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Biomedical subjects

T P Germanson

Publications and source records attributed to T P Germanson.

11 recordsLinked to original sources

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. PARTICIPANTS: Patients on eight wards involved in outbreak from late 1994 through early 1995. METHODS: Cases were matched by ward and culture date with up to two controls. Risk factors were evaluated with four multivariate models using conditional logistic regression. The first evaluated proximity to other VRE patients and isolation status. The second evaluated proximity to unisolated VRE cases and three variables independently predictive after adjustment for proximity. The third evaluated seven significant univariate predictors in addition to proximity to unisolated VRE in backward, stepwise logistic regression. The fourth assessed proximity to VRE with all other variables collected, clustered in a principal components analysis. Pulsed-field gel electrophoresis was performed to assess clonality of two outbreak strains. RESULTS: The incidence of transmission declined significantly after CDC guidelines were implemented. Proximity to unisolated VRE cases during the prior week was a significant predictor of acquisition in each of four multivariate models. Other significant risk factors in multivariate models included a history of major trauma and treatment with metronidazole. Pulsed-field gel electrophoresis confirmed the clonality of two outbreak strains. CONCLUSIONS: VRE was transmitted between patients during a hospital epidemic, with proximity to previously unisolated VRE patients being an important risk factor. Weekly surveillance cultures and contact isolation of colonized patients significantly reduced spread

Adolescent↗

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 sufficient sample size to show a valid comparison of safety devices, based on injury rates, is rarely feasible in a single facility outside of a formal research trial. Thus, calculations of injury rates should not be used by employers for product evaluations to compare the effectiveness of safety devices. This article provides examples of sample-size requirements for statistically valid comparisons, ranging from 100,000 to 4.5 million of each device, depending on study design, and expected reductions in needlestick injury rates.

Blood-Borne Pathogens↗

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. Low-, medium-, and high-risk groups for unfavorable outcome were devised using CART and a stepwise logistic regression analysis. Admission factors incorporated into both classification schemes were: level of consciousness, age, location of aneurysm (basilar versus other), and the Glasgow Coma Score. The CART prediction tree also branched on a dichotomy of admission glucose level. The two multivariate classifications were then compared with a prediction scheme based on the single best performing prognostic factor, level of consciousness in an independent series, NICSAH II (n = 353), and also in the original training dataset. RESULTS: A similar discrimination of risk was achieved by the three classification systems in the testing sample (NICSAH II). The 8%, 19%, and 52% rates of unfavorable outcome obtained from low-, medium-, and high-risk groups defined by LOC approximated those obtained using the more complex multivariate systems. CONCLUSION: Although multivariate classification systems are useful to characterize the relationship of multiple risk factors to outcome, the simple clinical measure LOC is favored as a concise and practical classification for predicting the probability of unfavorable outcome after aneurysmal SAH.

Calcium Channel Blockers↗

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.

Bacteremia↗

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. The women in the study were older than the men (mean age 51.4 years vs 47.3 years, respectively, p<0.001). Female patients harbored aneurysms of the internal carotid artery more frequently than male patients (36.8% vs. 18.0%, p<0.001) and more often had multiple aneurysms (32.4% vs. 17.6%, p<0.001). On the other hand, anterior cerebral artery aneurysms were more commonly encountered in men (46.1% in men vs. 26.6% in women, p<0.001). Other baseline prognostic factors were balanced between the gender groups. Surgery was performed equally in both sexes (98%), although the time to operation was shorter for women (mean 3.6 days for women vs. 5.3 days for men, p = 0.0002). In the placebo group, the occurrence of vasospasm was not statistically different between the two groups. Primary causes of death and disability were the same, and favorable outcome rates at 3 months were not statistically different between the genders (69.7% for women vs. 73.4% for men, p = 0.243). The odds of a favorable outcome in women versus one in men were not statistically significant either before of after adjustment for age. These observations lead the authors to suggest that although women are older and harbor more aneurysms, the 3-month outcome for women and men who experience aneurysmal subarachnoid hemorrhage is the same.

Adult↗

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. Twenty-three percent of the individuals enrolled were older than 60 years of age. Women outnumbered men in all age groups. Level of consciousness (p = 0.0002) and World Federation of Neurological Surgeons grade (p = 0.0001) at admission worsened with advancing age. Age was also related to the presence of a thick subarachnoid clot (p = 0.0001), intraventricular hemorrhage (p = 0.0003), and hydrocephalus (p = 0.0001) on an admission computerized tomography scan. The rebleeding rate increased from 4.5% in the youngest age group to 16.4% in patients more than 70 years of age (p = 0.002). As expected, preexisting medical conditions, such as diabetes (p = 0.028), hypertension (p = 0.0001), and pulmonary (p = 0.0084), myocardial (p = 0.0001), and cerebrovascular diseases (p = 0.0001), were positively associated with age. There were no age-related differences in the day of admission following SAH, timing of the surgery and/or location, and size (small vs. large) of the ruptured aneurysm. During the treatment period, the incidence of severe complications (that is, those complications considered life threatening by the reporting investigator) increased with advancing age, occurring in 28%, 33%, 36%, 40%, and 46% of the patients in each advancing age group, respectively (p = 0.0002). No differences were observed in the reported frequency of surgical complications. No age-related differences were found in the overall incidence of angiographic vasospasm; however, symptomatic vasospasm was more frequently reported in the older age groups (p = 0.01). Overall outcome, assessed using the Glasgow Outcome Scale at 3 months post-SAH, was poorer with advancing age (p < 0.001). Multivariate analysis of overall outcome, adjusting for the different prognostic factors, did not remove the age effect, which suggests that the aging brain has a less optimal response to the initial bleeding. Age as a risk factor is a continuum; however, there seems to be a significant increased risk of poor outcome after the age of 60 years.

Adult↗

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. METHODS: Patients with pneumococcal bacteremia who were at least 2 years old and had chronic illness indicating the need for pneumococcal vaccine, or who were at least 65 years old were compared with matched control subjects for frequency of prior vaccination. Matching variables included date of admission, age, sex, race, type and duration of chronic illness serving as the major vaccine indication, number of vaccine indications and number of medical hospitalizations since licensure of the pneumococcal vaccine in 1978, and type of primary medical care. RESULTS: Pneumococcal vaccination was documented in the records of six (7%) of 85 cases and 26 (17%) of 152 control subjects, suggesting 81% efficacy in conditional logistical regression analysis (95% confidence interval, 34% to 94%, P = .008). CONCLUSIONS: Four case-control studies at three universities have now demonstrated significant protective efficacy of pneumococcal vaccine for preventing pneumococcal bacteremia. The development of antibiotic-resistant Streptococcus pneumoniae indicates an urgent need for an increased rate of vaccination among high-risk patients and for the development of more immunogenic conjugate vaccines that may enhance efficacy among elderly and immunocompromised patients as well as infants.

Adolescent↗

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. The paper also presents a practical approach for reducing the number of strata using discriminant regions with a method of assessing the effectiveness of this approach. An example from a large database of severe head trauma patients illustrates the utility of the measure.

Clinical Trials as Topic↗

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 (0.075 mg/kg/hr) administered by continuous intravenous infusion for up to 14 days following SAH. Patients in all neurological grades were eligible for the study. During the study period, 184 patients were randomly assigned to receive high-dose nicardipine and 181 to receive the low dose. There were no significant differences in patient age, admission neurological condition, or amount and distribution of blood clot on initial computerized tomography scan. Patients in the high-dose group received a significantly smaller proportion of the planned dose than those in the low-dose group (80% +/- 0.2% vs. 86% +/- 0.2%, p < 0.05), largely because of premature treatment termination after adverse medical events. The incidence of symptomatic vasospasm was 31% in both groups, and the overall 3-month outcomes were nearly identical. These data suggest that, from a clinical standpoint, the results of high-dose and low-dose nicardipine treatment are virtually equivalent, but administration of low-dose nicardipine is attended by fewer side effects.

Adult↗

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. Duration of catheterization was significantly longer for colonized lines (p less than .001). Eight of 26 (30.8%) peripheral intravenous catheters remaining in place for more than three days were colonized, compared with 33 of 284 (11.6%) at three days or less (p = 0.012). Coagulase-negative staphylococcus was the organism most frequently isolated from catheter tips and bloodstream infections. Catheter colonization rates in this population were higher than those found in adults. Heavily manipulated devices and those in place for longer periods of time were the most frequently colonized.

Age Factors↗

The contribution of blast cell properties to outcome variation in acute myeloblastic leukemia (AML).

The blast cell population in AML includes progenitors capable of colony formation in culture. Certain properties of these progenitors have been determined, including their capacity for self-renewal and their sensitivities to the chemotherapeutic drugs cytosine arabinoside (Ara-C) and adriamycin (Adria). Wide patient to patient variation was found in these properties, although they were stable during the course of the disease in each patient. We tested the properties, together with clinical risk factors, as attributes contributing to the variation in remission induction and survival. As univariate parameters, self-renewal and Ara-C sensitivity contributed to remission induction, but only self-renewal was related to survival. In multivariate analysis, self-renewal, age and percentage blasts in the marrow contributed to outcome variation; drug sensitivities were not significant. We conclude that self-renewal, a biological property of malignant AML clones, although measured in culture, plays a significant role in determining response to treatment and survival in AML.

Analysis of Variance↗