Medicolegal Issues

In the Literature


In This Edition

Clinical Shorts


This randomized, prospective, placebo-controlled, multicenter trial demonstrated that valsartan did not reduce the incidence of recurrent atrial fibrillation in patients with cardiovascular disease, diabetes, or left atrial enlargement.

Citation: The GISSI-AF Investigators. Valsartan for prevention of recurrent atrial fibrillation. N Engl J Med. 2009;360:1606-1617.


Systematic review of randomized, controlled trials comparing genotype-guided to standard warfarin dosing found RCT data too nascent to identify a difference in major bleeding rates or time in the therapeutic range.

Citation: Kangelaris KN, Bent S, Nussbaum RL, Garcia DA, Tice JA. Genetic testing before anticoagulation? A systematic review of pharmacogenetic dosing of warfarin. J Gen Intern Med. 2009;24(5):656-664.


Retrospective, observational, cohort study of 830 patients with severe sepsis shows that initial lactate over 2 mmol/L is a predictor of 28-day mortality, independent of organ system dysfunction or shock.

Citation: Mikkelsen ME, Miltiades AN, Gaieski DF, et al. Serum lactate is associated with mortality in severe sepsis independent of organ failure and shock. Crit Care Med. 2009;37(5):1670-1677.


A prospective study of 322,263 men and 223,390 women shows that red- and processed-meat intake is associated with modest increases in total mortality, cancer mortality, and cardiovascular disease mortality.

Citation: Sinha R, Cross AJ, Graubard BI, Leitzmann MF, Schatzkin A. Meat intake and mortality: a prospective study of over half a million people. Arch Intern Med. 2009;169(6):562-571.

Addition of Pharmacists to Inpatient Teams Reduces Drug-Related Readmissions, Morbidity, and Costs for Elderly Patients

Clinical question: Would a ward-based pharmacist reduce morbidity, subsequent ED visits, and readmissions for elderly patients?

Background: Adverse drug events can cause significant drug-related morbidity and mortality, and lead to unnecessary healthcare costs. Elderly patients are more vulnerable to these effects given the polypharmacy often associated with their care. The effectiveness of a ward-based pharmacist intervention for elderly patients has not yet been studied.

Study design: Randomized controlled trial.

Setting: Two acute-care, internal-medicine wards at the University Hospital of Uppsala in Uppsala, Sweden.

Synopsis: Three hundred sixty-eight hospitalized patients ages 80 or older were randomized to control or intervention groups. The latter received enhanced services from a pharmacist who was integrated into the inpatient team. This individual performed medication reconciliation, reviewed the medication list, and advised the treating physician. The pharmacist educated and monitored patients during the hospitalization, counseled them at discharge, communicated pertinent medication information to the primary-care physicians (PCPs), and called the patients two months after discharge.

The primary outcome measure was the frequency of all hospital visits (ED visits plus hospital readmissions) during 12-month follow-up. The secondary outcome measure was the cost of hospital care.

The intervention group had a 16% reduction in all hospital visits and a 47% reduction in ED visits. There were five times as many drug-related readmissions in the control group compared with the intervention group, but the study did not have enough power to show a reduction in the total number of readmissions alone. The cost of hospital care minus the cost of the intervention resulted in a net savings of $230 per patient.

Bottom line: For elderly patients, adding a pharmacist to the inpatient team could lead to significant reductions in morbidity and, on a population basis, healthcare costs.

Citation: Gillespie U, Alassaad A, Henrohn D, et al. A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009;169(9):894-900.

Geriatric Care Coordination at Discharge Reduces Readmission Rates at 30 Days

Clinical question: Does a discharge planning service package affect readmission rates and ED visits?

Background: Elderly patients are at high risk for readmission after a hospitalization. Coordinated care packages, although effective in congestive heart failure (CHF) and chronic obstructive pulmonary disease (COPD) management, have yielded inconsistent results in terms of decreasing readmission rates for patients with a broader range of medical issues.

Study design: Randomized controlled pilot study.

Setting: A single large academic medical center in Texas.

Synopsis: Forty-one elderly patients at high risk for readmission—because of their age and comorbidities—were enrolled within 72 hours of admission. Patients randomized to the care bundle arm received daily education about medication reconciliation, health conditions, and self-care provided by study pharmacists and nurses. The intervention required approximately 40 minutes per day: 20 to 25 minutes for the care coordinators and 20 minutes for the pharmacists. A post-discharge phone call to review medication and confirm follow-up instructions was included.

Eight patients in the control group and two patients in the intervention arm were readmitted or seen in the ED within 30 days after discharge (38% vs. 10%, P=0.004). At 60 days, the difference between the two groups was no longer significant. The intervention group had a longer time interval before its first readmission (36.2 days vs. 15.7 days). The sample was too small to determine the effect on length of hospitalization.

Limitations of the study include its small sample size and unclear costs of the intervention.

Bottom line: Geriatric discharge bundles might decrease readmission and ED visits after discharge, but larger studies are needed to confirm this finding.

Citation: Koehler BE, Richter KM, Youngblood L, et al. Reduction of 30-day post-discharge hospital readmission or emergency department (ED) visit rates in high-risk elderly medical patients through delivery of a targeted care bundle. J Hosp Med. 2009;4(4):211-218.

Clinical Shorts


This prospective cohort study of 8,574 adults in the Netherlands demonstrated a significant, independent, and direct relationship between levels of microalbuminuria and the risk of venous thromboembolism (VTE).

Citation: Mahmoodi BK, Gansevoort RT, Veeger NJ, et al. Microalbuminuria and risk of venous thromboembolism. JAMA. 2009;301(17):1790-1797.


Higher RDW is associated with increased mortality in patients with symptomatic cardiovascular disease. This cross-sectional study used NHANES III data to demonstrate that higher RDW is strongly associated with all-cause mortality.

Citation: Patel KV, Ferrucci L, Ershler WB, Longo DL, Guralnik JM. Red blood cell distribution width and the risk of death in middle-aged and older adults. Arch Intern Med. 2009;169(5):515-523.


A population-based cohort study showed that hospital visits for syncope, bradycardia, permanent pacemaker placement, and hip fractures increase for elderly patients with dementia receiving cholinesterase inhibitors.

Citation: Gill SS, Anderson GM, Fischer HD, et al. Syncope and its consequences in patients with dementia receiving cholinesterase inhibitors: a population-based cohort study. Arch Intern Med. 2009;169(9):867-873.

Computer-Assisted Medication Reconciliation Might Reduce Unintentional Drug Discrepancies with Potential for Harm

Clinical question: Does a computerized medication reconciliation intervention reduce unintentional medication discrepancies?

Background: Given the high prevalence of unintentional medication discrepancies in hospitalized patients and the potential for harm, medication reconciliation is a national patient safety goal. Little data exist on the efficacy of medication reconciliation interventions for reducing medication discrepancies.

Study design: Cluster-randomized controlled trial.

Setting: Two large academic hospitals in Boston.

Synopsis: Using 14 medical teams, the study enrolled and randomized 322 patients to a floor with intervention or to a floor with traditional care. The intervention teams utilized a computerized order entry application designed to facilitate medication reconciliation, as well as a process redesign for physicians, nurses, and pharmacists.

The primary outcome was the number of unintentional medication discrepancies with the potential for causing harm (PADEs) per patient.

Patients randomized to the intervention group had a 28% reduction in relative risk compared with the control group (1.05 PADEs vs. 1.44 PADEs; absolute relative risk 0.72 (0.52-0.99)). The absolute relative risk reduction between the two arms was 0.39 PADE per patient (NNT=2.6). The intervention was associated with a significant reduction in PADEs at discharge but not at admission. The effects of the intervention were greater in patients with a higher PADE score.

Bottom line: This computerized medication reconciliation program with process redesign was associated with reduced risk of unintentional medication discrepancies with potential for causing harms (PADEs).

Citation: Schnipper JL, Hamann C, Ndumele CD, et al. Effect of an electronic medication reconciliation application and process redesign on potential adverse drug events: a cluster-randomized trial. Arch Intern Med. 2009;169(8):771-780.

End-of-Life Discussions Associated with Lower Healthcare Costs

Clinical question: What is the impact of patient-physician discussions of end-of-life care on healthcare costs in the final week of a patient’s life?

Background: Life-sustaining medical care of patients with advanced cancer is costly, with disproportionate spending at the end of a patient’s life. The link between discussions of end-of-life care preferences and healthcare expenditure has not been studied thoroughly.

Study design: Prospective observational study.

Setting: Seven sites in Connecticut, Texas, New Hampshire, and Massachusetts.

Synopsis: More than 600 patients with advanced cancer were recruited from September 2002 through December 2007 as part of the Coping With Cancer study. The 188 patients (31%) who reported end-of-life discussions with their physicians at baseline were less likely to undergo mechanical ventilator use or resuscitation, or to be admitted or die in an intensive-care unit in the final week of life. They were more likely to receive outpatient hospice care and had less physical distress in the last week than those who did not.

The mean aggregate cost of care in this group was $1,876, which was 36% lower than in the group that did not discuss end-of-life care ($2,917), P=0.002. In addition, higher medical costs were associated with worse quality of death, as reported by caregivers.

This study is limited by its observational design.

Bottom line: Physician communication with patients regarding end-of-life care preferences is associated with lower costs in the final week of life.

Citation: Zhang B, Wright AA, Huskamp HA, et al. Health care costs in the last week of life: associations with end-of-life conversations. Arch Intern Med. 2009;169(5):480-488.

Reduction of ED Visits and Hospitalizations for Chronically Ill and Homeless Adults

Clinical question: Can a case management and housing program reduce the utilization of ED and hospital medical services among chronically ill homeless adults?

Background: Homeless adults have high rates of chronic illness, have poor access to uninterrupted primary healthcare, and frequently use costly medical services, including those provided by EDs and inpatient hospitalizations. Studies to determine the efficacy of housing and case management services in reducing hospital and ED utilization in this population are lacking.

Study design: Randomized controlled trial.

Setting: A public teaching hospital and a private nonprofit hospital in Chicago.

Synopsis: Four hundred seven chronically ill and homeless adults were randomized to receive a case management and housing intervention or traditional care following an index hospitalization. The intervention group received assistance with stable housing on discharge and biweekly case management services throughout the study period. Traditional care consisted of routine inpatient discharge planning and transportation to a shelter.

Patients were followed for 18 months for the primary outcomes: number of hospitalizations, total hospital days, and number of ED visits.

After adjusting for differences in baseline variables, the intervention group was found to have significantly lower rates of hospitalization (relative reduction 29%), total hospital days (29%), and ED visits (24%). The authors did not find a difference in mortality or quality of life between the two groups.

Limitations of this study include a small sample size, limited geographic distribution of subjects, and the lack of a cost-benefit analysis of the intervention.

Bottom line: Case management and housing interventions can decrease hospitalizations and ED visits among chronically ill homeless adults.

Citation: Sadowski LS, Kee RA, VanderWeele TJ, Buchanan D. Effect of a housing and case management program on emergency department visits and hospitalizations among chronically ill homeless adults: a randomized trial. JAMA. 2009;301(17):1771-1778.

Intravenous Esomeprazole Reduces Recurrent Bleeding from Peptic Ulcers

Clinical question: Does intravenous esomeprazole prevent recurrent peptic ulcer bleeding, compared with placebo?

Background: U.S. hospitals admit more than 300,000 patients per year for peptic ulcer bleeding. Asian studies of proton pump inhibitors have demonstrated improved outcomes in patients with bleeding caused by peptic ulcers, but these results have not been consistently replicated in studies in Western Europe or North America.

Study design: Randomized, placebo-controlled, double-blind trial.

Setting: Ninety-one hospital EDs in 16 countries.

Synopsis: The study team randomized 764 adult patients with a single bleeding gastric or duodenal ulcer after successful endoscopic hemostasis. The study group received esomeprazole (80 mg bolus, given intravenously over 30 minutes, followed by an 8 mg/hour infusion for 71.5 hours). The second group received placebo. Each group subsequently received 40 mg/day of oral esomeprazole for 27 days.

Recurrent bleeding within 72 hours was reduced by nearly half in the intravenous esomeprazole arm compared with placebo (5.9% vs. 10.3%, P=0.026). This remained significant at seven and 30 days. Intravenous esomeprazole also reduced endoscopic retreatment (6.4% vs. 11.6%; P=0.012) and demonstrated a trend toward reduction in surgery (2.7% vs. 5.4%) and all-cause mortality (0.8% vs. 2.1%).

Study limitations included a lack of standardization of endoscopic therapy across institutions.

Bottom line: Given after endoscopic hemostatis, intravenous esomeprazole followed by oral esomeprazole reduced recurrent bleeding in patients with a single duodenal or gastric ulcer.

Citation: Sung JJ, Barkun A, Kuipers EJ, et al. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2009;150(7):455-464.

Discharge Time and Duration Affected by Several Factors During Hospitalization

Clinical question: What are the factors affecting late and long discharges in a general medical unit?

Background: The mismatch between admission and discharge times is a problem for many hospitals; admissions occur early in the day whereas, discharges occur later in the day. The reasons behind delays in discharge and prolongation of discharges are not fully understood.

Study design: Prospective cohort study.

Setting: A general medical unit without house staff coverage at an academic medical center in Baltimore.

Synopsis: Care providers completed surveys on 201 consecutive discharges from January to April 2005. Outcome variables included time of discharge and discharge duration.

Mean discharge time was 3:09 p.m. Delay in discharge was associated with a need for ambulance transportation (1.5 hours), need for prescriptions to be filled at the hospital (1.4 hours), and for patients whose final test was a procedure (1.2 hours) or consult (1.1 hours).

Median discharge time was 7.6 hours. Longer discharge duration was associated with discharge to a location other than home (28.9 hours), need for consultation (14.8 hours), or need for a procedure (13.4 hours) before discharge.

African-American race, gender, age, and comorbid psychiatric and substance abuse disorders were not associated with either late or prolonged discharges.

Bottom line: Final-day tests, procedures, and consults, as well as complex discharge arrangements, prolong and delay discharges more than the characteristics of patients themselves.

Citation: Chen LM, Freitag MH, Franco M, Sullivan CD, Dickson C, Brancati FL. Natural history of late discharges from a general medical ward. J Hosp Med. 2009;4(4):226-233.

Administration of Parenteral Medication a Common Point at Which Errors Occur in ICUs

Clinical question: To what extent are medication administration errors a problem across ICUs, and what are some ways to prevent them?

Background: High-acuity and complex systems increase the likelihood of medical errors in ICUs. The first multinational Sentinel Events Evaluation study reported an ICU medication error rate of 10.5 per 100 patient days at the prescription and administration stages of medication delivery.

Study design: Multinational observational, prospective, cross-sectional study.

Setting: One hundred thirteen ICUs in 27 countries on five continents.

Synopsis: This study addressed five types of medication error at the administration stage in the ICU in a 24-hour timeframe: wrong drug, wrong dose, wrong route, wrong time, and missed medication. The main outcome measures were the number and impact of administration errors, the distribution of error characteristics, and the distribution of contributing and preventive factors.

In the 1,328 critically ill patients included in the study, 861 medication errors were reported by structured questionnaire; 441 patients were affected by the errors. The prevalence was 74.5 errors per 100 patient days, and 12 patients (0.9%) suffered permanent harm or death. Most medication administration errors occurred during routine care, not during extraordinary situations. Most were omission errors.

This study is limited by its observational design and by the fact that self-reporting also carries the risk of under-reporting.

This study points out several ways to reduce medication errors. An independent predictor of decreased risk of medication errors of all types is an established incident reporting system. Routine checking of infusion pumps at every nursing shift change also reduced this risk.

Bottom line: This study confirmed that the administration of parenteral medications is a vulnerable point across many ICUs, and incident reporting systems and routine checks of infusion pumps are effective ways to reduce the risk of this type of error.

Citation: Valentin A, Capuzzo M, Guidet B, et al. Errors in administration of parenteral drugs in intensive care units: multinational prospective study. BMJ. 2009;338:b814. TH


The Value of Pediatric Hospitalist Programs

By Mark Shen, MD

Reviewed by Pediatric Editor Mark Shen, MD, medical director of hospital medicine at Dell Children’s Medical Center, Austin, Texas.

Clinical question: What is the value of pediatric hospitalist programs to hospital leaders?

Background: The growth of the HM field has resulted in an increase in both the absolute number of hospitalists and hospitalist programs in the U.S. Although the clinical impact of this model generally has been favorable, most programs still require significant financial subsidies, typically from hospitals. The perspective of hospital leaders on the reasons for giving these subsidies to pediatric hospitalist programs has not been examined.

Study design: Mailed survey to hospital leaders.

Setting: Hospitals with a pediatric hospitalist program.

Synopsis: A random sample of 213 (out of 761) American Hospital Association hospitals with an HM program and pediatric beds were selected for study. One hundred twelve pediatric hospitalist programs were confirmed at these institutions, and hospital leaders (CEOs, presidents, CFOs, CMOs, or others) were surveyed from each facility. The response rate was 69%. Almost all of the pediatric hospitalist programs (78%) were subsidized, and the vast majority of hospital leaders thought the programs increased patient satisfaction (94%) and referring physician satisfaction (90%), while decreasing length of stay (81%) and adverse events (81%). The hospital leaders also identified those four factors as the primary reasons for subsidization of the HM programs.

Although virtually all hospital leaders responding to the survey thought that pediatric hospitalist programs improved patient and referring physician satisfaction, they only reported measuring this impact 80% and 66% of the time, respectively. Thus, this survey was unable to link actual outcomes, such as increased satisfaction or decreased length of stay, to increased quantity or likelihood of funding. The literature on pediatric hospitalist programs’ impact on satisfaction, quality, and safety remains sparse; however, now there is valuable information with respect to why hospital leaders subsidize these groups.

Bottom line: Hospital leaders subsidize pediatric HM programs based on the belief that the hospitalists positively impact patient and referring physician satisfaction.

Citation: Freed GL, Dunham KM, Switalski KE, et al. Assessing the value of pediatric hospitalist programs: the perspective of hospital leaders. Acad Pediatr. 2009;9(3):192-196.

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