Botulinum toxin type B vs. type A in toxin-naïve patients with cervical dystonia: Randomized, double-blind, noninferiority trial.

The objective of this study was to compare efficacy, safety, and duration of botulinum toxin type A (BoNT-A) and type B (BoNT-B) in toxin-naïve cervical dystonia (CD) subjects. BoNT-naïve CD subjects were randomized to BoNT-A or BoNT-B and evaluated in a double-blind trial at baseline and every 4-weeks following one treatment. The primary measure was the change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) from baseline to week 4 post-injection.

Vaccination success rate and reaction profile with diluted and undiluted smallpox vaccine: a randomized controlled trial.

Context: Additional smallpox vaccine doses are needed to augment current US national stockpile. Aventis Pasteur smallpox vaccine (APSV), initially manufactured in the 1950s from the New York Board of Health vaccinia strain in a frozen preparation, appears as effective as lyophilized vaccine but the effectiveness of diluted doses of APSV is unclear.

Objective: To compare the vaccination success rate and the reaction profile of various APSV dilutions.

Control of endemic vancomycin-resistant Enterococcus among inpatients at a university hospital.

We sought to determine the ability of surveillance cultures and isolation of vancomycin-resistant Enterococcus (VRE)-colonized patients to control nosocomial VRE infection and colonization during a 5-year period (November 1994 through October 1999). During this period, VRE colonization was limited to 0.82% of admissions.

Spread of methicillin-resistant Staphylococcus aureus (MRSA) among household contacts of individuals with nosocomially acquired MRSA.

Objective: To determine the frequency with which methicillin-resistant Staphylococcus aureus (MRSA) is spread from colonized or infected patients to their household and community contacts.

Design: Retrospective cohort study.

Setting: University hospital.

Depressor and tachypneic responses to chemical stimulation of the ventral respiratory group are reduced by ablation of neurokinin-1 receptor-expressing neurons.

Our goal was to investigate whether the neurokinin-1 receptor (NK1R)-expressing cells of the rostral ventrolateral medulla (RVLM) regulate respiration and arterial pressure (AP). We examined the consequences of their ablation on the cardiorespiratory responses [phrenic nerve discharge (PND) and AP] caused by injecting dl-homocysteic acid (DLH) into the ventral respiratory group (VRG). In intact rats, DLH produced tachypnea only when injected into the pre-Bötzinger complex (pre-BötC).

Evaluating sharps safety devices: meeting OSHA's intent. Occupational Safety and Health Administration.

The Occupational Safety and Health Administration (OSHA) revised the Bloodborne Pathogen Standard and, on July 17, 2001, began enforcing the use of appropriate and effective sharps devices with engineered sharps-injury protection. OSHA requires employers to maintain a sharps-injury log that records, among other items, the type and brand of contaminated sharps device involved in each injury. Federal OSHA does not require needlestick injury rates to be calculated by brand or type of device.

A hospital epidemic of vancomycin-resistant Enterococcus: risk factors and control.

Objective: To determine risk factors for vancomycin-resistant Enterococcus (VRE) colonization during a hospital outbreak and to evaluate Centers for Disease Control and Prevention (CDC)-recommended control measures.

Design: Epidemiological study involving prospective identification of colonization and a case-control study.

Setting: A university hospital.

Plasma norepinephrine and atrial natriuretic peptide in heart failure: influence of felodipine in the third Vasodilator Heart Failure Trial. V-HeFT III investigators.

Background: Reflex activation of the sympathetic nervous system by short-acting dihydropyridine calcium channel antagonists has been reported to harm hypertensive patients. Different neurohormonal profiles and their response to treatment may influence the effectiveness of dihydropyridine vasodilator treatment of heart failure.

Methods: Four hundred fifty men with left ventricular (LV) systolic dysfunction were administered standard heart failure treatment and felodipine extended release (ER) or placebo in the Vasodilator Heart Failure Trial III (V-HeFT III).

Felodipine improves left ventricular emptying in patients with chronic heart failure: V-HeFT III echocardiographic substudy of multicenter reproducibility and detecting functional change.

Background: The echocardiographic substudy of the Vasodilator-Heart Failure Trial III (V-HeFT III) aimed to determine if felodipine treatment in patients with heart failure who were taking an angiotensin-converting enzyme inhibitor had a favorable effect on left ventricular (LV) structure and function. Earlier V-HeFT trials showed that hydralazine-isosorbide dinitrate improved ejection fraction (EF) and survival, whereas enalapril achieved greater survival with smaller increases in EF. Would the combination of a potent vasodilator and enalapril produce greater improvements in function and survival?

Methods And Results: Doppler-echocardiographic data were collected from 260 males with heart failure who were randomized to felodipine or a placebo.

Risk classification after aneurysmal subarachnoid hemorrhage.

Background: Prediction of patient outcome is an important aspect of the management and study of aneurysmal subarachnoid hemorrhage (SAH). In the present study, we evaluated the prognostic value of two multivariate approaches to risk classification, Classification and Regression Trees (CART) and multiple logistic regression, and compared them with the best single predictor of outcome, level of consciousness.

Methods: Data prospectively collected in the first Cooperative Aneurysm Study of intravenous nicardipine after aneurysmal SAH (NICSAH I, n = 885) were used to develop the prediction models.

Decompressive bifrontal craniectomy in the treatment of severe refractory posttraumatic cerebral edema.

Objective: The management of malignant posttraumatic cerebral edema remains a frustrating endeavor for the neurosurgeon and the intensivist. Mortality and morbidity rates remain high despite refinements in medical and pharmacological means of controlling elevated intracranial pressure; therefore, a comparison of medical management versus decompressive craniectomy in the management of malignant posttraumatic cerebral edema was undertaken.

Methods: At the University of Virginia Health Sciences Center, 35 bifrontal decompressive craniectomies were performed on patients suffering from malignant posttraumatic cerebral edema.

Intravascular catheter colonization in critically ill children.

In a prospective study, cultures were obtained of all intravascular catheters removed from children in an intensive care unit. Of 366 catheters removed from 217 children, 110 (30%) were found to be colonized, most commonly with coagulase-negative staphylococci. Despite the high rate of colonization, there were only nine instances (2%) of catheter-related bacteremia.

Age and outcome after aneurysmal subarachnoid hemorrhage: why do older patients fare worse?

Advanced age is a recognized prognostic indicator of poor outcome after subarachnoid hemorrhage (SAH). The relationship of age to other prognostic factors and outcome was evaluated using data from the multicenter randomized trial of nicardipine in SAH conducted in 21 neurosurgical centers in North America. Among the 906 patients who were studied, five different age groups were considered: 40 years or less, 41 to 50, 51 to 60, 61 to 70, and more than 71 years.

Gender-related differences in aneurysmal subarachnoid hemorrhage.

Female gender is a recognized risk factor for the occurrence of aneurysmal subarachnoid hemorrhage. In the present study the authors analyzed differences in admission characteristics and outcome between 578 women (64%) and 328 men (36%) who were enrolled in a recently completed clinical trial. The female-to-male ratio was nearly 2:1.

Preventing pneumococcal bacteremia in patients at risk. Results of a matched case-control study.

Background: Three randomized controlled trials of the effectiveness of pneumococcal vaccine in elderly and chronically ill adults in the United States have failed to show significant protective efficacy during 44,213 person-years of follow-up. Case-control studies have greater statistical power to detect significant prevention of rare diseases such as pneumococcal bacteremia, but they also have a greater susceptibility to bias, necessitating consistent results from multiple studies. Three case-control studies at two different universities have shown prevention of systemic infection, but another study found no benefit.

Multivariate analysis and prediction of outcome following penetrating head injury.

Schemes for predicting outcome in craniocerebral missile injury have ranged from Cushing's analysis that was based on the physical characteristics of the injury to complex logistic analyses that incorporate radiographic, laboratory, and clinical data. Generation of predictive scales is discussed, focusing on the utility of the Glasgow Coma Scale (GCS) score at presentation, presence or absence of coagulopathy, and radiographic evidence of the volume and type of tissue damage.

A randomized trial of intraoperative, intracisternal tissue plasminogen activator for the prevention of vasospasm.

A multicenter, randomized, blinded, placebo-controlled trial was conducted to study the possible role of intracisternally administered fibrinolytic agent recombinant tissue plasminogen activator (rt-PA) in preventing delayed onset cerebral vasospasm following aneurysmal subarachnoid hemorrhage (SAH). The target population was patients with ruptured saccular aneurysms causing severe SAH, placing them at high risk for vasospasm. Treatment consisted of a single 10 ml intraoperative injection of either vehicle buffer solution or rt-PA (1 mg/ml) into the opened basal subarachnoid cisterns immediately following aneurysm clipping.

A simple measure in defining optimal strata in clinical trials.

This paper deals with balancing groups with respect to prognostic factors in clinical trials, as a means of increasing the power of a study. We use the Mantel-Haenszel statistic to obtain a simple measure for assessing the relative efficiency of different factors for stratification and to find optimal cutpoints for the given factors. For any available database, the measure can be used to construct optimal strata for a clinical trial.

Medical complications of aneurysmal subarachnoid hemorrhage: a report of the multicenter, cooperative aneurysm study. Participants of the Multicenter Cooperative Aneurysm Study.

Objectives: This report examines the frequency, type, and prognostic factors of medical (nonneurologic) complications after subarachnoid hemorrhage in a large, prospective study. The influences of contemporary neurosurgical, neurological, and critical care practice on mortality and morbidity rates after aneurysmal subarachnoid hemorrhage are evaluated.

Design: A study of medical complications observed in the placebo limb of a large, randomized, controlled trial of the calcium antagonist, nicardipine, after subarachnoid hemorrhage.

Temporal profile of outcomes in severe head injury.

The authors present data describing the temporal progress of 786 severely head-injured patients from discharge to 12 months postinjury. Changes in outcome over time are characterized and the effects on these changes of patient age, Glasgow Coma Scale score, pupillary response, and type of injury are investigated. The feasibility of using these factors and the outcome at 3 months postinjury to predict the outcome at 6 months post-trauma is explored via logistic regression analysis.

A randomized trial of two doses of nicardipine in aneurysmal subarachnoid hemorrhage. A report of the Cooperative Aneurysm Study.

High-dose intravenous nicardipine has been shown to reduce the incidence of angiographic and symptomatic vasospasm in patients with aneurysmal subarachnoid hemorrhage (SAH), but treatment may be complicated by side effects, including hypotension or pulmonary edema/azotemia. From August, 1989, to January, 1991, 365 patients at 21 neurosurgical centers were entered into a randomized double-blind trial comparing high-dose (0.15 mg/kg/hr) nicardipine with a 50% lower dose (0.

Plasma glucose levels and outcome after aneurysmal subarachnoid hemorrhage.

Plasma glucose levels were studied in 616 patients admitted within 72 hours after subarachnoid hemorrhage (SAH). Glucose levels measured at admission showed a statistically significant association with Glasgow Coma Scale scores, Botterell grade, deposition of blood on computerized tomography (CT) scans, and level of consciousness at admission. Elevated glucose levels at admission predicted poor outcome.

Classification of civilian craniocerebral gunshot wounds: a multivariate analysis predictive of mortality.

Management of cerebral gunshot injuries has changed considerably since Cushing's (1916) and Matson's (1948) classification schemes, developed during World War I and World War II, respectively. These military injuries are characterized by either very high mass, low-velocity shrapnel wounds or by high muzzle velocity missiles causing extensive destruction of tissue. The preponderance of low muzzle velocity weapons seen in clinical practice and the availability of computed tomographic (CT) evaluation within minutes after presentation has altered the range of prognostic indicators available to the neurosurgeon and the amount of relative importance placed on each factor.

Intravascular catheter colonization and related bloodstream infection in critically ill neonates.

Intravascular catheter tip colonization was prospectively evaluated in critically ill neonates to determine its relationship to the type of device used, duration of catheterization, insertion site and nosocomial bloodstream infection. Sixty-one percent (376 of 621) of all intravascular catheter tips were retrieved from 91 infants. Thirteen percent (41 of 310) of peripheral intravenous, 14% (6 of 42) of umbilical, 21% (3 of 11) of central venous, 36% (4 of 11) of peripheral arterial and 100% (2 of 2) of femoral catheters were colonized.