A 77‐year‐old woman with hypothyroidism presented with a 2‐week history of head, neck, jaw, and tongue pain. She had also developed slurred speech and difficulty chewing. On examination she had a temperature of 38.0C. She was without neurological deficits. However, she did have difficulty protruding her tongue, which had a cyanotic appearance and was painful. Laboratory findings showed an erythrocyte sedimentation rate of 68 mm/hr. Temporal arteritis was suspected, and the patient was started on corticosteroids. A subsequent temporal artery biopsy revealed inflammation and thrombus formation consistent with temporal arteritis. On hospital day 3, she developed unilateral ischemia in her tongue, which eventually became necrotic (Fig. 1). Although tongue necrosis is rare, temporal arteritis is the most frequent cause. It is usually unilateral and caused by compromised blood supply as a result of vasculitis in one of the lingual arteries. Other causes of tongue necrosis such as embolus, abscess, syphilis, tongue carcinoma, and Hodgkin's disease should be excluded.1, 2 Although necrotic tongue tissue must sometimes be extensively debrided or resected, our patient required minimal debridement. At follow‐up 1 month later, she was recovering at home with ongoing speech therapy and a corticosteroid taper.

Figure 1

A 77‐year‐old woman with hypothyroidism presented with a 2‐week history of head, neck, jaw, and tongue pain. She had also developed slurred speech and difficulty chewing. On examination she had a temperature of 38.0C. She was without neurological deficits. However, she did have difficulty protruding her tongue, which had a cyanotic appearance and was painful. Laboratory findings showed an erythrocyte sedimentation rate of 68 mm/hr. Temporal arteritis was suspected, and the patient was started on corticosteroids. A subsequent temporal artery biopsy revealed inflammation and thrombus formation consistent with temporal arteritis. On hospital day 3, she developed unilateral ischemia in her tongue, which eventually became necrotic (Fig. 1). Although tongue necrosis is rare, temporal arteritis is the most frequent cause. It is usually unilateral and caused by compromised blood supply as a result of vasculitis in one of the lingual arteries. Other causes of tongue necrosis such as embolus, abscess, syphilis, tongue carcinoma, and Hodgkin's disease should be excluded.1, 2 Although necrotic tongue tissue must sometimes be extensively debrided or resected, our patient required minimal debridement. At follow‐up 1 month later, she was recovering at home with ongoing speech therapy and a corticosteroid taper.

Figure 1

A 77‐year‐old woman with hypothyroidism presented with a 2‐week history of head, neck, jaw, and tongue pain. She had also developed slurred speech and difficulty chewing. On examination she had a temperature of 38.0C. She was without neurological deficits. However, she did have difficulty protruding her tongue, which had a cyanotic appearance and was painful. Laboratory findings showed an erythrocyte sedimentation rate of 68 mm/hr. Temporal arteritis was suspected, and the patient was started on corticosteroids. A subsequent temporal artery biopsy revealed inflammation and thrombus formation consistent with temporal arteritis. On hospital day 3, she developed unilateral ischemia in her tongue, which eventually became necrotic (Fig. 1). Although tongue necrosis is rare, temporal arteritis is the most frequent cause. It is usually unilateral and caused by compromised blood supply as a result of vasculitis in one of the lingual arteries. Other causes of tongue necrosis such as embolus, abscess, syphilis, tongue carcinoma, and Hodgkin's disease should be excluded.1, 2 Although necrotic tongue tissue must sometimes be extensively debrided or resected, our patient required minimal debridement. At follow‐up 1 month later, she was recovering at home with ongoing speech therapy and a corticosteroid taper.

Figure 1

Enterococci are a leading cause of endocarditis and nosocomial infections. Vancomycin‐resistant enterococci (VRE) emerged in the 1980s and now represent most nosocomial isolates in the United States. The first case of VRE endocarditis was reported in 1996.1 Although increasing enterococcal antibiotic resistance has prompted increasing reliance on newer antibiotics,2 a recent review of VRE endocarditis noted that survival rates were similar to those for vancomycin‐sensitive enterococcal endocarditis.1 Cure was achieved in several patients with bacteriostatic agents in the absence of valve replacement, but no patients were infected with truly linezolid‐resistant organisms. This case of linezolid‐resistant VRE endocarditis represents the first reported cure of infective endocarditis with a tigecycline‐containing regimen.

CASE REPORT

A 62‐year‐old man presented with hypoglycemia and delirium. His medical history included diabetes mellitus, coronary and peripheral arterial disease, and end‐stage renal disease. He had had endocarditis of an unknown type 12 years prior to admission. He had recently developed septic shock because of a Candida parapsilosis, Enterobacter cloacae, and Staphylococcus epidermidis infection of a peripherally inserted central catheter (PICC) and received 14 days of vancomycin, meropenem, and fluconazole administered through a new PICC. This catheter was not removed, and 39 days after completion of the antibiotic therapy, he developed hypoglycemia, which was attributed to weight loss without adjustment of his insulin regimen. He was afebrile; examination revealed a new 3/6 holosystolic murmur radiating to the axilla. There were no other stigmata of infective endocarditis, and his PICC and arteriovenous fistula sites appeared normal. Delirium resolved after administration of intravenous glucose.

E. faecium grew from all 6 initial blood cultures. A transesophageal echocardiogram revealed a new 3‐mm mitral valve vegetation with perforation and severe regurgitation. He had definite endocarditis on the basis of 2 major criteria.3 He was given vancomycin (1 g IV, then administered by levels), then switched to linezolid (600 mg orally every 12 hours), and finally tigecycline (100 mg IV followed by 50 mg IV every 12 hours) plus daptomycin (6 mg/kg IV every 48 hours) as further sensitivity data became available.

The organism was resistant to ampicillin, chloramphenicol, and linezolid (MIC > 20 g/mL), as well as vancomycin (MIC > 50 g/mL), quinupristin/dalfopristin (MIC 2.5 g/mL), and gentamicin (MIC > 200 g/mL), and demonstrated high‐level streptomycin resistance (>2000 g/mL). It was intermediate to doxycycline (MIC 5 g/mL). It was susceptible to daptomycin (MIC 4 g/mL) and tigecycline (MIC 0.06 g/mL).

Blood cultures done on hospital days 1, 4, 6, and 7 (day 1 of tigecycline) were positive, and multiple cultures were negative from day 10 on. Because of the lack of experience with tigecycline in infective endocarditis, unrevascularized left‐main coronary artery disease, and severe mitral regurgitation, the patient was advised to undergo valve replacement and coronary artery bypass surgery after antibiotic therapy. Because he feared surgical complications, he refused and received 70 days of tigecycline plus daptomycin therapy, which was complicated only by nausea. He remained clinically well and had negative blood cultures 16 weeks after completion of therapy.

DISCUSSION

Tigecycline, the first available glycylcycline, is a minocycline‐derived antibiotic that remains active in the presence of the ribosomal modifications and efflux pumps that mediate tetracycline resistance. Thus, it possesses broad‐spectrum bacteriostatic activity, including activity against VRE. A PubMed search revealed no published data about the use of tigecycline for endocarditis in humans. However, tetracyclines have been used to treat endocarditis due to such organisms as Bartonella, Coxiella burnetti, or methicillin‐resistant Staphylococcus aureus (MRSA), frequently for prolonged courses. Tetracyclines were combined with other antibiotics in 5 published cases of VRE endocarditis. All patients survived; 3 were cured with the tetracycline regimen and 2 with other antimicrobials.1 In animal models of endocarditis, tigecycline stabilized vegetation counts of E. faecalis and reduced vegetation counts of MRSA and 1 strain of E. faecium.4

Daptomycin, the first available cyclic lipopeptide, kills by nonlytic depolarization of the bacterial cell membrane. In a recent study, daptomycin was non‐inferior to vancomycin or antistaphylococcal penicillins for S. aureus bacteremia or endocarditis. Although a few patients had left‐sided endocarditis, only 1 of them experienced a successful outcome with daptomycin therapy, and daptomycin displayed a trend toward higher rates of persistent or relapsing infection.5 Less evidence supports the use of daptomycin for serious enterococcal infections.2 One report noted the deaths of 6 of 10 patients treated with daptomycin for VRE bacteremia, including both patients with endocarditis.6 Daptomycin was used successfully in a case of VRE endocarditis in combination with gentamicin and rifampin for 11 weeks1 and at least 6 other reported cases of VRE bacteremia.7, 8

In summary, despite tigecycline's lack of bactericidal activity or proven efficacy in endocarditis, daptomycin's prior performance in VRE bacteremia, and the isolate's borderline daptomycin susceptibility, prolonged combination therapy resulted in a cure of VRE endocarditis. This success extends the experience with using both agents in the treatment of resistant infections. As linezolid‐resistant VRE and other resistant pathogens become more common, the need for research on treatment options becomes more urgent, and familiarity with novel and lesser‐used antibiotics becomes more crucial for hospitalists.

Enterococci are a leading cause of endocarditis and nosocomial infections. Vancomycin‐resistant enterococci (VRE) emerged in the 1980s and now represent most nosocomial isolates in the United States. The first case of VRE endocarditis was reported in 1996.1 Although increasing enterococcal antibiotic resistance has prompted increasing reliance on newer antibiotics,2 a recent review of VRE endocarditis noted that survival rates were similar to those for vancomycin‐sensitive enterococcal endocarditis.1 Cure was achieved in several patients with bacteriostatic agents in the absence of valve replacement, but no patients were infected with truly linezolid‐resistant organisms. This case of linezolid‐resistant VRE endocarditis represents the first reported cure of infective endocarditis with a tigecycline‐containing regimen.

CASE REPORT

A 62‐year‐old man presented with hypoglycemia and delirium. His medical history included diabetes mellitus, coronary and peripheral arterial disease, and end‐stage renal disease. He had had endocarditis of an unknown type 12 years prior to admission. He had recently developed septic shock because of a Candida parapsilosis, Enterobacter cloacae, and Staphylococcus epidermidis infection of a peripherally inserted central catheter (PICC) and received 14 days of vancomycin, meropenem, and fluconazole administered through a new PICC. This catheter was not removed, and 39 days after completion of the antibiotic therapy, he developed hypoglycemia, which was attributed to weight loss without adjustment of his insulin regimen. He was afebrile; examination revealed a new 3/6 holosystolic murmur radiating to the axilla. There were no other stigmata of infective endocarditis, and his PICC and arteriovenous fistula sites appeared normal. Delirium resolved after administration of intravenous glucose.

E. faecium grew from all 6 initial blood cultures. A transesophageal echocardiogram revealed a new 3‐mm mitral valve vegetation with perforation and severe regurgitation. He had definite endocarditis on the basis of 2 major criteria.3 He was given vancomycin (1 g IV, then administered by levels), then switched to linezolid (600 mg orally every 12 hours), and finally tigecycline (100 mg IV followed by 50 mg IV every 12 hours) plus daptomycin (6 mg/kg IV every 48 hours) as further sensitivity data became available.

The organism was resistant to ampicillin, chloramphenicol, and linezolid (MIC > 20 g/mL), as well as vancomycin (MIC > 50 g/mL), quinupristin/dalfopristin (MIC 2.5 g/mL), and gentamicin (MIC > 200 g/mL), and demonstrated high‐level streptomycin resistance (>2000 g/mL). It was intermediate to doxycycline (MIC 5 g/mL). It was susceptible to daptomycin (MIC 4 g/mL) and tigecycline (MIC 0.06 g/mL).

Blood cultures done on hospital days 1, 4, 6, and 7 (day 1 of tigecycline) were positive, and multiple cultures were negative from day 10 on. Because of the lack of experience with tigecycline in infective endocarditis, unrevascularized left‐main coronary artery disease, and severe mitral regurgitation, the patient was advised to undergo valve replacement and coronary artery bypass surgery after antibiotic therapy. Because he feared surgical complications, he refused and received 70 days of tigecycline plus daptomycin therapy, which was complicated only by nausea. He remained clinically well and had negative blood cultures 16 weeks after completion of therapy.

DISCUSSION

Tigecycline, the first available glycylcycline, is a minocycline‐derived antibiotic that remains active in the presence of the ribosomal modifications and efflux pumps that mediate tetracycline resistance. Thus, it possesses broad‐spectrum bacteriostatic activity, including activity against VRE. A PubMed search revealed no published data about the use of tigecycline for endocarditis in humans. However, tetracyclines have been used to treat endocarditis due to such organisms as Bartonella, Coxiella burnetti, or methicillin‐resistant Staphylococcus aureus (MRSA), frequently for prolonged courses. Tetracyclines were combined with other antibiotics in 5 published cases of VRE endocarditis. All patients survived; 3 were cured with the tetracycline regimen and 2 with other antimicrobials.1 In animal models of endocarditis, tigecycline stabilized vegetation counts of E. faecalis and reduced vegetation counts of MRSA and 1 strain of E. faecium.4

Daptomycin, the first available cyclic lipopeptide, kills by nonlytic depolarization of the bacterial cell membrane. In a recent study, daptomycin was non‐inferior to vancomycin or antistaphylococcal penicillins for S. aureus bacteremia or endocarditis. Although a few patients had left‐sided endocarditis, only 1 of them experienced a successful outcome with daptomycin therapy, and daptomycin displayed a trend toward higher rates of persistent or relapsing infection.5 Less evidence supports the use of daptomycin for serious enterococcal infections.2 One report noted the deaths of 6 of 10 patients treated with daptomycin for VRE bacteremia, including both patients with endocarditis.6 Daptomycin was used successfully in a case of VRE endocarditis in combination with gentamicin and rifampin for 11 weeks1 and at least 6 other reported cases of VRE bacteremia.7, 8

In summary, despite tigecycline's lack of bactericidal activity or proven efficacy in endocarditis, daptomycin's prior performance in VRE bacteremia, and the isolate's borderline daptomycin susceptibility, prolonged combination therapy resulted in a cure of VRE endocarditis. This success extends the experience with using both agents in the treatment of resistant infections. As linezolid‐resistant VRE and other resistant pathogens become more common, the need for research on treatment options becomes more urgent, and familiarity with novel and lesser‐used antibiotics becomes more crucial for hospitalists.

Enterococci are a leading cause of endocarditis and nosocomial infections. Vancomycin‐resistant enterococci (VRE) emerged in the 1980s and now represent most nosocomial isolates in the United States. The first case of VRE endocarditis was reported in 1996.1 Although increasing enterococcal antibiotic resistance has prompted increasing reliance on newer antibiotics,2 a recent review of VRE endocarditis noted that survival rates were similar to those for vancomycin‐sensitive enterococcal endocarditis.1 Cure was achieved in several patients with bacteriostatic agents in the absence of valve replacement, but no patients were infected with truly linezolid‐resistant organisms. This case of linezolid‐resistant VRE endocarditis represents the first reported cure of infective endocarditis with a tigecycline‐containing regimen.

CASE REPORT

A 62‐year‐old man presented with hypoglycemia and delirium. His medical history included diabetes mellitus, coronary and peripheral arterial disease, and end‐stage renal disease. He had had endocarditis of an unknown type 12 years prior to admission. He had recently developed septic shock because of a Candida parapsilosis, Enterobacter cloacae, and Staphylococcus epidermidis infection of a peripherally inserted central catheter (PICC) and received 14 days of vancomycin, meropenem, and fluconazole administered through a new PICC. This catheter was not removed, and 39 days after completion of the antibiotic therapy, he developed hypoglycemia, which was attributed to weight loss without adjustment of his insulin regimen. He was afebrile; examination revealed a new 3/6 holosystolic murmur radiating to the axilla. There were no other stigmata of infective endocarditis, and his PICC and arteriovenous fistula sites appeared normal. Delirium resolved after administration of intravenous glucose.

E. faecium grew from all 6 initial blood cultures. A transesophageal echocardiogram revealed a new 3‐mm mitral valve vegetation with perforation and severe regurgitation. He had definite endocarditis on the basis of 2 major criteria.3 He was given vancomycin (1 g IV, then administered by levels), then switched to linezolid (600 mg orally every 12 hours), and finally tigecycline (100 mg IV followed by 50 mg IV every 12 hours) plus daptomycin (6 mg/kg IV every 48 hours) as further sensitivity data became available.

The organism was resistant to ampicillin, chloramphenicol, and linezolid (MIC > 20 g/mL), as well as vancomycin (MIC > 50 g/mL), quinupristin/dalfopristin (MIC 2.5 g/mL), and gentamicin (MIC > 200 g/mL), and demonstrated high‐level streptomycin resistance (>2000 g/mL). It was intermediate to doxycycline (MIC 5 g/mL). It was susceptible to daptomycin (MIC 4 g/mL) and tigecycline (MIC 0.06 g/mL).

Blood cultures done on hospital days 1, 4, 6, and 7 (day 1 of tigecycline) were positive, and multiple cultures were negative from day 10 on. Because of the lack of experience with tigecycline in infective endocarditis, unrevascularized left‐main coronary artery disease, and severe mitral regurgitation, the patient was advised to undergo valve replacement and coronary artery bypass surgery after antibiotic therapy. Because he feared surgical complications, he refused and received 70 days of tigecycline plus daptomycin therapy, which was complicated only by nausea. He remained clinically well and had negative blood cultures 16 weeks after completion of therapy.

DISCUSSION

Tigecycline, the first available glycylcycline, is a minocycline‐derived antibiotic that remains active in the presence of the ribosomal modifications and efflux pumps that mediate tetracycline resistance. Thus, it possesses broad‐spectrum bacteriostatic activity, including activity against VRE. A PubMed search revealed no published data about the use of tigecycline for endocarditis in humans. However, tetracyclines have been used to treat endocarditis due to such organisms as Bartonella, Coxiella burnetti, or methicillin‐resistant Staphylococcus aureus (MRSA), frequently for prolonged courses. Tetracyclines were combined with other antibiotics in 5 published cases of VRE endocarditis. All patients survived; 3 were cured with the tetracycline regimen and 2 with other antimicrobials.1 In animal models of endocarditis, tigecycline stabilized vegetation counts of E. faecalis and reduced vegetation counts of MRSA and 1 strain of E. faecium.4

Daptomycin, the first available cyclic lipopeptide, kills by nonlytic depolarization of the bacterial cell membrane. In a recent study, daptomycin was non‐inferior to vancomycin or antistaphylococcal penicillins for S. aureus bacteremia or endocarditis. Although a few patients had left‐sided endocarditis, only 1 of them experienced a successful outcome with daptomycin therapy, and daptomycin displayed a trend toward higher rates of persistent or relapsing infection.5 Less evidence supports the use of daptomycin for serious enterococcal infections.2 One report noted the deaths of 6 of 10 patients treated with daptomycin for VRE bacteremia, including both patients with endocarditis.6 Daptomycin was used successfully in a case of VRE endocarditis in combination with gentamicin and rifampin for 11 weeks1 and at least 6 other reported cases of VRE bacteremia.7, 8

In summary, despite tigecycline's lack of bactericidal activity or proven efficacy in endocarditis, daptomycin's prior performance in VRE bacteremia, and the isolate's borderline daptomycin susceptibility, prolonged combination therapy resulted in a cure of VRE endocarditis. This success extends the experience with using both agents in the treatment of resistant infections. As linezolid‐resistant VRE and other resistant pathogens become more common, the need for research on treatment options becomes more urgent, and familiarity with novel and lesser‐used antibiotics becomes more crucial for hospitalists.

A 54‐year‐old man with hypertension and type 2 diabetes mellitus entered the Chest Pain Evaluation Unit of a teaching hospital after 12 hours of intermittent thoracic discomfort. The pain began during dinner and was sharp, bandlike, and located beneath the sternum and across the entire chest. He had dyspnea but no diaphoresis or nausea. A recumbent position relieved the pain after dinner, but it recurred during the night and again the following morning. He did not smoke and had no family history of coronary artery disease.

A useful approach in evaluating acute chest pain is to employ a hierarchical differential diagnosis that emphasizes life‐threatening disorders requiring prompt recognition and intervention. Most prominent are cardiac ischemia, pericardial tamponade, pneumothorax, pulmonary embolus, esophageal rupture, and aortic dissection. The concurrent dyspnea and retrosternal location and intermittent nature of the pain that this patient has are consistent with myocardial ischemia, but the sharp quality of the pain and the relief gained by being recumbent are atypical. Pain with pericarditis is characteristically pleuritic and often worse when lying down. The pain of pneumothorax is typically unilateral, not intermittent, and unlikely to improve with recumbency. Although pain during eating suggests the possibility of an esophageal source, spontaneous rupture usually follows vomiting. The pain is typically continuous and severe. The pain of pulmonary embolism may be unilateral and pleuritic but often is more diffuse. Relief by recumbency is unusual, but the intermittent nature could suggest recurrent emboli. The patient has a history of hypertension, which predisposes him to aortic dissection, in which the pain is typically sharp, continuous, and severe but occasionally intermittent. Among numerous less urgent diagnoses are esophagitis and thoracic diabetic radiculopathy.

Important features to look for during this patient's examination include: disappearance of the radial pulse during inhalation, a simple screening test that is insensitive but very specific for pericardial tamponade; elevated neck veins, which can occur with tension pneumothorax, massive pulmonary embolism, and pericardial tamponade; pericardial and pleural friction rubs; discrepant blood pressures in the 2 arms, sometimes a sign of aortic dissection; local thoracic tenderness from chest wall disorders; and sensory examination of the chest surface, which is often abnormal in diabetic thoracic radiculopathy. Given this patient's age and history of diabetes, I am most concerned about myocardial ischemia. The most appropriate diagnostic tests include an electrocardiogram and a chest radiograph.

The patient appeared apprehensive but reported no pain. He had a temperature of 36.0 C, heart rate of 95 beats/minute, blood pressure of 138/77 mm Hg, respiratory rate of 16/minute, and oxygen saturation of 99% while breathing ambient air. Blood pressures were equal in both arms. Jugular venous distention was absent, and the lung and cardiac examinations had normal results. His pain did not increase on chest wall palpation. Examination of the abdomen, extremities, and the neurologic system showed normal results.

The results of laboratory tests showed a leukocyte count of 12,700/cm³, with 85% neutrophils, 8% lymphocytes, 6% monocytes, and 1% eosinophils. The hematocrit was 45%, and the platelet count was 172,000/cm³. The results of his chemistry panel were remarkable only for a glucose of 225 mg/dL. An electrocardiogram (ECG) showed a normal sinus rhythm and left anterior fascicular block without acute ST‐ or T‐wave changes. Prior ECGs were unavailable. An anteroposterior radiograph disclosed low lung volumes and bibasilar opacities. No pleural effusion was noted. Serial serum troponin and creatine kinase levels were normal. A Tc‐99m tetrofosmin cardiac nuclear perfusion test performed at rest demonstrated a moderate area of mildly decreased uptake along the inferior wall extending to the apex. An exercise treadmill test, terminated after 1 minute, 45 seconds because of chest pain, provoked no ECG changes diagnostic of ischemic disease.

The absence of elevated jugular venous pressure virtually eliminates pericardial tamponade as a diagnosis, and the chest film excludes pneumothorax. The intermittent nature of the chest pain, the absence on the chest radiograph of such findings as mediastinal gas, left pneumothorax, or hydropneumothorax, and the lack of a predisposing cause make esophageal rupture unlikely. Pulmonary emboli remain a consideration despite the normal oxygen saturation because there is no hypoxemia in a substantial minority of such cases. The normal cardiac enzyme levels and the lack of significant changes on the ECG exclude that a myocardial infarction has recently occurred, but cardiac ischemia remains a possibility, especially because the patient had chest pain on exercise and the nuclear scan indicated diminished blood flow to the inferior left ventricle. Aortic dissection still lurks as a possibility. The inferior wall abnormalities seen on the scan could result from dissection into the right coronary artery, which is more frequently involved than the left, or compression of it by an enlarged aorta, but they also may be artifacts. The leukocytosis may be a nonspecific response to stress but could indicate, although unlikely, infections such as mediastinitis from esophageal rupture or bacterial aortitis.

A conscientious clinician would repeat the history, reexamine the patient, and scrutinize the chest film to determine what the bilateral opacities represent. Given the story so far, however, I might consider a thoracic computed tomography (CT) angiogram because I am most concerned about pulmonary emboli and aortic dissection.

On hospital day 3, the patient had worsening dyspnea and persistent chest pain. His temperature was 39.3C, and his oxygen saturation decreased to 89% while breathing room air. Repeat chest radiography showed new bilateral pleural effusions and increased bibasilar opacification (Fig. 1). His leukocyte count was 19,000/cm³, with 88% neutrophils, 6% lymphocytes, 5% monocytes, and 1% eosinophils. Care was transferred from the chest pain team to an inpatient general medicine ward team. A pulmonary CT angiogram showed no large central clots but suggested emboli in the right superior subsegmental artery and a right upper lobe subsegmental artery. Bilateral pleural effusions were observed, as were bilateral pleural‐based atelectasis or infiltrates in the lower lungs. A hiatal hernia was noted, but no aortic dissection. The patient received supplemental oxygen, intravenous levofloxacin, and unfractionated heparin by continuous infusion.

Figure 1

Without other information, I will assume that the fever is part of the patient's original disease and not a nosocomial infection or drug fever. At this point, a crucial part of the evaluation is examining the CT scan with experienced radiologists to determine whether the abnormalities noted are genuinely convincing for pulmonary emboli. If the findings are equivocal, the next step might be a pulmonary angiogram or the indirect approach of evaluating the leg veins with ultrasound, reasoning that the presence of proximal leg vein thromboses would require anticoagulation in any event.

The patient's worsening chest pain and hypoxemia are consistent with multiple pulmonary emboli. Bilateral pleural effusions and leukocytosis can occur but are uncommon. Because of the fever, another possibility is septic pulmonary emboli, but he has no evidence of suppurative thrombophlebitis of the peripheral veins, apparent infection elsewhere, or previous intravenous drug abuse causing right‐sided endocarditis. An alternative diagnosis is infection of an initially bland pulmonary infarct.

An important consideration is a thoracentesis, depending on how persuasive the CT diagnosis of pulmonary embolism is and the size of the pleural effusions. It should be done before instituting antimicrobial therapy, which may decrease the yield of the cultures, and before starting heparin, which increases the risk of bleeding and occasionally causes a substantial, even fatal hemothorax.

The patient's oxygenation and dyspnea did not improve. Over the next day, he repeatedly mentioned that swallowing, particularly solid foods, worsened his chest pain. He had a temperature of 39.9C, a heart rate of 121 beats/minute, blood pressure of 149/94 mm Hg, a respiratory rate of 28/minute, and oxygen saturation of 93% while breathing 40% oxygen. He had inspiratory splinting, percussive dullness at both lung bases, and distant heart sounds. A contrast esophagogram showed distal narrowing that prevented solid contrast from passing, but no hiatal hernia. Blood and urine cultures obtained before antibiotic therapy were sterile. Duplex ultrasonography of bilateral lower extremities showed no evidence of deep venous thrombosis. A pulmonary angiogram revealed no emboli, and heparin was discontinued. Bilateral thoracentesis yielded grossly bloody fluid. Repeat chest CT (Fig. 2) demonstrated large bilateral effusions, a new large pericardial effusion, and a prominence at the gastroesophageal junction more concerning for a soft‐tissue mass than for a hiatal hernia, although the quality of the study was suboptimal because of an absence of oral contrast.

Figure 2

The CT scan suggests a paraesophageal abscess from an esophageal rupture. As mentioned earlier, if rupture occurs spontaneously, it typically follows retching or vomiting and is called Boerhaave's syndrome. Another consideration is a rupture secondary to an external insult, such as trauma or ingestion of a caustic substance. In evaluating these possibilities, the patient should have been asked 4 questions at the initial interview that I neglected to explicitly highlight earlier. First, what was he eating when he developed the chest pain? Second, did the pain begin during swallowing? Third, did he have previous symptoms suggesting an esophageal disorder such as dysphagia, odynophagia, or heartburn? These might indicate a cancer that could perforate or another problem such as a stricture or disordered esophageal motility that might have caused a swallowed item to lodge in the esophagus. Finally, did he have retching or vomiting? Though not routinely part of the review of systems, the former 2 questions are an appropriate history‐prompted line of questioning of a patient with onset of chest pain while eating.

At this point, a reasonable approach would be an esophagoscopy to delineate any intraluminal problems, such as a cancer or a foreign body. The apparent obstruction seen on barium swallow may be from extrinsic pressure from a paraesophageal abscess. The patient should receive broad‐spectrum antimicrobial therapy effective against oral anaerobes. Although occasionally patients recover with antibiotics alone, surgery is usually required. I am surprised that the original CT scan did not show evidence of an esophageal perforation. Possibly, the hiatal hernia was a paraesophageal abscess poorly characterized because of the lack of oral contrast.

The team, concerned about esophageal perforation, began the patient on intravenous clindamycin. The patient underwent video‐assisted thoracoscopic drainage, which yielded a moderate amount of turbid, bloody fluid from each hemithorax. The pericardium contained approximately 500 cm³ of turbid fluid. Gram stain and culture of these fluids were negative. No esophageal or mediastinal mass was noted during surgery. Intraoperative esophagogastroduodenoscopy with endoscopic ultrasound showed a healing linear mucosal tear in the distal esophagus (Fig. 3) as well as air/fluid collection in the esophageal soft tissue (not shown).

Figure 3

On further questioning postoperatively, the patient reported eating bony fish during the dinner when he first experienced chest pain. The patient received a 21‐day course of oral clindamycin and completely recovered. Five weeks later, a chest CT showed decreased distal esophageal thickening and no mediastinal air.

COMMENTARY

Esophageal perforation is an uncommon but life‐threatening cause of chest pain. In most series iatrogenic injury accounts for more than 70% of cases, whereas most of the other cases have spontaneous (5%20%) or traumatic (4%10%) causes (Table 1).14 Perforation as a complication of ingesting fish bones, although rare, is well described and continues to be reported.57

Diagnosis of esophageal perforation secondary to a foreign body may be difficult because of the considerable overlap of symptoms with other causes of chest pain and failure to consider this infrequent condition in the absence of a classic history of retching. To diagnose such a disease, physicians must gather data from various sourcesespecially the history, physical examination, and medical recordformulate hypotheses, integrate results from diagnostic tests, and then assess the importance of the available information in the context of a differential diagnosis. Incorrectly evaluating or failing to obtain essential data can lead to incorrect or delayed diagnoses.

A 54‐year‐old man with hypertension and type 2 diabetes mellitus entered the Chest Pain Evaluation Unit of a teaching hospital after 12 hours of intermittent thoracic discomfort. The pain began during dinner and was sharp, bandlike, and located beneath the sternum and across the entire chest. He had dyspnea but no diaphoresis or nausea. A recumbent position relieved the pain after dinner, but it recurred during the night and again the following morning. He did not smoke and had no family history of coronary artery disease.

A useful approach in evaluating acute chest pain is to employ a hierarchical differential diagnosis that emphasizes life‐threatening disorders requiring prompt recognition and intervention. Most prominent are cardiac ischemia, pericardial tamponade, pneumothorax, pulmonary embolus, esophageal rupture, and aortic dissection. The concurrent dyspnea and retrosternal location and intermittent nature of the pain that this patient has are consistent with myocardial ischemia, but the sharp quality of the pain and the relief gained by being recumbent are atypical. Pain with pericarditis is characteristically pleuritic and often worse when lying down. The pain of pneumothorax is typically unilateral, not intermittent, and unlikely to improve with recumbency. Although pain during eating suggests the possibility of an esophageal source, spontaneous rupture usually follows vomiting. The pain is typically continuous and severe. The pain of pulmonary embolism may be unilateral and pleuritic but often is more diffuse. Relief by recumbency is unusual, but the intermittent nature could suggest recurrent emboli. The patient has a history of hypertension, which predisposes him to aortic dissection, in which the pain is typically sharp, continuous, and severe but occasionally intermittent. Among numerous less urgent diagnoses are esophagitis and thoracic diabetic radiculopathy.

Important features to look for during this patient's examination include: disappearance of the radial pulse during inhalation, a simple screening test that is insensitive but very specific for pericardial tamponade; elevated neck veins, which can occur with tension pneumothorax, massive pulmonary embolism, and pericardial tamponade; pericardial and pleural friction rubs; discrepant blood pressures in the 2 arms, sometimes a sign of aortic dissection; local thoracic tenderness from chest wall disorders; and sensory examination of the chest surface, which is often abnormal in diabetic thoracic radiculopathy. Given this patient's age and history of diabetes, I am most concerned about myocardial ischemia. The most appropriate diagnostic tests include an electrocardiogram and a chest radiograph.

The patient appeared apprehensive but reported no pain. He had a temperature of 36.0 C, heart rate of 95 beats/minute, blood pressure of 138/77 mm Hg, respiratory rate of 16/minute, and oxygen saturation of 99% while breathing ambient air. Blood pressures were equal in both arms. Jugular venous distention was absent, and the lung and cardiac examinations had normal results. His pain did not increase on chest wall palpation. Examination of the abdomen, extremities, and the neurologic system showed normal results.

The results of laboratory tests showed a leukocyte count of 12,700/cm³, with 85% neutrophils, 8% lymphocytes, 6% monocytes, and 1% eosinophils. The hematocrit was 45%, and the platelet count was 172,000/cm³. The results of his chemistry panel were remarkable only for a glucose of 225 mg/dL. An electrocardiogram (ECG) showed a normal sinus rhythm and left anterior fascicular block without acute ST‐ or T‐wave changes. Prior ECGs were unavailable. An anteroposterior radiograph disclosed low lung volumes and bibasilar opacities. No pleural effusion was noted. Serial serum troponin and creatine kinase levels were normal. A Tc‐99m tetrofosmin cardiac nuclear perfusion test performed at rest demonstrated a moderate area of mildly decreased uptake along the inferior wall extending to the apex. An exercise treadmill test, terminated after 1 minute, 45 seconds because of chest pain, provoked no ECG changes diagnostic of ischemic disease.

The absence of elevated jugular venous pressure virtually eliminates pericardial tamponade as a diagnosis, and the chest film excludes pneumothorax. The intermittent nature of the chest pain, the absence on the chest radiograph of such findings as mediastinal gas, left pneumothorax, or hydropneumothorax, and the lack of a predisposing cause make esophageal rupture unlikely. Pulmonary emboli remain a consideration despite the normal oxygen saturation because there is no hypoxemia in a substantial minority of such cases. The normal cardiac enzyme levels and the lack of significant changes on the ECG exclude that a myocardial infarction has recently occurred, but cardiac ischemia remains a possibility, especially because the patient had chest pain on exercise and the nuclear scan indicated diminished blood flow to the inferior left ventricle. Aortic dissection still lurks as a possibility. The inferior wall abnormalities seen on the scan could result from dissection into the right coronary artery, which is more frequently involved than the left, or compression of it by an enlarged aorta, but they also may be artifacts. The leukocytosis may be a nonspecific response to stress but could indicate, although unlikely, infections such as mediastinitis from esophageal rupture or bacterial aortitis.

A conscientious clinician would repeat the history, reexamine the patient, and scrutinize the chest film to determine what the bilateral opacities represent. Given the story so far, however, I might consider a thoracic computed tomography (CT) angiogram because I am most concerned about pulmonary emboli and aortic dissection.

On hospital day 3, the patient had worsening dyspnea and persistent chest pain. His temperature was 39.3C, and his oxygen saturation decreased to 89% while breathing room air. Repeat chest radiography showed new bilateral pleural effusions and increased bibasilar opacification (Fig. 1). His leukocyte count was 19,000/cm³, with 88% neutrophils, 6% lymphocytes, 5% monocytes, and 1% eosinophils. Care was transferred from the chest pain team to an inpatient general medicine ward team. A pulmonary CT angiogram showed no large central clots but suggested emboli in the right superior subsegmental artery and a right upper lobe subsegmental artery. Bilateral pleural effusions were observed, as were bilateral pleural‐based atelectasis or infiltrates in the lower lungs. A hiatal hernia was noted, but no aortic dissection. The patient received supplemental oxygen, intravenous levofloxacin, and unfractionated heparin by continuous infusion.

Figure 1

Without other information, I will assume that the fever is part of the patient's original disease and not a nosocomial infection or drug fever. At this point, a crucial part of the evaluation is examining the CT scan with experienced radiologists to determine whether the abnormalities noted are genuinely convincing for pulmonary emboli. If the findings are equivocal, the next step might be a pulmonary angiogram or the indirect approach of evaluating the leg veins with ultrasound, reasoning that the presence of proximal leg vein thromboses would require anticoagulation in any event.

The patient's worsening chest pain and hypoxemia are consistent with multiple pulmonary emboli. Bilateral pleural effusions and leukocytosis can occur but are uncommon. Because of the fever, another possibility is septic pulmonary emboli, but he has no evidence of suppurative thrombophlebitis of the peripheral veins, apparent infection elsewhere, or previous intravenous drug abuse causing right‐sided endocarditis. An alternative diagnosis is infection of an initially bland pulmonary infarct.

An important consideration is a thoracentesis, depending on how persuasive the CT diagnosis of pulmonary embolism is and the size of the pleural effusions. It should be done before instituting antimicrobial therapy, which may decrease the yield of the cultures, and before starting heparin, which increases the risk of bleeding and occasionally causes a substantial, even fatal hemothorax.

The patient's oxygenation and dyspnea did not improve. Over the next day, he repeatedly mentioned that swallowing, particularly solid foods, worsened his chest pain. He had a temperature of 39.9C, a heart rate of 121 beats/minute, blood pressure of 149/94 mm Hg, a respiratory rate of 28/minute, and oxygen saturation of 93% while breathing 40% oxygen. He had inspiratory splinting, percussive dullness at both lung bases, and distant heart sounds. A contrast esophagogram showed distal narrowing that prevented solid contrast from passing, but no hiatal hernia. Blood and urine cultures obtained before antibiotic therapy were sterile. Duplex ultrasonography of bilateral lower extremities showed no evidence of deep venous thrombosis. A pulmonary angiogram revealed no emboli, and heparin was discontinued. Bilateral thoracentesis yielded grossly bloody fluid. Repeat chest CT (Fig. 2) demonstrated large bilateral effusions, a new large pericardial effusion, and a prominence at the gastroesophageal junction more concerning for a soft‐tissue mass than for a hiatal hernia, although the quality of the study was suboptimal because of an absence of oral contrast.

Figure 2

The CT scan suggests a paraesophageal abscess from an esophageal rupture. As mentioned earlier, if rupture occurs spontaneously, it typically follows retching or vomiting and is called Boerhaave's syndrome. Another consideration is a rupture secondary to an external insult, such as trauma or ingestion of a caustic substance. In evaluating these possibilities, the patient should have been asked 4 questions at the initial interview that I neglected to explicitly highlight earlier. First, what was he eating when he developed the chest pain? Second, did the pain begin during swallowing? Third, did he have previous symptoms suggesting an esophageal disorder such as dysphagia, odynophagia, or heartburn? These might indicate a cancer that could perforate or another problem such as a stricture or disordered esophageal motility that might have caused a swallowed item to lodge in the esophagus. Finally, did he have retching or vomiting? Though not routinely part of the review of systems, the former 2 questions are an appropriate history‐prompted line of questioning of a patient with onset of chest pain while eating.

At this point, a reasonable approach would be an esophagoscopy to delineate any intraluminal problems, such as a cancer or a foreign body. The apparent obstruction seen on barium swallow may be from extrinsic pressure from a paraesophageal abscess. The patient should receive broad‐spectrum antimicrobial therapy effective against oral anaerobes. Although occasionally patients recover with antibiotics alone, surgery is usually required. I am surprised that the original CT scan did not show evidence of an esophageal perforation. Possibly, the hiatal hernia was a paraesophageal abscess poorly characterized because of the lack of oral contrast.

The team, concerned about esophageal perforation, began the patient on intravenous clindamycin. The patient underwent video‐assisted thoracoscopic drainage, which yielded a moderate amount of turbid, bloody fluid from each hemithorax. The pericardium contained approximately 500 cm³ of turbid fluid. Gram stain and culture of these fluids were negative. No esophageal or mediastinal mass was noted during surgery. Intraoperative esophagogastroduodenoscopy with endoscopic ultrasound showed a healing linear mucosal tear in the distal esophagus (Fig. 3) as well as air/fluid collection in the esophageal soft tissue (not shown).

Figure 3

On further questioning postoperatively, the patient reported eating bony fish during the dinner when he first experienced chest pain. The patient received a 21‐day course of oral clindamycin and completely recovered. Five weeks later, a chest CT showed decreased distal esophageal thickening and no mediastinal air.

COMMENTARY

Esophageal perforation is an uncommon but life‐threatening cause of chest pain. In most series iatrogenic injury accounts for more than 70% of cases, whereas most of the other cases have spontaneous (5%20%) or traumatic (4%10%) causes (Table 1).14 Perforation as a complication of ingesting fish bones, although rare, is well described and continues to be reported.57

Diagnosis of esophageal perforation secondary to a foreign body may be difficult because of the considerable overlap of symptoms with other causes of chest pain and failure to consider this infrequent condition in the absence of a classic history of retching. To diagnose such a disease, physicians must gather data from various sourcesespecially the history, physical examination, and medical recordformulate hypotheses, integrate results from diagnostic tests, and then assess the importance of the available information in the context of a differential diagnosis. Incorrectly evaluating or failing to obtain essential data can lead to incorrect or delayed diagnoses.

A 54‐year‐old man with hypertension and type 2 diabetes mellitus entered the Chest Pain Evaluation Unit of a teaching hospital after 12 hours of intermittent thoracic discomfort. The pain began during dinner and was sharp, bandlike, and located beneath the sternum and across the entire chest. He had dyspnea but no diaphoresis or nausea. A recumbent position relieved the pain after dinner, but it recurred during the night and again the following morning. He did not smoke and had no family history of coronary artery disease.

A useful approach in evaluating acute chest pain is to employ a hierarchical differential diagnosis that emphasizes life‐threatening disorders requiring prompt recognition and intervention. Most prominent are cardiac ischemia, pericardial tamponade, pneumothorax, pulmonary embolus, esophageal rupture, and aortic dissection. The concurrent dyspnea and retrosternal location and intermittent nature of the pain that this patient has are consistent with myocardial ischemia, but the sharp quality of the pain and the relief gained by being recumbent are atypical. Pain with pericarditis is characteristically pleuritic and often worse when lying down. The pain of pneumothorax is typically unilateral, not intermittent, and unlikely to improve with recumbency. Although pain during eating suggests the possibility of an esophageal source, spontaneous rupture usually follows vomiting. The pain is typically continuous and severe. The pain of pulmonary embolism may be unilateral and pleuritic but often is more diffuse. Relief by recumbency is unusual, but the intermittent nature could suggest recurrent emboli. The patient has a history of hypertension, which predisposes him to aortic dissection, in which the pain is typically sharp, continuous, and severe but occasionally intermittent. Among numerous less urgent diagnoses are esophagitis and thoracic diabetic radiculopathy.

Important features to look for during this patient's examination include: disappearance of the radial pulse during inhalation, a simple screening test that is insensitive but very specific for pericardial tamponade; elevated neck veins, which can occur with tension pneumothorax, massive pulmonary embolism, and pericardial tamponade; pericardial and pleural friction rubs; discrepant blood pressures in the 2 arms, sometimes a sign of aortic dissection; local thoracic tenderness from chest wall disorders; and sensory examination of the chest surface, which is often abnormal in diabetic thoracic radiculopathy. Given this patient's age and history of diabetes, I am most concerned about myocardial ischemia. The most appropriate diagnostic tests include an electrocardiogram and a chest radiograph.

The patient appeared apprehensive but reported no pain. He had a temperature of 36.0 C, heart rate of 95 beats/minute, blood pressure of 138/77 mm Hg, respiratory rate of 16/minute, and oxygen saturation of 99% while breathing ambient air. Blood pressures were equal in both arms. Jugular venous distention was absent, and the lung and cardiac examinations had normal results. His pain did not increase on chest wall palpation. Examination of the abdomen, extremities, and the neurologic system showed normal results.

The results of laboratory tests showed a leukocyte count of 12,700/cm³, with 85% neutrophils, 8% lymphocytes, 6% monocytes, and 1% eosinophils. The hematocrit was 45%, and the platelet count was 172,000/cm³. The results of his chemistry panel were remarkable only for a glucose of 225 mg/dL. An electrocardiogram (ECG) showed a normal sinus rhythm and left anterior fascicular block without acute ST‐ or T‐wave changes. Prior ECGs were unavailable. An anteroposterior radiograph disclosed low lung volumes and bibasilar opacities. No pleural effusion was noted. Serial serum troponin and creatine kinase levels were normal. A Tc‐99m tetrofosmin cardiac nuclear perfusion test performed at rest demonstrated a moderate area of mildly decreased uptake along the inferior wall extending to the apex. An exercise treadmill test, terminated after 1 minute, 45 seconds because of chest pain, provoked no ECG changes diagnostic of ischemic disease.

The absence of elevated jugular venous pressure virtually eliminates pericardial tamponade as a diagnosis, and the chest film excludes pneumothorax. The intermittent nature of the chest pain, the absence on the chest radiograph of such findings as mediastinal gas, left pneumothorax, or hydropneumothorax, and the lack of a predisposing cause make esophageal rupture unlikely. Pulmonary emboli remain a consideration despite the normal oxygen saturation because there is no hypoxemia in a substantial minority of such cases. The normal cardiac enzyme levels and the lack of significant changes on the ECG exclude that a myocardial infarction has recently occurred, but cardiac ischemia remains a possibility, especially because the patient had chest pain on exercise and the nuclear scan indicated diminished blood flow to the inferior left ventricle. Aortic dissection still lurks as a possibility. The inferior wall abnormalities seen on the scan could result from dissection into the right coronary artery, which is more frequently involved than the left, or compression of it by an enlarged aorta, but they also may be artifacts. The leukocytosis may be a nonspecific response to stress but could indicate, although unlikely, infections such as mediastinitis from esophageal rupture or bacterial aortitis.

A conscientious clinician would repeat the history, reexamine the patient, and scrutinize the chest film to determine what the bilateral opacities represent. Given the story so far, however, I might consider a thoracic computed tomography (CT) angiogram because I am most concerned about pulmonary emboli and aortic dissection.

On hospital day 3, the patient had worsening dyspnea and persistent chest pain. His temperature was 39.3C, and his oxygen saturation decreased to 89% while breathing room air. Repeat chest radiography showed new bilateral pleural effusions and increased bibasilar opacification (Fig. 1). His leukocyte count was 19,000/cm³, with 88% neutrophils, 6% lymphocytes, 5% monocytes, and 1% eosinophils. Care was transferred from the chest pain team to an inpatient general medicine ward team. A pulmonary CT angiogram showed no large central clots but suggested emboli in the right superior subsegmental artery and a right upper lobe subsegmental artery. Bilateral pleural effusions were observed, as were bilateral pleural‐based atelectasis or infiltrates in the lower lungs. A hiatal hernia was noted, but no aortic dissection. The patient received supplemental oxygen, intravenous levofloxacin, and unfractionated heparin by continuous infusion.

Figure 1

Without other information, I will assume that the fever is part of the patient's original disease and not a nosocomial infection or drug fever. At this point, a crucial part of the evaluation is examining the CT scan with experienced radiologists to determine whether the abnormalities noted are genuinely convincing for pulmonary emboli. If the findings are equivocal, the next step might be a pulmonary angiogram or the indirect approach of evaluating the leg veins with ultrasound, reasoning that the presence of proximal leg vein thromboses would require anticoagulation in any event.

The patient's worsening chest pain and hypoxemia are consistent with multiple pulmonary emboli. Bilateral pleural effusions and leukocytosis can occur but are uncommon. Because of the fever, another possibility is septic pulmonary emboli, but he has no evidence of suppurative thrombophlebitis of the peripheral veins, apparent infection elsewhere, or previous intravenous drug abuse causing right‐sided endocarditis. An alternative diagnosis is infection of an initially bland pulmonary infarct.

An important consideration is a thoracentesis, depending on how persuasive the CT diagnosis of pulmonary embolism is and the size of the pleural effusions. It should be done before instituting antimicrobial therapy, which may decrease the yield of the cultures, and before starting heparin, which increases the risk of bleeding and occasionally causes a substantial, even fatal hemothorax.

The patient's oxygenation and dyspnea did not improve. Over the next day, he repeatedly mentioned that swallowing, particularly solid foods, worsened his chest pain. He had a temperature of 39.9C, a heart rate of 121 beats/minute, blood pressure of 149/94 mm Hg, a respiratory rate of 28/minute, and oxygen saturation of 93% while breathing 40% oxygen. He had inspiratory splinting, percussive dullness at both lung bases, and distant heart sounds. A contrast esophagogram showed distal narrowing that prevented solid contrast from passing, but no hiatal hernia. Blood and urine cultures obtained before antibiotic therapy were sterile. Duplex ultrasonography of bilateral lower extremities showed no evidence of deep venous thrombosis. A pulmonary angiogram revealed no emboli, and heparin was discontinued. Bilateral thoracentesis yielded grossly bloody fluid. Repeat chest CT (Fig. 2) demonstrated large bilateral effusions, a new large pericardial effusion, and a prominence at the gastroesophageal junction more concerning for a soft‐tissue mass than for a hiatal hernia, although the quality of the study was suboptimal because of an absence of oral contrast.

Figure 2

The CT scan suggests a paraesophageal abscess from an esophageal rupture. As mentioned earlier, if rupture occurs spontaneously, it typically follows retching or vomiting and is called Boerhaave's syndrome. Another consideration is a rupture secondary to an external insult, such as trauma or ingestion of a caustic substance. In evaluating these possibilities, the patient should have been asked 4 questions at the initial interview that I neglected to explicitly highlight earlier. First, what was he eating when he developed the chest pain? Second, did the pain begin during swallowing? Third, did he have previous symptoms suggesting an esophageal disorder such as dysphagia, odynophagia, or heartburn? These might indicate a cancer that could perforate or another problem such as a stricture or disordered esophageal motility that might have caused a swallowed item to lodge in the esophagus. Finally, did he have retching or vomiting? Though not routinely part of the review of systems, the former 2 questions are an appropriate history‐prompted line of questioning of a patient with onset of chest pain while eating.

At this point, a reasonable approach would be an esophagoscopy to delineate any intraluminal problems, such as a cancer or a foreign body. The apparent obstruction seen on barium swallow may be from extrinsic pressure from a paraesophageal abscess. The patient should receive broad‐spectrum antimicrobial therapy effective against oral anaerobes. Although occasionally patients recover with antibiotics alone, surgery is usually required. I am surprised that the original CT scan did not show evidence of an esophageal perforation. Possibly, the hiatal hernia was a paraesophageal abscess poorly characterized because of the lack of oral contrast.

The team, concerned about esophageal perforation, began the patient on intravenous clindamycin. The patient underwent video‐assisted thoracoscopic drainage, which yielded a moderate amount of turbid, bloody fluid from each hemithorax. The pericardium contained approximately 500 cm³ of turbid fluid. Gram stain and culture of these fluids were negative. No esophageal or mediastinal mass was noted during surgery. Intraoperative esophagogastroduodenoscopy with endoscopic ultrasound showed a healing linear mucosal tear in the distal esophagus (Fig. 3) as well as air/fluid collection in the esophageal soft tissue (not shown).

Figure 3

On further questioning postoperatively, the patient reported eating bony fish during the dinner when he first experienced chest pain. The patient received a 21‐day course of oral clindamycin and completely recovered. Five weeks later, a chest CT showed decreased distal esophageal thickening and no mediastinal air.

COMMENTARY

Esophageal perforation is an uncommon but life‐threatening cause of chest pain. In most series iatrogenic injury accounts for more than 70% of cases, whereas most of the other cases have spontaneous (5%20%) or traumatic (4%10%) causes (Table 1).14 Perforation as a complication of ingesting fish bones, although rare, is well described and continues to be reported.57

Diagnosis of esophageal perforation secondary to a foreign body may be difficult because of the considerable overlap of symptoms with other causes of chest pain and failure to consider this infrequent condition in the absence of a classic history of retching. To diagnose such a disease, physicians must gather data from various sourcesespecially the history, physical examination, and medical recordformulate hypotheses, integrate results from diagnostic tests, and then assess the importance of the available information in the context of a differential diagnosis. Incorrectly evaluating or failing to obtain essential data can lead to incorrect or delayed diagnoses.

In April 2003 the Health Resources and Services Administration of the U.S. Department of Health and Human Services (DHHS) announced the formation of the Organ Donation Breakthrough Collaborative (ODBC).1 The Organ Donation Breakthrough Collaborative created 58 national donation service areas (DSAs) to organize the transplant community across the United States. Each of the 58 organ procurement organizations (OPOs) is joined to a regional transplant center or centers and donor hospitals to form a DSA. The ODBC's goal is to achieve a cadaveric organ donation rate of 75% or higher from hospitals within each DSA.2

A requirement for organ donation from patients facing imminent or cardiac death has been introduced to increase the supply of transplantable organs and shorten the waiting time for transplantation candidates.35 This type of organ donation represents a significant source of organs required for future expansion of transplantation practice in the United States. The requirement for donation in imminent or cardiac death is implemented through the collaboration of the Advisory Committee on Organ Transplantation of the DHHS (Table 1), the Centers for Medicare & Medicaid Services (CMS), and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).3, 57 The organ donor pool of those facing imminent or cardiac death has also been expanded to include neurologically intact patients who may not fulfill brain death criteria before withdrawal of life support.4, 8, 9

The President's Council on Bioethics independently evaluated the issues surrounding deceased organ donation and procurement.10 The President's Council on Bioethics has expressed major concerns about several issues pertinent to cardiac or imminent death organ donation that have not been addressed explicitly by the bodies that have made recommendations for reforming or expanding that type of organ donation in the United States. The debate on organ procurement in imminent or cardiac death has come to the forefront because of doubts about its ethical appropriateness and acceptance within the medical profession and the community at large. This review focuses on the serious issues related to organ procurement from patients facing imminent or cardiac death.

Organ Procurement and the Dead Donor Rule

Organ procurement is only permitted when the donor is already dead (ie, the dead donor rule), and the act of organ recovery cannot have been the immediate act to cause that death.10, 11 There are 2 criteria for death as defined in the Uniform Determination of Death Act (UDDA; Table 1): an individual who has sustained irreversible cessation of either (1) circulatory and respiratory functions or (2) all functions of the entire brain, including the brain stem, is considered dead and this determination of death must have been made in accordance with accepted medical standards.12 When organs are procured from an individual in whom all brain function has ceased but normal cardiac pump activity is continuing, it is referred to as heart‐beating organ donation. Organ procurement after cessation of cardiac pump activity and cardiorespiratory functions is referred to as non‐heart‐beating organ donation (NHBOD). Organ procurement from an individual in imminent or cardiac death is considered NHBOD.

Non‐heart‐beating organ donors can be neurologically intact and do not fulfill the brain death criterion prior to cessation of cardiac pump activity. In response to this dilemma, the University of Pittsburgh Medical Centre developed a protocol for donation of organs that permitted their procurement from patients who were pulseless and apneic for 2 minutes and did not fulfill brain criteria and who had previously given consent for organ donation.13 Because it is uncertain if cessation of cardiorespiratory function is irreversible after only a short time, the Institute of Medicine (IOM) extended the time required for pulselessness and apnea from 2 to 5 minutes before permitting organ procurement.14 Waiting longer than 5 minutes for the determination of death would compromise the quality of procured organs because of warm ischemia time and would influence the functioning of grafts in transplant recipients.

One of the pivotal assumptions for NHBOD acceptance is that 5 minutes of pulselessness and apnea eliminates the possibility that the procurement process itself could be the cause of death and fulfills the dead donor rule.14, 15 The cardiorespiratory death criteria were derived from observations that did not evaluate delayed autoresuscitation (spontaneous return of circulation) or simultaneous cessation of brain electrical activity (as recorded in brain death).1618 The death criteria applied for organ procurement must also comply with the irreversibility requirement of the UDDA.11, 12

The true incidence, temporal characteristics, and predictors of autoresuscitation in humans remain unknown because of underreporting in the literature. However, there have been case reports of autoresuscitation with return of neurologic function (also called the Lazarus phenomenon) after 10 minutes of cardiac asystole.19, 20 Maleck et al. and Adhiyaman et al. described autoresuscitation 5 minutes or longer after cardiorespiratory arrest in 44% and 50% of the published case reports, respectively.19, 20 Although cardiac asystole leads to the loss of arterial pulse pressure, circulatory arterial mean pressure is maintained in diastole by arteriolar vasomotor tone. The relaxation (diastole) phase systemic arterial to venous pressure gradient provides the perfusion pressure for vital organs and the spontaneous return of circulation after circulatory arrest.21 It is likely that autoresuscitation occurs because of the persistence of circulatory vasomotor tone after cessation of cardiac function. The time course of systemic vascular tone after circulatory arrest has not been well characterized in humans. However, the IOM criteria did not account for the incidence of delayed autoresuscitation in humans even though the Maastricht protocol (developed by the University of Zurich, Zurich, Switzerland) acknowledged this phenomenon and required at least 10 minutes to elapse after cardiorespiratory arrest before starting organ procurement.22 The 10‐minute waiting time did not compromise the quality of the organs procured.

The cardiorespiratory death criteria for organ procurement also ignore cardiac electrical activity (such as pulseless electrical activity or ventricular fibrillation) on an electrocardiogram. Research with cardiac ultrasonography and indwelling arterial catheters confirms that pulseless cardiac electrical activity can be associated with cardiac mechanical contractions, although these contractions are too weak to be detected by blood pressure monitoring.23 The presence of cardiac electrical activity on an electrocardiogram can also increase the likelihood that delayed autoresuscitation will occur.19, 20 Furthermore, whether there is brain electrical activity or neurologic function when cardiac electrical activity is still observed on an electrocardiogram remains unknown.24 It can be argued that donors who have already suffered severe neurologic injury cannot have meaningful neurologic function at the time of cardiorespiratory death. However, the presence of brain activity becomes relevant for organ donors with intact neurologic and brain function prior to cardiorespiratory arrest when only cardiorespiratory criteria for organ procurement are being used.4, 8, 9

In situ circulatory support with extracorporeal perfusion in organ donors has also refuted that cardiorespiratory arrest for 5 minutes fulfills the UDDA requirement because reversibility can occur during the procurement process. In situ extracorporeal perfusion is initiated 5 minutes after cardiorespiratory arrest of donors in order to preserve organs for procurement.25 Coronary and cerebral reperfusion can lead to the return of cardiac and neurologic functions (also called reanimation) of donors during the procurement process. Mechanical occlusion of the aortic arch and pharmacological agents are required to suppress donor reanimation during organ procurement.26 Martin et al. documented that in situ extracorporeal perfusion returned full neurologic and cardiac function 25 minute after cardiorespiratory arrest that occurred outside the hospital.27 Similar observations of full neurologic recovery and survival to hospital discharge were reported after in situ extracorporeal perfusion for in‐hospital cardiorespiratory arrest.28 These observations confirm that the time required for irreversible loss of neurologic function after cessation of circulation is much longer than the 25 minutes of cardiorespiratory arrest required to begin the process of organ procurement in NHBOD.

The incidence of donor reanimation during procurement is unknown because its reporting violates the dead donor rule and can create legal concerns.11 It can be argued that reanimation of organ donors is irrelevant because it does not mean survival. However, the occurrence of reanimation invalidates the premise that the cardiorespiratory criteria for organ procurement comply with the uniform determination of death. Others have accepted the inaccuracy of these criteria for determining death for procurement of organs from deceased donors and proposed abandoning the dead donor rule in order to permit recovery of transplantable organs before death.29

In the face of the uncertainty in determining death and in response to a media and marketing campaign by organ procurement organizations (OPOs) to promote public enrollment in deceased organ donation, the transplant community renamed NHBOD cardiac death organ donation.30, 31 The use of the term cardiac death is scientifically inaccurate and perhaps misleading. This term is used to denote the cessation of circulation and cardiac pump activity. The term cardiac death can be misinterpreted as meaning the heart has irreversibly ceased at the time of procurement, thus contradicting the scientific evidence for spontaneous resumption of cardiac function and autoresuscitation.19, 20 Alternatively, the use of this term can falsely imply that neurologic activity or brain stem function has ceased irreversibly after loss of cardiac activity, when scientific evidence suggests that brain stem function can remain after cardiac arrest.32

Consent for Organ Donation

Several state laws and federal regulations have been enacted to ensure that organ donation and transplantation practice comply with the ethical and legal standards of society (Table 1). The current regulations require hospitals across the United States to provde regional OPOs with early notification of all patients whose deaths are imminent before life support has been withdrawn so that discussion of organ donation with surrogate decision makers can be initiated independently and consent obtained.3, 5, 9 The Organ Donation Breakthrough Collaborative has set a goal of each OPO accomplishing a target organ donation rate of 75% or higher at local hospitals within an assigned donation service area (DSA).1, 2, 5 The financial and administrative incentives for the OPO to achieve that target organ donation rate have introduced undisclosed conflict within the donation consent process.33 Self‐serving bias of OPOs can influence whether pertinent information necessary for surrogate decision makers to provide informed consent is disclosed.34 As an example of this bias, alternative options for care and palliation may be discussed with surrogate decision makers with less enthusiasm than are the benefits and altruistic notion of organ donation. In obtaining donation consent, OPOs often avoid disclosing details of perimortem interventions performed on donors that are required for successful procurement of transplantable organs.10, 34, 35 After receiving consent for organ donation, OPO staffs also assume the responsibility of planning donor medical care and treatment pathways essential for maintaining organ viability and of preparing for subsequent procurement.5, 36 In essence, the care of the dying patient is guided by a team whose primary interest is the preservation of organs until procurement has been accomplished.

The Uniform Anatomical Gift Act (UAGA) assigns explicit priority to the donor's expressed intent so that consent for organ donation becomes irrevocable and does not require the consent or concurrence of any person after the donor's death (Table 1).9, 37 The donor's authorization to donate, recorded on an organ donor card, the individual's driver's license, or a donor registry, becomes a legally binding advance directive. The UAGA amendment enables OPOs to procure organs without family consent and in certain instances after family refusal to donate.37

Other consent options for organ donation from deceased donors have been proposed to maximize OPO recovery of transplantable organs in the United States (Table 2).8 The IOM has considered presumed consent for organ donation as a favorable option.8 Presumed consent means the default option is consent to donation, that if an individual has not expressly rejected donation, that individual is considered to have consented to organ donation. Legislative enactment of presumed consent enables OPOs to avoid the potential for surrogates to deny consent for donation, thus increasing the pool of future organ donors. The revised UAGA replaces nondonation with the intent to donate organs as the default option. In the default option, all measures necessary to ensure the medical suitability of an organ for transplantation can not be withheld or withdrawn until the OPO has determined medical suitability of the individual as a prospective donor (Table 1). The default option overrides the expression of intent in a declaration or advance health‐care directives not to have life prolonged by withholding or withdrawing life support system unless the individual has expressed refusal of donation (Tables 1 and 2). The revised UAGA presumes that for prospective donors the desire to save lives by making an anatomical gift trumps the desire to have life support systems withheld or withdrawn. Mandated consent (or conscription) has also been proposed for recovery of cadaveric organs (Table 2).38 Under mandated consent, consent for organ donation is automatic from all deceased individuals; therefore, OPOs would not require or request consent because removal of all needed transplantable cadaveric organs would be compulsory. OPO staffs would no longer have to discuss organ procurement from potential donors with family members or other surrogates. An alternative form of donation consent is mandated choice, which requires each individual to decide in advance either to agree to organ donation or to refuse it. Mandated choice is the IOM's least favorite option because it would require extensive public informational programs on organ donation to facilitate individual choices and decision making (Table 2).8

End‐of‐Life Care

Quality of end‐of‐life (EOL) care for an organ donor, as for any individual whose treatment is being withdrawn, is considered the highest priority of care and must not be compromised by the donation process. Yet no studies have investigated the impact of organ donation on the quality of EOL care in NHBOD.35 Previous reports have criticized the quality of EOL care offered to dying patients in intensive care units (ICUs).39, 40 Many of these patients are undergoing withdrawal of life support in anticipation of death and are considered candidates for NHBOD. The Robert Wood Johnson Foundation (RWJF) Critical Care End‐Of‐Life Peer Workgroup developed 53 EOL quality indicators to standardize and measure the quality of EOL care.41 These quality indicators, organized in 7 domains, focus on delivering patient‐ and family‐centered care and facilitating a good death experience in the ICU (Table 3).

In a subsequent U.S. survey, the Critical Care Peer Workgroup of the Promoting Excellence in End‐of‐Life Care Project reported that more than 75% of ICUs were still not monitoring the quality of EOL care.42 The survey also identified multiple barriers to optimal EOL care found in most ICUs. The study group proposed several strategies to overcome these barriers and improve the quality of EOL care (Table 3).42, 43 It can also be inferred from the survey findings that most ICUs are unprepared and lack the necessary tools to appropriately inform patients and families of the trade‐off in EOL care for NHBOD. The President's Council for Bioethics has also warned that NHBOD can transform EOL care from a peaceful dignified death into a profanely high‐tech death experience for donors' families.10

Several aspects of medical care that are neither palliative nor beneficial are performed for donor management for NHBOD and can explain the feared transformation of the death experience. The revised UAGA reaffirms that all measures necessary to ensure the medical suitability of an organ for transplantation cannot be withheld or withdrawn from the prospective donor and overrides the expression of intent by a prospective donor in either a declaration or advance health‐care directive not to have life prolonged by use of life support systems (Table 1).9 The 2007 amendment to revised UAGA section 21 recognizes the conflict between all measures necessary to ensure organs viability for transplantation and appropriate EOL care and requires the attending physician and OPO to resolve the conflict with the prospective donor or surrogate decision‐maker.9

OPOs apply donor management critical pathways to potential organ donors in order to maintain organ viability for successful execution of organ procurement.36 The University of Wisconsin developed a protocol and an evaluation tool to determine the eligibility of potential candidates for NHBOD.44 The protocol entails temporary discontinuation of mechanical ventilation for a trial of spontaneous respiration lasting up to 10 minutes to determine the likelihood of cardiorespiratory death within 60‐90 minutes of the withdrawal of life support. Those patients predicted by the University of Wisconsin evaluation tool to survive a longer time are not candidates for NHBOD and are transferred to palliative care. Those patients who meet the necessary criteria of the University of Wisconsin evaluation tool become candidates for NHBOD and undergo additional antemortem testing, invasive vascular instrumentation, and infusion of medications essential for organ preservation.36 The instrumentation and medications used for organ preservation can also expedite death on withdrawal of life support.45 Other interventions (such as circulatory support with invasive and noninvasive devices, extracorporeal perfusion and oxygenation, endotracheal reintubation, mechanical ventilation, and bronchoscopy) are performed when cardiorespiratory death is pronounced in order to maintain organ viability and can inadvertently reanimate the donor during the procurement process.26

The process of obtaining donation consent and subsequent donor management protocols for NHBOD deviate from more than 60% of the RWJF quality indicators recommended for optimal EOL care.35, 36, 41 Therefore, NHBOD can have a profound impact on the quality of EOL care. There has been a recent proposal to abbreviate the original RWJF quality indicators to include 14 of the 53 (26%) original quality indicators described for optimal EOL care in the ICU (Table 3).46 Many of the quality indicators expected to be negatively affected by NHBOD are not included in the proposal for an abbreviated list. There has been a concern that the application of an abbreviated rather than a comprehensive metrics for EOL care can portray an incomplete assessment and perhaps misinform donors and their families about the potential trade‐off in EOL care. The President's Council on Bioethics has emphasized that comprehensive evaluation of the quality of EOL care is an ethical imperative so that families can decide if the trade‐off is acceptable for organ donation.10 Deciding to donate organs at the end of life can be stressful for many families, and therefore they must be fully informed of the possible consequences. Posttraumatic stress disorders, anxiety, depression, and decreased quality of life have been reported in the deceased's family members who shared in stressful EOL decisions.47 Posttraumatic stress disorders have been reported in family members of deceased organ donors.48 Organ‐focused behavior by professionals requesting consent for organ donation and ambivalent decision making by family members appeared to increase the risk of relatives of deceased donors subsequently developing traumatic memories and stress disorders. The processes required for successful accomplishment of donation consent and subsequent organ recovery can interfere with many of the interventions that lessen the burden of bereavement of relatives of ICU decedents.49

The variability in decision making by health care providers about medical futility and EOL care has been given as a reason for concern about the implementation of NHBOD.50 The variability of EOL practice raises the possibility of conflicted decision making on medical futility within institutions that have transplant programs.50 Ethical conflicts and moral distress have been reported among health care providers who were directly involved in organ procurement in NHBOD.51 The pressure to recover transplantable organs from NHBOD candidates has been associated with health care professionals' perception of euthanasia and premature determination of medical futility and withdrawal of life support. The long‐term psychological impact of NHBOD practice on caregivers, health care providers, and professionals remains unknown.

CONCLUSIONS

In conclusion, NHBOD influences medical care at critical time points to maximize the procurement of transplantable organs and minimize their warm ischemia time with negative consequences on the EOL care for the prospective donors and their families (see Figure 1).

Figure 1

Mandatory implementation of NHBOD in the face of difficulties surrounding the quality of EOL care for donors raises concern across the medical profession and community. There is a need for better scientific validation of the timing of organ procurement to ensure that organ recovery is not the irreversible event defining death in NHBOD. The desire of OPOs or their affiliates to maximize recovery of transplantable organs introduces self‐serving bias into obtaining consent for organ donation and violates the basic tenet of true informed consent. The use of comprehensive quality indicators of EOL care will help to determine the impact of NHBOD on donors, families, caregivers, and health care providers.

In April 2003 the Health Resources and Services Administration of the U.S. Department of Health and Human Services (DHHS) announced the formation of the Organ Donation Breakthrough Collaborative (ODBC).1 The Organ Donation Breakthrough Collaborative created 58 national donation service areas (DSAs) to organize the transplant community across the United States. Each of the 58 organ procurement organizations (OPOs) is joined to a regional transplant center or centers and donor hospitals to form a DSA. The ODBC's goal is to achieve a cadaveric organ donation rate of 75% or higher from hospitals within each DSA.2

A requirement for organ donation from patients facing imminent or cardiac death has been introduced to increase the supply of transplantable organs and shorten the waiting time for transplantation candidates.35 This type of organ donation represents a significant source of organs required for future expansion of transplantation practice in the United States. The requirement for donation in imminent or cardiac death is implemented through the collaboration of the Advisory Committee on Organ Transplantation of the DHHS (Table 1), the Centers for Medicare & Medicaid Services (CMS), and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).3, 57 The organ donor pool of those facing imminent or cardiac death has also been expanded to include neurologically intact patients who may not fulfill brain death criteria before withdrawal of life support.4, 8, 9

The President's Council on Bioethics independently evaluated the issues surrounding deceased organ donation and procurement.10 The President's Council on Bioethics has expressed major concerns about several issues pertinent to cardiac or imminent death organ donation that have not been addressed explicitly by the bodies that have made recommendations for reforming or expanding that type of organ donation in the United States. The debate on organ procurement in imminent or cardiac death has come to the forefront because of doubts about its ethical appropriateness and acceptance within the medical profession and the community at large. This review focuses on the serious issues related to organ procurement from patients facing imminent or cardiac death.

Organ Procurement and the Dead Donor Rule

Organ procurement is only permitted when the donor is already dead (ie, the dead donor rule), and the act of organ recovery cannot have been the immediate act to cause that death.10, 11 There are 2 criteria for death as defined in the Uniform Determination of Death Act (UDDA; Table 1): an individual who has sustained irreversible cessation of either (1) circulatory and respiratory functions or (2) all functions of the entire brain, including the brain stem, is considered dead and this determination of death must have been made in accordance with accepted medical standards.12 When organs are procured from an individual in whom all brain function has ceased but normal cardiac pump activity is continuing, it is referred to as heart‐beating organ donation. Organ procurement after cessation of cardiac pump activity and cardiorespiratory functions is referred to as non‐heart‐beating organ donation (NHBOD). Organ procurement from an individual in imminent or cardiac death is considered NHBOD.

Non‐heart‐beating organ donors can be neurologically intact and do not fulfill the brain death criterion prior to cessation of cardiac pump activity. In response to this dilemma, the University of Pittsburgh Medical Centre developed a protocol for donation of organs that permitted their procurement from patients who were pulseless and apneic for 2 minutes and did not fulfill brain criteria and who had previously given consent for organ donation.13 Because it is uncertain if cessation of cardiorespiratory function is irreversible after only a short time, the Institute of Medicine (IOM) extended the time required for pulselessness and apnea from 2 to 5 minutes before permitting organ procurement.14 Waiting longer than 5 minutes for the determination of death would compromise the quality of procured organs because of warm ischemia time and would influence the functioning of grafts in transplant recipients.

One of the pivotal assumptions for NHBOD acceptance is that 5 minutes of pulselessness and apnea eliminates the possibility that the procurement process itself could be the cause of death and fulfills the dead donor rule.14, 15 The cardiorespiratory death criteria were derived from observations that did not evaluate delayed autoresuscitation (spontaneous return of circulation) or simultaneous cessation of brain electrical activity (as recorded in brain death).1618 The death criteria applied for organ procurement must also comply with the irreversibility requirement of the UDDA.11, 12

The true incidence, temporal characteristics, and predictors of autoresuscitation in humans remain unknown because of underreporting in the literature. However, there have been case reports of autoresuscitation with return of neurologic function (also called the Lazarus phenomenon) after 10 minutes of cardiac asystole.19, 20 Maleck et al. and Adhiyaman et al. described autoresuscitation 5 minutes or longer after cardiorespiratory arrest in 44% and 50% of the published case reports, respectively.19, 20 Although cardiac asystole leads to the loss of arterial pulse pressure, circulatory arterial mean pressure is maintained in diastole by arteriolar vasomotor tone. The relaxation (diastole) phase systemic arterial to venous pressure gradient provides the perfusion pressure for vital organs and the spontaneous return of circulation after circulatory arrest.21 It is likely that autoresuscitation occurs because of the persistence of circulatory vasomotor tone after cessation of cardiac function. The time course of systemic vascular tone after circulatory arrest has not been well characterized in humans. However, the IOM criteria did not account for the incidence of delayed autoresuscitation in humans even though the Maastricht protocol (developed by the University of Zurich, Zurich, Switzerland) acknowledged this phenomenon and required at least 10 minutes to elapse after cardiorespiratory arrest before starting organ procurement.22 The 10‐minute waiting time did not compromise the quality of the organs procured.

The cardiorespiratory death criteria for organ procurement also ignore cardiac electrical activity (such as pulseless electrical activity or ventricular fibrillation) on an electrocardiogram. Research with cardiac ultrasonography and indwelling arterial catheters confirms that pulseless cardiac electrical activity can be associated with cardiac mechanical contractions, although these contractions are too weak to be detected by blood pressure monitoring.23 The presence of cardiac electrical activity on an electrocardiogram can also increase the likelihood that delayed autoresuscitation will occur.19, 20 Furthermore, whether there is brain electrical activity or neurologic function when cardiac electrical activity is still observed on an electrocardiogram remains unknown.24 It can be argued that donors who have already suffered severe neurologic injury cannot have meaningful neurologic function at the time of cardiorespiratory death. However, the presence of brain activity becomes relevant for organ donors with intact neurologic and brain function prior to cardiorespiratory arrest when only cardiorespiratory criteria for organ procurement are being used.4, 8, 9

In situ circulatory support with extracorporeal perfusion in organ donors has also refuted that cardiorespiratory arrest for 5 minutes fulfills the UDDA requirement because reversibility can occur during the procurement process. In situ extracorporeal perfusion is initiated 5 minutes after cardiorespiratory arrest of donors in order to preserve organs for procurement.25 Coronary and cerebral reperfusion can lead to the return of cardiac and neurologic functions (also called reanimation) of donors during the procurement process. Mechanical occlusion of the aortic arch and pharmacological agents are required to suppress donor reanimation during organ procurement.26 Martin et al. documented that in situ extracorporeal perfusion returned full neurologic and cardiac function 25 minute after cardiorespiratory arrest that occurred outside the hospital.27 Similar observations of full neurologic recovery and survival to hospital discharge were reported after in situ extracorporeal perfusion for in‐hospital cardiorespiratory arrest.28 These observations confirm that the time required for irreversible loss of neurologic function after cessation of circulation is much longer than the 25 minutes of cardiorespiratory arrest required to begin the process of organ procurement in NHBOD.

The incidence of donor reanimation during procurement is unknown because its reporting violates the dead donor rule and can create legal concerns.11 It can be argued that reanimation of organ donors is irrelevant because it does not mean survival. However, the occurrence of reanimation invalidates the premise that the cardiorespiratory criteria for organ procurement comply with the uniform determination of death. Others have accepted the inaccuracy of these criteria for determining death for procurement of organs from deceased donors and proposed abandoning the dead donor rule in order to permit recovery of transplantable organs before death.29

In the face of the uncertainty in determining death and in response to a media and marketing campaign by organ procurement organizations (OPOs) to promote public enrollment in deceased organ donation, the transplant community renamed NHBOD cardiac death organ donation.30, 31 The use of the term cardiac death is scientifically inaccurate and perhaps misleading. This term is used to denote the cessation of circulation and cardiac pump activity. The term cardiac death can be misinterpreted as meaning the heart has irreversibly ceased at the time of procurement, thus contradicting the scientific evidence for spontaneous resumption of cardiac function and autoresuscitation.19, 20 Alternatively, the use of this term can falsely imply that neurologic activity or brain stem function has ceased irreversibly after loss of cardiac activity, when scientific evidence suggests that brain stem function can remain after cardiac arrest.32

Consent for Organ Donation

Several state laws and federal regulations have been enacted to ensure that organ donation and transplantation practice comply with the ethical and legal standards of society (Table 1). The current regulations require hospitals across the United States to provde regional OPOs with early notification of all patients whose deaths are imminent before life support has been withdrawn so that discussion of organ donation with surrogate decision makers can be initiated independently and consent obtained.3, 5, 9 The Organ Donation Breakthrough Collaborative has set a goal of each OPO accomplishing a target organ donation rate of 75% or higher at local hospitals within an assigned donation service area (DSA).1, 2, 5 The financial and administrative incentives for the OPO to achieve that target organ donation rate have introduced undisclosed conflict within the donation consent process.33 Self‐serving bias of OPOs can influence whether pertinent information necessary for surrogate decision makers to provide informed consent is disclosed.34 As an example of this bias, alternative options for care and palliation may be discussed with surrogate decision makers with less enthusiasm than are the benefits and altruistic notion of organ donation. In obtaining donation consent, OPOs often avoid disclosing details of perimortem interventions performed on donors that are required for successful procurement of transplantable organs.10, 34, 35 After receiving consent for organ donation, OPO staffs also assume the responsibility of planning donor medical care and treatment pathways essential for maintaining organ viability and of preparing for subsequent procurement.5, 36 In essence, the care of the dying patient is guided by a team whose primary interest is the preservation of organs until procurement has been accomplished.

The Uniform Anatomical Gift Act (UAGA) assigns explicit priority to the donor's expressed intent so that consent for organ donation becomes irrevocable and does not require the consent or concurrence of any person after the donor's death (Table 1).9, 37 The donor's authorization to donate, recorded on an organ donor card, the individual's driver's license, or a donor registry, becomes a legally binding advance directive. The UAGA amendment enables OPOs to procure organs without family consent and in certain instances after family refusal to donate.37

Other consent options for organ donation from deceased donors have been proposed to maximize OPO recovery of transplantable organs in the United States (Table 2).8 The IOM has considered presumed consent for organ donation as a favorable option.8 Presumed consent means the default option is consent to donation, that if an individual has not expressly rejected donation, that individual is considered to have consented to organ donation. Legislative enactment of presumed consent enables OPOs to avoid the potential for surrogates to deny consent for donation, thus increasing the pool of future organ donors. The revised UAGA replaces nondonation with the intent to donate organs as the default option. In the default option, all measures necessary to ensure the medical suitability of an organ for transplantation can not be withheld or withdrawn until the OPO has determined medical suitability of the individual as a prospective donor (Table 1). The default option overrides the expression of intent in a declaration or advance health‐care directives not to have life prolonged by withholding or withdrawing life support system unless the individual has expressed refusal of donation (Tables 1 and 2). The revised UAGA presumes that for prospective donors the desire to save lives by making an anatomical gift trumps the desire to have life support systems withheld or withdrawn. Mandated consent (or conscription) has also been proposed for recovery of cadaveric organs (Table 2).38 Under mandated consent, consent for organ donation is automatic from all deceased individuals; therefore, OPOs would not require or request consent because removal of all needed transplantable cadaveric organs would be compulsory. OPO staffs would no longer have to discuss organ procurement from potential donors with family members or other surrogates. An alternative form of donation consent is mandated choice, which requires each individual to decide in advance either to agree to organ donation or to refuse it. Mandated choice is the IOM's least favorite option because it would require extensive public informational programs on organ donation to facilitate individual choices and decision making (Table 2).8

End‐of‐Life Care

Quality of end‐of‐life (EOL) care for an organ donor, as for any individual whose treatment is being withdrawn, is considered the highest priority of care and must not be compromised by the donation process. Yet no studies have investigated the impact of organ donation on the quality of EOL care in NHBOD.35 Previous reports have criticized the quality of EOL care offered to dying patients in intensive care units (ICUs).39, 40 Many of these patients are undergoing withdrawal of life support in anticipation of death and are considered candidates for NHBOD. The Robert Wood Johnson Foundation (RWJF) Critical Care End‐Of‐Life Peer Workgroup developed 53 EOL quality indicators to standardize and measure the quality of EOL care.41 These quality indicators, organized in 7 domains, focus on delivering patient‐ and family‐centered care and facilitating a good death experience in the ICU (Table 3).

In a subsequent U.S. survey, the Critical Care Peer Workgroup of the Promoting Excellence in End‐of‐Life Care Project reported that more than 75% of ICUs were still not monitoring the quality of EOL care.42 The survey also identified multiple barriers to optimal EOL care found in most ICUs. The study group proposed several strategies to overcome these barriers and improve the quality of EOL care (Table 3).42, 43 It can also be inferred from the survey findings that most ICUs are unprepared and lack the necessary tools to appropriately inform patients and families of the trade‐off in EOL care for NHBOD. The President's Council for Bioethics has also warned that NHBOD can transform EOL care from a peaceful dignified death into a profanely high‐tech death experience for donors' families.10

Several aspects of medical care that are neither palliative nor beneficial are performed for donor management for NHBOD and can explain the feared transformation of the death experience. The revised UAGA reaffirms that all measures necessary to ensure the medical suitability of an organ for transplantation cannot be withheld or withdrawn from the prospective donor and overrides the expression of intent by a prospective donor in either a declaration or advance health‐care directive not to have life prolonged by use of life support systems (Table 1).9 The 2007 amendment to revised UAGA section 21 recognizes the conflict between all measures necessary to ensure organs viability for transplantation and appropriate EOL care and requires the attending physician and OPO to resolve the conflict with the prospective donor or surrogate decision‐maker.9

OPOs apply donor management critical pathways to potential organ donors in order to maintain organ viability for successful execution of organ procurement.36 The University of Wisconsin developed a protocol and an evaluation tool to determine the eligibility of potential candidates for NHBOD.44 The protocol entails temporary discontinuation of mechanical ventilation for a trial of spontaneous respiration lasting up to 10 minutes to determine the likelihood of cardiorespiratory death within 60‐90 minutes of the withdrawal of life support. Those patients predicted by the University of Wisconsin evaluation tool to survive a longer time are not candidates for NHBOD and are transferred to palliative care. Those patients who meet the necessary criteria of the University of Wisconsin evaluation tool become candidates for NHBOD and undergo additional antemortem testing, invasive vascular instrumentation, and infusion of medications essential for organ preservation.36 The instrumentation and medications used for organ preservation can also expedite death on withdrawal of life support.45 Other interventions (such as circulatory support with invasive and noninvasive devices, extracorporeal perfusion and oxygenation, endotracheal reintubation, mechanical ventilation, and bronchoscopy) are performed when cardiorespiratory death is pronounced in order to maintain organ viability and can inadvertently reanimate the donor during the procurement process.26

The process of obtaining donation consent and subsequent donor management protocols for NHBOD deviate from more than 60% of the RWJF quality indicators recommended for optimal EOL care.35, 36, 41 Therefore, NHBOD can have a profound impact on the quality of EOL care. There has been a recent proposal to abbreviate the original RWJF quality indicators to include 14 of the 53 (26%) original quality indicators described for optimal EOL care in the ICU (Table 3).46 Many of the quality indicators expected to be negatively affected by NHBOD are not included in the proposal for an abbreviated list. There has been a concern that the application of an abbreviated rather than a comprehensive metrics for EOL care can portray an incomplete assessment and perhaps misinform donors and their families about the potential trade‐off in EOL care. The President's Council on Bioethics has emphasized that comprehensive evaluation of the quality of EOL care is an ethical imperative so that families can decide if the trade‐off is acceptable for organ donation.10 Deciding to donate organs at the end of life can be stressful for many families, and therefore they must be fully informed of the possible consequences. Posttraumatic stress disorders, anxiety, depression, and decreased quality of life have been reported in the deceased's family members who shared in stressful EOL decisions.47 Posttraumatic stress disorders have been reported in family members of deceased organ donors.48 Organ‐focused behavior by professionals requesting consent for organ donation and ambivalent decision making by family members appeared to increase the risk of relatives of deceased donors subsequently developing traumatic memories and stress disorders. The processes required for successful accomplishment of donation consent and subsequent organ recovery can interfere with many of the interventions that lessen the burden of bereavement of relatives of ICU decedents.49

The variability in decision making by health care providers about medical futility and EOL care has been given as a reason for concern about the implementation of NHBOD.50 The variability of EOL practice raises the possibility of conflicted decision making on medical futility within institutions that have transplant programs.50 Ethical conflicts and moral distress have been reported among health care providers who were directly involved in organ procurement in NHBOD.51 The pressure to recover transplantable organs from NHBOD candidates has been associated with health care professionals' perception of euthanasia and premature determination of medical futility and withdrawal of life support. The long‐term psychological impact of NHBOD practice on caregivers, health care providers, and professionals remains unknown.

CONCLUSIONS

In conclusion, NHBOD influences medical care at critical time points to maximize the procurement of transplantable organs and minimize their warm ischemia time with negative consequences on the EOL care for the prospective donors and their families (see Figure 1).

Figure 1

Mandatory implementation of NHBOD in the face of difficulties surrounding the quality of EOL care for donors raises concern across the medical profession and community. There is a need for better scientific validation of the timing of organ procurement to ensure that organ recovery is not the irreversible event defining death in NHBOD. The desire of OPOs or their affiliates to maximize recovery of transplantable organs introduces self‐serving bias into obtaining consent for organ donation and violates the basic tenet of true informed consent. The use of comprehensive quality indicators of EOL care will help to determine the impact of NHBOD on donors, families, caregivers, and health care providers.

In April 2003 the Health Resources and Services Administration of the U.S. Department of Health and Human Services (DHHS) announced the formation of the Organ Donation Breakthrough Collaborative (ODBC).1 The Organ Donation Breakthrough Collaborative created 58 national donation service areas (DSAs) to organize the transplant community across the United States. Each of the 58 organ procurement organizations (OPOs) is joined to a regional transplant center or centers and donor hospitals to form a DSA. The ODBC's goal is to achieve a cadaveric organ donation rate of 75% or higher from hospitals within each DSA.2

A requirement for organ donation from patients facing imminent or cardiac death has been introduced to increase the supply of transplantable organs and shorten the waiting time for transplantation candidates.35 This type of organ donation represents a significant source of organs required for future expansion of transplantation practice in the United States. The requirement for donation in imminent or cardiac death is implemented through the collaboration of the Advisory Committee on Organ Transplantation of the DHHS (Table 1), the Centers for Medicare & Medicaid Services (CMS), and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).3, 57 The organ donor pool of those facing imminent or cardiac death has also been expanded to include neurologically intact patients who may not fulfill brain death criteria before withdrawal of life support.4, 8, 9

The President's Council on Bioethics independently evaluated the issues surrounding deceased organ donation and procurement.10 The President's Council on Bioethics has expressed major concerns about several issues pertinent to cardiac or imminent death organ donation that have not been addressed explicitly by the bodies that have made recommendations for reforming or expanding that type of organ donation in the United States. The debate on organ procurement in imminent or cardiac death has come to the forefront because of doubts about its ethical appropriateness and acceptance within the medical profession and the community at large. This review focuses on the serious issues related to organ procurement from patients facing imminent or cardiac death.

Organ Procurement and the Dead Donor Rule

Organ procurement is only permitted when the donor is already dead (ie, the dead donor rule), and the act of organ recovery cannot have been the immediate act to cause that death.10, 11 There are 2 criteria for death as defined in the Uniform Determination of Death Act (UDDA; Table 1): an individual who has sustained irreversible cessation of either (1) circulatory and respiratory functions or (2) all functions of the entire brain, including the brain stem, is considered dead and this determination of death must have been made in accordance with accepted medical standards.12 When organs are procured from an individual in whom all brain function has ceased but normal cardiac pump activity is continuing, it is referred to as heart‐beating organ donation. Organ procurement after cessation of cardiac pump activity and cardiorespiratory functions is referred to as non‐heart‐beating organ donation (NHBOD). Organ procurement from an individual in imminent or cardiac death is considered NHBOD.

Non‐heart‐beating organ donors can be neurologically intact and do not fulfill the brain death criterion prior to cessation of cardiac pump activity. In response to this dilemma, the University of Pittsburgh Medical Centre developed a protocol for donation of organs that permitted their procurement from patients who were pulseless and apneic for 2 minutes and did not fulfill brain criteria and who had previously given consent for organ donation.13 Because it is uncertain if cessation of cardiorespiratory function is irreversible after only a short time, the Institute of Medicine (IOM) extended the time required for pulselessness and apnea from 2 to 5 minutes before permitting organ procurement.14 Waiting longer than 5 minutes for the determination of death would compromise the quality of procured organs because of warm ischemia time and would influence the functioning of grafts in transplant recipients.

One of the pivotal assumptions for NHBOD acceptance is that 5 minutes of pulselessness and apnea eliminates the possibility that the procurement process itself could be the cause of death and fulfills the dead donor rule.14, 15 The cardiorespiratory death criteria were derived from observations that did not evaluate delayed autoresuscitation (spontaneous return of circulation) or simultaneous cessation of brain electrical activity (as recorded in brain death).1618 The death criteria applied for organ procurement must also comply with the irreversibility requirement of the UDDA.11, 12

The true incidence, temporal characteristics, and predictors of autoresuscitation in humans remain unknown because of underreporting in the literature. However, there have been case reports of autoresuscitation with return of neurologic function (also called the Lazarus phenomenon) after 10 minutes of cardiac asystole.19, 20 Maleck et al. and Adhiyaman et al. described autoresuscitation 5 minutes or longer after cardiorespiratory arrest in 44% and 50% of the published case reports, respectively.19, 20 Although cardiac asystole leads to the loss of arterial pulse pressure, circulatory arterial mean pressure is maintained in diastole by arteriolar vasomotor tone. The relaxation (diastole) phase systemic arterial to venous pressure gradient provides the perfusion pressure for vital organs and the spontaneous return of circulation after circulatory arrest.21 It is likely that autoresuscitation occurs because of the persistence of circulatory vasomotor tone after cessation of cardiac function. The time course of systemic vascular tone after circulatory arrest has not been well characterized in humans. However, the IOM criteria did not account for the incidence of delayed autoresuscitation in humans even though the Maastricht protocol (developed by the University of Zurich, Zurich, Switzerland) acknowledged this phenomenon and required at least 10 minutes to elapse after cardiorespiratory arrest before starting organ procurement.22 The 10‐minute waiting time did not compromise the quality of the organs procured.

The cardiorespiratory death criteria for organ procurement also ignore cardiac electrical activity (such as pulseless electrical activity or ventricular fibrillation) on an electrocardiogram. Research with cardiac ultrasonography and indwelling arterial catheters confirms that pulseless cardiac electrical activity can be associated with cardiac mechanical contractions, although these contractions are too weak to be detected by blood pressure monitoring.23 The presence of cardiac electrical activity on an electrocardiogram can also increase the likelihood that delayed autoresuscitation will occur.19, 20 Furthermore, whether there is brain electrical activity or neurologic function when cardiac electrical activity is still observed on an electrocardiogram remains unknown.24 It can be argued that donors who have already suffered severe neurologic injury cannot have meaningful neurologic function at the time of cardiorespiratory death. However, the presence of brain activity becomes relevant for organ donors with intact neurologic and brain function prior to cardiorespiratory arrest when only cardiorespiratory criteria for organ procurement are being used.4, 8, 9

In situ circulatory support with extracorporeal perfusion in organ donors has also refuted that cardiorespiratory arrest for 5 minutes fulfills the UDDA requirement because reversibility can occur during the procurement process. In situ extracorporeal perfusion is initiated 5 minutes after cardiorespiratory arrest of donors in order to preserve organs for procurement.25 Coronary and cerebral reperfusion can lead to the return of cardiac and neurologic functions (also called reanimation) of donors during the procurement process. Mechanical occlusion of the aortic arch and pharmacological agents are required to suppress donor reanimation during organ procurement.26 Martin et al. documented that in situ extracorporeal perfusion returned full neurologic and cardiac function 25 minute after cardiorespiratory arrest that occurred outside the hospital.27 Similar observations of full neurologic recovery and survival to hospital discharge were reported after in situ extracorporeal perfusion for in‐hospital cardiorespiratory arrest.28 These observations confirm that the time required for irreversible loss of neurologic function after cessation of circulation is much longer than the 25 minutes of cardiorespiratory arrest required to begin the process of organ procurement in NHBOD.

The incidence of donor reanimation during procurement is unknown because its reporting violates the dead donor rule and can create legal concerns.11 It can be argued that reanimation of organ donors is irrelevant because it does not mean survival. However, the occurrence of reanimation invalidates the premise that the cardiorespiratory criteria for organ procurement comply with the uniform determination of death. Others have accepted the inaccuracy of these criteria for determining death for procurement of organs from deceased donors and proposed abandoning the dead donor rule in order to permit recovery of transplantable organs before death.29

In the face of the uncertainty in determining death and in response to a media and marketing campaign by organ procurement organizations (OPOs) to promote public enrollment in deceased organ donation, the transplant community renamed NHBOD cardiac death organ donation.30, 31 The use of the term cardiac death is scientifically inaccurate and perhaps misleading. This term is used to denote the cessation of circulation and cardiac pump activity. The term cardiac death can be misinterpreted as meaning the heart has irreversibly ceased at the time of procurement, thus contradicting the scientific evidence for spontaneous resumption of cardiac function and autoresuscitation.19, 20 Alternatively, the use of this term can falsely imply that neurologic activity or brain stem function has ceased irreversibly after loss of cardiac activity, when scientific evidence suggests that brain stem function can remain after cardiac arrest.32

Consent for Organ Donation

Several state laws and federal regulations have been enacted to ensure that organ donation and transplantation practice comply with the ethical and legal standards of society (Table 1). The current regulations require hospitals across the United States to provde regional OPOs with early notification of all patients whose deaths are imminent before life support has been withdrawn so that discussion of organ donation with surrogate decision makers can be initiated independently and consent obtained.3, 5, 9 The Organ Donation Breakthrough Collaborative has set a goal of each OPO accomplishing a target organ donation rate of 75% or higher at local hospitals within an assigned donation service area (DSA).1, 2, 5 The financial and administrative incentives for the OPO to achieve that target organ donation rate have introduced undisclosed conflict within the donation consent process.33 Self‐serving bias of OPOs can influence whether pertinent information necessary for surrogate decision makers to provide informed consent is disclosed.34 As an example of this bias, alternative options for care and palliation may be discussed with surrogate decision makers with less enthusiasm than are the benefits and altruistic notion of organ donation. In obtaining donation consent, OPOs often avoid disclosing details of perimortem interventions performed on donors that are required for successful procurement of transplantable organs.10, 34, 35 After receiving consent for organ donation, OPO staffs also assume the responsibility of planning donor medical care and treatment pathways essential for maintaining organ viability and of preparing for subsequent procurement.5, 36 In essence, the care of the dying patient is guided by a team whose primary interest is the preservation of organs until procurement has been accomplished.

The Uniform Anatomical Gift Act (UAGA) assigns explicit priority to the donor's expressed intent so that consent for organ donation becomes irrevocable and does not require the consent or concurrence of any person after the donor's death (Table 1).9, 37 The donor's authorization to donate, recorded on an organ donor card, the individual's driver's license, or a donor registry, becomes a legally binding advance directive. The UAGA amendment enables OPOs to procure organs without family consent and in certain instances after family refusal to donate.37

Other consent options for organ donation from deceased donors have been proposed to maximize OPO recovery of transplantable organs in the United States (Table 2).8 The IOM has considered presumed consent for organ donation as a favorable option.8 Presumed consent means the default option is consent to donation, that if an individual has not expressly rejected donation, that individual is considered to have consented to organ donation. Legislative enactment of presumed consent enables OPOs to avoid the potential for surrogates to deny consent for donation, thus increasing the pool of future organ donors. The revised UAGA replaces nondonation with the intent to donate organs as the default option. In the default option, all measures necessary to ensure the medical suitability of an organ for transplantation can not be withheld or withdrawn until the OPO has determined medical suitability of the individual as a prospective donor (Table 1). The default option overrides the expression of intent in a declaration or advance health‐care directives not to have life prolonged by withholding or withdrawing life support system unless the individual has expressed refusal of donation (Tables 1 and 2). The revised UAGA presumes that for prospective donors the desire to save lives by making an anatomical gift trumps the desire to have life support systems withheld or withdrawn. Mandated consent (or conscription) has also been proposed for recovery of cadaveric organs (Table 2).38 Under mandated consent, consent for organ donation is automatic from all deceased individuals; therefore, OPOs would not require or request consent because removal of all needed transplantable cadaveric organs would be compulsory. OPO staffs would no longer have to discuss organ procurement from potential donors with family members or other surrogates. An alternative form of donation consent is mandated choice, which requires each individual to decide in advance either to agree to organ donation or to refuse it. Mandated choice is the IOM's least favorite option because it would require extensive public informational programs on organ donation to facilitate individual choices and decision making (Table 2).8

End‐of‐Life Care

Quality of end‐of‐life (EOL) care for an organ donor, as for any individual whose treatment is being withdrawn, is considered the highest priority of care and must not be compromised by the donation process. Yet no studies have investigated the impact of organ donation on the quality of EOL care in NHBOD.35 Previous reports have criticized the quality of EOL care offered to dying patients in intensive care units (ICUs).39, 40 Many of these patients are undergoing withdrawal of life support in anticipation of death and are considered candidates for NHBOD. The Robert Wood Johnson Foundation (RWJF) Critical Care End‐Of‐Life Peer Workgroup developed 53 EOL quality indicators to standardize and measure the quality of EOL care.41 These quality indicators, organized in 7 domains, focus on delivering patient‐ and family‐centered care and facilitating a good death experience in the ICU (Table 3).

In a subsequent U.S. survey, the Critical Care Peer Workgroup of the Promoting Excellence in End‐of‐Life Care Project reported that more than 75% of ICUs were still not monitoring the quality of EOL care.42 The survey also identified multiple barriers to optimal EOL care found in most ICUs. The study group proposed several strategies to overcome these barriers and improve the quality of EOL care (Table 3).42, 43 It can also be inferred from the survey findings that most ICUs are unprepared and lack the necessary tools to appropriately inform patients and families of the trade‐off in EOL care for NHBOD. The President's Council for Bioethics has also warned that NHBOD can transform EOL care from a peaceful dignified death into a profanely high‐tech death experience for donors' families.10

Several aspects of medical care that are neither palliative nor beneficial are performed for donor management for NHBOD and can explain the feared transformation of the death experience. The revised UAGA reaffirms that all measures necessary to ensure the medical suitability of an organ for transplantation cannot be withheld or withdrawn from the prospective donor and overrides the expression of intent by a prospective donor in either a declaration or advance health‐care directive not to have life prolonged by use of life support systems (Table 1).9 The 2007 amendment to revised UAGA section 21 recognizes the conflict between all measures necessary to ensure organs viability for transplantation and appropriate EOL care and requires the attending physician and OPO to resolve the conflict with the prospective donor or surrogate decision‐maker.9

OPOs apply donor management critical pathways to potential organ donors in order to maintain organ viability for successful execution of organ procurement.36 The University of Wisconsin developed a protocol and an evaluation tool to determine the eligibility of potential candidates for NHBOD.44 The protocol entails temporary discontinuation of mechanical ventilation for a trial of spontaneous respiration lasting up to 10 minutes to determine the likelihood of cardiorespiratory death within 60‐90 minutes of the withdrawal of life support. Those patients predicted by the University of Wisconsin evaluation tool to survive a longer time are not candidates for NHBOD and are transferred to palliative care. Those patients who meet the necessary criteria of the University of Wisconsin evaluation tool become candidates for NHBOD and undergo additional antemortem testing, invasive vascular instrumentation, and infusion of medications essential for organ preservation.36 The instrumentation and medications used for organ preservation can also expedite death on withdrawal of life support.45 Other interventions (such as circulatory support with invasive and noninvasive devices, extracorporeal perfusion and oxygenation, endotracheal reintubation, mechanical ventilation, and bronchoscopy) are performed when cardiorespiratory death is pronounced in order to maintain organ viability and can inadvertently reanimate the donor during the procurement process.26

The process of obtaining donation consent and subsequent donor management protocols for NHBOD deviate from more than 60% of the RWJF quality indicators recommended for optimal EOL care.35, 36, 41 Therefore, NHBOD can have a profound impact on the quality of EOL care. There has been a recent proposal to abbreviate the original RWJF quality indicators to include 14 of the 53 (26%) original quality indicators described for optimal EOL care in the ICU (Table 3).46 Many of the quality indicators expected to be negatively affected by NHBOD are not included in the proposal for an abbreviated list. There has been a concern that the application of an abbreviated rather than a comprehensive metrics for EOL care can portray an incomplete assessment and perhaps misinform donors and their families about the potential trade‐off in EOL care. The President's Council on Bioethics has emphasized that comprehensive evaluation of the quality of EOL care is an ethical imperative so that families can decide if the trade‐off is acceptable for organ donation.10 Deciding to donate organs at the end of life can be stressful for many families, and therefore they must be fully informed of the possible consequences. Posttraumatic stress disorders, anxiety, depression, and decreased quality of life have been reported in the deceased's family members who shared in stressful EOL decisions.47 Posttraumatic stress disorders have been reported in family members of deceased organ donors.48 Organ‐focused behavior by professionals requesting consent for organ donation and ambivalent decision making by family members appeared to increase the risk of relatives of deceased donors subsequently developing traumatic memories and stress disorders. The processes required for successful accomplishment of donation consent and subsequent organ recovery can interfere with many of the interventions that lessen the burden of bereavement of relatives of ICU decedents.49

The variability in decision making by health care providers about medical futility and EOL care has been given as a reason for concern about the implementation of NHBOD.50 The variability of EOL practice raises the possibility of conflicted decision making on medical futility within institutions that have transplant programs.50 Ethical conflicts and moral distress have been reported among health care providers who were directly involved in organ procurement in NHBOD.51 The pressure to recover transplantable organs from NHBOD candidates has been associated with health care professionals' perception of euthanasia and premature determination of medical futility and withdrawal of life support. The long‐term psychological impact of NHBOD practice on caregivers, health care providers, and professionals remains unknown.

CONCLUSIONS

In conclusion, NHBOD influences medical care at critical time points to maximize the procurement of transplantable organs and minimize their warm ischemia time with negative consequences on the EOL care for the prospective donors and their families (see Figure 1).

Figure 1

Mandatory implementation of NHBOD in the face of difficulties surrounding the quality of EOL care for donors raises concern across the medical profession and community. There is a need for better scientific validation of the timing of organ procurement to ensure that organ recovery is not the irreversible event defining death in NHBOD. The desire of OPOs or their affiliates to maximize recovery of transplantable organs introduces self‐serving bias into obtaining consent for organ donation and violates the basic tenet of true informed consent. The use of comprehensive quality indicators of EOL care will help to determine the impact of NHBOD on donors, families, caregivers, and health care providers.

The adverse outcomes associated with hospitalization of older patients, such as functional decline and increased nursing home placement, have been well documented.19 Low mobility, defined as being limited to a bed or chair, has also been associated with these adverse outcomes, even after controlling for severity of illness.10 Early ambulation has been a common practice for years following many types of orthopedic operations, including hip fracture repair and total joint replacement.11, 12 A recent study demonstrated that time to ambulation after surgery was an independent predictor of the development of postoperative complications such as pneumonia and delirium.13

In the early 1980s, early ambulation became the cornerstone of cardiac rehabilitation after acute myocardial infarction.14, 15 Until recently, with the exception of postmyocardial infarction, the use of early ambulation for patients admitted with medical illnesses has not been studied. In the last few years, researchers have begun to explore the use of early ambulation for patients after cardiac catheterization and for those admitted with deep‐vein thrombosis and pneumonia.1620 Although many of these studies have been small, they have found early ambulation not to be associated with worse outcomes. Indeed, a study of early ambulation for patients with community‐acquired pneumonia demonstrated decreased hospital costs and increased functional ability prior to discharge.20

Although the literature documents the adverse consequences associated with bed rest2123 and the beneficial effects of early ambulation, patients continue to spend a significant amount of their hospital stay limited to a bed or a chair. The prevalence of low mobility in older patients ranges from 23% to 33% during hospitalization for medical illness.9, 10 Despite the high prevalence and the associated adverse outcomes of low mobility among hospitalized older adults, the factors associated with low mobility in the hospital setting have not been systematically explored. Identification of such factors is the first step toward recognizing potentially modifiable factors and developing targeted interventions to improve hospital care.

We conceptualized a variety of factors or barriers that could potentially affect the level of mobility achieved by older hospitalized patients. Using professional experience and expert opinion, a conceptual model of potential barriers to mobility was developed (Fig. 1). As Figure 1 illustrates, the model has 4 major categories: patient‐related factors, including illness severity or comorbid conditions; treatment‐related factors such as catheters and intravenous lines; institution‐related factors such as nursing‐to‐patient ratio; and attitudinal factors related to perspectives on mobility and concerns about falling. This model was reviewed and feedback provided by a multidisciplinary group of colleagues including physicians, nurses, physical therapists, medical educators, and medical sociologists.

Figure 1

The objectives of this study were to employ qualitative methodology to identify and contextualize perceived barriers to mobility during hospitalization from the perspectives of older patients, their primary nurses, and their resident physicians; to compare and contrast the perceived barriers among these 3 groups; and to compare perceived barriers to mobility with our conceptual model.

METHODS

RESULTS

Fifty‐seven patients age 75 years were admitted to the medical service during the study period. Of those, 18 were excluded because they were too ill according to their physician (n = 6), had a nonmedical illness (n = 5), were discharged before being interviewed (n = 3), or were being cared for by a previously enrolled nurse or physician (n = 4). Of the 39 who were eligible for the study, 7 declined participation (6 patients, 1 physician), and data were lost for 3 as a result of technical difficulties with the tape recorder. A total of 29 participants had an interview transcribed: 10 patients, 10 nurses, and 9 physicians. As in other qualitative inquiries, data saturation was achieved after about 10 interviews,27 but we continued recruitment to permit comparison of themes identified by patients, nurses, and physicians.

Table 1 presents baseline characteristics of the patients. The mean age of the nurses was 34.9 9.9 years, all were female, and 60% were black. The mean age of the resident physicians was 29.1 2.2 years; 44% were female; and 78% were white, 22% were Latino, and none were black.

Figure 2 presents barriers most frequently noted by participants. These barriers were similar among the 3 groups for symptoms and hospital‐related factors like catheters and lack of staff. Lack of patient motivation, lack of ambulatory devices, and medical reasons necessitating bed rest were reported more frequently by health care providers than by patients. On admission, 40% of patients had bed rest ordered. By hospital day 3, all patients had out‐of‐bed orders, and 70% had had physical therapy ordered.

Figure 2

DISCUSSION

Many of the barriers described in the original conceptual model (Fig. 1) were cited by participants from all 3 groups: patients, nurses and physicians. These included patient‐related factors like symptoms and need for assistance, concern about falls, and lack of staff to assist with ambulation. Although attitudes toward mobility were cited in the model and by participants, there was significant disagreement between the 3 groups about the cause of the attitudinal barrier. Health care providers cited lack of patient motivation, whereas patients perceived health care providers as not being interested in mobility or viewing it as important. Health care providers frequently employed stereotypes to describe the potential reasons for the perceived attitudes toward mobility, often linking lack of motivation or interest in getting out of bed to patients being old. Patients linked the lack of importance attached to mobility to the numerous duties of staff members and believed that assistance with mobility was less important than other duties. Physicians and nurses were both more likely than patients to mention factors like urinary catheters, intravenous lines, and other medical reasons that necessitated bed rest. Although more than half the nurses commented on the lack of ambulatory devices for ambulation, no physicians and only 1 patient perceived this lack to be a barrier.

The model presented appears to have face validity, with participants citing many of the factors originally identified as barriers to mobility. The original model did not include consideration of environmental factors such as the number of chairs in the room or the location of the television. Such environmental factors can be conceptualized as institution‐related factors.

In addition, the impact of physician activity orders for bed rest was not specifically discussed by participants, although 45% of participants did comment on the need for bed rest because of a medical condition. A review of the medical records for activity orders indicated 40% of the patients initially had orders for bed rest. Another recent study demonstrated 33% of older patients were on bed rest at some point during their hospital stay10 and should be retained in the model as a treatment‐related consideration.

Several barriers noted in the original model and by participants may not be modifiable, such as comorbid conditions and illness severity. But other perceived barriers may be, and recognition of these factors present potential targets for a future multicomponent intervention to enhance hospital mobility. This multicomponent approach has been highly successful for geriatric syndromes like falls28 and delirium.29

During hospitalization, a focus on early removal of catheters and intravenous lines may encourage mobility. In a recent study absence of a urinary catheter was a predictor of patients with activity limitations regaining ambulatory ability while hospitalized.30 Availability of ambulatory devices may allow nurses to ambulate patients without consulting physical therapy. Another potential solution would be a hospitalwide walking program. The feasibility of a walking program was demonstrated in a small pilot study at a community‐based hospital using specially trained transporters to walk ward patients during slow periods. These periods included nights and weekends, when patients were more likely to be available and when physical therapy was often not present. On average, participants spent 2.4 days in the program, with an average of 5.6 walks per patient. However, additional research is needed, as the study was too small to demonstrate the effects of the walking program on length of stay or functional decline.31

Other barriers, while potentially modifiable, may be more difficult to address and may involve changing the culture of the hospital. For instance, concern about falls was a common theme, echoed by all 3 groups. Physicians were the most likely to spontaneously mention falls as a concern. The nurses shared this concern, frequently citing the use of bed rails as a part of their fall protocol, despite available literature demonstrating that this approach was not efficacious.3234 Nurses also consistently reported asking patients to call for help to ambulate, yet both patients and nurses noted a lack of nursing time to assist with ambulation. The default solution providers reported using was utilizing physical therapists, who were available to walk with patients only once or twice a day. Research on the best methods to prevent falls during hospitalization is limited. Given the current medicolegal environment and the emphasis on fall prevention by the Joint Commission on Accreditation of Healthcare Organizations and other government entities, it is not surprising that bed rest and mobility limitation are being used as a method of minimizing falls. Until data about successful fall‐prevention strategies are available, minimization of mobility may remain the default solution.

Strengths of the present study include the use of qualitative methods to explore potential barriers to mobility, a method that allows participants to describe in their own words their attitudes, beliefs, and expectations about mobility during hospitalization. Face‐to‐face interviewing of the 3 major groups involved in the hospital experience (patients, nurses, and physicians) facilitated the collection of detailed contextualized information on factors expected to affect a patient's level of mobility during hospitalization. This enabled hypothesis generation and sensitization to issues that need further quantitative investigation with larger groups.

The study also had several limitations. First, only resident physicians were included, and their answers may not reflect the opinions of other, more experienced physicians. However, resident physicians were chosen for this study because they play important roles in delivering hands‐on care in teaching hospitals and would need to be involved in any future interventions designed to enhanced patient mobility. Second, a sample size of 29 participants, approximately 10 persons in each group, may not reflect the thinking of those throughout the hospital. However, sampling was continued until no new themes or barriers emerged, and major themes emerged consistently throughout the interviews with all 3 groups. Interviews were conducted at a large, urban university hospital, and so results may not be generalizable to smaller community hospitals. Last, although the 3 major groupspatients, nurses, and physicianswere included in the interviews, the opinions of other stakeholders who may have had perspectives on mobility such as family members were not solicited and may need to be incorporated into the model.

This study presents the perceived barriers to mobility from the perspectives of patients their nurses and physicians. The modifiable and nonmodifiable factors that might affect mobility during hospitalization that made up the original theoretical model were consistent with the barriers cited by the participants. Importantly, this research has led to the identification of other barriers such as environmental factors that may also influence the mobility of older patients. This research has provided insights into potentially modifiable factors of the well‐documented phenomenon of low mobility of hospitalized older persons10 and identified several targets for a multicomponent intervention to minimize low mobility. Possible interventions include a progressive walking program initiated early in the hospital stay, provision of assistive devices to patients who need them, and early removal of catheters and intravenous lines. Further research is needed to explore other factors associated with low mobility, such as specific medical conditions for which bed rest may be ordered, and to evaluate the impact that specific interventions may have on the mobility of older persons during hospitalization.

The adverse outcomes associated with hospitalization of older patients, such as functional decline and increased nursing home placement, have been well documented.19 Low mobility, defined as being limited to a bed or chair, has also been associated with these adverse outcomes, even after controlling for severity of illness.10 Early ambulation has been a common practice for years following many types of orthopedic operations, including hip fracture repair and total joint replacement.11, 12 A recent study demonstrated that time to ambulation after surgery was an independent predictor of the development of postoperative complications such as pneumonia and delirium.13

In the early 1980s, early ambulation became the cornerstone of cardiac rehabilitation after acute myocardial infarction.14, 15 Until recently, with the exception of postmyocardial infarction, the use of early ambulation for patients admitted with medical illnesses has not been studied. In the last few years, researchers have begun to explore the use of early ambulation for patients after cardiac catheterization and for those admitted with deep‐vein thrombosis and pneumonia.1620 Although many of these studies have been small, they have found early ambulation not to be associated with worse outcomes. Indeed, a study of early ambulation for patients with community‐acquired pneumonia demonstrated decreased hospital costs and increased functional ability prior to discharge.20

Although the literature documents the adverse consequences associated with bed rest2123 and the beneficial effects of early ambulation, patients continue to spend a significant amount of their hospital stay limited to a bed or a chair. The prevalence of low mobility in older patients ranges from 23% to 33% during hospitalization for medical illness.9, 10 Despite the high prevalence and the associated adverse outcomes of low mobility among hospitalized older adults, the factors associated with low mobility in the hospital setting have not been systematically explored. Identification of such factors is the first step toward recognizing potentially modifiable factors and developing targeted interventions to improve hospital care.

We conceptualized a variety of factors or barriers that could potentially affect the level of mobility achieved by older hospitalized patients. Using professional experience and expert opinion, a conceptual model of potential barriers to mobility was developed (Fig. 1). As Figure 1 illustrates, the model has 4 major categories: patient‐related factors, including illness severity or comorbid conditions; treatment‐related factors such as catheters and intravenous lines; institution‐related factors such as nursing‐to‐patient ratio; and attitudinal factors related to perspectives on mobility and concerns about falling. This model was reviewed and feedback provided by a multidisciplinary group of colleagues including physicians, nurses, physical therapists, medical educators, and medical sociologists.

Figure 1

The objectives of this study were to employ qualitative methodology to identify and contextualize perceived barriers to mobility during hospitalization from the perspectives of older patients, their primary nurses, and their resident physicians; to compare and contrast the perceived barriers among these 3 groups; and to compare perceived barriers to mobility with our conceptual model.

METHODS

RESULTS

Fifty‐seven patients age 75 years were admitted to the medical service during the study period. Of those, 18 were excluded because they were too ill according to their physician (n = 6), had a nonmedical illness (n = 5), were discharged before being interviewed (n = 3), or were being cared for by a previously enrolled nurse or physician (n = 4). Of the 39 who were eligible for the study, 7 declined participation (6 patients, 1 physician), and data were lost for 3 as a result of technical difficulties with the tape recorder. A total of 29 participants had an interview transcribed: 10 patients, 10 nurses, and 9 physicians. As in other qualitative inquiries, data saturation was achieved after about 10 interviews,27 but we continued recruitment to permit comparison of themes identified by patients, nurses, and physicians.

Table 1 presents baseline characteristics of the patients. The mean age of the nurses was 34.9 9.9 years, all were female, and 60% were black. The mean age of the resident physicians was 29.1 2.2 years; 44% were female; and 78% were white, 22% were Latino, and none were black.

Figure 2 presents barriers most frequently noted by participants. These barriers were similar among the 3 groups for symptoms and hospital‐related factors like catheters and lack of staff. Lack of patient motivation, lack of ambulatory devices, and medical reasons necessitating bed rest were reported more frequently by health care providers than by patients. On admission, 40% of patients had bed rest ordered. By hospital day 3, all patients had out‐of‐bed orders, and 70% had had physical therapy ordered.

Figure 2

DISCUSSION

Many of the barriers described in the original conceptual model (Fig. 1) were cited by participants from all 3 groups: patients, nurses and physicians. These included patient‐related factors like symptoms and need for assistance, concern about falls, and lack of staff to assist with ambulation. Although attitudes toward mobility were cited in the model and by participants, there was significant disagreement between the 3 groups about the cause of the attitudinal barrier. Health care providers cited lack of patient motivation, whereas patients perceived health care providers as not being interested in mobility or viewing it as important. Health care providers frequently employed stereotypes to describe the potential reasons for the perceived attitudes toward mobility, often linking lack of motivation or interest in getting out of bed to patients being old. Patients linked the lack of importance attached to mobility to the numerous duties of staff members and believed that assistance with mobility was less important than other duties. Physicians and nurses were both more likely than patients to mention factors like urinary catheters, intravenous lines, and other medical reasons that necessitated bed rest. Although more than half the nurses commented on the lack of ambulatory devices for ambulation, no physicians and only 1 patient perceived this lack to be a barrier.

The model presented appears to have face validity, with participants citing many of the factors originally identified as barriers to mobility. The original model did not include consideration of environmental factors such as the number of chairs in the room or the location of the television. Such environmental factors can be conceptualized as institution‐related factors.

In addition, the impact of physician activity orders for bed rest was not specifically discussed by participants, although 45% of participants did comment on the need for bed rest because of a medical condition. A review of the medical records for activity orders indicated 40% of the patients initially had orders for bed rest. Another recent study demonstrated 33% of older patients were on bed rest at some point during their hospital stay10 and should be retained in the model as a treatment‐related consideration.

Several barriers noted in the original model and by participants may not be modifiable, such as comorbid conditions and illness severity. But other perceived barriers may be, and recognition of these factors present potential targets for a future multicomponent intervention to enhance hospital mobility. This multicomponent approach has been highly successful for geriatric syndromes like falls28 and delirium.29

During hospitalization, a focus on early removal of catheters and intravenous lines may encourage mobility. In a recent study absence of a urinary catheter was a predictor of patients with activity limitations regaining ambulatory ability while hospitalized.30 Availability of ambulatory devices may allow nurses to ambulate patients without consulting physical therapy. Another potential solution would be a hospitalwide walking program. The feasibility of a walking program was demonstrated in a small pilot study at a community‐based hospital using specially trained transporters to walk ward patients during slow periods. These periods included nights and weekends, when patients were more likely to be available and when physical therapy was often not present. On average, participants spent 2.4 days in the program, with an average of 5.6 walks per patient. However, additional research is needed, as the study was too small to demonstrate the effects of the walking program on length of stay or functional decline.31

Other barriers, while potentially modifiable, may be more difficult to address and may involve changing the culture of the hospital. For instance, concern about falls was a common theme, echoed by all 3 groups. Physicians were the most likely to spontaneously mention falls as a concern. The nurses shared this concern, frequently citing the use of bed rails as a part of their fall protocol, despite available literature demonstrating that this approach was not efficacious.3234 Nurses also consistently reported asking patients to call for help to ambulate, yet both patients and nurses noted a lack of nursing time to assist with ambulation. The default solution providers reported using was utilizing physical therapists, who were available to walk with patients only once or twice a day. Research on the best methods to prevent falls during hospitalization is limited. Given the current medicolegal environment and the emphasis on fall prevention by the Joint Commission on Accreditation of Healthcare Organizations and other government entities, it is not surprising that bed rest and mobility limitation are being used as a method of minimizing falls. Until data about successful fall‐prevention strategies are available, minimization of mobility may remain the default solution.

Strengths of the present study include the use of qualitative methods to explore potential barriers to mobility, a method that allows participants to describe in their own words their attitudes, beliefs, and expectations about mobility during hospitalization. Face‐to‐face interviewing of the 3 major groups involved in the hospital experience (patients, nurses, and physicians) facilitated the collection of detailed contextualized information on factors expected to affect a patient's level of mobility during hospitalization. This enabled hypothesis generation and sensitization to issues that need further quantitative investigation with larger groups.

The study also had several limitations. First, only resident physicians were included, and their answers may not reflect the opinions of other, more experienced physicians. However, resident physicians were chosen for this study because they play important roles in delivering hands‐on care in teaching hospitals and would need to be involved in any future interventions designed to enhanced patient mobility. Second, a sample size of 29 participants, approximately 10 persons in each group, may not reflect the thinking of those throughout the hospital. However, sampling was continued until no new themes or barriers emerged, and major themes emerged consistently throughout the interviews with all 3 groups. Interviews were conducted at a large, urban university hospital, and so results may not be generalizable to smaller community hospitals. Last, although the 3 major groupspatients, nurses, and physicianswere included in the interviews, the opinions of other stakeholders who may have had perspectives on mobility such as family members were not solicited and may need to be incorporated into the model.

This study presents the perceived barriers to mobility from the perspectives of patients their nurses and physicians. The modifiable and nonmodifiable factors that might affect mobility during hospitalization that made up the original theoretical model were consistent with the barriers cited by the participants. Importantly, this research has led to the identification of other barriers such as environmental factors that may also influence the mobility of older patients. This research has provided insights into potentially modifiable factors of the well‐documented phenomenon of low mobility of hospitalized older persons10 and identified several targets for a multicomponent intervention to minimize low mobility. Possible interventions include a progressive walking program initiated early in the hospital stay, provision of assistive devices to patients who need them, and early removal of catheters and intravenous lines. Further research is needed to explore other factors associated with low mobility, such as specific medical conditions for which bed rest may be ordered, and to evaluate the impact that specific interventions may have on the mobility of older persons during hospitalization.

The adverse outcomes associated with hospitalization of older patients, such as functional decline and increased nursing home placement, have been well documented.19 Low mobility, defined as being limited to a bed or chair, has also been associated with these adverse outcomes, even after controlling for severity of illness.10 Early ambulation has been a common practice for years following many types of orthopedic operations, including hip fracture repair and total joint replacement.11, 12 A recent study demonstrated that time to ambulation after surgery was an independent predictor of the development of postoperative complications such as pneumonia and delirium.13

In the early 1980s, early ambulation became the cornerstone of cardiac rehabilitation after acute myocardial infarction.14, 15 Until recently, with the exception of postmyocardial infarction, the use of early ambulation for patients admitted with medical illnesses has not been studied. In the last few years, researchers have begun to explore the use of early ambulation for patients after cardiac catheterization and for those admitted with deep‐vein thrombosis and pneumonia.1620 Although many of these studies have been small, they have found early ambulation not to be associated with worse outcomes. Indeed, a study of early ambulation for patients with community‐acquired pneumonia demonstrated decreased hospital costs and increased functional ability prior to discharge.20

Although the literature documents the adverse consequences associated with bed rest2123 and the beneficial effects of early ambulation, patients continue to spend a significant amount of their hospital stay limited to a bed or a chair. The prevalence of low mobility in older patients ranges from 23% to 33% during hospitalization for medical illness.9, 10 Despite the high prevalence and the associated adverse outcomes of low mobility among hospitalized older adults, the factors associated with low mobility in the hospital setting have not been systematically explored. Identification of such factors is the first step toward recognizing potentially modifiable factors and developing targeted interventions to improve hospital care.

We conceptualized a variety of factors or barriers that could potentially affect the level of mobility achieved by older hospitalized patients. Using professional experience and expert opinion, a conceptual model of potential barriers to mobility was developed (Fig. 1). As Figure 1 illustrates, the model has 4 major categories: patient‐related factors, including illness severity or comorbid conditions; treatment‐related factors such as catheters and intravenous lines; institution‐related factors such as nursing‐to‐patient ratio; and attitudinal factors related to perspectives on mobility and concerns about falling. This model was reviewed and feedback provided by a multidisciplinary group of colleagues including physicians, nurses, physical therapists, medical educators, and medical sociologists.

Figure 1

The objectives of this study were to employ qualitative methodology to identify and contextualize perceived barriers to mobility during hospitalization from the perspectives of older patients, their primary nurses, and their resident physicians; to compare and contrast the perceived barriers among these 3 groups; and to compare perceived barriers to mobility with our conceptual model.

METHODS

RESULTS

Fifty‐seven patients age 75 years were admitted to the medical service during the study period. Of those, 18 were excluded because they were too ill according to their physician (n = 6), had a nonmedical illness (n = 5), were discharged before being interviewed (n = 3), or were being cared for by a previously enrolled nurse or physician (n = 4). Of the 39 who were eligible for the study, 7 declined participation (6 patients, 1 physician), and data were lost for 3 as a result of technical difficulties with the tape recorder. A total of 29 participants had an interview transcribed: 10 patients, 10 nurses, and 9 physicians. As in other qualitative inquiries, data saturation was achieved after about 10 interviews,27 but we continued recruitment to permit comparison of themes identified by patients, nurses, and physicians.

Table 1 presents baseline characteristics of the patients. The mean age of the nurses was 34.9 9.9 years, all were female, and 60% were black. The mean age of the resident physicians was 29.1 2.2 years; 44% were female; and 78% were white, 22% were Latino, and none were black.

Figure 2 presents barriers most frequently noted by participants. These barriers were similar among the 3 groups for symptoms and hospital‐related factors like catheters and lack of staff. Lack of patient motivation, lack of ambulatory devices, and medical reasons necessitating bed rest were reported more frequently by health care providers than by patients. On admission, 40% of patients had bed rest ordered. By hospital day 3, all patients had out‐of‐bed orders, and 70% had had physical therapy ordered.

Figure 2

DISCUSSION

Many of the barriers described in the original conceptual model (Fig. 1) were cited by participants from all 3 groups: patients, nurses and physicians. These included patient‐related factors like symptoms and need for assistance, concern about falls, and lack of staff to assist with ambulation. Although attitudes toward mobility were cited in the model and by participants, there was significant disagreement between the 3 groups about the cause of the attitudinal barrier. Health care providers cited lack of patient motivation, whereas patients perceived health care providers as not being interested in mobility or viewing it as important. Health care providers frequently employed stereotypes to describe the potential reasons for the perceived attitudes toward mobility, often linking lack of motivation or interest in getting out of bed to patients being old. Patients linked the lack of importance attached to mobility to the numerous duties of staff members and believed that assistance with mobility was less important than other duties. Physicians and nurses were both more likely than patients to mention factors like urinary catheters, intravenous lines, and other medical reasons that necessitated bed rest. Although more than half the nurses commented on the lack of ambulatory devices for ambulation, no physicians and only 1 patient perceived this lack to be a barrier.

The model presented appears to have face validity, with participants citing many of the factors originally identified as barriers to mobility. The original model did not include consideration of environmental factors such as the number of chairs in the room or the location of the television. Such environmental factors can be conceptualized as institution‐related factors.

In addition, the impact of physician activity orders for bed rest was not specifically discussed by participants, although 45% of participants did comment on the need for bed rest because of a medical condition. A review of the medical records for activity orders indicated 40% of the patients initially had orders for bed rest. Another recent study demonstrated 33% of older patients were on bed rest at some point during their hospital stay10 and should be retained in the model as a treatment‐related consideration.

Several barriers noted in the original model and by participants may not be modifiable, such as comorbid conditions and illness severity. But other perceived barriers may be, and recognition of these factors present potential targets for a future multicomponent intervention to enhance hospital mobility. This multicomponent approach has been highly successful for geriatric syndromes like falls28 and delirium.29

During hospitalization, a focus on early removal of catheters and intravenous lines may encourage mobility. In a recent study absence of a urinary catheter was a predictor of patients with activity limitations regaining ambulatory ability while hospitalized.30 Availability of ambulatory devices may allow nurses to ambulate patients without consulting physical therapy. Another potential solution would be a hospitalwide walking program. The feasibility of a walking program was demonstrated in a small pilot study at a community‐based hospital using specially trained transporters to walk ward patients during slow periods. These periods included nights and weekends, when patients were more likely to be available and when physical therapy was often not present. On average, participants spent 2.4 days in the program, with an average of 5.6 walks per patient. However, additional research is needed, as the study was too small to demonstrate the effects of the walking program on length of stay or functional decline.31

Other barriers, while potentially modifiable, may be more difficult to address and may involve changing the culture of the hospital. For instance, concern about falls was a common theme, echoed by all 3 groups. Physicians were the most likely to spontaneously mention falls as a concern. The nurses shared this concern, frequently citing the use of bed rails as a part of their fall protocol, despite available literature demonstrating that this approach was not efficacious.3234 Nurses also consistently reported asking patients to call for help to ambulate, yet both patients and nurses noted a lack of nursing time to assist with ambulation. The default solution providers reported using was utilizing physical therapists, who were available to walk with patients only once or twice a day. Research on the best methods to prevent falls during hospitalization is limited. Given the current medicolegal environment and the emphasis on fall prevention by the Joint Commission on Accreditation of Healthcare Organizations and other government entities, it is not surprising that bed rest and mobility limitation are being used as a method of minimizing falls. Until data about successful fall‐prevention strategies are available, minimization of mobility may remain the default solution.

Strengths of the present study include the use of qualitative methods to explore potential barriers to mobility, a method that allows participants to describe in their own words their attitudes, beliefs, and expectations about mobility during hospitalization. Face‐to‐face interviewing of the 3 major groups involved in the hospital experience (patients, nurses, and physicians) facilitated the collection of detailed contextualized information on factors expected to affect a patient's level of mobility during hospitalization. This enabled hypothesis generation and sensitization to issues that need further quantitative investigation with larger groups.

The study also had several limitations. First, only resident physicians were included, and their answers may not reflect the opinions of other, more experienced physicians. However, resident physicians were chosen for this study because they play important roles in delivering hands‐on care in teaching hospitals and would need to be involved in any future interventions designed to enhanced patient mobility. Second, a sample size of 29 participants, approximately 10 persons in each group, may not reflect the thinking of those throughout the hospital. However, sampling was continued until no new themes or barriers emerged, and major themes emerged consistently throughout the interviews with all 3 groups. Interviews were conducted at a large, urban university hospital, and so results may not be generalizable to smaller community hospitals. Last, although the 3 major groupspatients, nurses, and physicianswere included in the interviews, the opinions of other stakeholders who may have had perspectives on mobility such as family members were not solicited and may need to be incorporated into the model.

This study presents the perceived barriers to mobility from the perspectives of patients their nurses and physicians. The modifiable and nonmodifiable factors that might affect mobility during hospitalization that made up the original theoretical model were consistent with the barriers cited by the participants. Importantly, this research has led to the identification of other barriers such as environmental factors that may also influence the mobility of older patients. This research has provided insights into potentially modifiable factors of the well‐documented phenomenon of low mobility of hospitalized older persons10 and identified several targets for a multicomponent intervention to minimize low mobility. Possible interventions include a progressive walking program initiated early in the hospital stay, provision of assistive devices to patients who need them, and early removal of catheters and intravenous lines. Further research is needed to explore other factors associated with low mobility, such as specific medical conditions for which bed rest may be ordered, and to evaluate the impact that specific interventions may have on the mobility of older persons during hospitalization.

The delivery of safe, high‐quality care to hospitalized patients depends on effective communication among providers.1, 2 Inpatients may receive care from a number of specialists in addition to their primary hospital physicians, and each provider may practice in a group that transfers care of individual patients among its members. This issue is exacerbated in teaching hospitals because fellows, residents, and interns make frequent transfers of care because of work‐hour rules.3, 4 Finally, teams of physician providers making management decisions must effectively communicate with other members of the care team, such as nurses, dieticians, and social workers, who also may be part of a group practice involving transfers. A patient hospitalized for just a few days in a modern hospital may receive care from dozens of providers and be the subject of multiple transfers of care, or handoffs, that require effective communication. Therefore, as part of its 2006 National Patient Safety Goals,5 the Joint Commission on Accreditation of Health Care Organizations (JCAHO) now requires that each hospital implement a standardized, structured approach to transfers of care.

Transfers of care have been shown to be a source of medical errors and adverse patient outcomes.2, 6, 7 In many cases, the critical information necessary to avert medical errors exists but is not available in real time to providers.6

Traditionally, provider teams have relied on the patient chart, in concert with direct patient evaluation, to provide the information to guide decision making during a hospitalization. Unfortunately, the structure of the chart in most hospitals has evolved little over the past 80 years810 and remains organized so that information is more easily filed than retrieved, read, or summarized.811 Typically, electronic medical records (EMRs) mimic the appearance of paper records and include similar organizational flaws.12 As a result, many providers have created ad hoc informational systems, separate from the chart, designed to track a patient's progress over time and to facilitate transfers of care. These sign‐out systems, which are intended to complement verbal sign‐out between providers,1315 range in complexity from simple handwritten index cards16 to adapted spreadsheets, PDA systems,17, 18 and more complex data systems (eg, FileMaker Pro)19 and often contain crucial information not found elsewhere in the medical record.20, 21

Although sign‐out systems are crucial to patient safety, they have several drawbacks. First, ad‐hoc informational systems may not be standardized, resulting in content and accuracy that vary among providers.22 These systems may fail to identify critical elements of a patient's condition, promoting ineffective communication and placing the patient at increased risk of adverse events.7, 13, 23

These observations underscore the need for a standardized patient‐tracking instrument that can distill crucial patient information, enhance communication, support transfers, improve efficiency, and enhance continuity of patient care.

We aimed to develop an integrated, problem‐based patient‐tracking tool as part of our hospital's EMR. The tool, SynopSIS, supports patient tracking, transfers of care (ie, sign‐outs), and daily rounds.

METHODS

PROGRAM DESCRIPTION

Conceptual Model

We developed this conceptual model by integrating existing scholarship and input from stakeholders at our institution. First, we reviewed existing literature on documentation and transfers of care. Next, we conducted several focus group sessions with our EMR Residents' Advisory Group to conceptualize work flow and handoff needs for hospital physicians across specialties. We arrived at this model after several iterations of feedback from providers.

SynopSIS maps patient data available in the EMR to each of the 3 main functions according to type of clinical decisions supported by that function (Fig. 1). For example, data needed for effective patient tracking, such as likely functional status, are required to make decisions over the course of a patient's hospitalization. Similarly, data needed for sign‐out are used to make decisions over the course of a shift, typically overnight; and data needed for morning rounds are used to make decisions for the day. Although the information required for each function overlaps considerably, there are specialized data elements unique to each function.

Figure 1

Description of Functionality

SynopSIS is integrated with our hospital's EMR, General Electric (GE) Centricity Enterprise. The physician interface for SynopSIS is shown in Figure 2. After selecting a patient from a list corresponding to a given inpatient service (eg, Medicine Team B), the user selects the menu option to view the SynopSIS screen, which provides an at a glance overview of the patient's current condition. Different fields on the screen support each of SynopSIS's 3 main functions. At the top, the patient's demographic and registration information is displayed, including name, location, age, medical record number, and attending physician. Below are fields viewable and editable by users of the EMR. The Admission Diagnosis/Course and Problem List fields support patient tracking and allow a receiving physician to understand the reason for the patient's admission, the overall course of the illness, and the current active problems. The problem list is entered by the primary hospital physician. The Anticipated Problems/To Do List field supports the sign‐out function from which providers can coordinate care‐related activities and make contingency plans for anticipated events. The patients' most recent laboratory results and vital signs are displayed on the lower left of the screen for easy reference during face‐to‐face physician sign‐outs. Finally, the CODE status, Allergies, and Medications fields allow efficient tracking of information. Temporarily, until the pharmacy component of the EMR goes into use, the primary hospital physician will enter and update the medications. When the pharmacy is linked to the EMR, medications will be added directly from the inpatient pharmacy records to the EMR‐linked sign‐out tool.

Figure 2

This on‐screen SynopSIS view is distinct from the summary screen typically seen in EMRs, including vendor‐based and the Veterans' Affairs systems. For instance, the Veterans' Affairs summary screen incorporates clinical and nonclinical data, including demographic and payment information, upcoming appointments, and patient‐specific information such as allergies. Moreover, it is not editable by primary hospital physicians. Unlike a summary screen, which collates select patient information from other parts of the EMR, SynopSIS is specific to the current acute hospitalization and includes information not found elsewhere in the medical record.

To support rounding, SynopSIS gathers and presents data from the EMR in a printed Rounds Report (Fig. 3). The report is generated for all patients assigned to an inpatient service (eg, Medicine Team B) and emphasizes clarity and brevity using a format validated in the medical literature.24, 25 Each patient's report covers one fourth of a standard 8‐by‐11‐inch landscape‐printed page. The top half of each of these quarter‐page patient reports displays data stored in SynopSIS's interface and summarizes the patient's illness and the course of that illness. The lower half displays vital signs, intake/output, and laboratory data over the 24 hours from the time of printing. The most recent value and the range over the previous 24 hours of all vital signs are displayed. Intake/output totals are listed together with a structured breakdown. Laboratory results for the past 24 hours are listed with the most immediate prior values, allowing providers to discern trends. We envision providers obtaining a rounds report on arrival each day before examining their patients.

Figure 3

Importantly, although SynopSIS is part of the patient's medical record, physician users may change or overwrite the data in any field. This ability is a critical feature of the toolthe focus is on providing an interpretable snapshot of the patient. Data may be removed as their importance lessens or as the patient's condition changes, which contrasts with unchangeable documentation geared for alternative purposes, such as billing or medical‐legal requirements. Deleted data are saved in the medical record and are viewable by audit.

DISCUSSION

Several systems have been developed to enhance communication among providers and to support the transfer of care of hospitalized patients.13, 14, 16, 19, 24, 25 We have developed a tool to support patient tracking, sign‐out, and rounding that incorporates key elements of previously designed systems and may improve communication among providers. SynopSIS helps to fulfill the 2006 JCAHO accreditation requirement for standardized communication for transfers of care when used with appropriate verbal communication, including an opportunity to ask and respond to questions.5 Research from other safety‐oriented industries recommends standardized information transfer, which SynopSIS will provide.20 What is innovative about SynopSIS is that it is not a stand‐alone system, but an integrated part of the EMR.

Currently, fewer than 5% of hospitals have an electronic sign‐out tool linked to hospital information systems27; therefore, SynopSIS has great potential for dissemination. In technical terms, this tool was coded by GE and could be readily adopted by any other GE Centricity Enterprise customer. Moreover, the conceptual model, the design strategy, and the critical system elements should be relevant to effective patient tracking, sign‐out, and rounding across different IT platforms.

Despite its strengths, the SynopSIS system has several limitations. First, appropriate transfer of care is a learned process that incorporates well‐described provider and system elements.15, 21, 2830 This tool cannot perform sign‐out; it makes up one part of an effective sign‐out process. As our institution implements SynopSIS, we will also proceed with educational efforts and infrastructure to improve the sign‐out process. Second, although data can be overwritten, prior screen versions are archived in the database. Because SynopSIS is part of the medical record, users may omit sensitive or clinically useful information because of medical‐legal concerns, such as sensitive family dynamics or patient behavioral issues that providers may be reluctant to document in the patient chart. Currently, such information is conveyed verbally during sign‐out. Third, as information gathering and transfer become more automated, informal person‐to‐person interactions among providers (eg, physicians and nurses) may erode. However, we expect that SynopSIS actually will enhance the quality of this communication because it places them on the same page. Finally, SynopSIS generates paper reports that must be disposed of in accordance with standards of patient confidentiality.

We believe that SynopSIS will improve the quality of care through several mechanisms. Because this single‐screen summary will be available to all members of a patients' care team, it is possible that SynopSIS will enable providers to share management plans more readily. Although nursing and care management do not use SynopSIS for their own handoffs, they have clamored for the ability to view it. In addition, rotating providers can readily assume care of an unfamiliar patient. By automating data‐gathering tasks, SynopSIS may foster efficiency and increase time with patients during rounds. For trainee providers in particular, such increased efficiency should allow more time for education and alleviate some of the pressures of duty‐hour compliance. Most important, SynopSIS frees the EMR from emulating the historic paper chart as its method of supporting clinical work flow and communication. That paradigm does not harness the power of today's EMR databases and integration capabilities31 and creates extra work through interruptive work flow and redundant effort.32 With SynopSIS reengineering, instead of providers having to serve the needs of the chart, the chart serves the needs of providers and patients.

Future clinical documentation and EMR systems should focus on provider work flow to improve quality and efficiency in patient care. Moreover, involving providers, including residents, in system design fosters innovation and optimally applies information technology to supporting clinical practice.

The delivery of safe, high‐quality care to hospitalized patients depends on effective communication among providers.1, 2 Inpatients may receive care from a number of specialists in addition to their primary hospital physicians, and each provider may practice in a group that transfers care of individual patients among its members. This issue is exacerbated in teaching hospitals because fellows, residents, and interns make frequent transfers of care because of work‐hour rules.3, 4 Finally, teams of physician providers making management decisions must effectively communicate with other members of the care team, such as nurses, dieticians, and social workers, who also may be part of a group practice involving transfers. A patient hospitalized for just a few days in a modern hospital may receive care from dozens of providers and be the subject of multiple transfers of care, or handoffs, that require effective communication. Therefore, as part of its 2006 National Patient Safety Goals,5 the Joint Commission on Accreditation of Health Care Organizations (JCAHO) now requires that each hospital implement a standardized, structured approach to transfers of care.

Transfers of care have been shown to be a source of medical errors and adverse patient outcomes.2, 6, 7 In many cases, the critical information necessary to avert medical errors exists but is not available in real time to providers.6

Traditionally, provider teams have relied on the patient chart, in concert with direct patient evaluation, to provide the information to guide decision making during a hospitalization. Unfortunately, the structure of the chart in most hospitals has evolved little over the past 80 years810 and remains organized so that information is more easily filed than retrieved, read, or summarized.811 Typically, electronic medical records (EMRs) mimic the appearance of paper records and include similar organizational flaws.12 As a result, many providers have created ad hoc informational systems, separate from the chart, designed to track a patient's progress over time and to facilitate transfers of care. These sign‐out systems, which are intended to complement verbal sign‐out between providers,1315 range in complexity from simple handwritten index cards16 to adapted spreadsheets, PDA systems,17, 18 and more complex data systems (eg, FileMaker Pro)19 and often contain crucial information not found elsewhere in the medical record.20, 21

Although sign‐out systems are crucial to patient safety, they have several drawbacks. First, ad‐hoc informational systems may not be standardized, resulting in content and accuracy that vary among providers.22 These systems may fail to identify critical elements of a patient's condition, promoting ineffective communication and placing the patient at increased risk of adverse events.7, 13, 23

These observations underscore the need for a standardized patient‐tracking instrument that can distill crucial patient information, enhance communication, support transfers, improve efficiency, and enhance continuity of patient care.

We aimed to develop an integrated, problem‐based patient‐tracking tool as part of our hospital's EMR. The tool, SynopSIS, supports patient tracking, transfers of care (ie, sign‐outs), and daily rounds.

METHODS

PROGRAM DESCRIPTION

Conceptual Model

We developed this conceptual model by integrating existing scholarship and input from stakeholders at our institution. First, we reviewed existing literature on documentation and transfers of care. Next, we conducted several focus group sessions with our EMR Residents' Advisory Group to conceptualize work flow and handoff needs for hospital physicians across specialties. We arrived at this model after several iterations of feedback from providers.

SynopSIS maps patient data available in the EMR to each of the 3 main functions according to type of clinical decisions supported by that function (Fig. 1). For example, data needed for effective patient tracking, such as likely functional status, are required to make decisions over the course of a patient's hospitalization. Similarly, data needed for sign‐out are used to make decisions over the course of a shift, typically overnight; and data needed for morning rounds are used to make decisions for the day. Although the information required for each function overlaps considerably, there are specialized data elements unique to each function.

Figure 1

Description of Functionality

SynopSIS is integrated with our hospital's EMR, General Electric (GE) Centricity Enterprise. The physician interface for SynopSIS is shown in Figure 2. After selecting a patient from a list corresponding to a given inpatient service (eg, Medicine Team B), the user selects the menu option to view the SynopSIS screen, which provides an at a glance overview of the patient's current condition. Different fields on the screen support each of SynopSIS's 3 main functions. At the top, the patient's demographic and registration information is displayed, including name, location, age, medical record number, and attending physician. Below are fields viewable and editable by users of the EMR. The Admission Diagnosis/Course and Problem List fields support patient tracking and allow a receiving physician to understand the reason for the patient's admission, the overall course of the illness, and the current active problems. The problem list is entered by the primary hospital physician. The Anticipated Problems/To Do List field supports the sign‐out function from which providers can coordinate care‐related activities and make contingency plans for anticipated events. The patients' most recent laboratory results and vital signs are displayed on the lower left of the screen for easy reference during face‐to‐face physician sign‐outs. Finally, the CODE status, Allergies, and Medications fields allow efficient tracking of information. Temporarily, until the pharmacy component of the EMR goes into use, the primary hospital physician will enter and update the medications. When the pharmacy is linked to the EMR, medications will be added directly from the inpatient pharmacy records to the EMR‐linked sign‐out tool.

Figure 2

This on‐screen SynopSIS view is distinct from the summary screen typically seen in EMRs, including vendor‐based and the Veterans' Affairs systems. For instance, the Veterans' Affairs summary screen incorporates clinical and nonclinical data, including demographic and payment information, upcoming appointments, and patient‐specific information such as allergies. Moreover, it is not editable by primary hospital physicians. Unlike a summary screen, which collates select patient information from other parts of the EMR, SynopSIS is specific to the current acute hospitalization and includes information not found elsewhere in the medical record.

To support rounding, SynopSIS gathers and presents data from the EMR in a printed Rounds Report (Fig. 3). The report is generated for all patients assigned to an inpatient service (eg, Medicine Team B) and emphasizes clarity and brevity using a format validated in the medical literature.24, 25 Each patient's report covers one fourth of a standard 8‐by‐11‐inch landscape‐printed page. The top half of each of these quarter‐page patient reports displays data stored in SynopSIS's interface and summarizes the patient's illness and the course of that illness. The lower half displays vital signs, intake/output, and laboratory data over the 24 hours from the time of printing. The most recent value and the range over the previous 24 hours of all vital signs are displayed. Intake/output totals are listed together with a structured breakdown. Laboratory results for the past 24 hours are listed with the most immediate prior values, allowing providers to discern trends. We envision providers obtaining a rounds report on arrival each day before examining their patients.

Figure 3

Importantly, although SynopSIS is part of the patient's medical record, physician users may change or overwrite the data in any field. This ability is a critical feature of the toolthe focus is on providing an interpretable snapshot of the patient. Data may be removed as their importance lessens or as the patient's condition changes, which contrasts with unchangeable documentation geared for alternative purposes, such as billing or medical‐legal requirements. Deleted data are saved in the medical record and are viewable by audit.

DISCUSSION

Several systems have been developed to enhance communication among providers and to support the transfer of care of hospitalized patients.13, 14, 16, 19, 24, 25 We have developed a tool to support patient tracking, sign‐out, and rounding that incorporates key elements of previously designed systems and may improve communication among providers. SynopSIS helps to fulfill the 2006 JCAHO accreditation requirement for standardized communication for transfers of care when used with appropriate verbal communication, including an opportunity to ask and respond to questions.5 Research from other safety‐oriented industries recommends standardized information transfer, which SynopSIS will provide.20 What is innovative about SynopSIS is that it is not a stand‐alone system, but an integrated part of the EMR.

Currently, fewer than 5% of hospitals have an electronic sign‐out tool linked to hospital information systems27; therefore, SynopSIS has great potential for dissemination. In technical terms, this tool was coded by GE and could be readily adopted by any other GE Centricity Enterprise customer. Moreover, the conceptual model, the design strategy, and the critical system elements should be relevant to effective patient tracking, sign‐out, and rounding across different IT platforms.

Despite its strengths, the SynopSIS system has several limitations. First, appropriate transfer of care is a learned process that incorporates well‐described provider and system elements.15, 21, 2830 This tool cannot perform sign‐out; it makes up one part of an effective sign‐out process. As our institution implements SynopSIS, we will also proceed with educational efforts and infrastructure to improve the sign‐out process. Second, although data can be overwritten, prior screen versions are archived in the database. Because SynopSIS is part of the medical record, users may omit sensitive or clinically useful information because of medical‐legal concerns, such as sensitive family dynamics or patient behavioral issues that providers may be reluctant to document in the patient chart. Currently, such information is conveyed verbally during sign‐out. Third, as information gathering and transfer become more automated, informal person‐to‐person interactions among providers (eg, physicians and nurses) may erode. However, we expect that SynopSIS actually will enhance the quality of this communication because it places them on the same page. Finally, SynopSIS generates paper reports that must be disposed of in accordance with standards of patient confidentiality.

We believe that SynopSIS will improve the quality of care through several mechanisms. Because this single‐screen summary will be available to all members of a patients' care team, it is possible that SynopSIS will enable providers to share management plans more readily. Although nursing and care management do not use SynopSIS for their own handoffs, they have clamored for the ability to view it. In addition, rotating providers can readily assume care of an unfamiliar patient. By automating data‐gathering tasks, SynopSIS may foster efficiency and increase time with patients during rounds. For trainee providers in particular, such increased efficiency should allow more time for education and alleviate some of the pressures of duty‐hour compliance. Most important, SynopSIS frees the EMR from emulating the historic paper chart as its method of supporting clinical work flow and communication. That paradigm does not harness the power of today's EMR databases and integration capabilities31 and creates extra work through interruptive work flow and redundant effort.32 With SynopSIS reengineering, instead of providers having to serve the needs of the chart, the chart serves the needs of providers and patients.

Future clinical documentation and EMR systems should focus on provider work flow to improve quality and efficiency in patient care. Moreover, involving providers, including residents, in system design fosters innovation and optimally applies information technology to supporting clinical practice.

The delivery of safe, high‐quality care to hospitalized patients depends on effective communication among providers.1, 2 Inpatients may receive care from a number of specialists in addition to their primary hospital physicians, and each provider may practice in a group that transfers care of individual patients among its members. This issue is exacerbated in teaching hospitals because fellows, residents, and interns make frequent transfers of care because of work‐hour rules.3, 4 Finally, teams of physician providers making management decisions must effectively communicate with other members of the care team, such as nurses, dieticians, and social workers, who also may be part of a group practice involving transfers. A patient hospitalized for just a few days in a modern hospital may receive care from dozens of providers and be the subject of multiple transfers of care, or handoffs, that require effective communication. Therefore, as part of its 2006 National Patient Safety Goals,5 the Joint Commission on Accreditation of Health Care Organizations (JCAHO) now requires that each hospital implement a standardized, structured approach to transfers of care.

Transfers of care have been shown to be a source of medical errors and adverse patient outcomes.2, 6, 7 In many cases, the critical information necessary to avert medical errors exists but is not available in real time to providers.6

Traditionally, provider teams have relied on the patient chart, in concert with direct patient evaluation, to provide the information to guide decision making during a hospitalization. Unfortunately, the structure of the chart in most hospitals has evolved little over the past 80 years810 and remains organized so that information is more easily filed than retrieved, read, or summarized.811 Typically, electronic medical records (EMRs) mimic the appearance of paper records and include similar organizational flaws.12 As a result, many providers have created ad hoc informational systems, separate from the chart, designed to track a patient's progress over time and to facilitate transfers of care. These sign‐out systems, which are intended to complement verbal sign‐out between providers,1315 range in complexity from simple handwritten index cards16 to adapted spreadsheets, PDA systems,17, 18 and more complex data systems (eg, FileMaker Pro)19 and often contain crucial information not found elsewhere in the medical record.20, 21

Although sign‐out systems are crucial to patient safety, they have several drawbacks. First, ad‐hoc informational systems may not be standardized, resulting in content and accuracy that vary among providers.22 These systems may fail to identify critical elements of a patient's condition, promoting ineffective communication and placing the patient at increased risk of adverse events.7, 13, 23

These observations underscore the need for a standardized patient‐tracking instrument that can distill crucial patient information, enhance communication, support transfers, improve efficiency, and enhance continuity of patient care.

We aimed to develop an integrated, problem‐based patient‐tracking tool as part of our hospital's EMR. The tool, SynopSIS, supports patient tracking, transfers of care (ie, sign‐outs), and daily rounds.

METHODS

PROGRAM DESCRIPTION

Conceptual Model

We developed this conceptual model by integrating existing scholarship and input from stakeholders at our institution. First, we reviewed existing literature on documentation and transfers of care. Next, we conducted several focus group sessions with our EMR Residents' Advisory Group to conceptualize work flow and handoff needs for hospital physicians across specialties. We arrived at this model after several iterations of feedback from providers.

SynopSIS maps patient data available in the EMR to each of the 3 main functions according to type of clinical decisions supported by that function (Fig. 1). For example, data needed for effective patient tracking, such as likely functional status, are required to make decisions over the course of a patient's hospitalization. Similarly, data needed for sign‐out are used to make decisions over the course of a shift, typically overnight; and data needed for morning rounds are used to make decisions for the day. Although the information required for each function overlaps considerably, there are specialized data elements unique to each function.

Figure 1

Description of Functionality

SynopSIS is integrated with our hospital's EMR, General Electric (GE) Centricity Enterprise. The physician interface for SynopSIS is shown in Figure 2. After selecting a patient from a list corresponding to a given inpatient service (eg, Medicine Team B), the user selects the menu option to view the SynopSIS screen, which provides an at a glance overview of the patient's current condition. Different fields on the screen support each of SynopSIS's 3 main functions. At the top, the patient's demographic and registration information is displayed, including name, location, age, medical record number, and attending physician. Below are fields viewable and editable by users of the EMR. The Admission Diagnosis/Course and Problem List fields support patient tracking and allow a receiving physician to understand the reason for the patient's admission, the overall course of the illness, and the current active problems. The problem list is entered by the primary hospital physician. The Anticipated Problems/To Do List field supports the sign‐out function from which providers can coordinate care‐related activities and make contingency plans for anticipated events. The patients' most recent laboratory results and vital signs are displayed on the lower left of the screen for easy reference during face‐to‐face physician sign‐outs. Finally, the CODE status, Allergies, and Medications fields allow efficient tracking of information. Temporarily, until the pharmacy component of the EMR goes into use, the primary hospital physician will enter and update the medications. When the pharmacy is linked to the EMR, medications will be added directly from the inpatient pharmacy records to the EMR‐linked sign‐out tool.

Figure 2

This on‐screen SynopSIS view is distinct from the summary screen typically seen in EMRs, including vendor‐based and the Veterans' Affairs systems. For instance, the Veterans' Affairs summary screen incorporates clinical and nonclinical data, including demographic and payment information, upcoming appointments, and patient‐specific information such as allergies. Moreover, it is not editable by primary hospital physicians. Unlike a summary screen, which collates select patient information from other parts of the EMR, SynopSIS is specific to the current acute hospitalization and includes information not found elsewhere in the medical record.

To support rounding, SynopSIS gathers and presents data from the EMR in a printed Rounds Report (Fig. 3). The report is generated for all patients assigned to an inpatient service (eg, Medicine Team B) and emphasizes clarity and brevity using a format validated in the medical literature.24, 25 Each patient's report covers one fourth of a standard 8‐by‐11‐inch landscape‐printed page. The top half of each of these quarter‐page patient reports displays data stored in SynopSIS's interface and summarizes the patient's illness and the course of that illness. The lower half displays vital signs, intake/output, and laboratory data over the 24 hours from the time of printing. The most recent value and the range over the previous 24 hours of all vital signs are displayed. Intake/output totals are listed together with a structured breakdown. Laboratory results for the past 24 hours are listed with the most immediate prior values, allowing providers to discern trends. We envision providers obtaining a rounds report on arrival each day before examining their patients.

Figure 3

Importantly, although SynopSIS is part of the patient's medical record, physician users may change or overwrite the data in any field. This ability is a critical feature of the toolthe focus is on providing an interpretable snapshot of the patient. Data may be removed as their importance lessens or as the patient's condition changes, which contrasts with unchangeable documentation geared for alternative purposes, such as billing or medical‐legal requirements. Deleted data are saved in the medical record and are viewable by audit.

DISCUSSION

Several systems have been developed to enhance communication among providers and to support the transfer of care of hospitalized patients.13, 14, 16, 19, 24, 25 We have developed a tool to support patient tracking, sign‐out, and rounding that incorporates key elements of previously designed systems and may improve communication among providers. SynopSIS helps to fulfill the 2006 JCAHO accreditation requirement for standardized communication for transfers of care when used with appropriate verbal communication, including an opportunity to ask and respond to questions.5 Research from other safety‐oriented industries recommends standardized information transfer, which SynopSIS will provide.20 What is innovative about SynopSIS is that it is not a stand‐alone system, but an integrated part of the EMR.

Currently, fewer than 5% of hospitals have an electronic sign‐out tool linked to hospital information systems27; therefore, SynopSIS has great potential for dissemination. In technical terms, this tool was coded by GE and could be readily adopted by any other GE Centricity Enterprise customer. Moreover, the conceptual model, the design strategy, and the critical system elements should be relevant to effective patient tracking, sign‐out, and rounding across different IT platforms.

Despite its strengths, the SynopSIS system has several limitations. First, appropriate transfer of care is a learned process that incorporates well‐described provider and system elements.15, 21, 2830 This tool cannot perform sign‐out; it makes up one part of an effective sign‐out process. As our institution implements SynopSIS, we will also proceed with educational efforts and infrastructure to improve the sign‐out process. Second, although data can be overwritten, prior screen versions are archived in the database. Because SynopSIS is part of the medical record, users may omit sensitive or clinically useful information because of medical‐legal concerns, such as sensitive family dynamics or patient behavioral issues that providers may be reluctant to document in the patient chart. Currently, such information is conveyed verbally during sign‐out. Third, as information gathering and transfer become more automated, informal person‐to‐person interactions among providers (eg, physicians and nurses) may erode. However, we expect that SynopSIS actually will enhance the quality of this communication because it places them on the same page. Finally, SynopSIS generates paper reports that must be disposed of in accordance with standards of patient confidentiality.

We believe that SynopSIS will improve the quality of care through several mechanisms. Because this single‐screen summary will be available to all members of a patients' care team, it is possible that SynopSIS will enable providers to share management plans more readily. Although nursing and care management do not use SynopSIS for their own handoffs, they have clamored for the ability to view it. In addition, rotating providers can readily assume care of an unfamiliar patient. By automating data‐gathering tasks, SynopSIS may foster efficiency and increase time with patients during rounds. For trainee providers in particular, such increased efficiency should allow more time for education and alleviate some of the pressures of duty‐hour compliance. Most important, SynopSIS frees the EMR from emulating the historic paper chart as its method of supporting clinical work flow and communication. That paradigm does not harness the power of today's EMR databases and integration capabilities31 and creates extra work through interruptive work flow and redundant effort.32 With SynopSIS reengineering, instead of providers having to serve the needs of the chart, the chart serves the needs of providers and patients.

Future clinical documentation and EMR systems should focus on provider work flow to improve quality and efficiency in patient care. Moreover, involving providers, including residents, in system design fosters innovation and optimally applies information technology to supporting clinical practice.