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(Chest. 2002;122:612-617.)
© 2002 American College of Chest Physicians

Influence of Deviation From Guidelines on the Outcome of Community-Acquired Pneumonia*

Rosario Menéndez, MD; David Ferrando, MD; José M. Vallés, MD and Julia Vallterra, MD

* From the Pneumology Service, University Hospital La Fe, Valencia, Spain.

Correspondence to: Rosario Menéndez, MD, Servicio de Neumología, Hospital Universitario La Fe, Valencia 46009, Spain


   Abstract
TOP
 Abstract
Introduction
 Materials and Methods
 Results
 Discussion
 References
 
Study objectives: Consensus guidelines for the empirical treatment of community-acquired pneumonia (CAP) have been published. We investigated the following factors: (1) the degree of adherence to American Thoracic Society (ATS) and the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) guidelines; and (2) the influence of adhering to these guidelines on mortality and length of hospitalization.

Design: Prospective, observational study.

Setting: Tertiary-care teaching hospital.

Patients: Two hundred ninety-five patients with CAP who were consecutively admitted to the hospital and treated empirically.

Interventions: Patients were stratified according to the prognostic rule of Fine, and the antibiotic regimen prescribed in the first 24 h was evaluated as to whether or not it adhered to treatment guidelines.

Results: Adherence to SEPAR and ATS guidelines was 66% and 88%, respectively. There were no significant differences in mortality or duration of hospitalization between adherent and nonadherent regimens. However, mortality in severe CAP (Fine risk class V) was significantly higher in patients with nonadherent treatments (SEPAR: relative risk [RR], 2.6; 95% confidence interval [CI], 1.1 to 5.6; ATS: RR, 2.5; 95% CI, 1.1 to 5.8). In a multivariate analysis, adherence to ATS guidelines was independently associated with decreased mortality (RR, 0.3; 95% CI, 0.14 to 0.9) after adjusting for the Fine score.

Conclusions: Adherence was higher to ATS guidelines than to SEPAR guidelines. Severe CAP had a significantly higher mortality when the guidelines (both ATS and SEPAR) were not followed. Length of hospitalization was similar irrespective of adherence to either set of guidelines.

Key Words: community-acquired pneumonia • guidelines • length of hospital stay • mortality • prognosis • treatment


   Introduction
TOP
 Abstract
 Introduction
Materials and Methods
 Results
 Discussion
 References
 
Community-acquired pneumonia (CAP) is a common disease affecting three to five adults per thousand.1 2 3 Among hospitalized patients, CAP mortality ranges from 5 to 15%,4 and inadequate initial antibiotic treatment is a poor prognostic factor.5 6 7 However, in clinical practice, when antibiotic treatment needs to be administered, the causal microorganisms generally have yet to be identified. Since clinical and radiologic findings are not useful in predicting the etiologic agent, antibiotic treatment in CAP patients is as a rule prescribed empirically. To guide and assist in choosing the appropriate initial antibiotic regimen to be followed, different scientific societies have published several clinical guidelines8 9 that take into account different risk factors, such as age, comorbidity, and initial clinical severity.10 These guidelines must be implemented at a local level in each country. In 1997, the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) published a set of guidelines for the diagnosis and treatment of CAP in Spain.11 This document is similar, but not identical, to the recommendations issued earlier by the American Thoracic Society (ATS).9

It is likely, but not proven, that acceptance of and compliance to guidelines are related to an improvement in the prognosis of patients with CAP. However, it remains to be determined whether the strict adherence to the treatment recommended by these documents constitutes the best therapeutic option in each and every patient. Guidelines do incorporate some degree of uncertainty arising from the heterogeneity of the patients’ clinical condition and differences in etiologic microorganisms, and the quality of the evidence backing their recommendations is difficult to establish.12 13 14 Nevertheless, the efficacy of the treatment recommended by guidelines can be established by analyzing several parameters, such as their influence on change in treatment practices, their effects on mortality, as well as their impact on health care-related costs.

This study was designed to determine the empirical antibiotic regimen initially used in the treatment of patients with CAP in Spain and whether it adhered to that recommended by the SEPAR and ATS guidelines. The potential differences in mortality and length of hospital stay, which is the main source of health care-related costs, in patients treated according to the recommendations of each of the two documents were also investigated. These outcomes were analyzed taking into account the initial mortality risk in each patient, as recognized by Fine et al.15


   Materials and Methods
TOP
 Abstract
 Introduction
 Materials and Methods
Results
 Discussion
 References
 
From February 1998 to March 1999 (13 months), we conducted a prospective observational study at a university referral hospital that provides medical care for 500,000 people living in urban and rural areas. A certified pulmonary specialist is on duty every day at the hospital, 7 days a week, and is involved in admittance and treatment decisions. The study included all consecutive patients (> 16 years of age) who were admitted to the Respiratory Service showing clinical symptoms of pneumonia accompanied by the appearance of a new pulmonary infiltrate on the chest radiograph. The following patients were excluded: (1) those who had been hospitalized during the previous 10 days, (2) those who exhibited immunosuppression (AIDS, receiving chemotherapy or other immunosuppressive drugs), (3) those with aspiration pneumonia or tuberculosis, and (4) those with a confirmed alternative diagnosis. Patients residing in nursing homes were not excluded.

Before beginning the study, its aims and methods were presented to and discussed with all of the physicians in the Respiratory Service. The choice of empirical antibiotic therapy was entirely dependent on the physician treating the patient. Although the physicians were aware that the study was taking place, we did not intervene in the decision or inquire about the antibiotic choice, in order not to modify subsequent choices. All demographic and clinical data, as well as the evolution of the patient (deaths and length of stay), were recorded on a questionnaire specifically designed for the study. These data included the following: the age and sex of the patient; previous stay in a geriatric residence; any comorbidity (diabetes mellitus, chronic heart failure, COPD, cerebrovascular disease, cancer, liver and/or renal disease); findings of the physical examination on admission (respiratory and heart rate, body temperature, BP, and mental state); results of initial biochemical analyses (hematocrit, leukocyte count, renal function, sodium and potassium values, and arterial blood gases); and chest radiographic findings.

All patients were classified according to the SEPAR and ATS guidelines,9 11 as well as to the mortality risk scale of Fine et al.15 The SEPAR document classifies CAP according to its clinical severity and the presence or absence of risk factors for unusual pathogens. CAP is considered severe if one or more of the following criteria are present: hemodynamic instability; new onset of mental impairment; increased respiratory effort (respiratory rate > 30/min); multilobar involvement; presence of significant pleural effusion; respiratory failure (PaO2/fraction of inspired oxygen ratio < 300); acute renal failure; leukopenia (< 4,000/mL), or severe leukocytosis (> 30,000/mL); anemia; hypoalbuminemia; or bacteremia and/or septic metastasis. Risk factors for unusual pathogens include aging, presence of comorbidity (COPD, chronic heart failure, liver cirrhosis, chronic renal failure, diabetes mellitus, and alcoholism), lack of apparent response to an empirically correct antibiotic treatment, and radiologic signs suggestive of the presence of unusual pathogens. This document indicates that treatment for hospitalized CAP patients should include a third-generation cephalosporin (or amoxicillin-clavulanic acid), which should be combined with macrolides whenever unusual pathogens, including Legionella spp, are suspected, or CAP is severe.

In contrast to the SEPAR guidelines, the ATS document recommends that hospitalized CAP patients be administered a second-generation or third-generation cephalosporin (or a ß-lactam plus a ß-lactamase inhibitor) with the option of adding a macrolide. In the case of severe CAP, the guidelines indicate the prescription of a macrolide (with or without rifampin) and either a third-generation cephalosporin with antipseudomonal activity, or imipenem/cilastatin or ciprofloxacin.

Hospitalization criteria are similar in both the SEPAR and ATS documents. We considered the treatment prescribed during the first 24 h of hospitalization to be the initial treatment. All initial empirical antimicrobial therapy, whether or not adhering to either set of guidelines, was recorded. Prior antimicrobial treatment received in the outpatient setting for this infection was also recorded as a dichotomous variable (yes/no). All surviving patients were visited 30 days after discharge.

Statistical Analysis
Statistical analysis was carried out using a commercial statistical program (version 10.0; SPSS; Chicago, IL). Qualitative variables were compared using the {chi}2 test. As some quantitative variables did not follow a pattern of normal distribution, the Mann-Whitney U test was used to determine the statistical significance of the differences. Values of p <= 0.05 were considered significant. Two multivariate statistical analyses were performed by stepwise logistical regression using mortality as a dependent variable and the Fine score (five risk classes) as an independent variable; adherence to ATS guidelines was a variable in one of the analyses, and adherence to SEPAR guidelines was a variable in the other. These logistical regression analyses were performed using the likelihood probability ratio method and with the criteria p in (0.05), p out (0.1). Variables remaining in the multivariate analysis model that showed p <= 0.05 were considered significant.


   Results
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
Discussion
 References
 
We studied 295 patients (175 men and 120 women), with a mean ± SD age of 70.1 ± 15 years. Table 1 shows the percentage of adherence to both guidelines according to the initial risk class as defined by Fine et al.15


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  		Table 1. Distribution of Patients According to the Risk Groups, and Percentage of Adherence to SEPAR or ATS Guidelines*

 
Antibiotic treatment included the combination of a ß-lactam (third-generation cephalosporin or amoxicillin-clavulanic acid) and a macrolide (61%); a third-generation cephalosporin alone (18.6%); amoxicillin-clavulanic acid alone (6.1%); quinolones, alone or in combination with macrolides (5.1%); macrolides alone (4.4%); a second-generation cephalosporin, cefuroxime (3.4%); and others (1.3%). In 194 patients (65.8%), the antibiotic treatment followed the guidelines issued by SEPAR. Two hundred fifty-nine patients (87.8%) received antibiotic treatment that followed the ATS recommendations.

Prior ambulatory antimicrobial treatment had been prescribed in 36% of patients; in these patients, in-hospital empirical treatment adhered to ATS guidelines in 84%, compared with 90% in the group without prior treatment (p > 0.05); for the SEPAR guidelines, these results were 73% and 69%, respectively (p > 0.05).

Thirty-one patients (10.5%) died during hospitalization. Twelve of the patients who died belonged to the group that did not adhere to SEPAR guidelines (38.7% of this group), and 7 patients who died belonged to the group that did not adhere to the ATS guidelines (22.6% of the group). Differences in overall mortality did not reach statistical significance when analyzed according to adherence to guidelines, although a value of p = 0.06 was found in the case of ATS. However, when patients were stratified according to risk class (Table 2 ), mortality was found to be significantly higher in class V patients receiving treatment that did not adhere to either the SEPAR guidelines (20.6% vs 53.3%, respectively, p < 0.05; relative risk [RR], 2.6; 95% confidence interval [CI], 1.1 to 5.8) or ATS guidelines (25% vs 66%, respectively, p < 0.05; RR, 2.6; 95% CI, 1.2 to 5.6).


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  		Table 2. Mortality According to Adherence to SEPAR and ATS Guidelines in Patients Stratified by Risk Class*

 
Logistical regression analysis to predict mortality showed that both the Fine score and the adherence to guidelines were significant and independent variables; the Fine score was identified as a mortality risk factor (RR, 2.8; 95% CI, 1.7 to 4.7), and adherence to ATS guidelines was independently associated with decreased mortality (RR, 0.3; 95% CI, 0.14 to 0.9). However, when adherence to SEPAR guidelines was analyzed, the mathematical model found it to be a nonsignificant variable, as it had already been identified in the univariate analysis.

The mean duration of hospital stay was 9.7 ± 5.4 days (median, 9 days). In the group not adhering to the SEPAR guidelines, mean duration of hospital stay was 9.9 ± 6 days (median, 9 days), compared to 9.5 ± 5.1 days (median, 8 days) in those receiving treatment according to the SEPAR guidelines (Table 3 ). In the group not adhering to ATS guidelines, duration of hospital stay was 9.9 ± 5.6 days (median, 9 days), compared to 9.7 ± 5.4 days (median, 8 days) for those adhering to the ATS guidelines. These differences were not statistically significant. Mortality and length of stay according to the initial antibiotic treatment, irrespective of guidelines, are shown in Table 4 .


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  		Table 3. Length of Hospital Stay in Days in Relation to Risk Class*

 

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  		Table 4. Mortality and Length of Stay According to the Initial Antibiotic Treatment

 

   Discussion
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
References
 
The most important findings of this study are as follows: (1) there was higher adherence to the ATS guidelines than to the SEPAR guidelines (88% vs 66%, respectively); (2) despite differences between the recommendations in the two documents, mortality in patients with the most severe CAP (Fine risk class V) was much higher (almost double) when guidelines were not followed; (3) adherence to ATS guidelines was independently associated with decreased mortality; and (4) length of hospital stay was not influenced by the adherence to the ATS or SEPAR guidelines.

Clinical guidelines recommended by scientific societies have been widely published and have entered into widespread use over the past few years in almost every medical field. It is presumed that these documents should facilitate daily work, improve medical therapies, and reduce the variability of clinical practice. However, there is little evidence of their influence on patient prognosis, or their impact on relevant social and economic variables such as health care-related costs or length of hospitalization.16 17 18 For instance, Gleason et al17 were unable to show significant differences in medical outcomes in CAP outpatients treated according to, or not according to, the ATS guidelines.17

In Spain, the SEPAR guidelines11 for CAP management were published in 1997, 5 years after the publication of the ATS document,9 and several other guidelines19 20 21 and relevant revisions22 23 24 25 26 have since been published. Our study found that there is more adherence to the ATS guidelines than to the local guidelines, which may be due to the following: (1) the earlier release of the ATS guidelines; (2) the higher influence of the ATS recommendations on the medical community; (3) greater freedom of treatment choice in the ATS guidelines with respect to the combination of macrolides, as well as to the use of second-generation cephalosporins (in the SEPAR document, only third-generation cephalosporins are recommended for hospitalized CAP patients, due to the high rate of antimicrobial resistance of Streptococcus pneumoniae in Spain); and (4) the combined use of macrolides is more complex in the original Spanish guidelines,11 although a more recent revision shows more flexibility.27

Mortality rates in our study were similar to those reported by other researchers.28 29 Overall mortality was similar when treatment adhered to either SEPAR or ATS guidelines. While nonadherence to SEPAR guidelines had little impact on mortality, nonadherence to ATS guidelines resulted in a nearly doubled mortality; however, the difference in overall mortality did not reach statistical significance. Two other studies investigating initial empirical treatment according to the ATS document30 or the British Thoracic Society guidelines18 likewise did not demonstrate a difference in overall mortality. This may reflect a ß error due to sample size and other factors that influence survival.

The risk scale by Fine et al,15 which estimates the role of 20 clinical factors, is a valid and useful tool to predict mortality in hospitalized patients with CAP. We found that adherence to guidelines had a greater influence on mortality in the highest risk group (class V). Despite differences in the ATS and SEPAR guidelines, mortality was similarly affected by adherence to either set of guidelines in this high-risk subset.

These results provide important evidence that nonadherence to guidelines has a negative influence on mortality in high-risk patients, thereby showing that there is room for improvement in patient care.31 Logistic regression adjusted according to Fine risk class demonstrated that nonadherence to the ATS guidelines adversely affected mortality (p < 0.05). Nonadherence to SEPAR guidelines did not have a significant effect. However, this observation needs to be replicated in a larger number of patients before conclusions about the significant impact on survival can be reached. Further, because this was an observational study, there could have been differences in patients selected for nonadherence to the ATS protocol that are not part of the Fine criteria, but still adversely impact survival.

A more detailed analysis of mortality data according to the initial empirical treatment, whether or not it complied with guidelines, also led to interesting observations. The frequent use of a ß-lactammacrolide combination probably reflects the high prevalence of Legionella28 in the Mediterranean area, although more recent studies have shown that the most frequent etiological agents in this area are S pneumoniae and Mycoplasma pneumoniae.32 Gleason et al33 recommended the use of a third-generation cephalosporin in combination with a macrolide, based on higher survival trends compared with other antibiotic regimens. Similar to their study, our data suggest that mortality may be higher with amoxicillin-clavulanic acid or a combination of aminoglycosides and other antibiotics, although data in our study were too small to prove statistical significance, and neither study was randomized. In a large study performed in nonteaching hospitals, Dudas et al34 also found decreased mortality in patients with CAP empirically treated with a ß-lactam and a macrolide.

Length of hospital stay was not significantly affected by adherence to the guidelines, although the median value was 1 day shorter with guideline adherence. This is in keeping with results published by Marras and Chan30 and Hirani and Macfarlane.18 However, Stahl et al35 reported that the early use of macrolides (during the first 24 h of hospital admission) reduces the length of stay, although a companion editorial by Dowell36 indicates that this observation may be due to a systematic bias. Gleason et al33 were unable to find differences in length of hospitalization according to the use of different antibiotic regimens. Length of hospital stay for patients with CAP is influenced by many factors, including initial clinical severity of the disease, different clinical practices, presence of comorbidity, and characteristics of the hospital,37 38 39 40 41 42 which may override the potential effect of a specific antibiotic regimen on length of stay. It has been suggested that new fluoroquinolones43 and doxycycline44 may have an influence on outcome and length of stay. As doxycycline is not used in Spain for the treatment of CAP, and the newer fluoroquinolones were introduced at a later date, we have no data on their use.

This study has several potential limitations that should be addressed. Firstly, it is an observational nonrandomized study. This reduces the level of confidence for its main finding, ie, that in patients with severe CAP nonadherence to guidelines increases mortality. The study design does not allow us to rule out the possibility that treatments not adhering to guidelines may have been chosen for a group of patients with more severe initial disease, despite their belonging to the same risk class as other patients. Secondly, the therapeutic changes introduced after the initial antibiotic treatment had been prescribed were not investigated; however, using multivariate analysis, Gleason et al33 showed that such changes did not influence the final outcome.

In summary, the results of this study show that nonadherence to published guidelines for the empirical treatment of CAP may contribute to increased mortality, particularly in patients with severe disease. These data support the recommendations of these guidelines. Similar retrospective evaluation or prospective randomized trials should be undertaken to evaluate the need for future changes in treatment guidelines.


   Footnotes
 
Abbreviations: ATS = American Thoracic Society; CAP = community-acquired pneumonia; CI = confidence interval; RR = relative risk; SEPAR = Spanish Society of Pulmonology and Thoracic Surgery

Received for publication December 11, 2000. Accepted for publication January 30, 2002.


   References
TOP
 Abstract
 Introduction
 Materials and Methods
 Results
 Discussion
 References
 

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R. Menendez, M.J. Cremades, E. Martinez-Moragon, J.J. Soler, S. Reyes, and M. Perpina
Duration of length of stay in pneumonia: influence of clinical factors and hospital type
Eur. Respir. J., October 1, 2003; 22(4): 643 - 648.
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