Validation of Scoring Systems for Predicting Severe Community-Acquired Pneumonia

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1 ORIGINAL ARTICLE Validation of Scoring Systems for Predicting Severe Community-Acquired Pneumonia Hajime Fukuyama, Tadashi Ishida, Hiromasa Tachibana, Hiroaki Nakagawa, Masahiro Iwasaku, Mika Saigusa, Hiroshige Yoshioka, Machiko Arita and Toru Hashimoto Abstract Objective Several scoring systems have been derived to identify patients with severe community-acquired pneumonia (CAP). Recently, España et al (Am J Respir Crit Care Med 174: , 2006) developed a clinical prediction rule that predicts hospital mortality, the need for mechanical ventilation, and risk for septic shock. We assessed the performance of this rule and compared it with other published scoring systems. Methods A prospective study was conducted of patients with CAP who were hospitalized at our hospital from April 2007 till May Clinical and laboratory features at presentation were recorded and used in order to calculate España rule, the pneumonia severity index (PSI), CURB-65, A-DROP, the 2007 Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) prediction rule and SMART-COP. The sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were compared for adverse outcomes. We also assessed the association of the España rule criteria and adverse outcomes. Results A total of 505 patients were enrolled in the study. The overall in-hospital mortality rate was 6.5%, and 6.3% of patients were admitted to the intensive care unit (ICU). Sixty-two (12.3%) patients were defined as having severe CAP (in-hospital death or need for mechanical ventilation or septic shock). España rule achieved highest sensitivity and NPV in predicting severe CAP. When ICU admission was the outcome measure, the IDSA/ATS rule and SMART-COP were regarded to be good predictors. Conclusion España rule performed well in identifying patients with severe CAP. As a result, each of the severity scores has advantages and limitations for predicting adverse outcomes. Key words: community-acquired pneumonia, prediction rule, España rule, severity, adverse outcomes (Intern Med 50: , 2011) () Introduction Community-acquired pneumonia (CAP) is a common and serious disease. Severity scores are often used in the initial assessment and are quite useful in management decisions. Most published severity scores, such as the Pneumonia Severity Index [PSI] (1) have been described to predict mortality and to decide whether a given patient can be treated as an outpatient or should be admitted to the hospital. These scores, however, are less accurate in identifying patients with severe CAP who require intensive care unit (ICU) admission for ventilatory or circulatory support (2-4). Delayed transfer to the ICU may be associated with increased mortality (5). There is a need for the establishment of valid criteria for the identification of severe CAP and ICU admission. In a recent article, España and colleagues have reported a new clinical prediction rule for severe community acquired pneumonia (SCAP) (6-8). Using prospective and retrospective data from five Spanish hospitals, España and colleagues identified eight clinically available variables that can help identify patients with or at risk for hospital mortality, need for mechanical ventilation, and septic shock. The variables of scores are grouped into major (ph <7.30 and systolic pressure <90 mmhg) and minor (confusion, urea >30 mg/ dl, respiratory rate >30/min, X-ray multilobar/bilateral lung affecation, PaO2 <54 or PaO2/FIO2 <250 mmhg, age 80 years). The evaluation of SCAP is based on the presence of Department of Respiratory Medicine, Kurashiki Central Hospital, Japan Received for publication February 7, 2011; Accepted for publication May 22, 2011 Correspondence to Dr. Hajime Fukuyama, fukuyama_hajime@hosp.pref.okinawa.jp 1917

2 one major criterion or two or more minor criteria. In this study, we have validated España rule in predicting adverse outcomes. Then we compared the results of applying España rule with those derived from the application of four other severity scores: the PSI (1), the British Thoracic Society s CURB-65 (9), the Japanese Respiratory Society s A-DROP (10), and the 2007 Infectious Diseases Society of America/American Thoracic Society (IDSA/ATS) guidelines prediction rule (11). Additionally, we also evaluated the SMART-COP scoring system (12) which was developed and published after the start of this study. Materials and Methods Study design and subjects The study was conducted at Kurashiki Central Hospital (a 1,135-bed community hospital in Kurashiki City, Okayama, Japan). All consecutive patients admitted to the hospital with pneumonia from April 2007 till May 2009 were prospectively recruited and followed up. Pneumonia was defined as a new infiltrate together with symptoms and signs of a lower respiratory tract infection: fever (>38 ), cough, purulent sputum. Patients with pneumonia were classified into following groups: hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), healthcare-associated pneumonia (HCAP), and CAP. HAP was defined as pneumonia that occurred 48 hours or more after admission. VAP was defined as pneumonia that arose more than 48 hours after endotracheal intubation. HCAP was defined as pneumonia in a patient with more than one of the following risk factors: 1) Hospitalization for two days or more in the preceding 90 days, 2) Residence in a nursing home or extended care facility, 3) Home infusion therapy including antibiotics, 4) Home wound care, 5) Chronic dialysis within 30 days. Patients were classified into CAP if they did not meet the criteria for HAP, VAP and HCAP. HAP, VAP and HCAP were excluded from the study. We also excluded patients if they were considered to have co-morbid conditions which were distinguished from pneumonia diagnostically or therapeutically during follow-up. The study was performed according to the Japanese ethical guidelines for epidemiologic research and approved by the internal review board of Kurashiki Central Hospital. Data collection and evaluation The following parameters were recorded at admission: age, sex, tobacco use, co-morbidity, clinical symptoms and signs, arterial blood gas measurements, chest radiograph findings, laboratory parameters. Chest radiograph findings were determined by more than two doctors. ICU admission, septic shock, the need for invasive mechanical ventilation, initial treatment failure, recurrence, length of hospital stay, readmission within 30 days, and in-hospital mortality were noted. The diagnosis of aspiration pneumonia was made when a patient developed pneumonia after an aspiration or aspiration contents were absorbed from the respiratory tract. In addition, we undertook one of the swallowing function tests in suspected cases: water swallowing test and video fluorography. We calculated España rule (8 variables), the PSI (20 variables), CURB-65 (5 variables), A-DROP (5 variables) and the IDSA/ATS rule (11 variables) at hospital admission. And SMART-COP (8 variables) was calculated retrospectively. Missing values were set to normal. Definition of severe CAP Severe CAP is often used to describe patients with pneumonia treated in the ICU (13). However, the decision to admit a patient with CAP to the ICU may depend on subjective clinical judgment and on that of local practices in the healthcare setting. Therefore, there is no universally accepted definition for severe CAP. As described in the article by España and colleagues, we used the term severe CAP as community-acquired pneumonia with at least one of the following outcomes: in-hospital death, need for mechanical ventilation, and septic shock. Statistic analysis All data were analyzed and processed on SPSS Version 16.0 for Windows. Categorical variables were compared using χ 2 or Fisher exact test. The level of statistical significance was set at p=0.05. The univariate association of España rule and that of each of the severity criteria with adverse events are expressed as the relative risk and the 95% confidence interval. The performance of the severity scores in predicting adverse outcomes was evaluated by calculating and comparing their sensitivity, specificity, and positive predictive value (PPV) and negative predictive value (NPV). Results A total of 505 patients were enrolled in the study. The baseline characteristics and outcome measures for patients with CAP are described in Table 1. The median age was 76 years. The overall in-hospital mortality rate was 6.5%, and 6.3% of patients were admitted to the ICU. Sixty (11.9%) patients were defined as having severe CAP (in-hospital death or need for mechanical ventilation or septic shock). Table 2 shows univariate analysis of the eight criteria of España rule for adverse outcomes. All variables in the criteria except for age ( 80 years) were individually predictive of severe CAP. Age ( 80 years) was not a predictive factor of mortality and ICU admission. Table 3 shows values of all prediction rules for the adverse outcomes. Because information on arterial blood gases was not available for 205 patients (40.6%), we excluded these patients from the evaluation. España rule achieved highest sensitivity and NPV in predicting severe CAP. However, España rule had lower specificity and PPV compared with four other severity scores (CURB-65, A-DROP, the IDSA/ATS rule, SMART-COP). España rule was similar to 1918

3 Table 1. Baseline Characteristics and Outcome Measures of Patients with Community-acquired Pneumonia Characteristics n = 505 n(%) or median(iqr) Age, y ears 76 (67-83) Sex, Male/Female 339/166 History of smoking 303 (60.0) Comorbidity, median Chronic pulmonary disease 200 (39.6) Chronic heart disease 126 (25.0) Chronic liver disease 36 (7.1) Chronic renal disease 31 (6.1) Cerebrovascular disease 120 (23.8) Diabetes mellitus 100 (19.8) C ancer 47 (9.3) Collagen vascular disease 21 (4.2) D ementia 40 (7.9) I mmunosuppression 22 (4.4) Home oxygen therapy 26 (5.1) A spiration 124 (24.6) Clinical parameters Altered mental status 87(17.2) Pulse rate, / minute 97 (85-110) Respiratory rate, / minute 22 (19-28) Systolic blood pressure, m mhg 126 ( ) Diastolic blood pressure, m mhg 71 (60-82) Body temperature, º C ( ) Laboratory and X-ray findings CRP, m g/dl ( ) Glucose, m g/dl 128 ( ) Albumin, g /dl 3. 2 ( ) Blood urea nitrogen, mg/dl 18 (14-26) Sodium, m Eq/L 137 ( ) Hematocrit, % ( ) WBC count, 10 3 /mm ( ) Platelet count, 10 4 /mm ( ) PaO 2/F IO ( ) PaCO 2, Torr 37.3 ( ) Arterial ph 7.44 ( ) Multilobar/bilateral lung affectation in X-ray 280 (55.4) Outcome measures In-hospital mortality 33 (6.5) Mechanical ventilation 38 (7.5) Septic shock 28 (5.5) ICU admission 32 (6.3) Initial treatment failure 57 (11.3) Recurrence 64 (12.7) Length of hospital stay, days 10 (7-18) Readmission within 30days 27 (5.3) ICU=intensive care unit; IQR=interquartile range the PSI, but it showed slightly better results. The IDSA/ATS rule and SMART-COP performed well for predicting ICU admission. Discussion España rule is a simple score that uses eight variables, which are easily accessible at the time of emergency department (ED) admission. The main point of the rule is to help identify patients with severe CAP, or those who are at risk for developing it at the time of admission. In our study, we evaluated España rule and compared its performance with other published scores for different outcomes. The present results showed that España rule achieved sensitivity of 98.2%, specificity of 39.3%, PPV of 27.2%, and NPV of 99.0% in predicting SCAP. These results were similar to those reported by España et al (6). España rule had a high sensitivity and NPV for adverse outcomes. However, the specificity and PPV were low. Thus, España rule tended to overestimate severe CAP in clinical practice. But it is important to identify the high risk group of patients and promptly admit them from the ED to the ICU, a severity score should demonstrate high sensitivity and high NPV, and it must be simple to work properly and usefully (3). Regarding this point, España rule may be useful for triaging patients in the ED setting. Patients who are identified as not severe by España rule are unlikely to die or require intensive care. España et al demonstrated its usefulness for identifying low-risk patients (8). Among the España rule 8 variables, older age (

4 Table 2. Univariate Analysis of España Rule Criteria for Outcomes Variable Severe CAP* ICU admission Mortality OR 95% CI p value OR 95% CI p value OR 95% CI p value Confusion (n=505) < < <0.001 Urea > 30 mg/dl (n=505) < < <0.001 Respiratory rate > 30/min (n=505) < < <0.001 Multilobar/bilateral X-ray (n=505) < < PaO 2 < 54 mmhg or PaO 2/F IO 2 < 250 mmhg (n=300) < < <0.001 Age 80 yr (n=505) ph < 7.30 (n=300) < < Systolic Pressure < 90mmHg (n=505) < < CI=confidence interval; ICU=intensive care unit; OR=odds ratio * Community-acquired pneumonia with in-hospital death or need for mechanical ventilation or septic shock Table 3. Predictive Performance of Severity Scores for Adverse Outcomes Severe CAP* España rule PSI (IV-V) A-DROP (3-5) CURB-65 (3-5) IDSA/ATS rule SMART-COP(3-11) ICU admission España rule PSI (IV-V) A-DROP (3-5) CURB-65 (3-5) IDSA/ATS rule SMART-COP(3-11) Mortality España rule PSI (IV-V) A-DROP (3-5) CURB-65 (3-5) IDSA/ATS rule SMART-COP(3-11) Sensitivity Specificity PPV NPV 55/56(98.2%) 54/56(96.4%) 40/56(71.4%) 35/56(62.5%) 51/56(91.1%) 54/56(96.4%) 29/31(93.5%) 29/31(93.5%) 22/31(71.0%) 24/31(77.4%) 29/31(93.5%) 31/31(100%) 29/30(96.7%) 28/30(93.3%) 23/30(76.7%) 18/30(60.0%) 26/30(86.7%) 28/30(93.3%) 95/242(39.3%) 84/242(34.7%) 151/242(62.4%) 175/242(72.3%) 165/242(68.2%) 121/242(50.0%) 94/267(35.2%) 84/267(31.5%) 158/267(59.2%) 189/267(70.8%) 168/267(62.9%) 123/267(46.1%) 95/268(35.4%) 84/268(31.3%) 160/268(59.7%) 184/268(68.7%) 166/268(61.9%) 121/268(45.1%) 55/202(27.2%) 54/212(25.5%) 40/131(30.5%) 35/102(34.3%) 51/128(39.8%) 54/175(30.9%) 29/202(14.4%) 29/212(13.7%) 22/131(16.8%) 24/102(23.5%) 29/128(22.7%) 31/175(17.7%) 29/202(14.4%) 28/212(13.2%) 23/131(17.6%) 18/102(17.6%) 26/128(20.3%) 28/175(16.0%) 95/96(99.0%) 84/86(97.7%) 151/167(90.4%) 175/196(89.3.%) 165/170(97.1%) 121/123(98.4%) 94/96(97.9%) 84/86(97.7%) 158/167(94.6%) 189/196(96.4%) 168/170(98.8%) 123/123(100%) 95/96(99.0%) 84/86(97.7%) 160/167(95.8%) 184/196(93.9%) 166/170(97.6%) 121/123(98.4%) NPV=negative predictive value; PPV=positive predictive value; * Community-acquired pneumonia with in-hospital death or need for mechanical ventilation or septic shock years) was not associated with adverse outcomes. Aggressive interventions may not be appropriate for many older patients and they tend not to be intubated and admitted to the ICU. One study identified that age younger than 80 years was independently associated with ICU admission (14). The data from the present study showed that age older than 85 years was associated with mortality (OR 1.98, p=0.05). With the aging progress in our country and medical technological change, it is thought that the median age of dying cases are older in the present study than in the past studies, also supported by the result that the median age (76 years) in this study is older than in the past studies. Arterial ph <7.30 was associated with severe CAP and ICU admission, but not associated with mortality. Most cases that the arterial ph <7.30 received mechanical ventilation support and were transferred to the ICU immediately. This might lead the decrease of mortality. Multilobar/bilateral lung affectation in X-rays was associated with adverse outcomes. The variable is included in the IDSA/ATS rule and has recently been reported to be related to treatment failure and poor prognosis (15). Fifty-five patients had multilobar/bilateral lung affectation in X-rays in the study. This is far higher than the incidence reported in the studies of España (6-8). One reason was that 124 patients (24.6%) were aspiration pneumonia, and 86 patients of them (69.4%) had multilobar/bilateral lung affectation in this study. The X-ray findings such as multilobar/bilateral involvement may be predictive factors for poor prognosis. The PSI scoring system is widely used and has been well validated. This score was primarily designed to identify patients with a low mortality risk who could safely be treated as outpatients. However, the PSI does not have an accurate prediction for the demand of ICU care (2, 4, 16). In the present study, España rule was slightly better than the PSI in predicting adverse outcomes. We think España rule is more useful, because the number of variables is only 8 in España rule compared to 20 in the PSI scoring system. CURB-65 is a scoring system that has also been widely 1920

5 studied. A-DROP is a scoring system proposed by the Japanese Respiratory Society; it is a modified version of CURB- 65. Both scoring systems have the advantage of being easy to use, with only five assessments. However, under the condition of the current study, they had poor sensitivity for predicting adverse outcomes. Consequently, many patients with severe CAP were incorrectly classified as having low-tointermediate risk (score 0-2). When ICU admission was the outcome measure, the IDSA/ATS rule and SMART-COP were good predictors. The IDSA/ATS rule has been developed and validated in predicting ICU admission (17, 18). But it goes without saying that two major criteria the need for invasive mechanical ventilation or vasopressor are regarded as obvious reasons for ICU admission. Further investigation is needed to validate the minor criteria. SMART-COP is also a clinical prediction rule that focuses on severe CAP which has been proposed in recent years. Charles and colleagues have developed the SMART-COP, which predicts the need for intensive respiratory or vasopressor support (12). One study has evaluated the usefulness of SMART-COP for young adults (19). Likewise, in studies reported before, the PSI had lower specificity, and CURB-65 had lower sensitivity (6, 7, 9, 10, 12). There are several limitations to our study that should be acknowledged. First, only hospitalized patients in a single center were included in this study. Thus, our study sample may not reflect the full spectrum of the patient population. Second, HCAP patients were excluded from the study. HCAP is a relatively new category of nosocomial pneumonia, and recent evidence indicates that HCAP differs from CAP with respect to pathogens and prognosis (20, 21). Therefore, we decided to exclude patients with HCAP. Recently, one study has evaluated the performance of PSI, CURB-65, and España rule in patients with CAP and HCAP (22). In the study, these scores had a good performance in patients with CAP but were less useful in patients with HCAP. Third, in our analyses, we assumed missing values. Because information about arterial blood gases was not available in 205 patients (40.6%), we evaluated the performance of severity scores with patients in whom all data were available. Arterial blood gas analysis tended not to be performed in patients without respiratory failure. Therefore, we could not exclude the possibility of elimination of low severity cases. There was no missing data except for arterial blood gases. In conclusion, España rule performed well in identifying patients with severe pneumonia, but it slightly overestimated the severity of pneumonia. Compared with other published severity scores, España rule had higher sensitivity and NPV. Each of the severity scores has advantages and limitations. Further research involving a large number of patients from different institutions and geographic areas is needed. The authors state that they have no Conflict of Interest (COI). Acknowledgement The authors thanks Drs. Kazuya Tsubouchi, Satoshi Konishi, Yohei Korogi, Akihiro Nishiyama, Kei Kunimasa, Chiya Iga, Akihiro Ito, Masaki Yamamoto, Toshihide Yokoyama, Satoshi Ubukata, Hidetoshi Hayashi, Maki Noyama, Hiroki Nagai and Fumiaki Tokioka for their support and data provided for our study. References 1. Fine MJ, Auble TE, Yealy DM, et al. A predicition rule to identify low-risk patients with community-acquired pneumonia. N Engl J Med 336: , Angus DC, Marrie TJ, Obrosky DS, et al. Severe communityacquired pneumonia: use of intensive care services and evaluation of American and British Thoracic Society Diagnostic criteria. Am J Respir Crit Care Med 166: , Buising KL, Thursky KA, Black JF, et al. A prospective comparison of severity scores for identifying patients with severe community acquired pneumonia: reconsidering what is meant by severe pneumonia. Thorax 61: , Valencia M, Badia JR, Cavalcanti M, et al. Pneumonia Severity Index class V patients with community-acquired pneumonia. Characteristics, outcomes and value of severity scores. Chest 132: , Leroy O, Santré C, Beuscart C, et al. A five-year study of severe community-acquired pneumonia with emphasis on prognosis in patients admitted to an intensive care unit. Intensive Care Med 21: 24-31, España PP, Capelastegui A, Gorordo I, et al. Development and validation of a clinical prediction rule for severe communityacquired pneumonia. Am J Respir Crit Care Med 174: , Yandiola PP, Capelastegui A, Quintana J, et al. Prospective comparison of severity scores for predicting clinically relevant outcomes for patients hospitalized with community-acquired pneumonia. Chest 135: , España PP, Capelastegui A, Quintana JM, et al. Validation and comparison of SCAP as a predictive score for identifying low-risk patients in community-acquired pneumonia. J infect 60: , Lim WS, van der Eerden MM, Laing R, et al. Defining community-acquired pneumonia severity on presentation to hospital: an international derivation and validation study. Thorax 58: , Miyashita N, Matsushima T, Oka M; Japanese Respiratory Society. The JRS guidelines for the management of communityacquired pneumonia in adults: an update and new recommendations. Intern Med 45: , Mandell LA, Wunderink RG, Anzueto A, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community acquired pneumonia in adults. Clin Infect Dis 44 (Suppl 2): S27-S72, Charles PG, Wolfe R, Whitby M, et al. SMART-COP: a tool for predicting the need for intensive respiratory or vasopressor support in community-acquired pneumonia. Clin Infect Dis 47: , Ewig S, Ruiz M, Mensa J, et al. Severe community-acquired pneumonia. Assessment of severity criteria. Am J Respir Crit Care Med 158: , Renaud B, Labarere J, Coma E, et al. Risk stratification of early admission to the intensive care unit of patients with no major criteria of severe community-acquired pneumonia: development of an international prediction rule. Crit Care 13: R54, Menedez R, Torres A, Zalacain R, et al. Risk factors to treatment 1921

6 failure in community acquired pneumonia: implications for disease outcome. Thorax 59: , Ewig S, de Roux A, Bauer T, et al. Validation of predictive rules and indices of American and British Thoracic Society diagnostic criteria. Am J Respir Crit Care Med 166: , Liapikou A, Ferrer M, Polverino E, et al. Severe communityacquired pneumonia: validation of Infectious Diseases Society of America/American Thoracic Society guidelines to predict an intensive care unit admission. Clin Infect Dis 48: , Phua J, See KC, Chan YH, et al. Validation and clinical implications of the IDSA/ATS minor criteria for severe communityacquired pneumonia. Thorax 64: , Chalmers JD, Singanayagam A, Hill AT. Predicting the need for mechanical ventilation and/or inotropic support for young adults admitted to the hospital with community-acquired pneumonia. Clin Infect Dis 47: , Kollef MH, Shorr A, Tabak YP, Gupta V, Liu LZ, Johannes RS. Epidemiology and outcomes of health-care-associated pneumonia: results from a large US database of culture-positive pneumonia. Chest 128: , Kollef MH, Morrow LE, Baughman RP, et al. Health careassociated pneumonia (HCAP): a critical appraisal to improve identification, management, and outcomes-proceedings of the HCAP summit. Clin Infect Dis 46 (suppl 4): S296-S334, Falcone M, Corrao S, Venditti M, Serra P, Licata G. Performance of PSI, CURB-65, and SCAP scores in predicting the outcome of patients with community-acquired and healthcare-associated pneumonia. Intern Emerg Med 2011 Jan 20. [Epub ahead of print] The Japanese Society of Internal Medicine

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