Body weight and prognosis in breast cancer.

We have examined the relationship between risk factors for breast cancer incidence and the subsequent prognosis of breast cancer among patients in a randomized controlled trial of adjuvant ovarian ablation. Body weight was the only risk factor found to be associated with statistically significant differences in survival. This finding could not be explained by a disproportionate number of anatomically more advanced tumors in the heavier women. In premenopausal women aged 45 years or more, the only group to benefit from adjuvant ovarian ablation, there was an interaction of treatment and weight, suggesting that weight exerts its influence on prognosis by a hormonal mechanism. The prognostic effect of weight was generally most marked in patients with tumors whose prognostic characteristics were favorable, and in these patients weight loss as an adjuvant treatment may reduce the frequency of disease recurrence.

The prevalence of psychiatric disorders in patients with alcohol and other drug problems.

A survey evaluated the lifetime and current prevalence of mental disorders in 501 patients seeking assistance with alcohol and other drug problems at an addiction research and treatment facility. Information was gathered using the National Institute of Mental Health Diagnostic Interview Schedule (DIS) and computer diagnoses were generated according to DSM-III criteria. Four fifths (78%) of the sample had a DIS lifetime psychiatric disorder in addition to substance use, and two thirds (65%) had a current DIS mental disorder. Excluding the unreliably diagnosed generalized anxiety disorder, the most common lifetime disorders were antisocial personality disorder, phobias, psychosexual dysfunctions, major depression, and dysthymia. Patients who abused both alcohol and other drugs were the most psychiatrically impaired. Patients with DIS psychiatric disorders had more severe alcohol and other drug problems. Barbiturate/sedative/hypnotic, amphetamine, and alcohol abusers were the most likely to have a DIS mental disorder.

The frequency of malignant neoplasms in patients with polymyositis-dermatomyositis. A controlled study.

Seventy-one patients with polymyositis-dermatomyositis (PM/DM) admitted to the Wellesley Hospital Rheumatic Disease Unit (RDU) in Toronto between 1965 and 1980 were followed up to 1981. The frequencies of malignant neoplasms occurring prior to or concurrent with initial RDU admission were compared, using case-control methods, with age- and sex-matched control groups with a diagnosis of any non-PM/DM rheumatic disease (rheumatic disease controls) or osteoarthritis, fibrositis, or fracture (noninflammatory musculoskeletal controls). In a cohort analysis, the incidence of malignant neoplasm subsequent to initial RDU admission in patients with PM/DM was compared with the expected incidence in the Canadian population. Fifteen of 71 patients with PM/DM had an antecedent or concurrent cancer compared with four of 71 rheumatic disease controls and one of 71 noninflammatory musculoskeletal controls. Cohort analysis showed no increase in the number of subsequent malignant neoplasms in patients with PM/DM compared with the age- and sex-matched Canadian population.

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.

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. Raimondi and Samuelson (1970) noted this difference in wound ballistics and offered a classification scheme based on initial neurologic assessment. No well-defined classification system for civilian craniocerebral gunshot wounds has been proposed that evaluates and integrates clinical, laboratory, and neuroradiologic data. A retrospective study was performed on all 62 civilians with gunshot wounds to the head admitted to the University of Virginia Hospital between December, 1984, and November, 1990. The patient population consists of 86% males and 14% females, with an age range of 10-72 years; 60% self-inflicted wounds and 32% patients who died en route or immediately upon arrival at the hospital. The overall mortality rate was 55% at 1 week postinjury. Although we have demonstrated an association between some previously defined factors and prognosis in civilian injury, such as admission Glasgow Coma Scale (GCS) (p = 0.001) and initial pupillary response (p less than 0.001), we have also defined other significant predictors of outcome including abnormal coagulation states on admission (p less than 0.001) and the neuroradiologic examination.(ABSTRACT TRUNCATED AT 250 WORDS)

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.

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.

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.

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

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. A control population was formed of patients whose data was accrued in the Traumatic Coma Data Bank. Patients who had undergone surgery were matched with one to four control patients based on sex, age, preoperative Glasgow Coma Scale scores, and maximum preoperative intracranial pressure (ICP). RESULTS: The overall rate of good recovery and moderate disability for the patients who underwent craniectomies was 37% (13 of 35 patients), whereas the mortality rate was 23% (8 of 35 patients). Pediatric patients had a higher rate of favorable outcome (44%, 8 of 18 patients) than did adult patients. Postoperative ICP was lower than preoperative ICP in patients who underwent decompression (P = 0.0003). Postoperative ICP was lower in patients who underwent surgery than late measurements of ICP in the matched control population. A statistically significant increased rate of favorable outcomes was seen in the patients who underwent surgery compared to the matched control patients (15.4%) (P = 0.014). All patients who exhibited sustained ICP values above 40 torr and those who underwent surgery more than 48 hours after the time of injury did poorly. Evaluation of the 20 patients who did not fit into either of those categories revealed a 60% rate of favorable outcome and a statistical advantage over control patients (P = 0.0001). CONCLUSION: Decompressive bifrontal craniectomy provides a statistical advantage over medical treatment of intractable posttraumatic cerebral hypertension and should be considered in the management of malignant posttraumatic cerebral swelling. If the operation can be accomplished before the ICP value exceeds 40 torr for a sustained period and within 48 hours of the time of injury, the potential to influence outcome is greatest.

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. The major efficacy endpoint in this trial was angiographic vasospasm, and the major safety concern was intracranial hemorrhage. One hundred patients were randomized, 49 to placebo and 51 to rt-PA treatment. Baseline population characteristics were similar between the two groups. Severity of intracranial hemorrhage on computed tomographic scans was also similar between groups: 87.2% of both placebo and rt-PA treated patients had thick subarachnoid clots, and the rates for intracerebral and intraventricular hemorrhage were, respectively, 16.3% and 22.5% for placebo and 23.5% and 21.6% for rt-PA. Nine randomized patients did not receive treatment in the operating room, and in 8 this was due to conditions felt unsafe for the administration of a fibrinolytic agent. The overall incidence of angiographic vasospasm measured between the seventh and eleventh day following SAH was similar between the two groups, with arterial narrowing detected in 74.4% of dosed placebo patients and 64.6% of rt-PA treated patients. However, there was a trend toward lesser degrees of vasospasm in the rt-PA treated group. The rates for no or mild, moderate, and severe vasospasm were 69%, 16% and 15% in the rt-PA treated group, versus 42%, 35% and 23% in the placebo group (P = 0.07). When only those patients with thick subarachnoid clots were considered at the treating centers, there was a 56% relative risk reduction of severe vasospasm in the rt-PA treated group, which was significant (P = 0.02).(ABSTRACT TRUNCATED AT 250 WORDS)

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. A good recovery, as assessed by the Glasgow Outcome Scale at 3 months, occurred in 70.2% of patients with normal glucose levels (< or = 120 mg/dl) and in 53.7% of patients with hyperglycemia (> 120 mg/dl) (p = 0.002). The death rates for these two groups were 6.7% and 19.9%, respectively (p = 0.001). The association was still maintained after adjusting for age (> or < or = 50 years) and thickness of clot on CT scans (thin or thick) in the subset of patients who were alert/drowsy at admission. Increased mean glucose levels between Days 3 and 7 also predicted a worse outcome; good recovery was observed in 132 (73.7%) of 179 patients who had normal mean glucose levels (< or = 120 mg/dl) and 160 (49.7%) of 322 who had elevated mean glucose levels (> 120 mg/dl) (p < 0.0001). Death occurred in 6.7% and 20.8% of the two groups, respectively (p < 0.0001). It is concluded that admission plasma glucose levels can serve as an objective prognostic indicator after SAH. Elevated glucose levels during the 1st week after SAH also predict a poor outcome. However, a causal link between hyperglycemia and outcome after delayed cerebral ischemia, although suggested by experimental data, cannot be established on the basis of this study.

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. The data indicate that a significant proportion of patients improve continuously during the first 6 months after injury; outcome tends to stabilize thereafter, which suggests that the response at this time may be the appropriate end point for clinical trials in severe head injury. Dichotomized outcomes are predictable with approximately 94% accuracy at 6 months postinjury; therefore, missing outcomes may safely be replaced by the corresponding predicted outcomes. The findings also indicate striking improvement over time in patients who are in a vegetative state at discharge, suggesting that decisions regarding withdrawal of supportive care should be postponed until 6 months after injury in these patients.

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.

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.

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.

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.

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.