Medicolegal Issues

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Literature at a Glance

Standardized Discharge Intervention Decreases Readmission Rates

Clinical question: Does a standardized discharge intervention lead to a decrease in ED visits and readmission rates following hospital discharge?

Background: Hospital discharge is a complex process that is not standardized at many institutions. Deficiencies in the process can lead to poor outcomes, unnecessary rehospitalizations, and increased costs. Previous studies of peridischarge interventions have yielded mixed results and typically focus on specific patient populations.

Study design: Randomized trial.

Setting: Boston Medical Center, a large, urban, academic medical center.

Synopsis: In this single-institution study, 749 English-speaking hospitalized adults were randomly assigned one of two discharge plans: a multidisciplinary package of discharge services or the usual discharge process. Patients in the intervention group were assigned a nurse discharge advocate who performed patient education, medication reconciliation, discharge coordination, and scheduled follow-up appointments. A pharmacist also telephoned participants two to four days after discharge to reinforce the discharge plan and review medications.

Participants in the intervention group had a 30% relative reduction in hospital utilization (defined as ED visit or hospital readmission) at 30 days. Overall, 21.6% of intervention patients and 26.9% of usual-discharge patients had at least one hospital utilization within 30 days of discharge.

This study was limited to a single center, and 27% of the patients did not meet eligibility criteria. The applicability also is limited by the resource utilization required for the intervention. The authors estimated that 0.5 full-time-equivalent (FTE) nursing time and 0.15 FTE pharmacist time was required to maintain 14 patients per week.

Bottom line: A systematic, intensive approach to discharges can reduce ED return visits and readmission rates.

Citation: Jack B, Chetty V, Anthony D, et al. A re-engineered hospital discharge program to decrease re-hospitalization. Ann Intern Med. 2009:150(3):178-187.


VATS Doesn’t Shorten Hospital Stays for Children with Empyema

Clinical question: Should video-assisted thoracoscopic surgery (VATS) or tube thoracostomy with fibrinolysis be the primary intervention of choice in children with an empyema?

Background: Rates of pediatric parapneumonic empyema are increasing, but optimal treatment has yet to be defined. VATS has gained attention in recent years as reports have publicized improved outcomes with early operative management of empyema in childhood when compared with primary tube thoracostomy alone. However, clear advantages of VATS over primary chest tube drainage with fibrinolytic therapy have not been demonstrated.

Study design: Prospective, randomized trial.

Setting: A U.S. tertiary-care children’s hospital.

Synopsis: Eighteen children under 18 with empyema—defined as loculated pleural fluid by computed tomography or ultrasound, or pleural fluid white blood cell count >10,000 cells/µl—were randomized to receive either VATS or percutaneous chest tube placement with alteplase infusion. Length of post-therapy hospitalization was nearly identical between the two groups. Cost was significantly higher in the VATS patient group.

This is the second prospective, randomized trial to demonstrate that VATS does not shorten hospital length of stay in children with empyema when compared with tube thoracostomy with fibrinolysis. Both studies enrolled a small sample size according to power calculations, based on retrospective data suggesting that VATS results in two fewer days of hospitalization when compared with chest tube with fibrinolysis. Additionally, both studies revealed nearly identical lengths of stay between the two groups, with significantly higher costs in those undergoing VATS.

Bottom line: Primary tube thoracostomy with fibrinolysis does not prolong hospitalization in children with empyema when compared with VATS.

Citation: St. Peter S, Tsao K, Harrison C, et al. Thoracoscopic decortication vs. tube thoracostomy with fibrinolysis for empyema in children: a prospective, randomized trial. J Pediatr Surg. 2009;44(1):106-111.

EMR Equals Lower Mortality, Fewer Complications, Lower Costs

Clinical question: Is improved automation of hospital information associated with reduced rates of inpatient mortality, complications, cost, and length of stay (LOS)?

Background: Clinical information technologies, including electronic medical records (EMR), are touted as an antidote for the fragmented, unsafe, and expensive American healthcare system. Most studies on the effect of such technologies are limited to a single site, and few involve commercially available information systems.

Study design: Cross-sectional study.

Setting: Urban hospitals in Texas.

Synopsis: Researchers used the previously validated Clinical Information Technology Assessment Tool to survey physicians providing inpatient care in 72 Texas hospitals. This tool measures the degree to which clinical information processes are computerized. Automation is divided into four subdomains: test results, notes and records, order entry, and decision support. To achieve a high score, a process must be fully computerized, the physician must know how to activate it, and the physician must choose the computerized process over alternatives. The authors examined the association between a hospital’s degree of automation and mortality, costs, and LOS among patients with myocardial infarction, congestive heart failure, coronary artery bypass grafting, and pneumonia.

Overall, greater automation was associated with lower mortality, fewer complications, and lower costs. No clear impact on LOS was found. Higher scores in the notes and records subdomains were most associated with lower mortality. Higher decision-support scores were most associated with lower complication rates and costs.

This study is one of the first to demonstrate the benefits of clinical information technologies across a variety of institutions using different information systems.

Bottom line: Hospitals with EMR, order entry, and clinical decision support have lower mortality rates, fewer complications, and lower costs.

Citation: Amarasingham R, Plantinga L, Diener-West M, et al. Clinical information technologies and inpatient outcomes. Arch Intern Med. 2009;169(2):108-114.

Short Takes


This randomized trial demonstrated no benefit from a 600-mg loading dose of clopidogrel versus 300 mg for patients with an acute coronary syndrome managed with an early invasive strategy.

Citation: Yong G, Rankin J, Ferguson L, et al. Randomized trial comparing 600-mg with 300-mg loading dose of clopidogrel in patients with non-ST elevation acute coronary syndrome undergoing percutaneous coronary intervention: results of the Platelet Responsiveness to Aspirin and Clopidogrel and Troponin Increment after Coronary intervention in Acute coronary Lesions (PRACTICAL) trial. Am Heart J. 2009;157(1):60.e1-9.


This randomized, controlled trial demonstrated that intensified treatment for congestive heart failure based on BNP levels did not improve 18-month survival free of hospitalization or improve quality of life compared with symptom-guided therapy.

Citation: Pfisterer M, Buser P, Rickli, H, et al. BNP-guided vs. symptom-guided heart failure therapy. JAMA. 2009;301(4)383-392.


Observational study of 20 medical ICU residents suggests severe objective and subjective sleepiness on the post-call day despite adherence to duty-hour restrictions.

Citation: Reddy R, Guntupalli K, Alapat P, Surani S, et al. Sleepiness in medical ICU residents. Chest. 2009;135(1):81-85.


Observational cohort study shows that each day of gentamicin treatment for infective endocarditis results in 0.5% decrease in endogenous creatinine clearance; this nephrotoxic effect was not associated with post-discharge mortality.

Citation: Buchholtz K, Larsen CT, Hassager C, et al. Severity of gentamicin’s nephrotoxic effect on patients with infective endocarditis: a prospective observational cohort study of 373 patients. Clin Infec Dis. 2009;48:65-71.


Randomized, controlled trial of 100 in-hospital cardiac arrest patients demonstrated robust improvement in return of spontaneous circulation and survival to discharge with combined vasopressin-epinephrine supplemented by corticosteroids during and after resuscitation.

Citation: Mentzelopoulos S, Zakynthinos S, Tzoufi M, et al. Vasopressin, epinephrine, and corticosteroids for in-hospital cardiac arrest. Arch Intern Med. 2009;169(1):15-24.


Retrospective, population-based study of elderly patients shows low occurrence (0.47%) of acute kidney injury requiring hospitalization after NSAID initiation, but reveals significant increase in risk with use of rofecoxib, indomethacin, and ibuprofen.

Citation: Winkelmayer W, Waikar S, Mogun H, et al. Non-selective and cyclooxygenase-2-selective NSAIDs and acute kidney injury. Am J Med. 2008;121:1092-1098.


Prospective, randomized, double-blind, placebo-controlled clinical trial of vitamin 400 IU vitamin E and 500 mg vitamin C, involving 14,641 men, did not show a reduced risk of major cardiovascular events.

Citation: Sesso H, Buring J, Christen W, et al. Vitamins E and C in the prevention of cardiovascular disease in men: the physicians’ health study II randomized controlled trial. JAMA. 2008;300(18):2123-2133.


Systematic review/meta-analysis shows accuracy of computed tomography angiography (CTA) in assessing presence and extent of peripheral arterial disease (PAD), but its appropriate application in the setting of particular patient populations and alternative diagnostic modalities needs further investigation.

Citation: Met R, Bipat S, Legemate DA, et al. Diagnostic performance of computed tomography angiography in peripheral arterial disease: a systematic review and meta-analysis. JAMA. 2009;301:415-424.

Radiologic Progression of Pulmonary Infiltrates Portends Worse Prognosis in Severe CAP Patients

Clinical question: In patients admitted to the ICU with severe community-acquired pneumonia (CAP), do bacteremia and rapid radiologic progression of pulmonary infiltrates increase the risk of shock and mortality?

Background: Severe CAP is associated with considerable morbidity and mortality; however, data focusing on short-term outcomes is limited. The role of the chest radiograph is established in diagnosis but is unclear as a prognostic tool. Bacteremia is associated with higher mortality risk but also is more common in patients with comorbid illnesses.

Study design: Retrospective cohort.

Setting: 33 hospitals in Spain.

Synopsis: This study retrospectively analyzed 457 patients with severe CAP admitted to the ICU between Dec. 1, 2000, and Feb. 28, 2002. Patients were classified into four groups according to the presence or absence of rapid radiographic spread of pulmonary infiltrates and CAP-associated bacteremia. Patients demonstrating significant worsening by chest radiography within the first 48 hours after admission had a threefold increase in the risk of death. Bacteremia was not associated with increased mortality.

The retrospective nature of this study is its major limitation. Other limitations are the probable inclusion of unrecognized bacteremia in the nonbacteremic groups, the fact that repeat chest radiographs were obtained only once (at 48 hours), and that the cause of radiographic deterioration was not examined.

This study contributes to the literature by identifying a subset of patients (those with worsening chest radiographs at 48 hours) who may benefit from further study and targeted interventions.

Bottom line: In severe CAP patients, radiographic worsening at 48 hours is a negative prognostic factor, while bacteremia is not associated with worse outcomes.

Citation: Lisboa T, Blot S, Waterer G, et al. Radiologic progression of pulmonary infiltrates predicts a worse prognosis in severe community-acquired pneumonia than bacteremia. Chest. 2009;135(1):165-172.

NSAIDs Increase Risk of Death and Cardiovascular Morbidity in CHF Patients

Clinical question: Is NSAID use by patients with congestive heart failure (CHF) associated with a higher risk of death or hospitalization due to acute myocardial infarction (MI) or heart failure?

Background: NSAID use is widespread and generally perceived to be low-risk given their over-the-counter availability. However, clinical guidelines discourage the use of NSAIDs in patients with chronic heart failure due to the risk of fluid retention and worsening heart failure.

Study design: Retrospective cohort.

Setting: All hospitals in Denmark.

Synopsis: This study identified 107,092 patients who survived their first hospitalizations due to heart failure between 1995 and 2004. Subsequent use of NSAIDs was determined from a national prescription registry. Patient records were retrospectively analyzed to assess mortality and hospitalization due to MI or heart failure.

At least one NSAID prescription was claimed by 33.9% of the patients after discharge. All NSAIDs were associated with higher death rates, and there was a dose-dependent increase in the risk of death. Ibuprofen and naproxen demonstrated increased mortality only at high doses. All NSAIDs that were studied increased the risk of hospitalization for MI or heart failure.

The observational design is the study’s major limitation. Other important limitations include lack of detailed information about heart failure diagnoses and indication for starting NSAID therapy.

This study intensifies the debate regarding the increased risk of cardiovascular events in NSAID patients, which has been ongoing since the publication of the VIGOR Study in 2000.

Bottom line: In patients with a history of heart failure, NSAIDs are associated with an increased risk of death and cardiovascular morbidity.

Citation: Gislason G, Rasmussen J, Abildstrom S, et al. Increased mortality and cardiovascular morbidity associated with use of non-steroidal anti-inflammatory drugs in chronic heart failure. Arch Intern Med. 2009;169(2):141-149.

Language Barriers Present Obstacle during ICU Family Meetings

Clinical question: Do family meetings that require the use of an interpreter have different characteristics than those in which an interpreter is not needed?

Background: Communication about end-of-life care is essential in the ICU, yet limited English proficiency (LEP) can be a barrier to effective discussions. Overall, outcomes and satisfaction are improved when interpreters are used, but specific effects on ICU family conferences are unknown.

Study design: Cross-sectional evaluation of family meetings.

Setting: Four hospitals in Seattle.

Synopsis: Fifty-one noninterpreted (English-speaking members only) and 10 interpreted (non-English-speaking members present) ICU family meetings were recorded and analyzed for the amount of speaking time and content. The total duration was similar for interpreted versus noninterpreted conferences (26.3 minutes vs. 32.0 minutes, P=0.25), but clinician speech was significantly less in the interpreted group (10.9 minutes vs. 19.6 minutes, P=0.001). Family speaking time was similar in both interpreted and noninterpreted conversations (7.1 minutes vs. 8.2 minutes, P=0.66). Clinicians used more emotional support for families in noninterpreted meetings, including active listening and pausing for questions.

This study is limited by the use of an audio recorder; a video recorder would have provided researchers with participants’ physical interaction and expressions. Additionally, the study does not differentiate between cultural and linguistic difficulties, or provide a reference for the degree of complexity of each conference.

Bottom line: Family meetings in the ICU that require the use of an interpreter provide less information and emotional support to family members than those in which an interpreter is not required.

Citation: Thornton J, Pham K, Engelberg R, et al. Families with limited English proficiency receive less information and support in interpreted intensive care unit family conferences. Crit Care Med. 2009;37(1):89-95.

Postoperative Delirium and Poor Outcomes

Clinical question: In patients 50 and older, what are the risk factors for the development of postoperative delirium, and how are outcomes affected by delirium?

Background: Delirium in the elderly postoperative patient is common. It results in increased costs, morbidity, and mortality. As the population ages, more elderly patients will undergo surgical procedures, so identification of delirium risk factors is essential.

Study design: Prospective, observational, cohort study.

Setting: Veterans Affairs Medical Center, Denver.

Synopsis: Researchers assessed 144 patients 50 and older who were scheduled to undergo surgical procedures with a planned, postoperative ICU stay for cognitive function, overall functional status, and comorbidities. Postoperatively, patients were assessed daily for the development of dementia using the cognitive assessment method-ICU instrument (CAM-ICU). Additionally, a validated chart review method for diagnosing delirium was used. The overall delirium incidence was 44%, and only 12% of cases had an identifiable etiology. The mean onset of delirium was 2.4 days; duration was 4.5 days. The incidence of delirium increased with age, reaching 92% in the 80- to 89-year-old group. In multivariate analysis, preoperative cognitive dysfunction was the strongest predictor of delirium.

Delirium development in patients 50 and older was associated with marked increases in costs ($50,000 vs. $32,000), length of stay (16 days vs. eight days), discharge to a facility (33% vs. 1%), and mortality (9% vs. 1%).

Limitations of this study included the patient population studied (97% men) and lack of data regarding medication use during hospitalization.

Bottom line: In older patients undergoing surgery requiring postoperative ICU care, delirium is common, is associated with prior cognitive dysfunction, and results in significant increases in LOS and mortality.

Citation: Robinson T, Raeburn C, Tran Z, et al. Postoperative delirium in the elderly: risk factors and outcomes. Ann Surg. 2009;249(1):173-178.

Meta-Analysis of Perioperative Beta-Blockers Doesn’t Support Routine Use

Clinical question: Are perioperative beta-blockers effective in preventing cardiac events in noncardiac surgery?

Background: The American College of Cardiology (ACC) and American Heart Association (AHA) guidelines for noncardiac surgery recommend beta-blockers for high-risk patients undergoing intermediate or high-risk surgery. The results of previous randomized controlled trials have been inconsistent.

Study design: Meta-analysis.

Setting: Literature search of PubMed, Embase, and the Cochrane Library.

Synopsis: Thirty-three randomized, controlled trials—which included 12,306 patients—were selected for statistical analysis. In these trials, beta-blockers were initiated in the perioperative period with 30-day followup for outcomes of interest. Overall, perioperative beta-blocker use was associated with a 35% risk reduction in nonfatal MI, a 116% increased risk of nonfatal stroke, and no significant difference in all-cause mortality. Trials with higher levels of bias showed greater statistical benefit of beta-blockers. Of note, the POISE trial carried the largest amount of weight, accounting for nearly two-thirds of the total number of patients included in treatment arms.

The application of this data is challenging, as studies differ in several important variables, such as timing of beta-blocker initiation, dosing regimen, and duration of treatment. The POISE trial, in particular, employed a very large dose of metoprolol, compared with doses of beta-blockers used in other studies. There is less data regarding the perioperative efficacy of beta-blockers when therapy is started well before surgery.

Bottom line: Current evidence does not support the routine use of beta-blockers started immediately prior to noncardiac surgery to prevent perioperative cardiac events.

Citation: Bangalore S, Wetterslev J, Pranesh S, et al. Perioperative beta-blockers in patients having non-cardiac surgery: a meta-analysis. Lancet. 2008;372:1962-1976.

Perioperative Ischemic Stroke an Important Cause of Morbidity and Mortality in Noncardiac Surgery

Clinical question: What are the incidence, risk factors, and outcomes of acute ischemic stroke in nonvascular surgery?

Background: Ischemic stroke is a well-understood complication of cardiovascular surgery. However, little data exist in medical literature regarding the frequency, associations, and outcomes of perioperative ischemic stroke in noncardiac surgery.

Study design: Observational chart review using administrative data.

Setting: The Nationwide Inpatient Sample, a public-use database, in which approximately 1,000 hospitals submit data from nonfederal acute-care hospitals.

Synopsis: Three common surgeries were sampled from an administrative database to characterize the epidemiology of perioperative ischemic stroke in noncardiac surgery. This outcome occurred in 0.7% of hemicolectomy patients; 0.2% of total hip replacement patients; and 0.6% of lobectomy/segmental lung resection patients. Studying the rate of perioperative ischemic stroke in coronary artery bypass graft (CABG) patients validated the authors’ method of data extraction. This rate was consistent with prior studies of this outcome in cardiovascular surgery patients.

Multivariate analysis showed that renal disease (odds ratio 3.0), atrial fibrillation (OR 2.0), prior stroke (OR 1.6), and valvular disease (OR 1.5) are statistically associated with an increased risk of perioperative ischemic stroke. The primary outcome was associated with a marked increase in the odds of in-hospital mortality or need for chronic care upon hospital discharge.

This study is limited by its use of administrative coding data, as well as potential bias introduced by the use of only three major types of surgery.

Bottom line: Ischemic stroke is a serious complication of intermediate and major noncardiovascular surgery. It is associated with poor patient outcomes; more evidence is needed to confirm associations with this outcome and to discover strategies to reduce risk.

Citation: Bateman B, Schum-acher H, Wang S, et al. Perioperative acute ischemic stroke in non-cardiac and nonvascular surgery. Anesthesiology. 2009;110:231-238.

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