Medicolegal Issues

In the Literature


In This Edition

CDAD is associated with high 30-day mortality rate but no less attributable mortality. Preventing horizontal transmission in the hospital may reduce mortality.

Does Ambulatory Use of Statins, Beta-blockers Reduce Mortality After Vascular Surgery?

Background: Mortality for vascular surgery remains high. Considering promising new data on use of perioperative statins, the question is, does use of statins and/or beta-blockers within 30 days of surgery reduce long-term mortality? Long-term post-operative mortality has not commonly been reported.

Study design: A retrospective observational cohort study.

Setting: Five Veterans Affairs (VA) medical centers in four western states.

Synopsis: Data were gathered from the regional Department of Veterans Affairs administrative and relational database for the 3,062 patients who had vascular surgery at five VA medical centers from January 1998 to March 2005. All had decreased long-term mortality after vascular surgery when they started taking beta-blockers or statins or both within 30 days before or after surgery, compared with patients taking neither drug. Higher-risk patients benefited the most from combination therapy with statins and beta-blockers, with a 33% reduction in mortality after two years.

Study results were limited by several factors, most related to the study’s retrospective nature. There were differences between users and non-users of statins and beta-blockers. Use of the medications was not random, only 1% of study participants were women, and perhaps most importantly, information regarding tobacco use was available for only 47% of the patients.

Bottom Line: The use of statins and beta-blockers in combination should be considered for all patients undergoing vascular surgery.

Citation: Barrett TW, Mori M, DeBoer D. Association of ambulatory use of statins and beta-blockers with long-term mortality after vascular surgery. J Hosp Med. 2007; 2(4):241-252.


Antimicrobial-Impregnated Urinary Catheter Decreases Bacteriuria, Funguria

Randomized controlled trial demonstrated that the use of nitrofurazone (Furacin)-impregnated urinary catheters in place of standard silicone catheters reduced the incidence of catheter-associated bacteriuria and funguria in trauma patients..

Citation: Stensballe J, Tvede M, Looms D, et al. Infection risk with nitrofurazone-impregnated urinary catheters in trauma patients. Ann Intern Med. 2007;147:285-293.

Pioglitazone May Decrease Risk of Death, Increase Risk of Serious Heart Failure

Meta-analysis of data from the drug manufacturer suggested lower death, nonfatal myocardial infarction (MI), and nonfatal stroke in diabetics taking pioglitizone (Actos) along with an increase in serious heart failure, without associated mortality..

Citation: Lincoff MA, Wolski K, Nicholls SJ, et al. Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus. JAMA. 2007;298(10):1180-1188.

Rosiglitazone Appears to Increase MI, Heart Failure

Meta-analysis suggested increased risk of MI and heart failure in patients taking rosiglitizone for more than a year but no significant increase in cardiovascular mortality.

Citation: Singh S, Loke YK, Furberg CD. Long-term risk of cardiovascular events with rosiglitazone. JAMA. 2007;298(10):1189-1195.

ACGME Duty-Hour Reform Does Not Increase Mortality in Medicare Patients

Observational study demonstrating duty-hour changes instituted by the Accreditation Council for Graduate Medical Education

(ACGME) two years prior to the study did not show a change in mortality among Medicare patients in teaching and non-teaching hospitals.

Citation: Volpp KG, Rosen AK, Rosenbaum PR, et al. Mortality among hospitalized Medicare beneficiaries in the first two years following ACGME resident duty hour reform. JAMA. 2007;298(9):975-983.

ACGME Duty-Hour Reform Decreases Mortality among VA Medical Patients

Observational study demonstrating ACGME duty-hour changes instituted two years prior to the study showed a reduction in mortality for selected medical diagnoses in patients in teaching-intensive VA hospitals.

Citation: Volpp KG, Rosen AK, Rosenbaum PR, et al. Mortality among patients in VA hospitals in the first 2 years following ACGME resident duty hour reform. JAMA. 2007;298(9):984-992.

In-Hospital Hypoglycemia Common without Attempting Tight Glycemic Control

Prospective, single-institution review reveals that with usual care, almost 10% of hospitalized patients treated with anti-hyperglycemic agents experience hypoglycemia and 4% of hypoglycemic episodes result in adverse events.

Citation: Varghese P, Gleason V, Sorokin R, et al. Hypoglycemia in hospitalized patients treated with antihyperglycemic agents. J Hosp Med. 2007;2:234-240.

What Are the Presenting Characteristics of Patients with PE?

Background: The identification of patients who should undergo diagnostic testing for pulmonary embolism (PE) rests on the identification of clinical signs and symptoms. Because these findings are frequently subtle, diagnosis of PE is often delayed or missed.

Study design: Prospective multicenter study.

Setting: Eight academic centers, using a study focusing on inpatients and outpatients.

Synopsis: The most common clinical symptoms associated with PE were the hemoptysis/pleuritic chest pain syndrome (44%) and uncomplicated dyspnea (36%). Circulatory collapse was uncommon (8%). The most common presenting signs were tachypnea (57%), orthopnea (36%), tachycardia (26%), decreased breath sounds (21%), and crackles (21%). Neither oxygen saturation nor the A-a gradient provides useful diagnostic value in excluding PE.

Compared with segmental pulmonary artery embolism, proximal pulmonary emboli more often presented with typical signs and symptoms. Dyspnea, tachypnea, or pleuritic chest pain occurred in 77% of patients with segmental artery embolism.

Bottom Line: Because symptoms may be mild or even absent, a high level of clinical suspicion is critical for identifying patients in whom further diagnostic testing for pulmonary embolism is warranted.

Citation: Stein PD, Afzal B, Fadi M, et al. Clinical characteristics of patients with acute pulmonary embolism: Data from PIOPED II. Am J Med. 2007;120:871-879.

What Incidence, Risk Factors, and Outcomes Are Associated with Upper-Extremity DVT?

Background: The incidence of upper-extremity deep-vein thrombosis (DVT) is increasing although the risk factors and clinical outcomes are not as well established as for lower-extremity DVT.

Study design: Retrospective observational study.

Setting: Twelve hospitals serving the community of Worchester, Mass.

Synopsis: In this study of 483 people with DVT, the incidence of lower-extremity DVT was six times as common as upper-extremity DVT. The risk factor most strongly associated with upper-extremity DVT was a history of a recent indwelling central venous catheter. In this study, patients with upper-extremity DVT (69) were less likely to receive long-term anticoagulation with warfarin (Coumadin) than patients with lower-extremity DVT, although there were no differences in observed outcomes.

Recurrent upper-extremity DVT occurred in 10 of the 69 patients. Only one patient (1.5%) with an upper-extremity DVT suffered a PE, compared with 15% of patients with lower-extremity DVT.

There was not a significant incidence of PE associated with upper-extremity DVT in this study because of the low number of cases of upper-extremity DVTs (n=69). But hospitalists should not use the data to infer that upper-extremity DVT is a benign condition not requiring aggressive treatment.

Bottom Line: Upper-extremity DVT is strongly associated with central venous catheters. Further study is needed to define its appropriate treatment, possible prophylaxis, and associated morbidity.

Citation: Spencer FA, Emery C, Lessard D, et al. Upper extremity deep vein thrombosis: a community-based perspective. Am J Med. 2007;120:678-684.

What Are Hospital Mortality Risk Factors among Critically Ill CDAD Patients?

Background: C. difficile-associated disease (CDAD) is an important hospital-acquired infection among critically ill patients. Risk factors for hospital mortality in critically ill patients with CDAD have not previously been identified.

Study design: A retrospective, single-center, observational, cohort study.

Setting: A 1,200-bed urban teaching facility.

Synopsis: During a two-year period, all patients in the ICU setting with a diagnosis of CDAD were evaluated. CDAD was defined by the presence of diarrhea or pseudomembranous colitis and a positive assay finding for C. difficile toxin A, toxin B, or both.

A crude 30-day mortality rate of 36.7% was found for patients with CDAD in the ICU setting. Significant risk factors for 30-day mortality included greater severity of illness, the presence of septic shock, and having CDAD develop on the hospital ward prior to ICU transfer. Mortality attributable to CDAD was relatively low (6.1%). CDAD was associated with an excess LOS in the ICU (2.2 days) and hospital LOS (4.5 days).

Bottom Line: CDAD is associated with high 30-day mortality rate but no less attributable mortality. Preventing horizontal transmission in the hospital may reduce mortality.

Citation: Kenneally C, Rosini JM, Skrupky LP, et al. Analysis of 30-day mortality for C. difficile-associated disease in the ICU setting. Chest. 2007;132:418-424.

Do Standardized Order Sets, Intensive Case Management Reduce LOS in CAP Patients?

Background: Community-acquired pneumonia (CAP) results in significant costs to the healthcare system. Length of stay (LOS) affects cost as well as risk for hospital-acquired medical complications. CAP studies have found that guideline adherence improves outcomes such as mortality but does not reduce LOS.

Study design: Sequential course of study with three consecutive blocks of patients.

Setting: Single-institution teaching hospital.

Synopsis: Three consecutive blocks of approximately 110 patients were enrolled. Block 1 patients underwent treatment not guided by order sets or case management. For block 2 patients, clinicians were reminded to use the order sets. If the care processes were not completed, case managers (trained medical residents) would intervene. Emphasis was placed on prompting for timely conversion to oral antibiotics and discharge.

For block 3 patients, clinicians were reminded to use order sets, but no case management was involved. Among the groups, no difference in pneumonia severity or time to clinical stability was found. The mean LOS was 8.8 days in block 1, 5.3 days in block 2, and 7.3 days in block 3.

Order sets (block 3) reduced LOS by 1.5 days (p=0.01) over conventional therapy (block 1). Order sets combined with case management (block 2) reduced LOS by 3.5 days (p<0.001) over conventional therapy.

Bottom Line: Standardized order sets combined with intensive case management reduce LOS in CAP. However, the cost effectiveness and long-term application of this approach are uncertain.

Citation: Fishbane S, Niederman MS, Daly C, et al. The impact of standardized order sets and intensive clinical case management on outcomes in community-acquired pneumonia. Arch Intern Med. 2007;167:1664-1669.

Glycemic control in non-critically ill hospitalized patients appears limited by failure to change treatment when indicated (clinical inertia) and diminution of treatment despite ongoing hyperglycemia (negative therapeutic momentum).

Do Daily Chest Radiographs Have Diagnostic, Therapeutic Value in Medical-Surgical ICUs?

Background: The American College of Radiology recommends daily chest radiographs (CXR) on patients in the intensive care unit (ICU), regardless of the patient’s clinical status. Previous non-blinded studies suggested CXR should be obtained in the ICU only when clinically indicated but did not address the utility of routine daily CXR in finding unsuspected pathology.

Study design: Prospective controlled study.

Setting: University-affiliated hospital ICU in the Netherlands.

Synopsis: For one year, 1,780 daily routine CXR on 559 ICU admissions were reviewed by a radiologist and blinded to the attending physician, who could view radiographs ordered with a clinical indication.

Daily CXR assisted in a diagnosis in 4.4% of cases, most frequently detecting infiltrates or tracheal tube malposition. These findings resulted in a change in clinical management in only 1.9% of the total. For the following six months, daily CXR was abandoned and data were collected on ICU length of stay, readmission, mortality, and cost. The study was not powered to detect differences between the two groups.

This is an observational study that does not provide outcome data on routine daily CXR in either specific disease states or on general ICU patients. Also, the mixed medical-surgical ICU setting may be difficult to generalize to some hospitalists’ practices.

Bottom Line: Routine daily CXR in the medical-surgical ICU has a low diagnostic and therapeutic value.

Citation: Hendrikse KA, Gratama JW, Jove W, et al. Low value of routine chest radiographs in a mixed medical-surgical ICU. Chest. 2007;132:823-828.

Does Frequent Nocturnal Hemodialysis Reduce LV Mass in Patients with ESRD?

Background: Left ventricle (LV) hypertrophy, heart failure, and sudden cardiac death are responsible for significant morbidity and mortality in patients with end-stage renal disease (ESRD). In the general population, reduction of LV mass lowers risk of major cardiovascular events. Some evidence suggests that nocturnal hemodialysis reduces LV mass and blood pressure, and improves mineral metabolism.

Study design: Small randomized controlled trial.

Setting: Two university medical centers in Alberta, Canada.

Synopsis: Fifty-two hemodialysis patients were randomized to receive nocturnal hemodialysis six times weekly or conventional hemodialysis three times weekly. Cardiovascular magnetic resonance imaging assessed LV mass at the beginning and end of six months. Secondary outcomes included health-related quality of life, predialysis systolic blood pressure, and calcium-phosphate product.

LV mass decreased with nocturnal hemodialysis (p=.04). Average systolic blood pressure dropped 7 mm Hg despite antihypertensive medication reductions or discontinuation in many patients receiving nocturnal hemodialysis. The calcium-phosphate product decreased, thus reducing the need for phosphate binders and calcium supplementation. No significant effect on health-related quality of life was found in the primary analysis; however, a small improvement was seen in the nocturnal hemodialysis arm when comparing values from the time of randomization and six months.

The outcomes measured were not validated in patients with ESRD. The dose of dialysis was not compared between the two groups. Confidence intervals were wide and the duration of follow-up limited. The study was underpowered for differences in mortality, quality of life, or adverse event rates.

Bottom Line: Frequent nocturnal hemodialysis may improve cardiovascular outcomes, reduce the need for medications, and enhance quality of life for patients with ESRD having the physical and mental capacity to perform it safely.

Citation: Culleton BF, Walsh M, Klarenbach SW, et al. Effect of frequent nocturnal hemodialysis vs. conventional hemodialysis on left ventricular mass and quality of life. JAMA. 2007;298(11):1291-1299.

Is Glycemic Control in Non-critically Ill Hospitalized Patients Adequate?

Background: In-hospital hyperglycemia is associated with adverse outcomes. Recent guidelines support tight glycemic control for most hospitalized patient populations. Little is known about the current practice of glycemic control in non-critically ill patients.

Study design: Retrospective cohort analysis.

Setting: A 200-bed tertiary-care U.S. teaching hospital.

Synopsis: Hospital databases were reviewed for 2,916 non-critically ill patients discharged after three days with a diagnosis of diabetes or hyperglycemia. Glycemic control was assessed by blood glucose (BG) measurement during the first 24 hours, BG prior to discharge, and overall hospital stay.

Hyperglycemia (BG more than 200 mg/dL) occurred in 20% to 25% of patients throughout the hospital stay or during the first or final 24 hours. The same percentage had at least one hypoglycemic episode (BG less than 70 mg/dL). Most patients received insulin, either alone or in combination with oral agents. Of those, 58% received short-acting bolus insulin, while only 42% were treated with basal-bolus insulin regimens. Insulin administered during the first and the final 24 hours increased in 54% of patients, decreased in 39%, and remained unchanged in 7%. Almost one-third had reductions in insulin therapy despite persistent hyperglycemia.

This single-site study did not distinguish between pre-existing diabetes, unrecognized diabetes, or stress-induced hyperglycemia. The electronic databases did not permit analysis of clinical decision-making behavior or the nutritional support utilized to explain the findings.

Bottom Line: Glycemic control in non-critically ill hospitalized patients appears limited by failure to change treatment when indicated (clinical inertia) and diminution of treatment despite ongoing hyperglycemia (negative therapeutic momentum).

Citation: Cook CV, Castro JC, Schmidt RE, et al. Diabetes care in hospitalized noncritically ill patients: More evidence for clinical inertia and negative therapeutic momentum. J Hosp Med. 2007;2:203-211.

Does Carvedilol Significantly Improve Outcomes in Youths with Symptomatic Systolic Heart Failure?

Background: Although beta-blockers improve symptoms and survival in adults with heart failure, little is known about these medications in children and adolescents. Treatment recommendations in children and adolescents with heart failure usually must be extrapolated from the results of clinical trials conducted in adults.

Study design: A multicenter, randomized, double-blind placebo controlled study.

Setting: 26 U.S. hospitals.

Synopsis: 161 children and adolescents with symptomatic systolic heart failure on conventional heart failure medications were randomized in a 1:1:1 ratio to twice-daily dosing with placebo, low-dose carvedilol (Coreg) or high-dose carvedilol for eight months. Patients were determined to have a response of worsened, improved, or unchanged, based on variables involving a change in New York Heart Association class, hospitalization requiring IV medications, or withdrawal from the study for treatment failure or lack of therapeutic response.

Carvedilol had no significant effect on the primary end points above, although there may have been some difference in benefit based on ventricular morphology. Because fewer patients overall experienced worsening of their heart failure than expected and because of the high rate of spontaneous improvement seen, the study may have been underpowered. Randomized clinical trials in pediatrics are exceedingly rare, and trials that are done routinely have study populations far smaller than this one.

Bottom Line: Carvedilol has not been shown to benefit children and adolescents with symptomatic systolic heart failure.

Citation: Shaddy RE, Boucek MM, Hsu DT, et al. Carvedilol for children and adolescents with heart failure: a randomized controlled trial. JAMA. 2007; 298(10):1171-1179. TH

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