was included in multivariate analysis.53 There was a post hoc determination of the 4-hour cutoff. Any of the cutoff times from 3 to 8 hours were associated with similar 30-day mortality. The researchers chose the 4-hour cutoff, even though adjusted ORs of the 4- and 8-hour cutoffs were identical. They attempted to control for confounders through the performance of multivariate analysis. Although the study controlled for many possible confounders, the possibility of missing others potentially biases the results, which may account for the fact that despite the multivariate analysis, patients who received antibiotics between 0 and 2 hours did not have any significant mortality reduction.

Early administration of antibiotics is reliant on the early diagnosis of pneumonia. Patients whose disease is more difficult to diagnose because of atypical presentations may receive their antibiotics later. If any of the factors that lead to the delayed diagnosis are also associated with mortality, then the link between early antibiotic administration and mortality may be spurious. Waterer et al54 examined these factors in a prospective Class II study. The researchers performed an observational study of time to first antibiotic dose in patients older than 18 years and diagnosed with CAP during their hospitalization. In univariate analysis, this study confirmed the aforementioned association between time to first antibiotic dose less than 4 hours and mortality. However, when the data were examined for factors that can cause a delayed diagnosis of pneumonia, 3 factors emerged: altered mental status, the absence of hypoxia, and the absence of fever. When reanalyzed controlling for these factors, all of the mortality benefit associated with time to first antibiotic dose less than 4 hours disappeared. Altered mental status and the absence of fever remained associated with increased mortality after the multivariate analysis. This study's results indicate that for patients presenting with CAP and altered mental status or the inability to mount a febrile response, it may be more difficult to rapidly diagnose pneumonia, and they may be at higher risk for death.54 The study by Houck et al53 did not specifically control for altered mental status or the presence of fever in the multivariate analysis.

In a prospective, observational Class II study, Silber et al55 examined the differences in time to clinical stability in 409 patients based on their door-to-antibiotic time. Three cohorts were analyzed: antibiotics in less than 4 hours, antibiotics in 4 to 8 hours, and antibiotics in greater than 8 hours. There were no statistically significant differences in time to clinical stability between the groups.

In another Class II study, Marrie and Wu56 implemented a CAP pathway for non-ICU patients at 6 Canadian hospitals. They prospectively analyzed the effects of time to first antibiotic dose on inhospital mortality. Of the 3,043 patients included in analysis, the mortality rate for time to first antibiotic dose less than 4 hours was 9.2% and the rate for time to first antibiotic dose greater than 4 hours was 8.6%. If patients who received antibiotics before their arrival at the ED were removed (as in the study by Houck et al53), the mortality rate for time to first antibiotic dose less than 4 hours was 8.3% and the mortality rate for time to first antibiotic dose greater than 4 hours was 8.1%, a nonsignificant difference.

Battleman et al57 performed a Class III, multicenter, retrospective analysis of 609 patients with a chart-coding diagnosis of pneumonia. They examined the association between time to first antibiotic dose and prolonged length of stay (prolonged length of stay was defined as ≥9 days). They found an association between shorter time to first antibiotic dose and fewer patients with prolonged length of stay. This finding was also observed in patients who received their antibiotics in the ED rather than on the floor. This study excluded patients who died, and the actual data analysis of prolonged length of stay was not provided. Potential factors that may lead to a delayed diagnosis were not included in the analysis.

Six-Hour Cutoff 

No research has specifically examined a 6-hour cutoff for the time to first antibiotic dose. This time period was part of the data of the study by Houck et al53 mentioned above. This cutoff had a significant association with reduced mortality (adjusted OR 0.84; 95% CI 0.73 to 0.95); but the conclusions are limited by all of the same factors present in the 4-hour cutoff.

Beyond 6 Hours 

An 8-hour cutoff for time to first antibiotic dose has been analyzed in a number of studies. A large, multicenter, retrospective, Class III study by Meehan et al48 demonstrated an association between antibiotic administration within 8 hours of ED arrival and mortality (adjusted OR 0.85; 95% CI 0.75 to 0.96). This study shares the same methodology as the analysis by Houck et al,53 and its conclusions are limited by many of the same issues. Patients were included based on claims data, which may have led to selection bias. Confounding factors such as altered mental status, the absence of fever, and other clinical factors hindering diagnosis were not included in the multivariate analysis.

The study by Marrie and Wu56 mentioned above also included data on time to first antibiotic dose less than 8 hours compared with greater than 8 hours. There was no significant mortality difference between these 2 groups. Even when patients who received antibiotics before arrival at the hospital were removed from the cohorts, no significant mortality benefit emerged for early antibiotic administration.§

Dedier et al47 retrospectively studied 1,062 CAP patients from 38 hospitals. This Class III study examined the effect of time to first antibiotic dose less than 8 hours on inpatient mortality, length of stay, and time to clinical stability. There were no significant associations with rapid antibiotic administration in any of these measures. There is insufficient evidence to establish a specific cutoff time for antibiotics administration in patients who are diagnosed with CAP in the ED. In the noncritically ill patient, it is prudent to administer antibiotics as soon as possible after a definitive diagnosis is made.

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Relevant industry relationships of subcommittee members: There were no relevant industry relationships disclosed by the subcommittee members.

Relevant industry relationships are those relationships with companies associated with products or services that significantly impact the specific aspect of disease addressed in the critical question.

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Appendix 

Appendix A. Literature classification schema.
Design/ClassTherapyDiagnosisPrognosis§
1Randomized, controlled trial or meta-analyses of randomized trialsProspective cohort using a criterion standardPopulation prospective cohort
2Nonrandomized trialRetrospective observationalRetrospective cohort
Case control
3
Case series

Case report

Other (eg, consensus, review)


Case series

Case report

Other (eg, consensus, review)


Case series

Case report

Other (eg, consensus, review)

Some designs (eg, surveys) will not fit this schema and should be assessed individually.

Objective is to measure therapeutic efficacy comparing ≥2 interventions.

Objective is to determine the sensitivity and specificity of diagnostic tests.

§Objective is to predict outcome including mortality and morbidity.

Appendix B. Approach to downgrading strength of evidence.
DowngradingDesign/Class
123
NoneIIIIII
1 levelIIIIIX
2 levelsIIIXX
Fatally flawedXXX

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  •  Confusion based on specific mental test or disorientation to person, place, or time, Urea >7 mmol/L (20 mg/dL), Respiratory Rate ≥30 breaths/min, Blood pressure systolic <90 mm Hg or diastolic ≤60 mm Hg, and age ≥65 years.
  •  Infectious Diseases Society of America/American Thoracic Society grading: moderate recommendation, level III evidence.
  •  Time to clinical stability is a composite measure of the first 24-hour period during which the patient has all of the following: systolic blood pressure ≥90 mm Hg, pulse rate ≤100 beats/min, respiratory rate ≤24 breaths/min, temperature ≤101°F, O2 saturation ≥90, and the ability to eat.
  • § P values of 0.81 were calculated from the study data with the SPSS 14.0 statistical package (SPSS, Inc, Chicago, IL).

 Approved by the ACEP Board of Directors, June 23, 2009

 Supported by the Emergency Nurses Association, July 21, 2009

 Earn CME Credit: Continuing Medical Education is available for this article at: http://www.ACEP.EMedHome.com.

PII: S0196-0644(09)01225-6

doi:10.1016/j.annemergmed.2009.07.002

Annals of Emergency Medicine
Volume 54, Issue 5 , Pages 704-731, November 2009