Community‐acquired pneumonia (CAP) is commonly defined as an infection of the pulmonary parenchyma that is associated with at least some symptoms and signs of acute infection, accompanied by the presence of an acute infiltrate on chest radiograph, in a patient not hospitalized or residing in a long‐term‐care facility for 14 days prior to the onset of symptoms.1 CAP continues to be a common and serious illness, causing substantial morbidity and mortality in the adult population. There are an estimated 56 million cases a year in the United States, with greater than 1 million hospitalizations. Community‐acquired pneumonia is one of the most common admitting diagnoses among adults, and with a 30‐day mortality between 10% and 14% for patients admitted to the hospital, it is the leading cause of infectious death in the United States.2 In elderly patients, hospitalization for CAP portends a poor long‐term prognosis. In a Medicare database, the 1‐year mortality for patients with CAP was nearly 40%, compared to 29% in patients with other diagnoses.3 Community‐acquired pneumonia is a model illness in hospital medicineit is a common disease that allows for evidence‐based and cost‐effective management. In addition, many national organizations have proposed multiple quality indicators for community‐acquired pneumonia, thus providing an opportunity for institutional quality improvement. This review article outlines the assessment and management of patients admitted to the hospital with community‐acquired pneumonia.

Etiology

Although many pathogens can cause community‐acquired pneumonia, the clinical syndromes and microbiology of CAP have traditionally been characterized as either typical or atypical. The typical organisms include Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, and the atypical organisms include Chlamydia spp., Mycoplasma pneumoniae, Legionella spp., and viruses. This historical distinction has recently come into question. It is now clear that the presenting symptoms, signs, and basic laboratory findings (including the chest radiograph) cannot be reliably used to predict the etiologic pathogen or to distinguish typical from atypical organisms.4 Rather, the specific causative agent of CAP depends more on the degree of patient illness. Table 1 shows what prospective studies with comprehensive diagnostic strategies determined to be the most common pathogens in patients hospitalized for CAP in ICU and non‐ICU settings.5 Streptococcus pneumoniae remains the most common cause of CAP in hospitalized patients and is the most common cause of fatal pneumonia, whereas Legionella spp. is a common cause of severe CAP, more often found in patients requiring admission to the intensive care unit. Gram‐negative bacilli can cause CAP in elderly patients and those recently treated with broad‐spectrum antibiotics or with underlying lung disease. Notably, though, despite improved diagnostic testing, only one quarter of all admitted patients with CAP have the etiologic agent defined, and therefore empiric therapy should be directed broadly at the most likely organisms.6

Clinical Presentation

Patients admitted to the hospital with CAP typically present with a brief history of respiratory complaints, including cough (greater than 90%), dyspnea (66%), sputum production (66%), and pleuritic chest pain (50%); see Table 2.7, 8 In 10%30% of patients, nonrespiratory complaints predominate, including headache, myalgias, fatigue, and gastrointestinal symptoms.6 Elderly patients, an increasing percentage of hospitalized patients, are less likely to present with typical CAP symptoms (such as cough) and more likely to have altered mental status as a presenting symptom.9

On physical examination, patients with CAP usually have signs of fever (80%), tachypnea (70%), and tachycardia (50%); see Table 2. Most will have a focal lung exam (>90%) with findings ranging from crackles to bronchial breath sounds.10 No exam finding is specific for the diagnosis of pneumonia, but the absence of fever, tachycardia, and tachypnea significantly reduces the probability of CAP in patients with suspected pneumonia.10 Furthermore, similar to the clinical history, the physical examination of elderly patients with community‐acquired pneumonia is not specific or sensitive for the diagnosis of CAP. For example, up to 40% of elderly patients subsequently determined to have CAP may not have fever.11

Leukocytosis is common in patients with CAP; however, its absence does not rule out disease.12 A number of guidelines recommend laboratory evaluation of electrolytes, urea nitrogen, creatinine, liver enzymes, and bilirubin, although these are used primarily for prognostication and are not specifically useful in the diagnosis of CAP.

DIAGNOSIS

Diagnostic Studies

The diagnosis of community‐acquired pneumonia requires that a patient have both signs and symptoms consistent with pulmonary infection and evidence of a new radiographic infiltrate. Therefore, most guidelines recommend that all patients with a possible diagnosis of CAP be evaluated with chest radiography.1, 14, 15

The specific radiographic findings in community‐acquired pneumonia range from lobar consolidation to hazy focal infiltrate to diffuse bilateral interstitial opacities (see Figure 1). Although chest radiography has traditionally been considered the gold standard for the diagnosis of CAP, its exact performance characteristics are unknown, and it is clearly not 100% sensitive or 100% specific. The utility of the chest radiograph can be limited by patient body habitus, underlying lung disease, or dehydration. Computed tomography (CT) scanning, although not recommended for routine use, can identify pulmonary consolidation in up to 30% of patients with a normal or equivocal chest radiograph in whom pneumonia is suspected and can also identify complications of pneumonia including an empyema or pulmonary abscess.16

Figure 1

Limitations in the performance of the chest radiograph have resulted in an interest in the diagnostic performance of serologic markers of infection such as C‐reactive protein (CRP), procalcitonin, and soluble triggering receptor expressed on myeloid cells (s‐TREM).1719 Preliminary evidence suggests these inflammatory markers may ultimately prove useful in differentiating infectious from noninfectious pulmonary processes, but regular use of these new tests cannot currently be recommended.

Most expert guidelines state that 2 sets of blood cultures should be taken and analyzed prior to antibiotic administration in all patients admitted to the hospital with suspected community‐acquired pneumonia.1, 14, 15 Isolation of bacteria from blood cultures in CAP is a very specific way to identify a causative organism in order to subsequently narrow therapy and also identifies a high‐risk group of patients because bacteremia is associated with increased mortality. Obtaining blood cultures within 24 hours of admission has been associated with 10% lower odds of 30‐day mortality in patients with CAP,20 and as a result, drawing blood cultures prior to antibiotic administration is a national quality indicator for CAP.

There are, however, a number of problems with the routine acquisition of blood cultures in all patients admitted with CAP. Practically, the cultures can be difficult to obtain, can potentially delay the initiation of antibiotics, and are often contaminated, which has been shown to increase both cost and length of stay.21, 22 The yield is generally low: the true‐positive bacteremia rate for admitted patients with CAP ranges from 6% to 9%, and the culture results rarely change management or outcomes.23, 24 Given these limitations, many have argued that blood cultures should be obtained with a more targeted approach. A recent study used a Medicare database to create a decision‐support tool to help maximize the value of blood cultures in CAP.25 The predictors of a positive blood culture are shown in Table 3. Not obtaining cultures on patients who had received prior antibiotics or had no risk factors resulted in about 40% fewer overall cultures while identifying approximately 90% of bacteremias. In their guidelines, the British Thoracic Society (BTS) advocates a similar strategy, recommending blood cultures be omitted in nonsevere pneumonia and in patients without comorbidities.15, 26 Although recommendations vary for non‐severe CAP in hospitalized patients, all professional society guidelines agree that blood cultures should be obtained in critically ill patients, and if cultures are obtained, they should be drawn prior to antibiotics.1, 14, 15, 26

Table 3.Independent Predictors of Bacteremia in Patients with Community‐Acquired Pneumonia24

Comorbidities
Liver disease
Vital signs
Systolic blood pressure < 90 mm Hg
Temperature < 35C or 40C
Pulse 125 beats/min
Laboratory and radiographic data
Blood urea nitrogen (BUN) 30 mg/dL
Sodium < 130 mmol/L
White blood cells < 5000/mm3 or > 20,000/mm3
Prior use of antibiotics (negative predictor)

Substantial controversy surrounds the utility of routine sputum gram stains and cultures for patients admitted to the hospital with CAP. The Infectious Disease Society of America (IDSA) and the British Thoracic Society (BTS) both recommend that all patients admitted to the hospital with community‐acquired pneumonia should have a gram stain and culture of expectorated sputum.1, 15, 26 Both organizations argue sputum collection is a simple and inexpensive procedure that can potentially identify pathogenic organisms and can affect both initial and long‐term antibiotic therapy. Most notably, they highlight gram stain specificity of greater than 80% for pneumococcal pneumonia. Conversely, the American Thoracic Society (ATS) argues that sputum gram stains and cultures generally have low sensitivity, specificity, and positive predictive value.14 Furthermore, they argue the utility of sputum testing is also limited practically; in one study 30% of patients could not produce an adequate sputum specimen and up to 30% had received prior antibiotic therapy, substantially reducing the yield.27 In another study, good‐quality sputum with a predominant morphotype could be obtained in only 14% of patients admitted with CAP.28 However, targeting sputum analysis to patients who have not received prior antibiotics and are able to produce an adequate sample improved the yield significantly.29 In addition, with increasing rates of antibiotic resistance among common community isolates (ie, S. Pneumoniae) and the increasing prevalence of infecting organisms not targeted by routine empiric therapy (methicillin‐resistant Staphylococcus Aureus [MRSA]), isolation of potential causative pathogens is increasingly important. We believe that severely ill patients with CAP (such as patients admitted to the ICU), as well as patients with identifiable risk factors for uncommon or drug‐resistant pathogens (eg, Pseudomonas aeruginosa, enteric gram‐negative rods, MRSA, etc.) should have sputum sent for gram stain and culture. Ideally, sputum obtained for gram stain and culture should be:

• 1

  Prior to antibiotic therapy,

• 2

  A deep‐cough, expectorated specimen,

• 3

  A purulent specimen (>25 polymorphonucleacytes and less than 10 squamous cells per high‐powered field), and

• 4

  Rapidly transported to the laboratory.

Subsequent gram stain and culture results should be interpreted in the specific clinical context and antibiotic choices targeted appropriately.

ADMISSION DECISION

Once the diagnosis of CAP has been made, the initial site where treatment will occur, whether the hospital or the home, must be determined. The decision to hospitalize should be based on 3 factors: 1) evaluation of the safety of home treatment, 2) calculation of the Pneumonia Severity Index (PSI), and 3) clinical judgment of the physician.27 The PSI, or PORT (Pneumonia Outcomes Research Team) score, is a validated prediction rule that quantifies mortality and allows for risk stratification of patients with community‐acquired pneumonia.2 The PSI combines clinical history, physical examination, and laboratory data at the time of admission to divide patients into 5 risk classes and to estimate 30‐day mortality (Figure 2), which ranges from 0.1% of patients in risk class I to 27.0% in risk class V.2

Figure 2

On the basis of the estimated prognosis and in the absence of concerns about home safety or comorbidities, patients in risk classes I, II, and III should be managed at home. Many prospective trials have shown that implementation of PSI significantly increases the number of low‐risk patients managed outside the hospital, with no differences in quality of life, complications, readmissions, or short‐term mortality.30, 31 Most recently, a trial randomizing patients in risk classes II and III to treatment in the hospital or at home found no significant differences in clinical outcomes but did find that patients were more satisfied with care at home.32 Because the number of patients with CAP being treated at home is increasing, the American College of Chest Physicians recently published a consensus statement on the management of community‐acquired pneumonia in the home.33 All national guidelines for the management of community‐acquired pneumonia recommend using the PSI to help determine the initial location of treatment, with the caveat that using the prediction rule should never supersede clinical judgment in the decision about whether to admit.1, 14, 15, 26, 27 A practical decision tree for the use of the PSI is shown in Figure 3.

Figure 3

There are no reliable prediction rules for deciding on whether admission to the intensive care unit is necessary. Hemodynamic instability requiring resuscitation and monitoring or respiratory failure requiring ventilatory support are clear indications for ICU admission. Additional variables such as tachypnea (respiratory rate 30), altered mental status, multilobar disease, and azotemia are associated with severe CAP and should prompt consideration of ICU admission, especially when 2 or more variables coexist.14

TREATMENT

DISCHARGE/FOLLOW‐UP PLANS

Patients hospitalized for community‐acquired pneumonia can be safely discharged when they have reached clinical stability, are able to tolerate oral medications, have no other active comorbid conditions, and have safe, close, appropriate outpatient follow‐up (see Table 7). Clinical pathways employing these discharge criteria have been found to be safe and effective in reducing the length of stay for CAP. Most important, patients should have met most if not all of the vital sign and clinical criteria noted in Table 5 in the criteria for switching to oral therapy. Patients with 2 or more abnormal vital signs (instabilities) within 24 hours prior to discharge are at high risk of readmission and mortality, but those with one or no abnormal vital signs generally have good outcomes.65 Absent other clinical factors or extenuating circumstances (persistent hypoxia, poor functional status, etc.), most patients with CAP should reach clinical stability by day 3 or 4, be considered for a switch to oral therapy, and, if stable, be discharged shortly thereafter.

When patients with CAP are discharged from the hospital, they should be counseled about the expected course of recovery. Most important, patients and families must be informed that many symptoms of CAP may persist well after hospitalization. In one study, up to 80% of patients reported persistent cough and fatigue 1 week after discharge, and up to 50% still had dyspnea and sputum production. In some, the cough can last for 46 weeks.8

All patients discharged after treatment of community‐acquired pneumonia should have follow‐up with their outpatient provider. The physician responsible for their inpatient care should communicate directly with the provider and outline the hospital course, the discharge medications, and the duration of antibiotic therapy. There is no specific time frame within which patients must be seen, but follow‐up should be dictated by patient age, comorbidities, clinical stability at discharge, and degree of illness. The American Thoracic Society guidelines do recommend patients with a substantial smoking history who are hospitalized with CAP have a follow‐up chest radiograph 46 weeks after discharge to establish a radiographic baseline and exclude the possibility of underlying malignancy.14 However, several studies have suggested that radiographic resolution may take 3 or more months in some patients, especially the elderly and those with multilobar disease.66

PREVENTION

Prevention of community‐acquired pneumonia and pneumonic syndromes has traditionally relied on vaccination with the polysaccharide pneumococcal pneumonia vaccine and the seasonal influenza vaccine. The vaccine for S. pneumoniae used in adults is composed of the 23 serotypes that cause 85%90% of the invasive pneumococcal infections in the United States. Although in randomized trials the vaccine has not consistently prevented community‐acquired pneumonia or death in elderly patients or those with comorbidities, it likely prevents invasive pneumococcal infection.67 National guidelines and the CDC recommend the pneumococcal vaccine be given to all patients older than 65 years and those with chronic medical conditions.1, 14, 15

The seasonal influenza vaccine has clearly been shown to decrease influenza‐related illness in elderly and high‐risk patient populations. As well, in a meta‐analysis and a large observational study of patients older than 65 years, vaccination against influenza prevented pneumonia, hospitalization, and death.68, 69 Vaccination of health care workers may also confer a benefit to elderly patients of reduced mortality. The CDC recommends the influenza vaccine for all patients more than 50 years old, those with comorbidities, those at high risk for influenza, and health care workers in both inpatient and outpatient settings.

Pneumococcal and influenza vaccination have traditionally been relegated to the outpatient setting. National guidelines and the CDC recommend vaccination of all eligible hospitalized patients. Vaccination is safe and effective with almost any medical illness, and both vaccines can be given simultaneously at discharge.69 Both JCAHO and CMS have defined administration of the pneumococcal and influenza vaccines to patients hospitalized with CAP as a quality measure. Using standing orders is the most effective means of ensuring vaccination.

Some evidence suggests that tobacco smokers are at increased risk of invasive pneumococcal disease or pneumonia.70 Patients hospitalized (for all illnesses, but for CAP in particular) should be counseled about smoking cessation and offered pharmacotherapy and outpatient follow‐up. And, finally, recent observational data suggests that use of acid suppressive therapy, including proton pump inhibitors and H‐2 receptor antagonists, may be associated with an increased risk of developing CAP.71 Patients using these agents who are admitted with CAP should have their indications for treatment reviewed, especially when the pneumonia has been recurrent and there is no clear indication for continued use of acid suppressive therapy, in which case they should be discontinued in the hospital.

CONCLUSIONS

Community‐acquired pneumonia remains a common cause for hospitalization of adult patients, with significant associated morbidity and mortality. Although there are multiple expert guidelines for the management of community‐acquired pneumonia, further research is urgently needed. Clinicians need improved diagnostic tests that enable an earlier and more accurate diagnosis of CAP. In addition, the etiologic agent causing CAP is rarely discovered; improved microbiologic studies might enable antibiotic therapy to be targeted to the organisms responsible. High‐quality randomized, controlled trials examining empiric antibiotic therapy in CAP are needed, especially related to the addition of agents covering atypical organisms. Last, the general management of patients hospitalized with CAP is marked by significant heterogeneity, and research and initiatives focusing on improving the quality and process of care of patients with CAP are needed.

Community‐acquired pneumonia (CAP) is commonly defined as an infection of the pulmonary parenchyma that is associated with at least some symptoms and signs of acute infection, accompanied by the presence of an acute infiltrate on chest radiograph, in a patient not hospitalized or residing in a long‐term‐care facility for 14 days prior to the onset of symptoms.1 CAP continues to be a common and serious illness, causing substantial morbidity and mortality in the adult population. There are an estimated 56 million cases a year in the United States, with greater than 1 million hospitalizations. Community‐acquired pneumonia is one of the most common admitting diagnoses among adults, and with a 30‐day mortality between 10% and 14% for patients admitted to the hospital, it is the leading cause of infectious death in the United States.2 In elderly patients, hospitalization for CAP portends a poor long‐term prognosis. In a Medicare database, the 1‐year mortality for patients with CAP was nearly 40%, compared to 29% in patients with other diagnoses.3 Community‐acquired pneumonia is a model illness in hospital medicineit is a common disease that allows for evidence‐based and cost‐effective management. In addition, many national organizations have proposed multiple quality indicators for community‐acquired pneumonia, thus providing an opportunity for institutional quality improvement. This review article outlines the assessment and management of patients admitted to the hospital with community‐acquired pneumonia.

Etiology

Although many pathogens can cause community‐acquired pneumonia, the clinical syndromes and microbiology of CAP have traditionally been characterized as either typical or atypical. The typical organisms include Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, and the atypical organisms include Chlamydia spp., Mycoplasma pneumoniae, Legionella spp., and viruses. This historical distinction has recently come into question. It is now clear that the presenting symptoms, signs, and basic laboratory findings (including the chest radiograph) cannot be reliably used to predict the etiologic pathogen or to distinguish typical from atypical organisms.4 Rather, the specific causative agent of CAP depends more on the degree of patient illness. Table 1 shows what prospective studies with comprehensive diagnostic strategies determined to be the most common pathogens in patients hospitalized for CAP in ICU and non‐ICU settings.5 Streptococcus pneumoniae remains the most common cause of CAP in hospitalized patients and is the most common cause of fatal pneumonia, whereas Legionella spp. is a common cause of severe CAP, more often found in patients requiring admission to the intensive care unit. Gram‐negative bacilli can cause CAP in elderly patients and those recently treated with broad‐spectrum antibiotics or with underlying lung disease. Notably, though, despite improved diagnostic testing, only one quarter of all admitted patients with CAP have the etiologic agent defined, and therefore empiric therapy should be directed broadly at the most likely organisms.6

Clinical Presentation

Patients admitted to the hospital with CAP typically present with a brief history of respiratory complaints, including cough (greater than 90%), dyspnea (66%), sputum production (66%), and pleuritic chest pain (50%); see Table 2.7, 8 In 10%30% of patients, nonrespiratory complaints predominate, including headache, myalgias, fatigue, and gastrointestinal symptoms.6 Elderly patients, an increasing percentage of hospitalized patients, are less likely to present with typical CAP symptoms (such as cough) and more likely to have altered mental status as a presenting symptom.9

On physical examination, patients with CAP usually have signs of fever (80%), tachypnea (70%), and tachycardia (50%); see Table 2. Most will have a focal lung exam (>90%) with findings ranging from crackles to bronchial breath sounds.10 No exam finding is specific for the diagnosis of pneumonia, but the absence of fever, tachycardia, and tachypnea significantly reduces the probability of CAP in patients with suspected pneumonia.10 Furthermore, similar to the clinical history, the physical examination of elderly patients with community‐acquired pneumonia is not specific or sensitive for the diagnosis of CAP. For example, up to 40% of elderly patients subsequently determined to have CAP may not have fever.11

Leukocytosis is common in patients with CAP; however, its absence does not rule out disease.12 A number of guidelines recommend laboratory evaluation of electrolytes, urea nitrogen, creatinine, liver enzymes, and bilirubin, although these are used primarily for prognostication and are not specifically useful in the diagnosis of CAP.

DIAGNOSIS

Diagnostic Studies

The diagnosis of community‐acquired pneumonia requires that a patient have both signs and symptoms consistent with pulmonary infection and evidence of a new radiographic infiltrate. Therefore, most guidelines recommend that all patients with a possible diagnosis of CAP be evaluated with chest radiography.1, 14, 15

The specific radiographic findings in community‐acquired pneumonia range from lobar consolidation to hazy focal infiltrate to diffuse bilateral interstitial opacities (see Figure 1). Although chest radiography has traditionally been considered the gold standard for the diagnosis of CAP, its exact performance characteristics are unknown, and it is clearly not 100% sensitive or 100% specific. The utility of the chest radiograph can be limited by patient body habitus, underlying lung disease, or dehydration. Computed tomography (CT) scanning, although not recommended for routine use, can identify pulmonary consolidation in up to 30% of patients with a normal or equivocal chest radiograph in whom pneumonia is suspected and can also identify complications of pneumonia including an empyema or pulmonary abscess.16

Figure 1

Limitations in the performance of the chest radiograph have resulted in an interest in the diagnostic performance of serologic markers of infection such as C‐reactive protein (CRP), procalcitonin, and soluble triggering receptor expressed on myeloid cells (s‐TREM).1719 Preliminary evidence suggests these inflammatory markers may ultimately prove useful in differentiating infectious from noninfectious pulmonary processes, but regular use of these new tests cannot currently be recommended.

Most expert guidelines state that 2 sets of blood cultures should be taken and analyzed prior to antibiotic administration in all patients admitted to the hospital with suspected community‐acquired pneumonia.1, 14, 15 Isolation of bacteria from blood cultures in CAP is a very specific way to identify a causative organism in order to subsequently narrow therapy and also identifies a high‐risk group of patients because bacteremia is associated with increased mortality. Obtaining blood cultures within 24 hours of admission has been associated with 10% lower odds of 30‐day mortality in patients with CAP,20 and as a result, drawing blood cultures prior to antibiotic administration is a national quality indicator for CAP.

There are, however, a number of problems with the routine acquisition of blood cultures in all patients admitted with CAP. Practically, the cultures can be difficult to obtain, can potentially delay the initiation of antibiotics, and are often contaminated, which has been shown to increase both cost and length of stay.21, 22 The yield is generally low: the true‐positive bacteremia rate for admitted patients with CAP ranges from 6% to 9%, and the culture results rarely change management or outcomes.23, 24 Given these limitations, many have argued that blood cultures should be obtained with a more targeted approach. A recent study used a Medicare database to create a decision‐support tool to help maximize the value of blood cultures in CAP.25 The predictors of a positive blood culture are shown in Table 3. Not obtaining cultures on patients who had received prior antibiotics or had no risk factors resulted in about 40% fewer overall cultures while identifying approximately 90% of bacteremias. In their guidelines, the British Thoracic Society (BTS) advocates a similar strategy, recommending blood cultures be omitted in nonsevere pneumonia and in patients without comorbidities.15, 26 Although recommendations vary for non‐severe CAP in hospitalized patients, all professional society guidelines agree that blood cultures should be obtained in critically ill patients, and if cultures are obtained, they should be drawn prior to antibiotics.1, 14, 15, 26

Table 3.Independent Predictors of Bacteremia in Patients with Community‐Acquired Pneumonia24

Comorbidities
Liver disease
Vital signs
Systolic blood pressure < 90 mm Hg
Temperature < 35C or 40C
Pulse 125 beats/min
Laboratory and radiographic data
Blood urea nitrogen (BUN) 30 mg/dL
Sodium < 130 mmol/L
White blood cells < 5000/mm3 or > 20,000/mm3
Prior use of antibiotics (negative predictor)

Substantial controversy surrounds the utility of routine sputum gram stains and cultures for patients admitted to the hospital with CAP. The Infectious Disease Society of America (IDSA) and the British Thoracic Society (BTS) both recommend that all patients admitted to the hospital with community‐acquired pneumonia should have a gram stain and culture of expectorated sputum.1, 15, 26 Both organizations argue sputum collection is a simple and inexpensive procedure that can potentially identify pathogenic organisms and can affect both initial and long‐term antibiotic therapy. Most notably, they highlight gram stain specificity of greater than 80% for pneumococcal pneumonia. Conversely, the American Thoracic Society (ATS) argues that sputum gram stains and cultures generally have low sensitivity, specificity, and positive predictive value.14 Furthermore, they argue the utility of sputum testing is also limited practically; in one study 30% of patients could not produce an adequate sputum specimen and up to 30% had received prior antibiotic therapy, substantially reducing the yield.27 In another study, good‐quality sputum with a predominant morphotype could be obtained in only 14% of patients admitted with CAP.28 However, targeting sputum analysis to patients who have not received prior antibiotics and are able to produce an adequate sample improved the yield significantly.29 In addition, with increasing rates of antibiotic resistance among common community isolates (ie, S. Pneumoniae) and the increasing prevalence of infecting organisms not targeted by routine empiric therapy (methicillin‐resistant Staphylococcus Aureus [MRSA]), isolation of potential causative pathogens is increasingly important. We believe that severely ill patients with CAP (such as patients admitted to the ICU), as well as patients with identifiable risk factors for uncommon or drug‐resistant pathogens (eg, Pseudomonas aeruginosa, enteric gram‐negative rods, MRSA, etc.) should have sputum sent for gram stain and culture. Ideally, sputum obtained for gram stain and culture should be:

• 1

  Prior to antibiotic therapy,

• 2

  A deep‐cough, expectorated specimen,

• 3

  A purulent specimen (>25 polymorphonucleacytes and less than 10 squamous cells per high‐powered field), and

• 4

  Rapidly transported to the laboratory.

Subsequent gram stain and culture results should be interpreted in the specific clinical context and antibiotic choices targeted appropriately.

ADMISSION DECISION

Once the diagnosis of CAP has been made, the initial site where treatment will occur, whether the hospital or the home, must be determined. The decision to hospitalize should be based on 3 factors: 1) evaluation of the safety of home treatment, 2) calculation of the Pneumonia Severity Index (PSI), and 3) clinical judgment of the physician.27 The PSI, or PORT (Pneumonia Outcomes Research Team) score, is a validated prediction rule that quantifies mortality and allows for risk stratification of patients with community‐acquired pneumonia.2 The PSI combines clinical history, physical examination, and laboratory data at the time of admission to divide patients into 5 risk classes and to estimate 30‐day mortality (Figure 2), which ranges from 0.1% of patients in risk class I to 27.0% in risk class V.2

Figure 2

On the basis of the estimated prognosis and in the absence of concerns about home safety or comorbidities, patients in risk classes I, II, and III should be managed at home. Many prospective trials have shown that implementation of PSI significantly increases the number of low‐risk patients managed outside the hospital, with no differences in quality of life, complications, readmissions, or short‐term mortality.30, 31 Most recently, a trial randomizing patients in risk classes II and III to treatment in the hospital or at home found no significant differences in clinical outcomes but did find that patients were more satisfied with care at home.32 Because the number of patients with CAP being treated at home is increasing, the American College of Chest Physicians recently published a consensus statement on the management of community‐acquired pneumonia in the home.33 All national guidelines for the management of community‐acquired pneumonia recommend using the PSI to help determine the initial location of treatment, with the caveat that using the prediction rule should never supersede clinical judgment in the decision about whether to admit.1, 14, 15, 26, 27 A practical decision tree for the use of the PSI is shown in Figure 3.

Figure 3

There are no reliable prediction rules for deciding on whether admission to the intensive care unit is necessary. Hemodynamic instability requiring resuscitation and monitoring or respiratory failure requiring ventilatory support are clear indications for ICU admission. Additional variables such as tachypnea (respiratory rate 30), altered mental status, multilobar disease, and azotemia are associated with severe CAP and should prompt consideration of ICU admission, especially when 2 or more variables coexist.14

TREATMENT

DISCHARGE/FOLLOW‐UP PLANS

Patients hospitalized for community‐acquired pneumonia can be safely discharged when they have reached clinical stability, are able to tolerate oral medications, have no other active comorbid conditions, and have safe, close, appropriate outpatient follow‐up (see Table 7). Clinical pathways employing these discharge criteria have been found to be safe and effective in reducing the length of stay for CAP. Most important, patients should have met most if not all of the vital sign and clinical criteria noted in Table 5 in the criteria for switching to oral therapy. Patients with 2 or more abnormal vital signs (instabilities) within 24 hours prior to discharge are at high risk of readmission and mortality, but those with one or no abnormal vital signs generally have good outcomes.65 Absent other clinical factors or extenuating circumstances (persistent hypoxia, poor functional status, etc.), most patients with CAP should reach clinical stability by day 3 or 4, be considered for a switch to oral therapy, and, if stable, be discharged shortly thereafter.

When patients with CAP are discharged from the hospital, they should be counseled about the expected course of recovery. Most important, patients and families must be informed that many symptoms of CAP may persist well after hospitalization. In one study, up to 80% of patients reported persistent cough and fatigue 1 week after discharge, and up to 50% still had dyspnea and sputum production. In some, the cough can last for 46 weeks.8

All patients discharged after treatment of community‐acquired pneumonia should have follow‐up with their outpatient provider. The physician responsible for their inpatient care should communicate directly with the provider and outline the hospital course, the discharge medications, and the duration of antibiotic therapy. There is no specific time frame within which patients must be seen, but follow‐up should be dictated by patient age, comorbidities, clinical stability at discharge, and degree of illness. The American Thoracic Society guidelines do recommend patients with a substantial smoking history who are hospitalized with CAP have a follow‐up chest radiograph 46 weeks after discharge to establish a radiographic baseline and exclude the possibility of underlying malignancy.14 However, several studies have suggested that radiographic resolution may take 3 or more months in some patients, especially the elderly and those with multilobar disease.66

PREVENTION

Prevention of community‐acquired pneumonia and pneumonic syndromes has traditionally relied on vaccination with the polysaccharide pneumococcal pneumonia vaccine and the seasonal influenza vaccine. The vaccine for S. pneumoniae used in adults is composed of the 23 serotypes that cause 85%90% of the invasive pneumococcal infections in the United States. Although in randomized trials the vaccine has not consistently prevented community‐acquired pneumonia or death in elderly patients or those with comorbidities, it likely prevents invasive pneumococcal infection.67 National guidelines and the CDC recommend the pneumococcal vaccine be given to all patients older than 65 years and those with chronic medical conditions.1, 14, 15

The seasonal influenza vaccine has clearly been shown to decrease influenza‐related illness in elderly and high‐risk patient populations. As well, in a meta‐analysis and a large observational study of patients older than 65 years, vaccination against influenza prevented pneumonia, hospitalization, and death.68, 69 Vaccination of health care workers may also confer a benefit to elderly patients of reduced mortality. The CDC recommends the influenza vaccine for all patients more than 50 years old, those with comorbidities, those at high risk for influenza, and health care workers in both inpatient and outpatient settings.

Pneumococcal and influenza vaccination have traditionally been relegated to the outpatient setting. National guidelines and the CDC recommend vaccination of all eligible hospitalized patients. Vaccination is safe and effective with almost any medical illness, and both vaccines can be given simultaneously at discharge.69 Both JCAHO and CMS have defined administration of the pneumococcal and influenza vaccines to patients hospitalized with CAP as a quality measure. Using standing orders is the most effective means of ensuring vaccination.

Some evidence suggests that tobacco smokers are at increased risk of invasive pneumococcal disease or pneumonia.70 Patients hospitalized (for all illnesses, but for CAP in particular) should be counseled about smoking cessation and offered pharmacotherapy and outpatient follow‐up. And, finally, recent observational data suggests that use of acid suppressive therapy, including proton pump inhibitors and H‐2 receptor antagonists, may be associated with an increased risk of developing CAP.71 Patients using these agents who are admitted with CAP should have their indications for treatment reviewed, especially when the pneumonia has been recurrent and there is no clear indication for continued use of acid suppressive therapy, in which case they should be discontinued in the hospital.

CONCLUSIONS

Community‐acquired pneumonia remains a common cause for hospitalization of adult patients, with significant associated morbidity and mortality. Although there are multiple expert guidelines for the management of community‐acquired pneumonia, further research is urgently needed. Clinicians need improved diagnostic tests that enable an earlier and more accurate diagnosis of CAP. In addition, the etiologic agent causing CAP is rarely discovered; improved microbiologic studies might enable antibiotic therapy to be targeted to the organisms responsible. High‐quality randomized, controlled trials examining empiric antibiotic therapy in CAP are needed, especially related to the addition of agents covering atypical organisms. Last, the general management of patients hospitalized with CAP is marked by significant heterogeneity, and research and initiatives focusing on improving the quality and process of care of patients with CAP are needed.

Community‐acquired pneumonia (CAP) is commonly defined as an infection of the pulmonary parenchyma that is associated with at least some symptoms and signs of acute infection, accompanied by the presence of an acute infiltrate on chest radiograph, in a patient not hospitalized or residing in a long‐term‐care facility for 14 days prior to the onset of symptoms.1 CAP continues to be a common and serious illness, causing substantial morbidity and mortality in the adult population. There are an estimated 56 million cases a year in the United States, with greater than 1 million hospitalizations. Community‐acquired pneumonia is one of the most common admitting diagnoses among adults, and with a 30‐day mortality between 10% and 14% for patients admitted to the hospital, it is the leading cause of infectious death in the United States.2 In elderly patients, hospitalization for CAP portends a poor long‐term prognosis. In a Medicare database, the 1‐year mortality for patients with CAP was nearly 40%, compared to 29% in patients with other diagnoses.3 Community‐acquired pneumonia is a model illness in hospital medicineit is a common disease that allows for evidence‐based and cost‐effective management. In addition, many national organizations have proposed multiple quality indicators for community‐acquired pneumonia, thus providing an opportunity for institutional quality improvement. This review article outlines the assessment and management of patients admitted to the hospital with community‐acquired pneumonia.

Etiology

Although many pathogens can cause community‐acquired pneumonia, the clinical syndromes and microbiology of CAP have traditionally been characterized as either typical or atypical. The typical organisms include Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis, and the atypical organisms include Chlamydia spp., Mycoplasma pneumoniae, Legionella spp., and viruses. This historical distinction has recently come into question. It is now clear that the presenting symptoms, signs, and basic laboratory findings (including the chest radiograph) cannot be reliably used to predict the etiologic pathogen or to distinguish typical from atypical organisms.4 Rather, the specific causative agent of CAP depends more on the degree of patient illness. Table 1 shows what prospective studies with comprehensive diagnostic strategies determined to be the most common pathogens in patients hospitalized for CAP in ICU and non‐ICU settings.5 Streptococcus pneumoniae remains the most common cause of CAP in hospitalized patients and is the most common cause of fatal pneumonia, whereas Legionella spp. is a common cause of severe CAP, more often found in patients requiring admission to the intensive care unit. Gram‐negative bacilli can cause CAP in elderly patients and those recently treated with broad‐spectrum antibiotics or with underlying lung disease. Notably, though, despite improved diagnostic testing, only one quarter of all admitted patients with CAP have the etiologic agent defined, and therefore empiric therapy should be directed broadly at the most likely organisms.6

Clinical Presentation

Patients admitted to the hospital with CAP typically present with a brief history of respiratory complaints, including cough (greater than 90%), dyspnea (66%), sputum production (66%), and pleuritic chest pain (50%); see Table 2.7, 8 In 10%30% of patients, nonrespiratory complaints predominate, including headache, myalgias, fatigue, and gastrointestinal symptoms.6 Elderly patients, an increasing percentage of hospitalized patients, are less likely to present with typical CAP symptoms (such as cough) and more likely to have altered mental status as a presenting symptom.9

On physical examination, patients with CAP usually have signs of fever (80%), tachypnea (70%), and tachycardia (50%); see Table 2. Most will have a focal lung exam (>90%) with findings ranging from crackles to bronchial breath sounds.10 No exam finding is specific for the diagnosis of pneumonia, but the absence of fever, tachycardia, and tachypnea significantly reduces the probability of CAP in patients with suspected pneumonia.10 Furthermore, similar to the clinical history, the physical examination of elderly patients with community‐acquired pneumonia is not specific or sensitive for the diagnosis of CAP. For example, up to 40% of elderly patients subsequently determined to have CAP may not have fever.11

Leukocytosis is common in patients with CAP; however, its absence does not rule out disease.12 A number of guidelines recommend laboratory evaluation of electrolytes, urea nitrogen, creatinine, liver enzymes, and bilirubin, although these are used primarily for prognostication and are not specifically useful in the diagnosis of CAP.

DIAGNOSIS

Diagnostic Studies

The diagnosis of community‐acquired pneumonia requires that a patient have both signs and symptoms consistent with pulmonary infection and evidence of a new radiographic infiltrate. Therefore, most guidelines recommend that all patients with a possible diagnosis of CAP be evaluated with chest radiography.1, 14, 15

The specific radiographic findings in community‐acquired pneumonia range from lobar consolidation to hazy focal infiltrate to diffuse bilateral interstitial opacities (see Figure 1). Although chest radiography has traditionally been considered the gold standard for the diagnosis of CAP, its exact performance characteristics are unknown, and it is clearly not 100% sensitive or 100% specific. The utility of the chest radiograph can be limited by patient body habitus, underlying lung disease, or dehydration. Computed tomography (CT) scanning, although not recommended for routine use, can identify pulmonary consolidation in up to 30% of patients with a normal or equivocal chest radiograph in whom pneumonia is suspected and can also identify complications of pneumonia including an empyema or pulmonary abscess.16

Figure 1

Limitations in the performance of the chest radiograph have resulted in an interest in the diagnostic performance of serologic markers of infection such as C‐reactive protein (CRP), procalcitonin, and soluble triggering receptor expressed on myeloid cells (s‐TREM).1719 Preliminary evidence suggests these inflammatory markers may ultimately prove useful in differentiating infectious from noninfectious pulmonary processes, but regular use of these new tests cannot currently be recommended.

Most expert guidelines state that 2 sets of blood cultures should be taken and analyzed prior to antibiotic administration in all patients admitted to the hospital with suspected community‐acquired pneumonia.1, 14, 15 Isolation of bacteria from blood cultures in CAP is a very specific way to identify a causative organism in order to subsequently narrow therapy and also identifies a high‐risk group of patients because bacteremia is associated with increased mortality. Obtaining blood cultures within 24 hours of admission has been associated with 10% lower odds of 30‐day mortality in patients with CAP,20 and as a result, drawing blood cultures prior to antibiotic administration is a national quality indicator for CAP.

There are, however, a number of problems with the routine acquisition of blood cultures in all patients admitted with CAP. Practically, the cultures can be difficult to obtain, can potentially delay the initiation of antibiotics, and are often contaminated, which has been shown to increase both cost and length of stay.21, 22 The yield is generally low: the true‐positive bacteremia rate for admitted patients with CAP ranges from 6% to 9%, and the culture results rarely change management or outcomes.23, 24 Given these limitations, many have argued that blood cultures should be obtained with a more targeted approach. A recent study used a Medicare database to create a decision‐support tool to help maximize the value of blood cultures in CAP.25 The predictors of a positive blood culture are shown in Table 3. Not obtaining cultures on patients who had received prior antibiotics or had no risk factors resulted in about 40% fewer overall cultures while identifying approximately 90% of bacteremias. In their guidelines, the British Thoracic Society (BTS) advocates a similar strategy, recommending blood cultures be omitted in nonsevere pneumonia and in patients without comorbidities.15, 26 Although recommendations vary for non‐severe CAP in hospitalized patients, all professional society guidelines agree that blood cultures should be obtained in critically ill patients, and if cultures are obtained, they should be drawn prior to antibiotics.1, 14, 15, 26

Table 3.Independent Predictors of Bacteremia in Patients with Community‐Acquired Pneumonia24

Comorbidities
Liver disease
Vital signs
Systolic blood pressure < 90 mm Hg
Temperature < 35C or 40C
Pulse 125 beats/min
Laboratory and radiographic data
Blood urea nitrogen (BUN) 30 mg/dL
Sodium < 130 mmol/L
White blood cells < 5000/mm3 or > 20,000/mm3
Prior use of antibiotics (negative predictor)

Substantial controversy surrounds the utility of routine sputum gram stains and cultures for patients admitted to the hospital with CAP. The Infectious Disease Society of America (IDSA) and the British Thoracic Society (BTS) both recommend that all patients admitted to the hospital with community‐acquired pneumonia should have a gram stain and culture of expectorated sputum.1, 15, 26 Both organizations argue sputum collection is a simple and inexpensive procedure that can potentially identify pathogenic organisms and can affect both initial and long‐term antibiotic therapy. Most notably, they highlight gram stain specificity of greater than 80% for pneumococcal pneumonia. Conversely, the American Thoracic Society (ATS) argues that sputum gram stains and cultures generally have low sensitivity, specificity, and positive predictive value.14 Furthermore, they argue the utility of sputum testing is also limited practically; in one study 30% of patients could not produce an adequate sputum specimen and up to 30% had received prior antibiotic therapy, substantially reducing the yield.27 In another study, good‐quality sputum with a predominant morphotype could be obtained in only 14% of patients admitted with CAP.28 However, targeting sputum analysis to patients who have not received prior antibiotics and are able to produce an adequate sample improved the yield significantly.29 In addition, with increasing rates of antibiotic resistance among common community isolates (ie, S. Pneumoniae) and the increasing prevalence of infecting organisms not targeted by routine empiric therapy (methicillin‐resistant Staphylococcus Aureus [MRSA]), isolation of potential causative pathogens is increasingly important. We believe that severely ill patients with CAP (such as patients admitted to the ICU), as well as patients with identifiable risk factors for uncommon or drug‐resistant pathogens (eg, Pseudomonas aeruginosa, enteric gram‐negative rods, MRSA, etc.) should have sputum sent for gram stain and culture. Ideally, sputum obtained for gram stain and culture should be:

• 1

  Prior to antibiotic therapy,

• 2

  A deep‐cough, expectorated specimen,

• 3

  A purulent specimen (>25 polymorphonucleacytes and less than 10 squamous cells per high‐powered field), and

• 4

  Rapidly transported to the laboratory.

Subsequent gram stain and culture results should be interpreted in the specific clinical context and antibiotic choices targeted appropriately.

ADMISSION DECISION

Once the diagnosis of CAP has been made, the initial site where treatment will occur, whether the hospital or the home, must be determined. The decision to hospitalize should be based on 3 factors: 1) evaluation of the safety of home treatment, 2) calculation of the Pneumonia Severity Index (PSI), and 3) clinical judgment of the physician.27 The PSI, or PORT (Pneumonia Outcomes Research Team) score, is a validated prediction rule that quantifies mortality and allows for risk stratification of patients with community‐acquired pneumonia.2 The PSI combines clinical history, physical examination, and laboratory data at the time of admission to divide patients into 5 risk classes and to estimate 30‐day mortality (Figure 2), which ranges from 0.1% of patients in risk class I to 27.0% in risk class V.2

Figure 2

On the basis of the estimated prognosis and in the absence of concerns about home safety or comorbidities, patients in risk classes I, II, and III should be managed at home. Many prospective trials have shown that implementation of PSI significantly increases the number of low‐risk patients managed outside the hospital, with no differences in quality of life, complications, readmissions, or short‐term mortality.30, 31 Most recently, a trial randomizing patients in risk classes II and III to treatment in the hospital or at home found no significant differences in clinical outcomes but did find that patients were more satisfied with care at home.32 Because the number of patients with CAP being treated at home is increasing, the American College of Chest Physicians recently published a consensus statement on the management of community‐acquired pneumonia in the home.33 All national guidelines for the management of community‐acquired pneumonia recommend using the PSI to help determine the initial location of treatment, with the caveat that using the prediction rule should never supersede clinical judgment in the decision about whether to admit.1, 14, 15, 26, 27 A practical decision tree for the use of the PSI is shown in Figure 3.

Figure 3

There are no reliable prediction rules for deciding on whether admission to the intensive care unit is necessary. Hemodynamic instability requiring resuscitation and monitoring or respiratory failure requiring ventilatory support are clear indications for ICU admission. Additional variables such as tachypnea (respiratory rate 30), altered mental status, multilobar disease, and azotemia are associated with severe CAP and should prompt consideration of ICU admission, especially when 2 or more variables coexist.14

TREATMENT

DISCHARGE/FOLLOW‐UP PLANS

Patients hospitalized for community‐acquired pneumonia can be safely discharged when they have reached clinical stability, are able to tolerate oral medications, have no other active comorbid conditions, and have safe, close, appropriate outpatient follow‐up (see Table 7). Clinical pathways employing these discharge criteria have been found to be safe and effective in reducing the length of stay for CAP. Most important, patients should have met most if not all of the vital sign and clinical criteria noted in Table 5 in the criteria for switching to oral therapy. Patients with 2 or more abnormal vital signs (instabilities) within 24 hours prior to discharge are at high risk of readmission and mortality, but those with one or no abnormal vital signs generally have good outcomes.65 Absent other clinical factors or extenuating circumstances (persistent hypoxia, poor functional status, etc.), most patients with CAP should reach clinical stability by day 3 or 4, be considered for a switch to oral therapy, and, if stable, be discharged shortly thereafter.

When patients with CAP are discharged from the hospital, they should be counseled about the expected course of recovery. Most important, patients and families must be informed that many symptoms of CAP may persist well after hospitalization. In one study, up to 80% of patients reported persistent cough and fatigue 1 week after discharge, and up to 50% still had dyspnea and sputum production. In some, the cough can last for 46 weeks.8

All patients discharged after treatment of community‐acquired pneumonia should have follow‐up with their outpatient provider. The physician responsible for their inpatient care should communicate directly with the provider and outline the hospital course, the discharge medications, and the duration of antibiotic therapy. There is no specific time frame within which patients must be seen, but follow‐up should be dictated by patient age, comorbidities, clinical stability at discharge, and degree of illness. The American Thoracic Society guidelines do recommend patients with a substantial smoking history who are hospitalized with CAP have a follow‐up chest radiograph 46 weeks after discharge to establish a radiographic baseline and exclude the possibility of underlying malignancy.14 However, several studies have suggested that radiographic resolution may take 3 or more months in some patients, especially the elderly and those with multilobar disease.66

PREVENTION

Prevention of community‐acquired pneumonia and pneumonic syndromes has traditionally relied on vaccination with the polysaccharide pneumococcal pneumonia vaccine and the seasonal influenza vaccine. The vaccine for S. pneumoniae used in adults is composed of the 23 serotypes that cause 85%90% of the invasive pneumococcal infections in the United States. Although in randomized trials the vaccine has not consistently prevented community‐acquired pneumonia or death in elderly patients or those with comorbidities, it likely prevents invasive pneumococcal infection.67 National guidelines and the CDC recommend the pneumococcal vaccine be given to all patients older than 65 years and those with chronic medical conditions.1, 14, 15

The seasonal influenza vaccine has clearly been shown to decrease influenza‐related illness in elderly and high‐risk patient populations. As well, in a meta‐analysis and a large observational study of patients older than 65 years, vaccination against influenza prevented pneumonia, hospitalization, and death.68, 69 Vaccination of health care workers may also confer a benefit to elderly patients of reduced mortality. The CDC recommends the influenza vaccine for all patients more than 50 years old, those with comorbidities, those at high risk for influenza, and health care workers in both inpatient and outpatient settings.

Pneumococcal and influenza vaccination have traditionally been relegated to the outpatient setting. National guidelines and the CDC recommend vaccination of all eligible hospitalized patients. Vaccination is safe and effective with almost any medical illness, and both vaccines can be given simultaneously at discharge.69 Both JCAHO and CMS have defined administration of the pneumococcal and influenza vaccines to patients hospitalized with CAP as a quality measure. Using standing orders is the most effective means of ensuring vaccination.

Some evidence suggests that tobacco smokers are at increased risk of invasive pneumococcal disease or pneumonia.70 Patients hospitalized (for all illnesses, but for CAP in particular) should be counseled about smoking cessation and offered pharmacotherapy and outpatient follow‐up. And, finally, recent observational data suggests that use of acid suppressive therapy, including proton pump inhibitors and H‐2 receptor antagonists, may be associated with an increased risk of developing CAP.71 Patients using these agents who are admitted with CAP should have their indications for treatment reviewed, especially when the pneumonia has been recurrent and there is no clear indication for continued use of acid suppressive therapy, in which case they should be discontinued in the hospital.

CONCLUSIONS

Community‐acquired pneumonia remains a common cause for hospitalization of adult patients, with significant associated morbidity and mortality. Although there are multiple expert guidelines for the management of community‐acquired pneumonia, further research is urgently needed. Clinicians need improved diagnostic tests that enable an earlier and more accurate diagnosis of CAP. In addition, the etiologic agent causing CAP is rarely discovered; improved microbiologic studies might enable antibiotic therapy to be targeted to the organisms responsible. High‐quality randomized, controlled trials examining empiric antibiotic therapy in CAP are needed, especially related to the addition of agents covering atypical organisms. Last, the general management of patients hospitalized with CAP is marked by significant heterogeneity, and research and initiatives focusing on improving the quality and process of care of patients with CAP are needed.

Toyota is widely recognized as one of the most successful companies in the world. Its automobiles have consistently placed at or near the top of the quality and customer satisfaction rankings published by J.D. Power and Associates and Consumer Reports. Toyota constantly focuses on the safety and well‐being of its employees and the quality of its cars through its relentless dedication to continuous improvement in everything it does. Toyota has recently become the world's number two auto manufacturer, and the company's net profit margin was more than 8 times that of the industry average. 1

How has Toyota been able to achieve such remarkable results in product quality, market share, and profit margins? Jeffrey Liker, in his book The Toyota Way, described the world‐renowned Toyota production system as supported by 2 pillars: continuous improvement and respect for people. The end result is a learning organization that values employee contributions and continuously strives to produce products of higher quality at lower cost. 1, 2 Lean production is the generic term used to describe the principles and methods of the Toyota Production System. Lean production has been implemented to improve performance in a broad array of industries, from aerospace and aluminum refining to financial services and insurance. The philosophy of lean thinking, which is derived from the Toyota Production System, is rapidly gaining a following among health care leaders, with a number of hospitals and medical groups around the country adopting a version of lean production as their systematic approach to improving quality and efficiency. In the coming years, the application of lean principles and methods could have a transformational effect on how health care is delivered, with the potential for dramatic gains in quality, safety, efficiency, and appropriateness.

LEAN CONCEPTS

To understand how lean production can be applied to improve the delivery of health care, some of the fundamental concepts and practice of lean must first be explained. 3, 4 The first step in a lean improvement initiative is to understand value as defined by our customers. 5 In clinical care delivery, external customers include patients, families, payers, and regulators. Internal customers include physicians, nurses, clerks, and others involved in the care process. What customers value usually includes care that is of high quality, safe, efficient and appropriate. The second step typically is to go to the workplace and observe firsthand how the process now operates. 6 As the flow of the process from beginning to end is seen, the observer learns to see and to understand the multiple areas of delay, inefficiency, and waste that may exist. 7, 8 A representational flowchart called a current‐state value stream map (CS VSM) is created to make the work visible and to depict graphically all the individual steps necessary to complete the process from beginning to end. It is important that the CS VSM be a factual depiction of how an entire process flows created by those who actually work in that process. The CS VSM does not state any exceptions to or provide any explanations for why certain steps are taken. It does include key measures such as process time (the actual time it takes to complete a particular step of the process), lead time (the total time it takes to complete the entire process, including waiting time), and first‐time quality (the percentage of time in which that step of the process is completed without defect); (see Figure 1).

Figure 1

In the hands of an improvement team, the current state map becomes a powerful tool that allows participants to systematically recognize and categorize waste. The CS VSM also allows workers to visualize how much opportunity there is for improving the existing process. Working from the CS VSM, the team members can identify specific areas of waste, delay, causes of error, and inefficiency. The team then brainstorms ideas for improvement, proposing how steps of the process might be combined, eliminated, error‐proofed, or otherwise improved to transform waste into value from the customer's perspective. In the third step, the team seeks to achieve the flow state in which the steps of the process follow one another without stopping. All ideas are welcomed at this stage and are placed on the current state map itself or arrayed elsewhere for consideration. Using the ideas generated by the team, a new and better process is designed and depicted on a flow map called the future‐state value stream map (FS VSM). 9, 10 The FS VSM represents an improved and streamlined or ideal way in which the process could be accomplished, as best the team was able to envision at this point (see Figure 2). Ideally, the process described in the FS VSM also allows customers to pull value when they need goods or services provided by the organization, rather than having to do the usual requesting and waiting seen in health care and other service industries. Creating processes from which customers pull what they need is the fourth step in lean design.

Figure 2

Once a future state map is devised and approved, the critical work of rapid deployment of an implementation plan for reaching the future state begins. An implementation plan explicitly identifies who is responsible for what aspect of implementation. Usually a senior leader or leadership group sponsoring the project is responsible for encouraging team members to think beyond their historical (and often political) limits and to support the team in overcoming barriers outside its control. As the individuals return to work and attempt to implement the new solutions, however, they will likely encounter areas of resistance and ambiguity that require creative solutions. The implementation phase focuses on and encourages the individual worker to experiment and work toward a solution that can be broadly adopted and disseminated for use as a standardized solution by all workers facing similar situations. 11, 12 Through this experimental development and dissemination of solutions, the agreed‐to future‐state map is revised. In this way the old future‐state map plays the role of the new current‐state map. There is an ongoing, continuous loop between the current‐ and future‐state maps through implementation and testing to develop the ideal way in which the process should flow toward the final product or service (see Figure 3). The fifth step, pursuing perfection, requires this continuous loop of all workers improving everything they do, every day. The hardest of all the steps, pursuing perfection requires an organization to commit to process improvement and the elimination of defects and waste on a daily and permanent basis. 5

Figure 3

The steps outlined above provide only the basic foundations of lean concepts, of course. A detailed description of learning about and applying lean within one's own organization requires further study and help. Readers interested in learning more about value stream mapping are referred to a workbook by Mike Rother and John Shook called Learning to See, Value Stream Mapping to Create Value and Eliminate Muda. 4 Further, there are consultants with lean expertise who are available to help hospitals get started on the lean journey.

The management philosophy of lean production methods has ties to other operational and quality‐improvement models such as total quality management (TQM)/continuous quality improvement (CQI), developed by W. E. Deming, and Six Sigma, developed by Motorola and General Electric. Although there are several overlapping points of philosophy and techniques, a feature distinguishing lean from these other models is in its value stream approach to driving change and eliminating waste within the process of providing a product for the customer. Lean is unique in its focus on the specification of value from the customer's perspective and on the identification and categorization of waste and its transformation to value using specific tools. The lean approach encourages individuals within the organization (from top to bottom) to learn to see the flow of their product's process and thus to help to identify areas of waste, with the ultimate goal of creating a product with built‐in quality with the least amount of waste. Both Six Sigma and TQM/CQI focus on the delivery of a high‐quality product. Once a system has been studied and standardized, Six Sigma utilizes rigorous statistical and data measurements to drive quality improvements in product delivery. 13 Total quality management/continuous quality improvement engages the entire organization in delivering a high‐quality product from the customer's standpoint by getting everyone in the organization involved in the continuous improvement effort. 14 Lean thinking builds directly on the plandocheckact cycle of CQI but adds tools to identify and transform waste, supplies metrics of timing and resources, and, most important, focuses intently on the creation of value as defined by the customer. A more detailed comparison of lean philosophy with these other quality‐improvement management philosophies is beyond the scope of this article on the introduction of lean methods for hospitals.

DOES HEALTH CARE NEED LEAN THINKERS?

So, should health care try to emulate the successes of an automobile manufacturing company? Before answering this question, consider the following about the health care system as we know it and the significant challenges it faces.

• A key take‐home message of the Institute of Medicine's 1999 report, To Err Is Human: Building a Safer Health System, was that errors are caused by poorly designed systems. 15

• The Centers for Medicare and Medicaid Services (CMS) reported that the cost of health care is rising rapidly and that the rate of growth is not sustainable. 16

• Studies by the RAND Corporation demonstrated considerable variability in the practice of medicine, raising important questions about the appropriateness and necessity of some medical care and procedures. 17, 18

• In Crossing the Quality Chasm: a New Health System for the 21st Century, the Institute of Medicine concluded that today's health care system functions at far lower levels than it can and should and recommended 6 aims for improving the health care system: health care should be safe, effective, patient centered, timely, efficient, and equitable. 19 This report is rich in detail about what the ideal health care system should look like and how application of lean philosophy and tools can help hospitals and physicians achieve that vision.

Although these challenges reflect a view of the health care system at a very macro level, the mechanism and process of driving change will need to be initiated at the more local and organizational level. Lean production focuses on the goal of continuously transforming waste into value from the customer's perspective. It provides a rigorous and systematic approach to process improvement, error proofing, and waste reduction. Manufacturing companies such as Toyota and Alcoa and financial service organizations such as Vanguard have enjoyed tremendous success in implementing lean production, reporting gains in both quality and efficiency. 11 It is time for health care leaders and practitioners to evaluate how lean techniques can be adapted and applied to addressing the pressing challenges of safety, quality, efficiency, and appropriateness in order to improve system reliability and timeliness. As hospitalists, we are at the forefront of these challenges and therefore are in a prime position to lead the change in how health care delivery is improved continuously using a rigorous system such as the Toyota production system.

LEAN IN HEALTH CARE: EXAMPLES OF SOME EARLY RESULTS

Lean health care is still a very novel concept to most health care institutions; however, there have been some early adopters of lean health care, and some of their experiences are described here:

• At Virginia Mason Medical Center (VMMC) in Seattle, Washington, changes implemented using lean production methods have resulted in decreased incidence of ventilator‐associated pneumoniafrom 34 cases with 5 deaths in 2002 to 4 cases with 1 death in 2004. This led to a cost reduction of nearly a half‐million dollars. VMMC has also reported increased profit margins and improvement in space utilization at its cancer center, enabling 57% more patients to be seen in the same allotted space; and it is now taking measures to decrease the number of medication errors by standardizing and mistake‐proofing the process of ordering, delivering, and administering medications, all using lean techniques. 12, 20

• At Park Nicollet Health Services (PNHS) in Minneapolis, Minnesota, implementation of lean production has enabled improved patient access through flow improvements. Results include increasing the number of CT and MRI scans performed per day by 2 and 1, respectively; creating a capacity for 10 additional chemotherapy and antibiotic infusion patients per day in the cancer center; reducing the waiting time of patients from 122 to 52 minutes at the urgent care clinic; standardizing surgical instrument use by the general surgery group, which resulted in processing more than 40,000 fewer instruments each month. These improvements achieved through applying lean concepts have resulted in Park Nicollet being recognized by the American Medical Group Association (AMGA) with its top‐rated Acclaim Award. 21 In addition, PNHS has been able to achieve a record 3.9% operating margin, which equates to a $7.5 million profit in 2004.

• In Pittsburgh, Pennsylvania, a group of hospitals participating in the Pittsburgh Regional Healthcare Initiative (PRHI) have implemented lean concepts to minimize the risk of developing central catheterrelated bloodstream infections. Several hospitals have been able to cut the incidence of central line infections by 50%‐90% through implementation of lean production methods. 12

• At Community Medical Center in Missoula, Montana, a series of pilot projects have been initiated to test lean methods. Some of the early results have demonstrated a reduction in turnaround time for pathology reports from the anatomical pathology lab from 5 to 2 days, a reduction in the number of steps and therefore the time from medication order to treatment initiation from 4 hours to 12 minutes, and a reduction in time for unit clerks to process new physician orders from an average of 43 minutes to 10 minutes during the hospital's busiest hours. 22

THE MICHIGAN LEAN EXPERIENCE

In the past year, the University of Michigan has begun to use lean production methods to improve the care of patients across various venues of hospitalization and flow toward discharge. Delays in placement of peripherally inserted central catheters (PICC) were associated with delays in appropriate and timely administration of intravenous medication, as well as in delays in discharges home or to extended‐care facilities (ECF) for continuation of medical care post‐hospitalization. Since the initiation of the lean PICC initiative, when adjusted for increased volume of demand, for 3 consecutive months 90%95% of the PICC lines have been inserted within 24 hours of request. This is a remarkable achievement, given that in the previous 12 months only 50%70% of PICC lines were placed within 24 hours of request. Even without adjusting for volume of demand, the lean PICC initiative has resulted in a 36% decrease in the average time to line placement and in a 50% decrease in the number of PICC referrals to interventional radiology (IR), thus decreasing the workload of a constrained resource.

As with all lean improvement projects, the entire value stream map was assessed in order to identify areas of intervention that would enhance the final product of the process for the patient (in this case, placing a PICC line as timely as possible). As we evaluated this value stream, one step in the process, occurring prior to placement of the line, appeared to be significantly wasteful: when the PICC nurse needed to search for data (such as locating a patient's chart for the order and reviewing labs and medication records) and to ensure that the patient was in his/her room and prepared for line placement. This step appeared to be inefficient use of the time of technically skilled individuals. The future state map of this process implemented the addition of an assisting individual who would ensure that these prework issues were prepared and completed in advance for the PICC nurses, thus making maximum use of the time of these skilled individuals in placing PICC lines, not in performing unskilled work. Another area where an intervention was believed beneficial was streamlining the process of chest x‐ray (CXR) ordering and reading in order to obtain PICC line confirmation. Performance of the previous process was not standardized and led to delays. The future state proposed a standard method of writing an order for a CXR, a standard method for getting that order to the radiology department, and a standard method for reading the films for dictation. This prevented the confusion and rework that had previously occurred. A last example of an intervention is that the PICC nurses began to internally defer to more experienced nurses if a less experienced nurse could not successfully place a PICC line in a patient. Previously, an unsuccessful attempt at bedside PICC placement warranted an IR referral, thus increasing the demand on an already constrained resource. This intervention by the PICC nurses drove down referrals to the IR suite by 50%. Although this may have led to a small increase in rework early in the process, it has led to a significant reduction in work downstream in the process. Thus, we believe that the overall work flow process has been served well by this intervention. As depicted in Figure 3, the lean process improvement method seeks to have continuous improvement, with the old future‐state map taking on the role of the new current‐state map. Since the initial development of these value stream maps, we have been working toward developing and implementing new areas of intervention, which will lead to new future‐state maps and to further improvement of this process, as the demand for PICC lines continues to rise.

Another critical segment in the care of hospitalized patients is the discharge process, including coordination of care to an outpatient or extended care facility (ECF) setting, which has several potential areas of disconnect that could result inpatients having untoward complications requiring rehospitalization, higher morbidity, or prolongation of suffering from their illnesses. The University of Michigan sees a tremendous opportunity to make a significant impact on patient care in this realm and has just initiated a lean project on the coordination of care. Team members on this project will be relevant process stakeholders, including those representing hospitalists, discharge planning, nursing, social work, a related home nursing company, a home infusion service, an ECF, ambulatory care, pharmacy, case management, nutrition, utilization review, patients and their families, and clinic physicians. The overall goal of the project is to optimize patient care from hospitalization to discharge and transfer of care to the outpatient setting.

CONCLUSION

The health care industry should learn about and consider adoption of lean techniques in order to improve its processes. More specifically, hospitals are prime locales for reaping the benefits of implementation of lean production, which can significantly affect how health care is delivered to patients. Toyota and other lean exemplars in the manufacturing industry have achieved a high level of success by utilizing the practice of lean. Early results from health care organizations suggest that utilizing lean production methods can lead to substantial improvements in the quality and efficiency of health care. To determine if the magnitude of success experienced by Toyota and other lean exemplars can also be achieved in the health care sector, it will be necessary to continuously test and evaluate the impact lean health care can have. In the hospital setting, where hospitalists are at the forefront of delivering care, it is incumbent on the hospitalist community to evaluate whether these techniques can make a difference in the quality, efficiency, and safety of the care provided to patients.

Lean thinking is still a novel idea to those in the health care sector, and as early adopters of this promising management model, we are very optimistic about the benefits of applying lean concepts in our hospital. Some of the first published reports and results presented on the benefits of lean in individual organizations are encouraging; however, as health care is a scientific community, we believe that future work should undergo rigorous evaluation on the benefits of lean and that such future works should be shared among the health care community through peer‐reviewed and published works.

Toyota is widely recognized as one of the most successful companies in the world. Its automobiles have consistently placed at or near the top of the quality and customer satisfaction rankings published by J.D. Power and Associates and Consumer Reports. Toyota constantly focuses on the safety and well‐being of its employees and the quality of its cars through its relentless dedication to continuous improvement in everything it does. Toyota has recently become the world's number two auto manufacturer, and the company's net profit margin was more than 8 times that of the industry average. 1

How has Toyota been able to achieve such remarkable results in product quality, market share, and profit margins? Jeffrey Liker, in his book The Toyota Way, described the world‐renowned Toyota production system as supported by 2 pillars: continuous improvement and respect for people. The end result is a learning organization that values employee contributions and continuously strives to produce products of higher quality at lower cost. 1, 2 Lean production is the generic term used to describe the principles and methods of the Toyota Production System. Lean production has been implemented to improve performance in a broad array of industries, from aerospace and aluminum refining to financial services and insurance. The philosophy of lean thinking, which is derived from the Toyota Production System, is rapidly gaining a following among health care leaders, with a number of hospitals and medical groups around the country adopting a version of lean production as their systematic approach to improving quality and efficiency. In the coming years, the application of lean principles and methods could have a transformational effect on how health care is delivered, with the potential for dramatic gains in quality, safety, efficiency, and appropriateness.

LEAN CONCEPTS

To understand how lean production can be applied to improve the delivery of health care, some of the fundamental concepts and practice of lean must first be explained. 3, 4 The first step in a lean improvement initiative is to understand value as defined by our customers. 5 In clinical care delivery, external customers include patients, families, payers, and regulators. Internal customers include physicians, nurses, clerks, and others involved in the care process. What customers value usually includes care that is of high quality, safe, efficient and appropriate. The second step typically is to go to the workplace and observe firsthand how the process now operates. 6 As the flow of the process from beginning to end is seen, the observer learns to see and to understand the multiple areas of delay, inefficiency, and waste that may exist. 7, 8 A representational flowchart called a current‐state value stream map (CS VSM) is created to make the work visible and to depict graphically all the individual steps necessary to complete the process from beginning to end. It is important that the CS VSM be a factual depiction of how an entire process flows created by those who actually work in that process. The CS VSM does not state any exceptions to or provide any explanations for why certain steps are taken. It does include key measures such as process time (the actual time it takes to complete a particular step of the process), lead time (the total time it takes to complete the entire process, including waiting time), and first‐time quality (the percentage of time in which that step of the process is completed without defect); (see Figure 1).

Figure 1

In the hands of an improvement team, the current state map becomes a powerful tool that allows participants to systematically recognize and categorize waste. The CS VSM also allows workers to visualize how much opportunity there is for improving the existing process. Working from the CS VSM, the team members can identify specific areas of waste, delay, causes of error, and inefficiency. The team then brainstorms ideas for improvement, proposing how steps of the process might be combined, eliminated, error‐proofed, or otherwise improved to transform waste into value from the customer's perspective. In the third step, the team seeks to achieve the flow state in which the steps of the process follow one another without stopping. All ideas are welcomed at this stage and are placed on the current state map itself or arrayed elsewhere for consideration. Using the ideas generated by the team, a new and better process is designed and depicted on a flow map called the future‐state value stream map (FS VSM). 9, 10 The FS VSM represents an improved and streamlined or ideal way in which the process could be accomplished, as best the team was able to envision at this point (see Figure 2). Ideally, the process described in the FS VSM also allows customers to pull value when they need goods or services provided by the organization, rather than having to do the usual requesting and waiting seen in health care and other service industries. Creating processes from which customers pull what they need is the fourth step in lean design.

Figure 2

Once a future state map is devised and approved, the critical work of rapid deployment of an implementation plan for reaching the future state begins. An implementation plan explicitly identifies who is responsible for what aspect of implementation. Usually a senior leader or leadership group sponsoring the project is responsible for encouraging team members to think beyond their historical (and often political) limits and to support the team in overcoming barriers outside its control. As the individuals return to work and attempt to implement the new solutions, however, they will likely encounter areas of resistance and ambiguity that require creative solutions. The implementation phase focuses on and encourages the individual worker to experiment and work toward a solution that can be broadly adopted and disseminated for use as a standardized solution by all workers facing similar situations. 11, 12 Through this experimental development and dissemination of solutions, the agreed‐to future‐state map is revised. In this way the old future‐state map plays the role of the new current‐state map. There is an ongoing, continuous loop between the current‐ and future‐state maps through implementation and testing to develop the ideal way in which the process should flow toward the final product or service (see Figure 3). The fifth step, pursuing perfection, requires this continuous loop of all workers improving everything they do, every day. The hardest of all the steps, pursuing perfection requires an organization to commit to process improvement and the elimination of defects and waste on a daily and permanent basis. 5

Figure 3

The steps outlined above provide only the basic foundations of lean concepts, of course. A detailed description of learning about and applying lean within one's own organization requires further study and help. Readers interested in learning more about value stream mapping are referred to a workbook by Mike Rother and John Shook called Learning to See, Value Stream Mapping to Create Value and Eliminate Muda. 4 Further, there are consultants with lean expertise who are available to help hospitals get started on the lean journey.

The management philosophy of lean production methods has ties to other operational and quality‐improvement models such as total quality management (TQM)/continuous quality improvement (CQI), developed by W. E. Deming, and Six Sigma, developed by Motorola and General Electric. Although there are several overlapping points of philosophy and techniques, a feature distinguishing lean from these other models is in its value stream approach to driving change and eliminating waste within the process of providing a product for the customer. Lean is unique in its focus on the specification of value from the customer's perspective and on the identification and categorization of waste and its transformation to value using specific tools. The lean approach encourages individuals within the organization (from top to bottom) to learn to see the flow of their product's process and thus to help to identify areas of waste, with the ultimate goal of creating a product with built‐in quality with the least amount of waste. Both Six Sigma and TQM/CQI focus on the delivery of a high‐quality product. Once a system has been studied and standardized, Six Sigma utilizes rigorous statistical and data measurements to drive quality improvements in product delivery. 13 Total quality management/continuous quality improvement engages the entire organization in delivering a high‐quality product from the customer's standpoint by getting everyone in the organization involved in the continuous improvement effort. 14 Lean thinking builds directly on the plandocheckact cycle of CQI but adds tools to identify and transform waste, supplies metrics of timing and resources, and, most important, focuses intently on the creation of value as defined by the customer. A more detailed comparison of lean philosophy with these other quality‐improvement management philosophies is beyond the scope of this article on the introduction of lean methods for hospitals.

DOES HEALTH CARE NEED LEAN THINKERS?

So, should health care try to emulate the successes of an automobile manufacturing company? Before answering this question, consider the following about the health care system as we know it and the significant challenges it faces.

• A key take‐home message of the Institute of Medicine's 1999 report, To Err Is Human: Building a Safer Health System, was that errors are caused by poorly designed systems. 15

• The Centers for Medicare and Medicaid Services (CMS) reported that the cost of health care is rising rapidly and that the rate of growth is not sustainable. 16

• Studies by the RAND Corporation demonstrated considerable variability in the practice of medicine, raising important questions about the appropriateness and necessity of some medical care and procedures. 17, 18

• In Crossing the Quality Chasm: a New Health System for the 21st Century, the Institute of Medicine concluded that today's health care system functions at far lower levels than it can and should and recommended 6 aims for improving the health care system: health care should be safe, effective, patient centered, timely, efficient, and equitable. 19 This report is rich in detail about what the ideal health care system should look like and how application of lean philosophy and tools can help hospitals and physicians achieve that vision.

Although these challenges reflect a view of the health care system at a very macro level, the mechanism and process of driving change will need to be initiated at the more local and organizational level. Lean production focuses on the goal of continuously transforming waste into value from the customer's perspective. It provides a rigorous and systematic approach to process improvement, error proofing, and waste reduction. Manufacturing companies such as Toyota and Alcoa and financial service organizations such as Vanguard have enjoyed tremendous success in implementing lean production, reporting gains in both quality and efficiency. 11 It is time for health care leaders and practitioners to evaluate how lean techniques can be adapted and applied to addressing the pressing challenges of safety, quality, efficiency, and appropriateness in order to improve system reliability and timeliness. As hospitalists, we are at the forefront of these challenges and therefore are in a prime position to lead the change in how health care delivery is improved continuously using a rigorous system such as the Toyota production system.

LEAN IN HEALTH CARE: EXAMPLES OF SOME EARLY RESULTS

Lean health care is still a very novel concept to most health care institutions; however, there have been some early adopters of lean health care, and some of their experiences are described here:

• At Virginia Mason Medical Center (VMMC) in Seattle, Washington, changes implemented using lean production methods have resulted in decreased incidence of ventilator‐associated pneumoniafrom 34 cases with 5 deaths in 2002 to 4 cases with 1 death in 2004. This led to a cost reduction of nearly a half‐million dollars. VMMC has also reported increased profit margins and improvement in space utilization at its cancer center, enabling 57% more patients to be seen in the same allotted space; and it is now taking measures to decrease the number of medication errors by standardizing and mistake‐proofing the process of ordering, delivering, and administering medications, all using lean techniques. 12, 20

• At Park Nicollet Health Services (PNHS) in Minneapolis, Minnesota, implementation of lean production has enabled improved patient access through flow improvements. Results include increasing the number of CT and MRI scans performed per day by 2 and 1, respectively; creating a capacity for 10 additional chemotherapy and antibiotic infusion patients per day in the cancer center; reducing the waiting time of patients from 122 to 52 minutes at the urgent care clinic; standardizing surgical instrument use by the general surgery group, which resulted in processing more than 40,000 fewer instruments each month. These improvements achieved through applying lean concepts have resulted in Park Nicollet being recognized by the American Medical Group Association (AMGA) with its top‐rated Acclaim Award. 21 In addition, PNHS has been able to achieve a record 3.9% operating margin, which equates to a $7.5 million profit in 2004.

• In Pittsburgh, Pennsylvania, a group of hospitals participating in the Pittsburgh Regional Healthcare Initiative (PRHI) have implemented lean concepts to minimize the risk of developing central catheterrelated bloodstream infections. Several hospitals have been able to cut the incidence of central line infections by 50%‐90% through implementation of lean production methods. 12

• At Community Medical Center in Missoula, Montana, a series of pilot projects have been initiated to test lean methods. Some of the early results have demonstrated a reduction in turnaround time for pathology reports from the anatomical pathology lab from 5 to 2 days, a reduction in the number of steps and therefore the time from medication order to treatment initiation from 4 hours to 12 minutes, and a reduction in time for unit clerks to process new physician orders from an average of 43 minutes to 10 minutes during the hospital's busiest hours. 22

THE MICHIGAN LEAN EXPERIENCE

In the past year, the University of Michigan has begun to use lean production methods to improve the care of patients across various venues of hospitalization and flow toward discharge. Delays in placement of peripherally inserted central catheters (PICC) were associated with delays in appropriate and timely administration of intravenous medication, as well as in delays in discharges home or to extended‐care facilities (ECF) for continuation of medical care post‐hospitalization. Since the initiation of the lean PICC initiative, when adjusted for increased volume of demand, for 3 consecutive months 90%95% of the PICC lines have been inserted within 24 hours of request. This is a remarkable achievement, given that in the previous 12 months only 50%70% of PICC lines were placed within 24 hours of request. Even without adjusting for volume of demand, the lean PICC initiative has resulted in a 36% decrease in the average time to line placement and in a 50% decrease in the number of PICC referrals to interventional radiology (IR), thus decreasing the workload of a constrained resource.

As with all lean improvement projects, the entire value stream map was assessed in order to identify areas of intervention that would enhance the final product of the process for the patient (in this case, placing a PICC line as timely as possible). As we evaluated this value stream, one step in the process, occurring prior to placement of the line, appeared to be significantly wasteful: when the PICC nurse needed to search for data (such as locating a patient's chart for the order and reviewing labs and medication records) and to ensure that the patient was in his/her room and prepared for line placement. This step appeared to be inefficient use of the time of technically skilled individuals. The future state map of this process implemented the addition of an assisting individual who would ensure that these prework issues were prepared and completed in advance for the PICC nurses, thus making maximum use of the time of these skilled individuals in placing PICC lines, not in performing unskilled work. Another area where an intervention was believed beneficial was streamlining the process of chest x‐ray (CXR) ordering and reading in order to obtain PICC line confirmation. Performance of the previous process was not standardized and led to delays. The future state proposed a standard method of writing an order for a CXR, a standard method for getting that order to the radiology department, and a standard method for reading the films for dictation. This prevented the confusion and rework that had previously occurred. A last example of an intervention is that the PICC nurses began to internally defer to more experienced nurses if a less experienced nurse could not successfully place a PICC line in a patient. Previously, an unsuccessful attempt at bedside PICC placement warranted an IR referral, thus increasing the demand on an already constrained resource. This intervention by the PICC nurses drove down referrals to the IR suite by 50%. Although this may have led to a small increase in rework early in the process, it has led to a significant reduction in work downstream in the process. Thus, we believe that the overall work flow process has been served well by this intervention. As depicted in Figure 3, the lean process improvement method seeks to have continuous improvement, with the old future‐state map taking on the role of the new current‐state map. Since the initial development of these value stream maps, we have been working toward developing and implementing new areas of intervention, which will lead to new future‐state maps and to further improvement of this process, as the demand for PICC lines continues to rise.

Another critical segment in the care of hospitalized patients is the discharge process, including coordination of care to an outpatient or extended care facility (ECF) setting, which has several potential areas of disconnect that could result inpatients having untoward complications requiring rehospitalization, higher morbidity, or prolongation of suffering from their illnesses. The University of Michigan sees a tremendous opportunity to make a significant impact on patient care in this realm and has just initiated a lean project on the coordination of care. Team members on this project will be relevant process stakeholders, including those representing hospitalists, discharge planning, nursing, social work, a related home nursing company, a home infusion service, an ECF, ambulatory care, pharmacy, case management, nutrition, utilization review, patients and their families, and clinic physicians. The overall goal of the project is to optimize patient care from hospitalization to discharge and transfer of care to the outpatient setting.

CONCLUSION

The health care industry should learn about and consider adoption of lean techniques in order to improve its processes. More specifically, hospitals are prime locales for reaping the benefits of implementation of lean production, which can significantly affect how health care is delivered to patients. Toyota and other lean exemplars in the manufacturing industry have achieved a high level of success by utilizing the practice of lean. Early results from health care organizations suggest that utilizing lean production methods can lead to substantial improvements in the quality and efficiency of health care. To determine if the magnitude of success experienced by Toyota and other lean exemplars can also be achieved in the health care sector, it will be necessary to continuously test and evaluate the impact lean health care can have. In the hospital setting, where hospitalists are at the forefront of delivering care, it is incumbent on the hospitalist community to evaluate whether these techniques can make a difference in the quality, efficiency, and safety of the care provided to patients.

Lean thinking is still a novel idea to those in the health care sector, and as early adopters of this promising management model, we are very optimistic about the benefits of applying lean concepts in our hospital. Some of the first published reports and results presented on the benefits of lean in individual organizations are encouraging; however, as health care is a scientific community, we believe that future work should undergo rigorous evaluation on the benefits of lean and that such future works should be shared among the health care community through peer‐reviewed and published works.

Toyota is widely recognized as one of the most successful companies in the world. Its automobiles have consistently placed at or near the top of the quality and customer satisfaction rankings published by J.D. Power and Associates and Consumer Reports. Toyota constantly focuses on the safety and well‐being of its employees and the quality of its cars through its relentless dedication to continuous improvement in everything it does. Toyota has recently become the world's number two auto manufacturer, and the company's net profit margin was more than 8 times that of the industry average. 1

How has Toyota been able to achieve such remarkable results in product quality, market share, and profit margins? Jeffrey Liker, in his book The Toyota Way, described the world‐renowned Toyota production system as supported by 2 pillars: continuous improvement and respect for people. The end result is a learning organization that values employee contributions and continuously strives to produce products of higher quality at lower cost. 1, 2 Lean production is the generic term used to describe the principles and methods of the Toyota Production System. Lean production has been implemented to improve performance in a broad array of industries, from aerospace and aluminum refining to financial services and insurance. The philosophy of lean thinking, which is derived from the Toyota Production System, is rapidly gaining a following among health care leaders, with a number of hospitals and medical groups around the country adopting a version of lean production as their systematic approach to improving quality and efficiency. In the coming years, the application of lean principles and methods could have a transformational effect on how health care is delivered, with the potential for dramatic gains in quality, safety, efficiency, and appropriateness.

LEAN CONCEPTS

To understand how lean production can be applied to improve the delivery of health care, some of the fundamental concepts and practice of lean must first be explained. 3, 4 The first step in a lean improvement initiative is to understand value as defined by our customers. 5 In clinical care delivery, external customers include patients, families, payers, and regulators. Internal customers include physicians, nurses, clerks, and others involved in the care process. What customers value usually includes care that is of high quality, safe, efficient and appropriate. The second step typically is to go to the workplace and observe firsthand how the process now operates. 6 As the flow of the process from beginning to end is seen, the observer learns to see and to understand the multiple areas of delay, inefficiency, and waste that may exist. 7, 8 A representational flowchart called a current‐state value stream map (CS VSM) is created to make the work visible and to depict graphically all the individual steps necessary to complete the process from beginning to end. It is important that the CS VSM be a factual depiction of how an entire process flows created by those who actually work in that process. The CS VSM does not state any exceptions to or provide any explanations for why certain steps are taken. It does include key measures such as process time (the actual time it takes to complete a particular step of the process), lead time (the total time it takes to complete the entire process, including waiting time), and first‐time quality (the percentage of time in which that step of the process is completed without defect); (see Figure 1).

Figure 1

In the hands of an improvement team, the current state map becomes a powerful tool that allows participants to systematically recognize and categorize waste. The CS VSM also allows workers to visualize how much opportunity there is for improving the existing process. Working from the CS VSM, the team members can identify specific areas of waste, delay, causes of error, and inefficiency. The team then brainstorms ideas for improvement, proposing how steps of the process might be combined, eliminated, error‐proofed, or otherwise improved to transform waste into value from the customer's perspective. In the third step, the team seeks to achieve the flow state in which the steps of the process follow one another without stopping. All ideas are welcomed at this stage and are placed on the current state map itself or arrayed elsewhere for consideration. Using the ideas generated by the team, a new and better process is designed and depicted on a flow map called the future‐state value stream map (FS VSM). 9, 10 The FS VSM represents an improved and streamlined or ideal way in which the process could be accomplished, as best the team was able to envision at this point (see Figure 2). Ideally, the process described in the FS VSM also allows customers to pull value when they need goods or services provided by the organization, rather than having to do the usual requesting and waiting seen in health care and other service industries. Creating processes from which customers pull what they need is the fourth step in lean design.

Figure 2

Once a future state map is devised and approved, the critical work of rapid deployment of an implementation plan for reaching the future state begins. An implementation plan explicitly identifies who is responsible for what aspect of implementation. Usually a senior leader or leadership group sponsoring the project is responsible for encouraging team members to think beyond their historical (and often political) limits and to support the team in overcoming barriers outside its control. As the individuals return to work and attempt to implement the new solutions, however, they will likely encounter areas of resistance and ambiguity that require creative solutions. The implementation phase focuses on and encourages the individual worker to experiment and work toward a solution that can be broadly adopted and disseminated for use as a standardized solution by all workers facing similar situations. 11, 12 Through this experimental development and dissemination of solutions, the agreed‐to future‐state map is revised. In this way the old future‐state map plays the role of the new current‐state map. There is an ongoing, continuous loop between the current‐ and future‐state maps through implementation and testing to develop the ideal way in which the process should flow toward the final product or service (see Figure 3). The fifth step, pursuing perfection, requires this continuous loop of all workers improving everything they do, every day. The hardest of all the steps, pursuing perfection requires an organization to commit to process improvement and the elimination of defects and waste on a daily and permanent basis. 5

Figure 3

The steps outlined above provide only the basic foundations of lean concepts, of course. A detailed description of learning about and applying lean within one's own organization requires further study and help. Readers interested in learning more about value stream mapping are referred to a workbook by Mike Rother and John Shook called Learning to See, Value Stream Mapping to Create Value and Eliminate Muda. 4 Further, there are consultants with lean expertise who are available to help hospitals get started on the lean journey.

The management philosophy of lean production methods has ties to other operational and quality‐improvement models such as total quality management (TQM)/continuous quality improvement (CQI), developed by W. E. Deming, and Six Sigma, developed by Motorola and General Electric. Although there are several overlapping points of philosophy and techniques, a feature distinguishing lean from these other models is in its value stream approach to driving change and eliminating waste within the process of providing a product for the customer. Lean is unique in its focus on the specification of value from the customer's perspective and on the identification and categorization of waste and its transformation to value using specific tools. The lean approach encourages individuals within the organization (from top to bottom) to learn to see the flow of their product's process and thus to help to identify areas of waste, with the ultimate goal of creating a product with built‐in quality with the least amount of waste. Both Six Sigma and TQM/CQI focus on the delivery of a high‐quality product. Once a system has been studied and standardized, Six Sigma utilizes rigorous statistical and data measurements to drive quality improvements in product delivery. 13 Total quality management/continuous quality improvement engages the entire organization in delivering a high‐quality product from the customer's standpoint by getting everyone in the organization involved in the continuous improvement effort. 14 Lean thinking builds directly on the plandocheckact cycle of CQI but adds tools to identify and transform waste, supplies metrics of timing and resources, and, most important, focuses intently on the creation of value as defined by the customer. A more detailed comparison of lean philosophy with these other quality‐improvement management philosophies is beyond the scope of this article on the introduction of lean methods for hospitals.

DOES HEALTH CARE NEED LEAN THINKERS?

So, should health care try to emulate the successes of an automobile manufacturing company? Before answering this question, consider the following about the health care system as we know it and the significant challenges it faces.

• A key take‐home message of the Institute of Medicine's 1999 report, To Err Is Human: Building a Safer Health System, was that errors are caused by poorly designed systems. 15

• The Centers for Medicare and Medicaid Services (CMS) reported that the cost of health care is rising rapidly and that the rate of growth is not sustainable. 16

• Studies by the RAND Corporation demonstrated considerable variability in the practice of medicine, raising important questions about the appropriateness and necessity of some medical care and procedures. 17, 18

• In Crossing the Quality Chasm: a New Health System for the 21st Century, the Institute of Medicine concluded that today's health care system functions at far lower levels than it can and should and recommended 6 aims for improving the health care system: health care should be safe, effective, patient centered, timely, efficient, and equitable. 19 This report is rich in detail about what the ideal health care system should look like and how application of lean philosophy and tools can help hospitals and physicians achieve that vision.

Although these challenges reflect a view of the health care system at a very macro level, the mechanism and process of driving change will need to be initiated at the more local and organizational level. Lean production focuses on the goal of continuously transforming waste into value from the customer's perspective. It provides a rigorous and systematic approach to process improvement, error proofing, and waste reduction. Manufacturing companies such as Toyota and Alcoa and financial service organizations such as Vanguard have enjoyed tremendous success in implementing lean production, reporting gains in both quality and efficiency. 11 It is time for health care leaders and practitioners to evaluate how lean techniques can be adapted and applied to addressing the pressing challenges of safety, quality, efficiency, and appropriateness in order to improve system reliability and timeliness. As hospitalists, we are at the forefront of these challenges and therefore are in a prime position to lead the change in how health care delivery is improved continuously using a rigorous system such as the Toyota production system.

LEAN IN HEALTH CARE: EXAMPLES OF SOME EARLY RESULTS

Lean health care is still a very novel concept to most health care institutions; however, there have been some early adopters of lean health care, and some of their experiences are described here:

• At Virginia Mason Medical Center (VMMC) in Seattle, Washington, changes implemented using lean production methods have resulted in decreased incidence of ventilator‐associated pneumoniafrom 34 cases with 5 deaths in 2002 to 4 cases with 1 death in 2004. This led to a cost reduction of nearly a half‐million dollars. VMMC has also reported increased profit margins and improvement in space utilization at its cancer center, enabling 57% more patients to be seen in the same allotted space; and it is now taking measures to decrease the number of medication errors by standardizing and mistake‐proofing the process of ordering, delivering, and administering medications, all using lean techniques. 12, 20

• At Park Nicollet Health Services (PNHS) in Minneapolis, Minnesota, implementation of lean production has enabled improved patient access through flow improvements. Results include increasing the number of CT and MRI scans performed per day by 2 and 1, respectively; creating a capacity for 10 additional chemotherapy and antibiotic infusion patients per day in the cancer center; reducing the waiting time of patients from 122 to 52 minutes at the urgent care clinic; standardizing surgical instrument use by the general surgery group, which resulted in processing more than 40,000 fewer instruments each month. These improvements achieved through applying lean concepts have resulted in Park Nicollet being recognized by the American Medical Group Association (AMGA) with its top‐rated Acclaim Award. 21 In addition, PNHS has been able to achieve a record 3.9% operating margin, which equates to a $7.5 million profit in 2004.

• In Pittsburgh, Pennsylvania, a group of hospitals participating in the Pittsburgh Regional Healthcare Initiative (PRHI) have implemented lean concepts to minimize the risk of developing central catheterrelated bloodstream infections. Several hospitals have been able to cut the incidence of central line infections by 50%‐90% through implementation of lean production methods. 12

• At Community Medical Center in Missoula, Montana, a series of pilot projects have been initiated to test lean methods. Some of the early results have demonstrated a reduction in turnaround time for pathology reports from the anatomical pathology lab from 5 to 2 days, a reduction in the number of steps and therefore the time from medication order to treatment initiation from 4 hours to 12 minutes, and a reduction in time for unit clerks to process new physician orders from an average of 43 minutes to 10 minutes during the hospital's busiest hours. 22

THE MICHIGAN LEAN EXPERIENCE

In the past year, the University of Michigan has begun to use lean production methods to improve the care of patients across various venues of hospitalization and flow toward discharge. Delays in placement of peripherally inserted central catheters (PICC) were associated with delays in appropriate and timely administration of intravenous medication, as well as in delays in discharges home or to extended‐care facilities (ECF) for continuation of medical care post‐hospitalization. Since the initiation of the lean PICC initiative, when adjusted for increased volume of demand, for 3 consecutive months 90%95% of the PICC lines have been inserted within 24 hours of request. This is a remarkable achievement, given that in the previous 12 months only 50%70% of PICC lines were placed within 24 hours of request. Even without adjusting for volume of demand, the lean PICC initiative has resulted in a 36% decrease in the average time to line placement and in a 50% decrease in the number of PICC referrals to interventional radiology (IR), thus decreasing the workload of a constrained resource.

As with all lean improvement projects, the entire value stream map was assessed in order to identify areas of intervention that would enhance the final product of the process for the patient (in this case, placing a PICC line as timely as possible). As we evaluated this value stream, one step in the process, occurring prior to placement of the line, appeared to be significantly wasteful: when the PICC nurse needed to search for data (such as locating a patient's chart for the order and reviewing labs and medication records) and to ensure that the patient was in his/her room and prepared for line placement. This step appeared to be inefficient use of the time of technically skilled individuals. The future state map of this process implemented the addition of an assisting individual who would ensure that these prework issues were prepared and completed in advance for the PICC nurses, thus making maximum use of the time of these skilled individuals in placing PICC lines, not in performing unskilled work. Another area where an intervention was believed beneficial was streamlining the process of chest x‐ray (CXR) ordering and reading in order to obtain PICC line confirmation. Performance of the previous process was not standardized and led to delays. The future state proposed a standard method of writing an order for a CXR, a standard method for getting that order to the radiology department, and a standard method for reading the films for dictation. This prevented the confusion and rework that had previously occurred. A last example of an intervention is that the PICC nurses began to internally defer to more experienced nurses if a less experienced nurse could not successfully place a PICC line in a patient. Previously, an unsuccessful attempt at bedside PICC placement warranted an IR referral, thus increasing the demand on an already constrained resource. This intervention by the PICC nurses drove down referrals to the IR suite by 50%. Although this may have led to a small increase in rework early in the process, it has led to a significant reduction in work downstream in the process. Thus, we believe that the overall work flow process has been served well by this intervention. As depicted in Figure 3, the lean process improvement method seeks to have continuous improvement, with the old future‐state map taking on the role of the new current‐state map. Since the initial development of these value stream maps, we have been working toward developing and implementing new areas of intervention, which will lead to new future‐state maps and to further improvement of this process, as the demand for PICC lines continues to rise.

Another critical segment in the care of hospitalized patients is the discharge process, including coordination of care to an outpatient or extended care facility (ECF) setting, which has several potential areas of disconnect that could result inpatients having untoward complications requiring rehospitalization, higher morbidity, or prolongation of suffering from their illnesses. The University of Michigan sees a tremendous opportunity to make a significant impact on patient care in this realm and has just initiated a lean project on the coordination of care. Team members on this project will be relevant process stakeholders, including those representing hospitalists, discharge planning, nursing, social work, a related home nursing company, a home infusion service, an ECF, ambulatory care, pharmacy, case management, nutrition, utilization review, patients and their families, and clinic physicians. The overall goal of the project is to optimize patient care from hospitalization to discharge and transfer of care to the outpatient setting.

CONCLUSION

The health care industry should learn about and consider adoption of lean techniques in order to improve its processes. More specifically, hospitals are prime locales for reaping the benefits of implementation of lean production, which can significantly affect how health care is delivered to patients. Toyota and other lean exemplars in the manufacturing industry have achieved a high level of success by utilizing the practice of lean. Early results from health care organizations suggest that utilizing lean production methods can lead to substantial improvements in the quality and efficiency of health care. To determine if the magnitude of success experienced by Toyota and other lean exemplars can also be achieved in the health care sector, it will be necessary to continuously test and evaluate the impact lean health care can have. In the hospital setting, where hospitalists are at the forefront of delivering care, it is incumbent on the hospitalist community to evaluate whether these techniques can make a difference in the quality, efficiency, and safety of the care provided to patients.

Lean thinking is still a novel idea to those in the health care sector, and as early adopters of this promising management model, we are very optimistic about the benefits of applying lean concepts in our hospital. Some of the first published reports and results presented on the benefits of lean in individual organizations are encouraging; however, as health care is a scientific community, we believe that future work should undergo rigorous evaluation on the benefits of lean and that such future works should be shared among the health care community through peer‐reviewed and published works.

Diabetes mellitus is a common comorbidity of hospitalization; in 2003 diabetes was a secondary diagnosis in 17.8% of all adult hospital discharges.1 When undiagnosed diabetes is included, the prevalence of inpatient diabetes or hyperglycemia may be as high as 38%.2 Recent studies show that hyperglycemia in hospitalized patients complicates numerous illnesses and is an independent predictor of adverse outcomes.3 Treatment of inpatient hyperglycemia improves outcomes, including mortality, for patients in surgical intensive care units4 and possibly for those admitted for myocardial infarction.5, 6 For these reasons, the American Diabetes Association and the American College of Endocrinology now recommend that glucose levels of all patients admitted to non‐critical‐care units be maintained below 180 mg/dL.3, 7

Evidence‐based recommendations for achieving these goals include effective protocols for subcutaneous insulin therapy for patients who do not require continuous intravenous insulin infusion. Components of these protocols include use of basal insulin and scheduled nutritional insulin, avoiding use of supplemental (sliding‐scale) insulin alone (which has been shown to be ineffective and possibly deleterious in prior studies),8 and adjustment of insulin orders to reflect nutritional intake, insulin sensitivity, and previous response to therapy.7

We conducted this study to evaluate the current state of glycemic control and adherence to current recommendations on a general medicine service run by hospitalists in a busy teaching hospital. We also sought to correlate insulin‐ordering practices with the quality of glycemic control in these patients.

METHODS

RESULTS

We prospectively identified 123 patients for the study. Subsequently, 16 patients were excluded, 11 who did not have diabetes or inpatient hyperglycemia (most of whom had been placed on insulin prophylactically to avoid steroid‐induced hyperglycemia), 2 who were admitted for diabetic ketoacidosis, 2 who were not on GMS teams 13, and 1 whose data could not be accessed. Characteristics of the remaining 107 study subjects are shown in Table 1. The mean age of the subjects was 65.2 years; 55% were men. Nine patients had no previous diagnosis of diabetes, 43% were taking insulin prior to admission, 14% had severe diabetic complications, and the median HbA_1C was 7.

Regarding insulin‐ordering practices (Table 2), 47 patients (43%) had basal insulin prescribed, while 4% of patients had an order for scheduled mealtime short‐ or rapid‐acting insulin. Of the 89 patients on sliding‐scale insulin, 80 (90%) had orders written for the default sliding scale built into the computerized physician order entry system at BWH. There was no correlation between intensity of the sliding scale and the patient's total daily insulin dose (data not shown). Of the patients on sliding‐scale insulin, 47% were prescribed basal insulin, 39% were prescribed oral agents, and 23% were prescribed neither.

Regarding glucose control, 317 of 1022 glucose meter readings (31%) were greater than 180 mg/dL, and the mean rate of glucose readings greater than 180 mg/dL per patient was also 31%. Approximately three quarters of all patients had at least one routine glucose reading greater than 180 mg/dL, and 35% of patients had at least 40% of their routine glucose readings greater than 180 mg/dL (Table 2). Twelve of 1022 readings (1.2%) were less than 60 mg/dL, and 11% of patients had at least one glucose reading less than 60 mg/dL (Table 2).

Despite a relatively constant percentage of glucose readings greater than 180 mg/dL per patient over the first 5 days of hospitalization (25%36% each day), we found no evidence of change in the percentage of patients prescribed basal insulin or the percentage of insulin given as basal insulin, and there was a small but significant increase in the total amount of insulin prescribed (Table 3). Of the 75 patients with at least one episode of hypo‐ or hyperglycemia, 43 (57%) were ever prescribed basal insulin, 29 (39%) were prescribed oral diabetes agents, and only 26 (35%) had any change to their insulin regimen during the first 5 days of their hospitalization on GMS. Of the 47 patients prescribed basal insulin in the hospital, 41 had been taking insulin prior to admission.

In a multivariable analysis of the mean glucose reading per patient‐day, we found several predictors of lower glucose readings, including diet‐controlled diabetes prior to admission and prescription of oral hypoglycemic medications in the hospital. We also found several predictors of higher glucose readings, including severe diabetic complications and higher glucose level at admission. Finally, we noted variation both by medical team (each composed of 1 medical attending, 1 resident, and 2 interns) and by floor of the hospital (each staffed by a different cadre of nurses). Adjusting for these factors (as well as for the daily use of dextrose‐containing intravenous fluids and steroids, sex, age, Charlson comorbidity score, APACHE 3 score, prior diagnosis of diabetes, HbA_1C level, and length of hospital stay) use of sliding‐scale insulin alone (eg, without scheduled basal or nutritional insulin) was associated with a daily average glucose reading that was 20 mg/dL higher than that for those prescribed scheduled insulin or those not prescribed a sliding scale at all (95% confidence interval, 5.035 mg/dL; Table 4). In a separate analysis, adjusting for the same clinical factors, we could find no relationship between change in daily dose of basal insulin and change in daily average glucose level (data not shown).

DISCUSSION

In this observational study, we found several deficiencies in the management of diabetes and hyperglycemia among hospitalized patients on a hospitalist‐run general medical service. These deficiencies were both in processes of care (eg, limited use of basal and especially nutritional insulin) and in outcomes (ie, glycemic control) compared with national guidelines. We also found evidence of clinical inertia when comparing outpatient to inpatient regimens, when evaluating daily changes in management, and when evaluating responses to previous hyperglycemia. Finally, we demonstrated that use of an insulin sliding scale by itself was associated with worse glycemic control after extensive adjustment for a variety of clinical factors.

Of note, other than the use of sliding‐scale insulin by itself, we could not find a relationship between specific daily adjustments to insulin orders and daily glycemic control in this study. However, we did find differences in glycemic control by medical team and by floor (the latter a proxy for nursing staff). This suggests that glycemic control depends on the exact details of how insulin is managed, rather than on crude measures of insulin adjustment such as change in dose in response to hyperglycemia. These findings also suggest that interventions focused on medical and nursing staff may be able to improve inpatient glycemic control.

The association between the use of oral diabetic agents and improved glucose control was notable and could represent an actual benefit of these agents (especially when added to sliding‐scale insulin by itself) and/or the result of uncontrolled confounding (ie, as a marker of well‐controlled diabetes). Further study is needed to distinguish among these possibilities.

Previous studies have shown evidence of poor inpatient glycemic control as well as the deleterious effects of sliding‐scale insulin by itself.8 This study is perhaps most notable for the suggestion that little, if anything, has changed over the previous decade in this area, despite recent well‐done observational and randomized controlled trials demonstrating the hazards of inpatient hyperglycemia and the publication of expert consensus statements on inpatient glucose management. Strategies to improve glucose control have been investigated to a greater extent in intensive care units12, 13 than on general medical wards,14 perhaps because the strength of evidence is strongest in this setting. Without such strong evidence for general medical patients, factors such as clinician fear of hypoglycemia, clinical inertia, and resistance to institutional change may play predominant roles.

Clinical inertia (ie, recognition of the problem but failure to act)15 has been demonstrated previously in the outpatient management of diabetes16, 17; this study provides evidence of the phenomenon in the inpatient setting. Work by Phillips and colleagues15 has shown that clinical inertia results from at least 3 problems: overestimation of care provided; use of soft reasons to avoid intensification of therapy; and lack of education, training, and practice organization aimed at achieving specific goals. All 3 problems likely contribute to clinical inertia in inpatient diabetes management. Revised educational programs; systems for improving care such as reminders, flow sheets, and order sets; and performance feedback can help address clinical inertia and improve care.15

This study should be viewed in light of its limitations, including relatively small sample size, thus limiting our ability to detect other possible significant predictors of glycemic control, and the use of a single institution, thus limiting generalizability. However, recent data from the University HealthSystem Consortium revealed that our institution was typical of the 37 participating academic medical centers in that study.18 In addition, only 9 patients were identified without a prior diagnosis of diabetes, raising the possibility that some patients with undiagnosed diabetes were missed in our study. However, our search strategy included a daily review of automatically abstracted laboratory values, making this possibility less likely. Strengths of this study include its prospective data collection methods with rigorous inclusion criteria, collection of detailed clinical data, and use of a novel statistical technique to more accurately assess the complex relationship between insulin use and glycemic control, appropriately adjusting for confounding by indication caused by prior glucose measurements.

Future research should focus on patient, clinician, and system barriers to improving inpatient glycemic management, using the clinical inertia framework as a starting point, and on the creation of insulin protocols that can be used and proven effective in the non‐ICU inpatient setting. Also needed are improved measures of the quality of glycemic control, insulin orders, and daily insulin adjustment.

In conclusion, inpatient glycemic management was shown to be in need of improvement. Institutionwide quality improvement efforts should probably target both physician and nursing behavior and should focus on increasing use of basal and nutritional insulin, as proposed in recent guidelines, avoiding use of sliding‐scale insulin by itself, and performing daily insulin adjustment in response to previous hypo‐ or hyperglycemia. Hospitalists can play a major role in these institutionwide quality improvement efforts.

Diabetes mellitus is a common comorbidity of hospitalization; in 2003 diabetes was a secondary diagnosis in 17.8% of all adult hospital discharges.1 When undiagnosed diabetes is included, the prevalence of inpatient diabetes or hyperglycemia may be as high as 38%.2 Recent studies show that hyperglycemia in hospitalized patients complicates numerous illnesses and is an independent predictor of adverse outcomes.3 Treatment of inpatient hyperglycemia improves outcomes, including mortality, for patients in surgical intensive care units4 and possibly for those admitted for myocardial infarction.5, 6 For these reasons, the American Diabetes Association and the American College of Endocrinology now recommend that glucose levels of all patients admitted to non‐critical‐care units be maintained below 180 mg/dL.3, 7

Evidence‐based recommendations for achieving these goals include effective protocols for subcutaneous insulin therapy for patients who do not require continuous intravenous insulin infusion. Components of these protocols include use of basal insulin and scheduled nutritional insulin, avoiding use of supplemental (sliding‐scale) insulin alone (which has been shown to be ineffective and possibly deleterious in prior studies),8 and adjustment of insulin orders to reflect nutritional intake, insulin sensitivity, and previous response to therapy.7

We conducted this study to evaluate the current state of glycemic control and adherence to current recommendations on a general medicine service run by hospitalists in a busy teaching hospital. We also sought to correlate insulin‐ordering practices with the quality of glycemic control in these patients.

METHODS

RESULTS

We prospectively identified 123 patients for the study. Subsequently, 16 patients were excluded, 11 who did not have diabetes or inpatient hyperglycemia (most of whom had been placed on insulin prophylactically to avoid steroid‐induced hyperglycemia), 2 who were admitted for diabetic ketoacidosis, 2 who were not on GMS teams 13, and 1 whose data could not be accessed. Characteristics of the remaining 107 study subjects are shown in Table 1. The mean age of the subjects was 65.2 years; 55% were men. Nine patients had no previous diagnosis of diabetes, 43% were taking insulin prior to admission, 14% had severe diabetic complications, and the median HbA_1C was 7.

Regarding insulin‐ordering practices (Table 2), 47 patients (43%) had basal insulin prescribed, while 4% of patients had an order for scheduled mealtime short‐ or rapid‐acting insulin. Of the 89 patients on sliding‐scale insulin, 80 (90%) had orders written for the default sliding scale built into the computerized physician order entry system at BWH. There was no correlation between intensity of the sliding scale and the patient's total daily insulin dose (data not shown). Of the patients on sliding‐scale insulin, 47% were prescribed basal insulin, 39% were prescribed oral agents, and 23% were prescribed neither.

Regarding glucose control, 317 of 1022 glucose meter readings (31%) were greater than 180 mg/dL, and the mean rate of glucose readings greater than 180 mg/dL per patient was also 31%. Approximately three quarters of all patients had at least one routine glucose reading greater than 180 mg/dL, and 35% of patients had at least 40% of their routine glucose readings greater than 180 mg/dL (Table 2). Twelve of 1022 readings (1.2%) were less than 60 mg/dL, and 11% of patients had at least one glucose reading less than 60 mg/dL (Table 2).

Despite a relatively constant percentage of glucose readings greater than 180 mg/dL per patient over the first 5 days of hospitalization (25%36% each day), we found no evidence of change in the percentage of patients prescribed basal insulin or the percentage of insulin given as basal insulin, and there was a small but significant increase in the total amount of insulin prescribed (Table 3). Of the 75 patients with at least one episode of hypo‐ or hyperglycemia, 43 (57%) were ever prescribed basal insulin, 29 (39%) were prescribed oral diabetes agents, and only 26 (35%) had any change to their insulin regimen during the first 5 days of their hospitalization on GMS. Of the 47 patients prescribed basal insulin in the hospital, 41 had been taking insulin prior to admission.

In a multivariable analysis of the mean glucose reading per patient‐day, we found several predictors of lower glucose readings, including diet‐controlled diabetes prior to admission and prescription of oral hypoglycemic medications in the hospital. We also found several predictors of higher glucose readings, including severe diabetic complications and higher glucose level at admission. Finally, we noted variation both by medical team (each composed of 1 medical attending, 1 resident, and 2 interns) and by floor of the hospital (each staffed by a different cadre of nurses). Adjusting for these factors (as well as for the daily use of dextrose‐containing intravenous fluids and steroids, sex, age, Charlson comorbidity score, APACHE 3 score, prior diagnosis of diabetes, HbA_1C level, and length of hospital stay) use of sliding‐scale insulin alone (eg, without scheduled basal or nutritional insulin) was associated with a daily average glucose reading that was 20 mg/dL higher than that for those prescribed scheduled insulin or those not prescribed a sliding scale at all (95% confidence interval, 5.035 mg/dL; Table 4). In a separate analysis, adjusting for the same clinical factors, we could find no relationship between change in daily dose of basal insulin and change in daily average glucose level (data not shown).

DISCUSSION

In this observational study, we found several deficiencies in the management of diabetes and hyperglycemia among hospitalized patients on a hospitalist‐run general medical service. These deficiencies were both in processes of care (eg, limited use of basal and especially nutritional insulin) and in outcomes (ie, glycemic control) compared with national guidelines. We also found evidence of clinical inertia when comparing outpatient to inpatient regimens, when evaluating daily changes in management, and when evaluating responses to previous hyperglycemia. Finally, we demonstrated that use of an insulin sliding scale by itself was associated with worse glycemic control after extensive adjustment for a variety of clinical factors.

Of note, other than the use of sliding‐scale insulin by itself, we could not find a relationship between specific daily adjustments to insulin orders and daily glycemic control in this study. However, we did find differences in glycemic control by medical team and by floor (the latter a proxy for nursing staff). This suggests that glycemic control depends on the exact details of how insulin is managed, rather than on crude measures of insulin adjustment such as change in dose in response to hyperglycemia. These findings also suggest that interventions focused on medical and nursing staff may be able to improve inpatient glycemic control.

The association between the use of oral diabetic agents and improved glucose control was notable and could represent an actual benefit of these agents (especially when added to sliding‐scale insulin by itself) and/or the result of uncontrolled confounding (ie, as a marker of well‐controlled diabetes). Further study is needed to distinguish among these possibilities.

Previous studies have shown evidence of poor inpatient glycemic control as well as the deleterious effects of sliding‐scale insulin by itself.8 This study is perhaps most notable for the suggestion that little, if anything, has changed over the previous decade in this area, despite recent well‐done observational and randomized controlled trials demonstrating the hazards of inpatient hyperglycemia and the publication of expert consensus statements on inpatient glucose management. Strategies to improve glucose control have been investigated to a greater extent in intensive care units12, 13 than on general medical wards,14 perhaps because the strength of evidence is strongest in this setting. Without such strong evidence for general medical patients, factors such as clinician fear of hypoglycemia, clinical inertia, and resistance to institutional change may play predominant roles.

Clinical inertia (ie, recognition of the problem but failure to act)15 has been demonstrated previously in the outpatient management of diabetes16, 17; this study provides evidence of the phenomenon in the inpatient setting. Work by Phillips and colleagues15 has shown that clinical inertia results from at least 3 problems: overestimation of care provided; use of soft reasons to avoid intensification of therapy; and lack of education, training, and practice organization aimed at achieving specific goals. All 3 problems likely contribute to clinical inertia in inpatient diabetes management. Revised educational programs; systems for improving care such as reminders, flow sheets, and order sets; and performance feedback can help address clinical inertia and improve care.15

This study should be viewed in light of its limitations, including relatively small sample size, thus limiting our ability to detect other possible significant predictors of glycemic control, and the use of a single institution, thus limiting generalizability. However, recent data from the University HealthSystem Consortium revealed that our institution was typical of the 37 participating academic medical centers in that study.18 In addition, only 9 patients were identified without a prior diagnosis of diabetes, raising the possibility that some patients with undiagnosed diabetes were missed in our study. However, our search strategy included a daily review of automatically abstracted laboratory values, making this possibility less likely. Strengths of this study include its prospective data collection methods with rigorous inclusion criteria, collection of detailed clinical data, and use of a novel statistical technique to more accurately assess the complex relationship between insulin use and glycemic control, appropriately adjusting for confounding by indication caused by prior glucose measurements.

Future research should focus on patient, clinician, and system barriers to improving inpatient glycemic management, using the clinical inertia framework as a starting point, and on the creation of insulin protocols that can be used and proven effective in the non‐ICU inpatient setting. Also needed are improved measures of the quality of glycemic control, insulin orders, and daily insulin adjustment.

In conclusion, inpatient glycemic management was shown to be in need of improvement. Institutionwide quality improvement efforts should probably target both physician and nursing behavior and should focus on increasing use of basal and nutritional insulin, as proposed in recent guidelines, avoiding use of sliding‐scale insulin by itself, and performing daily insulin adjustment in response to previous hypo‐ or hyperglycemia. Hospitalists can play a major role in these institutionwide quality improvement efforts.

Diabetes mellitus is a common comorbidity of hospitalization; in 2003 diabetes was a secondary diagnosis in 17.8% of all adult hospital discharges.1 When undiagnosed diabetes is included, the prevalence of inpatient diabetes or hyperglycemia may be as high as 38%.2 Recent studies show that hyperglycemia in hospitalized patients complicates numerous illnesses and is an independent predictor of adverse outcomes.3 Treatment of inpatient hyperglycemia improves outcomes, including mortality, for patients in surgical intensive care units4 and possibly for those admitted for myocardial infarction.5, 6 For these reasons, the American Diabetes Association and the American College of Endocrinology now recommend that glucose levels of all patients admitted to non‐critical‐care units be maintained below 180 mg/dL.3, 7

Evidence‐based recommendations for achieving these goals include effective protocols for subcutaneous insulin therapy for patients who do not require continuous intravenous insulin infusion. Components of these protocols include use of basal insulin and scheduled nutritional insulin, avoiding use of supplemental (sliding‐scale) insulin alone (which has been shown to be ineffective and possibly deleterious in prior studies),8 and adjustment of insulin orders to reflect nutritional intake, insulin sensitivity, and previous response to therapy.7

We conducted this study to evaluate the current state of glycemic control and adherence to current recommendations on a general medicine service run by hospitalists in a busy teaching hospital. We also sought to correlate insulin‐ordering practices with the quality of glycemic control in these patients.

METHODS

RESULTS

We prospectively identified 123 patients for the study. Subsequently, 16 patients were excluded, 11 who did not have diabetes or inpatient hyperglycemia (most of whom had been placed on insulin prophylactically to avoid steroid‐induced hyperglycemia), 2 who were admitted for diabetic ketoacidosis, 2 who were not on GMS teams 13, and 1 whose data could not be accessed. Characteristics of the remaining 107 study subjects are shown in Table 1. The mean age of the subjects was 65.2 years; 55% were men. Nine patients had no previous diagnosis of diabetes, 43% were taking insulin prior to admission, 14% had severe diabetic complications, and the median HbA_1C was 7.

Regarding insulin‐ordering practices (Table 2), 47 patients (43%) had basal insulin prescribed, while 4% of patients had an order for scheduled mealtime short‐ or rapid‐acting insulin. Of the 89 patients on sliding‐scale insulin, 80 (90%) had orders written for the default sliding scale built into the computerized physician order entry system at BWH. There was no correlation between intensity of the sliding scale and the patient's total daily insulin dose (data not shown). Of the patients on sliding‐scale insulin, 47% were prescribed basal insulin, 39% were prescribed oral agents, and 23% were prescribed neither.

Regarding glucose control, 317 of 1022 glucose meter readings (31%) were greater than 180 mg/dL, and the mean rate of glucose readings greater than 180 mg/dL per patient was also 31%. Approximately three quarters of all patients had at least one routine glucose reading greater than 180 mg/dL, and 35% of patients had at least 40% of their routine glucose readings greater than 180 mg/dL (Table 2). Twelve of 1022 readings (1.2%) were less than 60 mg/dL, and 11% of patients had at least one glucose reading less than 60 mg/dL (Table 2).

Despite a relatively constant percentage of glucose readings greater than 180 mg/dL per patient over the first 5 days of hospitalization (25%36% each day), we found no evidence of change in the percentage of patients prescribed basal insulin or the percentage of insulin given as basal insulin, and there was a small but significant increase in the total amount of insulin prescribed (Table 3). Of the 75 patients with at least one episode of hypo‐ or hyperglycemia, 43 (57%) were ever prescribed basal insulin, 29 (39%) were prescribed oral diabetes agents, and only 26 (35%) had any change to their insulin regimen during the first 5 days of their hospitalization on GMS. Of the 47 patients prescribed basal insulin in the hospital, 41 had been taking insulin prior to admission.

In a multivariable analysis of the mean glucose reading per patient‐day, we found several predictors of lower glucose readings, including diet‐controlled diabetes prior to admission and prescription of oral hypoglycemic medications in the hospital. We also found several predictors of higher glucose readings, including severe diabetic complications and higher glucose level at admission. Finally, we noted variation both by medical team (each composed of 1 medical attending, 1 resident, and 2 interns) and by floor of the hospital (each staffed by a different cadre of nurses). Adjusting for these factors (as well as for the daily use of dextrose‐containing intravenous fluids and steroids, sex, age, Charlson comorbidity score, APACHE 3 score, prior diagnosis of diabetes, HbA_1C level, and length of hospital stay) use of sliding‐scale insulin alone (eg, without scheduled basal or nutritional insulin) was associated with a daily average glucose reading that was 20 mg/dL higher than that for those prescribed scheduled insulin or those not prescribed a sliding scale at all (95% confidence interval, 5.035 mg/dL; Table 4). In a separate analysis, adjusting for the same clinical factors, we could find no relationship between change in daily dose of basal insulin and change in daily average glucose level (data not shown).

DISCUSSION

In this observational study, we found several deficiencies in the management of diabetes and hyperglycemia among hospitalized patients on a hospitalist‐run general medical service. These deficiencies were both in processes of care (eg, limited use of basal and especially nutritional insulin) and in outcomes (ie, glycemic control) compared with national guidelines. We also found evidence of clinical inertia when comparing outpatient to inpatient regimens, when evaluating daily changes in management, and when evaluating responses to previous hyperglycemia. Finally, we demonstrated that use of an insulin sliding scale by itself was associated with worse glycemic control after extensive adjustment for a variety of clinical factors.

Of note, other than the use of sliding‐scale insulin by itself, we could not find a relationship between specific daily adjustments to insulin orders and daily glycemic control in this study. However, we did find differences in glycemic control by medical team and by floor (the latter a proxy for nursing staff). This suggests that glycemic control depends on the exact details of how insulin is managed, rather than on crude measures of insulin adjustment such as change in dose in response to hyperglycemia. These findings also suggest that interventions focused on medical and nursing staff may be able to improve inpatient glycemic control.

The association between the use of oral diabetic agents and improved glucose control was notable and could represent an actual benefit of these agents (especially when added to sliding‐scale insulin by itself) and/or the result of uncontrolled confounding (ie, as a marker of well‐controlled diabetes). Further study is needed to distinguish among these possibilities.

Previous studies have shown evidence of poor inpatient glycemic control as well as the deleterious effects of sliding‐scale insulin by itself.8 This study is perhaps most notable for the suggestion that little, if anything, has changed over the previous decade in this area, despite recent well‐done observational and randomized controlled trials demonstrating the hazards of inpatient hyperglycemia and the publication of expert consensus statements on inpatient glucose management. Strategies to improve glucose control have been investigated to a greater extent in intensive care units12, 13 than on general medical wards,14 perhaps because the strength of evidence is strongest in this setting. Without such strong evidence for general medical patients, factors such as clinician fear of hypoglycemia, clinical inertia, and resistance to institutional change may play predominant roles.

Clinical inertia (ie, recognition of the problem but failure to act)15 has been demonstrated previously in the outpatient management of diabetes16, 17; this study provides evidence of the phenomenon in the inpatient setting. Work by Phillips and colleagues15 has shown that clinical inertia results from at least 3 problems: overestimation of care provided; use of soft reasons to avoid intensification of therapy; and lack of education, training, and practice organization aimed at achieving specific goals. All 3 problems likely contribute to clinical inertia in inpatient diabetes management. Revised educational programs; systems for improving care such as reminders, flow sheets, and order sets; and performance feedback can help address clinical inertia and improve care.15

This study should be viewed in light of its limitations, including relatively small sample size, thus limiting our ability to detect other possible significant predictors of glycemic control, and the use of a single institution, thus limiting generalizability. However, recent data from the University HealthSystem Consortium revealed that our institution was typical of the 37 participating academic medical centers in that study.18 In addition, only 9 patients were identified without a prior diagnosis of diabetes, raising the possibility that some patients with undiagnosed diabetes were missed in our study. However, our search strategy included a daily review of automatically abstracted laboratory values, making this possibility less likely. Strengths of this study include its prospective data collection methods with rigorous inclusion criteria, collection of detailed clinical data, and use of a novel statistical technique to more accurately assess the complex relationship between insulin use and glycemic control, appropriately adjusting for confounding by indication caused by prior glucose measurements.

Future research should focus on patient, clinician, and system barriers to improving inpatient glycemic management, using the clinical inertia framework as a starting point, and on the creation of insulin protocols that can be used and proven effective in the non‐ICU inpatient setting. Also needed are improved measures of the quality of glycemic control, insulin orders, and daily insulin adjustment.

In conclusion, inpatient glycemic management was shown to be in need of improvement. Institutionwide quality improvement efforts should probably target both physician and nursing behavior and should focus on increasing use of basal and nutritional insulin, as proposed in recent guidelines, avoiding use of sliding‐scale insulin by itself, and performing daily insulin adjustment in response to previous hypo‐ or hyperglycemia. Hospitalists can play a major role in these institutionwide quality improvement efforts.

Respect for patient autonomy is a primary ethical principle guiding the practice of medicine in the United States.1. The Patient Self‐Determination Act (PSDA), enacted to enhance autonomy at the end of life, has not fulfilled its promise for a number of reasons.24 No state mandates that on admission, hospitalized patients be asked to provide informed consent for end‐of‐life procedures. Despite informed consent being a requirement for all other invasive procedures when there is sufficient opportunity to obtain it (eg, in nonemergent situations with a capable patient),5 cardiopulmonary resuscitation (CPR) and mechanical ventilation are assumed, until otherwise stipulated, to be procedures that all patients want. It also has been assumed that patients would believe that a request for informed consent for such procedures on hospital admission implied they had significant risk of cardiopulmonary failure and that this would discourage or disturb acutely ill patients.6 Another impediment to obtaining informed consent is that many physicians may not have sufficient time or level of comfort to be able to routinely approach end‐of‐life discussions. In this prospective study, we hypothesized that acutely ill medical patients would be willing to provide informed consent for CPR and mechanical ventilation and to create written advance directives.

METHODS

This study was approved by the hospital's institutional review board. Patients admitted to the Department of Medicine from December 2003 through February 2004 were candidates for this study. Patients admitted for cardiac catheterization (and similar same‐day medical procedures) or critical illness (admitted to intensive care units) were excluded from the study. In our hospital, all patients are asked by admitting personnel (clerk and nurse) whether they already have advance directives. Some patients are also queried by their physicians about whether they wish to have CPR in the event of cardiopulmonary arrest during hospitalization. Patients who are not asked are assumed to be full codes, that is, they are to receive CPR and mechanical ventilation in the event of cardiac and respiratory failure. For those who are asked, there are generally 3 possible outcomes: (1) the patient chooses to accept CPR and mechanical ventilation, and nothing further is documented; (2) the patient chooses a code status, and it is documented in the admission orders and/or a formal code designation form with a progress note describing the discussion; or (3) the patient defers the decision.

Our data processing department generated a daily list of the patients admitted to the hospital on the previous day. Patients satisfying inclusion criteria were randomized (by a random number generator) to the intervention or the control group. Medical records of all patients were examined to ascertain demographic information, admission Acute Physiology and Chronic Health Evaluation (APACHE) II score, primary diagnosis, number of comorbid illnesses, and documentation of whether the patient had a preexisting advance directive or wishes regarding CPR and mechanical ventilation for that admission.

Patients in the control group were not approached by study personnel, but medical records were surveyed for their in‐hospital outcomes and changes in code or advance directive status. Patients randomized to the intervention arm were approached by 1 of 4 study physicians, who read from a script detailed information about life‐sustaining therapies and advance directives (see Appendix). This script was developed with hospital clinician‐experts and approved by members of the Department of Medicine.

Patients whose primary language was not English were interviewed through in‐house or 3‐way telephone (remote) translators. All patients in the treatment group were assessed during the scripted intervention to ascertain whether they had the capacity to make informed decisions, which was determined based on their ability: (a) to understand the information presented, (b) to consider the information in relation to their personal values, and (c) to communicate their wishes. If personnel doubted an individual's capacity in any of these 3 areas, then he or she was not included in the study (ie, excluded after randomization). In the control group, patients with documented dementia or delirium were also excluded.

As specified in the script, patients in the intervention group were asked at the end of the interview whether they wished to choose their in‐hospital CPR status for that admission. If a patient definitely wanted to change the status indicated in the hospital record, study personnel would communicate the patient's wishes to the admitting physician. Attending physicians were given the opportunity to speak with their patients before changing a code status, but if the physicians agreed with the change, study personnel would document it in the formal orders. Patients were also asked whether they wished to create advance directives; if so, staff from the hospital's patient relations department would meet with them to draft the documents.

The following outcomes were measured: 1) willingness of patients assigned to the intervention group to listen to the script about end‐of‐life/life‐sustaining therapies; 2) opinions of patients about whether the information in the intervention was useful versus whether it was disturbing; 3) the frequency with which patients who had proactively received the information chose or changed their code status; and 4) the frequency with which patients without a preexisting advance directive created one while hospitalized. Simple proportions of each of these variables (ie, observed number divided by total number) in the intervention and control groups were compared using software that calculates the significance of the difference between two percentages (Statistica). The demographics of the patients were compared using the unpaired Student's t test. A P value of < .05 was considered statistically significant.

RESULTS

A total of 585 patients admitted to the Department of Medicine between December 2003 and February 2004 were randomized for the study. Patients were excluded if they had insufficient capacity (133) or if they were rapidly discharged from the hospital (155). Patients who were excluded tended to be more ill (APACHE 8.1 vs. 7.3, P = .06) and were more likely to die while hospitalized (8% vs. 4%, P = .04). A total of 297 patients were included in the study, 136 in the intervention group and 161 in the control group. Baseline characteristics were similar between the 2 groups (see Table 1).

Did Patients Who Received the Intervention Clarify Their CPR Preference?

Of the 136 patients in the intervention arm, 49 (36%) had explicit documentation of their code status on admission, compared to 55 of the 161 patients in the control group (34%; P = .7). Documentation included listing the CPR status in the admission orders or in a completed code designation form. After receiving the intervention, 125 of the 136 patients in the intervention arm (92%) clarified their preferences about CPR and mechanical ventilation.

Of the 49 patients in the intervention group who had documented CPR status on admission, 48 were listed as full code (both CPR and mechanical ventilation), and 1 was documented as refusing both CPR and mechanical ventilation. Of the 48 patients who were full codes, 3 stated they did not want CPR and mechanical ventilation under any circumstances after the intervention. Their preferences were subsequently documented as formal orders. The remaining 45 (94%) stayed full codes (see Figure 1).

Figure 1

Of the 87 patients in the intervention group who had no explicit documentation of CPR status on hospital admission, 76 clarified their preference and 11 did not. Of the 76 patients, 71 wished to receive both CPR and mechanical ventilation, and 5 wanted neither. The status of the latter as no code, no ventilator was subsequently documented in the medical record with the consent of their attending physicians. One of these 5 patients became increasingly ill during hospitalization, with reduced capacity, and family members later asked that he receive only comfort care.

Of the 161 patients in the control group, 55 (34%) had documentation of their code status (ie, to receive CPR if needed) in the admission hospital record. By the end of hospitalization, 1 patient requested no CPR and no mechanical ventilation, and 2 received comfort care with cessation of other active life‐prolonging interventions. Of the 106 without initial code documentation, 4 were later documented as being no code, no ventilator and 2 as being comfort care (see Figure 1).

DISCUSSION

This study demonstrates that most (95%) hospitalized medical patients welcomed the opportunity to provide prospective informed consent for CPR and mechanical ventilation. Although only a small minority (4%) opted out of CPR/mechanical ventilation, a majority (92%) of those who received the educational intervention chose to accept those therapies if required. This study also demonstrates that hospitalization can be one point‐of‐care where patients can consider and create advance directives. The results of this study are consistent with those of the SUPPORT group4 and other7 studies about patient interest in making choices on CPR. Our study suggests that physicians can elicit patients' wishes about and record formal orders on CPR around the time of hospital admission.

The default action has been to administer CPR and mechanical ventilation after cardiopulmonary failure or arrest, that is, patients receive these procedures unless they state explicitly that they do not want them. Unlike with all other invasive procedures, no national regulation mandates obtaining informed consent prospectively, when possible, for these treatments, because it is assumed that patients would want these therapies rather than the alternative (ie, death). Indeed, it is appropriate to perform lifesaving procedures in emergencies without consent if the patient lacks capacity and a surrogate decision maker cannot be contacted quickly. This clinical approach is consistent with medical ethics: to err on the side of life when a patient's wishes are unknown or unclear. Nonetheless, having a full code as the default action denies patients the opportunity to provide informed consent for these highly invasive procedures because there often is ample opportunity to ask their permission. If patient self‐determination is the categorical imperative of American medicine, then current practice violates that principle at the moment when it may be most important, that is, when a patient's decision about whether to risk life‐sustaining therapies could promote survival or prolong dying. Our study demonstrates that a simple interventionsimply askingpromotes a decision and therefore patient autonomy in most cases.

When patients have opted for life‐sustaining therapies that subsequently have been administered or when patients have received such therapies by default, physicians and patients can be left in 2 situations. In one outcome the patient retains capacity, and the dialogue about life‐sustaining therapies can continue between patient and physician. In the second, frequent scenario, the patient is incapacitated. Until patient capacity can be restored, the physician must work with surrogate decision makers and preexisting advance directives to infer a patient's wishes about continuation of life‐sustaining care. Our data demonstrate that hospital admission is one point‐of‐care at which patients can be offered and can complete, albeit in small numbers, advance directives.8 Previous work with our patients demonstrated that many patients misunderstood advance directives and the degree of effort required to create them.9 We reasoned that more patients might create advance directives if we offered the service for free during hospitalization. We were very surprised at how infrequently patients created advance directives in this study, although this finding is consistent with others in the published literature.8 It is speculated that hospitalized patients may feel too ill to exert themselves and/or are not psychologically prepared to consider end‐of‐life directives (ie, I came to the hospital to get better, not to consider what should be done when I'm terminal ). Some patients may not trust physicians to use advance directives reliably.4, 10

Our study had several important limitations. First, and most important, not all patients who were randomized were enrolled in the study. The most common reasons for exclusion were rapid discharge from the hospital and mental status change calling into question a patient's capacity to make end‐of‐life decisions. Nonetheless, it is only competent patients who can be engaged to decide these questions for themselves. Surrogates (ie, loved ones), guided by advance directives, are left to address resuscitation decisions for those lacking capacity. In addition, patients' predilections may change with time,11 especially as death becomes more imminent. However, insofar as many patients have several hospital admissions as they approach the end of life and are more likely to possess capacity to consider CPR decisions during early admissions, their choices can be recorded repeatedly over time (with each admission or even as status changes during an admission) to inform decisions if they develop incapacity. Little more can be done to enhance autonomy regarding CPR beyond repeatedly educating and asking, as disease and specific illnesses progress. It can be argued that this intervention had little real overall effectmost patients who would have received CPR by default did in fact want it when informed and asked. This is an ethically problematic position for two reasons: it neglects the right of patients to decide for themselves, and it potentially subjects the small group of patients who would reject CPR if asked to an unwanted risky procedure (ie, one that may prolong dying). Another limitation of the present study is that patients were approached by doctors‐in‐training with whom they had had no prior therapeutic relationship. Although it would have been optimal for patients to be approached by their primary care physicians, this was not feasible. Even if we could have convinced all of our medical staff members to implement the intervention, it is unlikely that all would have adhered to a study script, which is what enabled standardization of the information shared with patients. Some physicians may disagree with the script's content. But the goal of this study was not to determine if specific information would affect outcomes; rather, it was to determine if patients were receptive to discussing these issues and making proactive choices regarding life‐sustaining therapies during hospitalization for acute illness. It is possible that using different scripts delivered by different personnel, ideally the patients' own doctors, might have elicited even greater rates of consent and proactive decision making. Finally, the degree to which these results can be generalized may vary based on the population sampled. White and well‐educated patients are more likely to engage in end‐of‐life decision making than non‐White and poorly educated patients.9, 12

In conclusion, this study suggests that capable patients hospitalized for medical problems are willing to give informed consent for (or reject) CPR and mechanical ventilation in the event of cardiopulmonary failure. The approach of the study was very simple. It took roughly 510 minutes to inform patients and elicit their choices. Allowing patients to choose, rather than assuming that CPR is the choice of patients by default, strenuously honors patient autonomy. If these findings are replicated in larger cohorts and at different centers, there would be little justification for not informing patients about and asking them to choose their CPR preferences for each hospitalization. In the meantime, caregivers might consider the appropriateness of addressing these issues when they admit acutely ill patients to the hospital.

Respect for patient autonomy is a primary ethical principle guiding the practice of medicine in the United States.1. The Patient Self‐Determination Act (PSDA), enacted to enhance autonomy at the end of life, has not fulfilled its promise for a number of reasons.24 No state mandates that on admission, hospitalized patients be asked to provide informed consent for end‐of‐life procedures. Despite informed consent being a requirement for all other invasive procedures when there is sufficient opportunity to obtain it (eg, in nonemergent situations with a capable patient),5 cardiopulmonary resuscitation (CPR) and mechanical ventilation are assumed, until otherwise stipulated, to be procedures that all patients want. It also has been assumed that patients would believe that a request for informed consent for such procedures on hospital admission implied they had significant risk of cardiopulmonary failure and that this would discourage or disturb acutely ill patients.6 Another impediment to obtaining informed consent is that many physicians may not have sufficient time or level of comfort to be able to routinely approach end‐of‐life discussions. In this prospective study, we hypothesized that acutely ill medical patients would be willing to provide informed consent for CPR and mechanical ventilation and to create written advance directives.

METHODS

This study was approved by the hospital's institutional review board. Patients admitted to the Department of Medicine from December 2003 through February 2004 were candidates for this study. Patients admitted for cardiac catheterization (and similar same‐day medical procedures) or critical illness (admitted to intensive care units) were excluded from the study. In our hospital, all patients are asked by admitting personnel (clerk and nurse) whether they already have advance directives. Some patients are also queried by their physicians about whether they wish to have CPR in the event of cardiopulmonary arrest during hospitalization. Patients who are not asked are assumed to be full codes, that is, they are to receive CPR and mechanical ventilation in the event of cardiac and respiratory failure. For those who are asked, there are generally 3 possible outcomes: (1) the patient chooses to accept CPR and mechanical ventilation, and nothing further is documented; (2) the patient chooses a code status, and it is documented in the admission orders and/or a formal code designation form with a progress note describing the discussion; or (3) the patient defers the decision.

Our data processing department generated a daily list of the patients admitted to the hospital on the previous day. Patients satisfying inclusion criteria were randomized (by a random number generator) to the intervention or the control group. Medical records of all patients were examined to ascertain demographic information, admission Acute Physiology and Chronic Health Evaluation (APACHE) II score, primary diagnosis, number of comorbid illnesses, and documentation of whether the patient had a preexisting advance directive or wishes regarding CPR and mechanical ventilation for that admission.

Patients in the control group were not approached by study personnel, but medical records were surveyed for their in‐hospital outcomes and changes in code or advance directive status. Patients randomized to the intervention arm were approached by 1 of 4 study physicians, who read from a script detailed information about life‐sustaining therapies and advance directives (see Appendix). This script was developed with hospital clinician‐experts and approved by members of the Department of Medicine.

Patients whose primary language was not English were interviewed through in‐house or 3‐way telephone (remote) translators. All patients in the treatment group were assessed during the scripted intervention to ascertain whether they had the capacity to make informed decisions, which was determined based on their ability: (a) to understand the information presented, (b) to consider the information in relation to their personal values, and (c) to communicate their wishes. If personnel doubted an individual's capacity in any of these 3 areas, then he or she was not included in the study (ie, excluded after randomization). In the control group, patients with documented dementia or delirium were also excluded.

As specified in the script, patients in the intervention group were asked at the end of the interview whether they wished to choose their in‐hospital CPR status for that admission. If a patient definitely wanted to change the status indicated in the hospital record, study personnel would communicate the patient's wishes to the admitting physician. Attending physicians were given the opportunity to speak with their patients before changing a code status, but if the physicians agreed with the change, study personnel would document it in the formal orders. Patients were also asked whether they wished to create advance directives; if so, staff from the hospital's patient relations department would meet with them to draft the documents.

The following outcomes were measured: 1) willingness of patients assigned to the intervention group to listen to the script about end‐of‐life/life‐sustaining therapies; 2) opinions of patients about whether the information in the intervention was useful versus whether it was disturbing; 3) the frequency with which patients who had proactively received the information chose or changed their code status; and 4) the frequency with which patients without a preexisting advance directive created one while hospitalized. Simple proportions of each of these variables (ie, observed number divided by total number) in the intervention and control groups were compared using software that calculates the significance of the difference between two percentages (Statistica). The demographics of the patients were compared using the unpaired Student's t test. A P value of < .05 was considered statistically significant.

RESULTS

A total of 585 patients admitted to the Department of Medicine between December 2003 and February 2004 were randomized for the study. Patients were excluded if they had insufficient capacity (133) or if they were rapidly discharged from the hospital (155). Patients who were excluded tended to be more ill (APACHE 8.1 vs. 7.3, P = .06) and were more likely to die while hospitalized (8% vs. 4%, P = .04). A total of 297 patients were included in the study, 136 in the intervention group and 161 in the control group. Baseline characteristics were similar between the 2 groups (see Table 1).